Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial. [Benefit of misoprostol for prevention of postpartum hemorrhage in cesarean section: a randomized controlled trial]. Oral misoprostol vs. intravenous oxytocin in reducing blood loss after emergency cesarean delivery. A double-blind placebo controlled randomised trial of misoprostol and oxytocin in the management of the third stage of labour. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. A prospective, double-blind, randomized comparison of prophylactic intramyometrial 15-methyl prostaglandin F2 alpha, 125 micrograms, and intravenous oxytocin, 20 units, for the control of blood loss at elective cesarean section. Misoprostol compared with methylergometrine for the prevention of postpartum haemorrhage: a double-blind randomised trial. A double-blind, randomized, placebo-controlled trial of misoprostol and routine uterotonics for the prevention of postpartum hemorrhage. Oral misoprostol for the prevention of primary post-partum hemorrhage during third stage of labor. Comparison of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor. A randomized controlled trial of prophylactic sublingual misoprostol versus intramuscular methyl-ergometrine versus intramuscular 15-methyl PGF2alpha in active management of third stage of labor. A study of prophylactic use of 15-methyl prostalglandin F2alpha in the active management of third stage of labour. Oral misoprostol for third stage of labor: a randomized placebo-controlled trial. Is rectal misoprostol really effective in the treatment of third stage of labor? A randomized controlled trial. Oral misoprostol for the third stage of labor: a randomized controlled trial. Misoprostol for prevention of postpartum hemorrhage. Sublingual misoprostol versus oxytocin infusion to reduce blood loss at cesarean section. Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial. Oral misoprostol in the third stage of labor. Sublingual misoprostol versus methylergometrine for active management of the third stage of labor. Administration of 400 μg of misoprostol to augment routine active management of the third stage of labor. [Role of misoprostol in the delivery outcome]. Pharmacokinetics and adverse-effect profile of rectally administered misoprostol in the third stage of labor. A double-blind randomized controlled trial of oral misoprostol and intramuscular syntometrine in the management of the third stage of labor. The misoprostol third stage of labour study: a randomised controlled comparison between orally administered misoprostol and standard management. A randomised controlled trial of misoprostol versus oxytocin in the active management of the third stage of labour. Randomized comparison of rectal misoprostol with Syntometrine for management of third stage of labor. A pilot-randomized comparison of sublingual misoprostol with syntometrine on the blood loss in third stage of labor. Rectal misoprostol in the prevention of postpartum hemorrhage: a placebo-controlled trial. Buccal misoprostol to decrease blood loss after vaginal delivery: a randomized trial. Buccal misoprostol to prevent hemorrhage at cesarean delivery: a randomized study. Administration of misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a randomised placebo-controlled trial. [Intrauterine misoprostol for the prevention of bleeding cesarean]. Carboprost trometamol in the management of the third stage of labor. Preventing the recurrence of atonic postpartum hemorrhage: a double-blind trial. Low-dose sublingual misoprostol versus methylergometrine for active management of the third stage of labor. Misoprostol versus oxytocin for the reduction of postpartum blood loss. Randomized controlled trial of rectal misoprostol versus oxytocin in third stage management. A prospective randomised trial to compare the efficacy and safety of hemabate and syntometrine for the prevention of primary postpartum haemorrhage. Active management of the third stage at caesarean section: a randomised controlled trial of misoprostol versus syntocinon. Rectal misoprostol versus intravenous oxytocin for prevention of postpartum hemorrhage. Rectal misoprostol vs. 15-methyl prostaglandin F2alpha for the prevention of postpartum hemorrhage. A randomized comparison of rectal misoprostol with syntometrine on blood loss in the third stage of labour. Dinoprostone vaginal insert versus intravenous oxytocin to reduce postpartum blood loss following vaginal or cesarean delivery. Randomized double masked trial of Zhi Byed 11, a Tibetan traditional medicine, versus misoprostol to prevent postpartum hemorrhage in Lhasa, Tibet. Oral misoprostol versus injectable methylergometrine in management of the third stage of labor. Rectal misoprostol versus oxytocin in the management of the third stage of labour. Prophylactic intramyometrial carboprost tromethamine does not substantially reduce blood loss relative to intramyometrial oxytocin at routine cesarean section. A randomized comparison of oxytocin, sulprostone and placebo in the management of the third stage of labour. Misoprostol versus oxytocin in the third stage of labor. Rectal misoprostol versus intravenous oxytocin for the prevention of postpartum hemorrhage after vaginal delivery. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. A randomized clinical trial comparing oral misoprostol with synthetic oxytocin or syntometrine in the third stage of labour. Misoprostol dose-related shivering and pyrexia in the third stage of labour. WHO Collaborative Trial of Misoprostol in the Management of the Third Stage of Labour. A randomized controlled study of prostaglandin 15-methyl F2 alpha compared with syntometrine for prophylactic use in the third stage of labour. Side-effects of oral misoprostol in the third stage of labour--a randomised placebo-controlled trial. Evaluation of two uterotonic medications for the management of the third stage of labor. A randomised placebo controlled trial of oral misoprostol in the third stage of labour.
To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation.
                Double blind randomised controlled trial.
                Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs).
                One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA.
                Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery.
                Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum.
                The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb > or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed.
                Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting. To assess the benefit of sublingual misoprostol in addition to standard oxytocin in the prevention of post-partum hemorrhage at caesarean section.
                This was a prospective randomized controlled clinical trial conducted from March to June 2007 at our department of obstetrics-Sousse-Tunisia, including 250 single low risk pregnant women undergoing caesarean section at gestational age>32 weeks gestation. Patients were randomly assigned to receive at cord clamping either sublingual 200microg misoprostol (Cytotec) with 20UI intravenous oxytocin (Oxytocin): bolus 10UI and infusion 10UI in 500ml Ringer Lactate): Group I, or only oxytocin at the same dose: Group II. The main outcome was total blood loss assessed by decrease in perioperative hematocrit. Secondary outcomes included measured collected blood loss, drop in hemoglobin level, additional oxytocin, side-effects and postoperative complications.
                The two groups were similar in demographic and obstetrical patient characteristics. Drop in hematocrit was more important in group II than in group I: 4.30%+/-3.14 versus. 1.10%+/-3.25; P=0.013. Drop in hemoglobin level was also more important in group II than in group I: 1.03g/dl+/-1.19 versus 0.54g/dl+/-1.17; P<0.01. Collected blood loss was less important in group I than in group II: 669.68cc+/-333.01 versus 852.52cc+/-295.08 ; P<0.01. Need for additional oxytocin and postoperative complications rate were more frequent in group II than in group I but the differences weren't significant. The rate of transient shivering, nausea and fever was significantly higher among women receiving misoprostol.
                Sublingual misoprostol (in addition to oxytocin) is effective in prevention of post-partum hemorrhage at caesarean sections when compared to oxytocin alone, without major side-effects. Larger studies are needed to confirm our results. To compare the effectiveness of oral misoprostol and intravenous oxytocin in reducing blood loss in women undergoing indicated or elective cesarean delivery (CD) under spinal anesthesia.
                In this prospective, double-blind pilot study, 56 parturients who received 5 IU of intravenous oxytocin after cord clamping were randomized to further receive either misoprostol orally and a placebo infusion intravenously or placebo orally and an oxytocin infusion intravenously.
                After adjustment was made for the sonographically estimated amniotic fluid volume, there was no statistical difference in blood loss between the 2 groups (mean+/-S.D., 1083+/-920 mL in the oxytocin group vs. 970+/-560 mL in the misoprostol group; P=.59).
                Oxytocin followed by oral misoprostol is as effective as an oxytocin injection followed by an oxytocin infusion in reducing postoperative blood loss after CD, and the protocol may be a safe, valuable, and cost-effective alternative to oxytocin alone. Visual estimation of intraoperative blood loss undervalues the effective value of misoprostol use by 30%. To compare oral misoprostol 400 microg with intramuscular oxytocin 10 IU in the routine management of the third stage.
                Double-blind placebo controlled trial.
                Main referral hospital and its associated polyclinics in Accra, Ghana.
                Four hundred and one low risk women, in the second stage of labour with anticipated vaginal delivery, who entered labour spontaneously.
                After delivery of the anterior shoulder of the baby, the women were randomised to receive either: 1. misoprostol 400 microg powder in water orally and 1 mL normal saline intramuscular injection (placebo); or 2. powdered cellulose in water orally (placebo) and 1 mL oxytocin 10 IU intramuscular injection.
                Change in haemoglobin concentration from before delivery to 12 hours postpartum. Secondary outcomes included need for additional oxytocics, blood loss > 500 mL and > 1,000 mL, operative intervention for postpartum haemorrhage, and side effects, including nausea, vomiting, diarrhoea, shivering and elevated temperature.
                Demographic characteristics were similar. There was no significant difference in change in haemoglobin concentration between the two groups (0.60 g/dL for misoprostol and 0.55 g/dL for oxytocin; relative difference 9.6%; 95% CI 20.5-39.6%; P = 0.54). There were no significant differences in secondary outcomes with the exception of shivering, which occurred more frequently in the misoprostol group (22.2% vs 5.7%; relative risk 4.73; 95% CI 2.31-9.68; P < 0.0001).
                In low risk women oral misoprostol appears to be as effective in minimising blood loss in the third stage of labour as intramuscular oxytocin. Shivering was noted more frequently with misoprostol use, but no other side effects were noted. Misoprostol has great potential for use in the third stage of labour especially in developing countries. In this study, 100 singleton pregnant women underwent a caesarean delivery under general anaesthesia and were studied in terms of postpartum bleeding using oxytocin or misoprostol. Patients were randomly divided into two equal groups. One group received two tabs of misoprostol 200 microg sublingually and the second group took intravenous infusion of 20 units of oxytocin at the rate of 10 cc/min immediately after delivery until full contraction of the uterine. The amount of blood loss was lower in misoprostol group comparing with oxytocin group (608.91 ml vs 673.9 ml) (p = 0.048) and this difference was statistically significant. The need to give additional oxytocin therapy in oxytocin group (36%) was significantly higher than misoprostol group (14%) (p = 0.032). It seems that the efficacy of sublingual misoprostol is equivalent to that of low dose intravenous oxytocin in reducing postpartum haemorrhage at caesarean section. Misoprostol has some other advantages like long shelf -life, stability at room temperature and oral use. Our purpose was to compare intramyometrial 15-methyl prostaglandin F2 alpha with intravenous oxytocin for controlling blood loss at elective cesarean section.
                A double-blind, randomized trial was performed with intramyometrial 15-methyl prostaglandin F2 alpha, 125 micrograms, or intravenous oxytocin, 20 U, in 60 women undergoing elective lower segment cesarean section at 36 to 41 weeks' gestation. Subjective assessment of the operative blood loss and early lochial discharge and objective change in hemoglobin and hematocrit before and 24 hours after delivery and the incidence of side effects were compared by nonparametric statistical tests.
                The mean estimated blood loss was similar in both groups, with 645 ml (SD 278, range 400 to 1500) in the 15-methyl prostaglandin F2 alpha group compared with 605 ml (SD 303, range 200 to 1750) in the oxytocin group. The mean fall in hemoglobin and hematocrit was greater in the 15-methyl prostaglandin F2 alpha group than in the oxytocin group, 0.98 gm/dl (SD 0.95) versus 0.65 gm/dl (SD 0.79) for hemoglobin and 2.58% (SD 2.96) versus 2% (SD 2.96) for hematocrit. None of these differences reached statistical significance. There were no differences in side effects and lochial discharge between the treatment groups. In both groups there was a decrease of approximately 1% in maternal arterial oxygen saturation.
                Routine intramyometrial 15-methyl prostaglandin F2 alpha, 125 micrograms, does not offer any obvious advantage over intravenous oxytocin, 20 U, in reducing operative blood loss at elective lower-segment cesarean section. To compare the efficacy and side effects of misoprostol, compared with methylergometrine, for the prevention of postpartum haemorrhage.
                A double-blind, randomised clinical trial of 200 women with apparently normal pregnancies.
                University teaching hospital.
                Two hundred women with apparently normal pregnancies.
                After the baby had been born, all women received two capsules by mouth and the contents of an ampule by intravenous injection. Each woman only received one active product. The capsules contained either a total of 600 microg misoprostol or placebo, and the ampule 200 microg of methylergometrine or placebo.
                Need for further oxytocic drugs, blood pressure, the presence of side effects, mean haemoglobin and haematocrit three days after delivery.
                Two hundred women completed the study (100 received methylergometrine and 100 misoprostol). Postpartum haemorrhage occurred in 4.3% of the methylergometrine group and 8.3% of the misoprostol group (P = 0.57). The need for further oxytocic drugs was 4.4% and 12.8% after methylergometrine and misoprostol, respectively (P = 0.065). One hour after the birth of the baby there was no difference in the mean systolic blood pressure (117 +/- 12 mmHg versus 115 +/- 11 mmHg) (P = 0.26) or the mean diastolic blood pressure (72 +/- 10 mmHg versus 71 +/- 11 mmHg for the groups receiving methylergometrine or misoprostol, respectively) (P = 0.97). The mean temperature in the misoprostol group rose to 37.4 degrees C, compared with 37 degrees C in the methylergometrine group (P < 0.0001). In the misoprostol group 34% developed fever (> 38 degrees C) compared with 3% in the methylergometrine group (P < 0.0001). Shivering (visual analogue score > or = 8) also occurred more often after misoprostol (42%) than after methylergometrine (8.5%) (P < 0.0001). The haemoglobin level (g/dL) on the third postpartum day was similar for both groups ( 11.0 and 11.2 for methylergometrine and misoprostol, respectively) (P = 0.39).
                This study suggests that although protection from postpartum haemorrhage using parenteral methylergometrine and oral misoprostol is nearly equal, misoprostol is associated with more side effects. To assess the effects of 400-μg sublingual misoprostol plus routine uterotonics on postpartum hemorrhage.
                A double-blind, placebo-controlled, randomized study was performed. After delivery of the child, eligible women received routine uterotonics and were randomly allocated to receive 400-μg misoprostol or placebo sublingually. The primary outcome measure was blood loss of at least 500 mL within 1 hour of taking the trial tablets.
                In total, 672 women received misoprostol and 673 received placebo. The baseline data were similar for both groups. Misoprostol plus routine uterotonics reduced postpartum blood loss, but the effect was not significant for blood loss of at least 500 mL (relative risk [RR] 0.96; 95% confidence interval [CI], 0.63-1.45) or blood loss of at least 1000 mL (RR 0.50; 95% CI, 0.15-1.66). Misoprostol also reduced the need for non-routine oxytocin, manual removal of the placenta, and hysterectomy, but these differences were not significant either. Misoprostol was associated with pyrexia and moderate/severe shivering. There was no death in either group.
                Misoprostol plus routine uterotonics resulted in modest reductions of blood loss in the third stage of labor, but the effects did not reach statistical significance. Larger studies are recommended.
                Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. To assess the effectiveness of oral misoprostol compared with methylergometrine in the prevention of primary post-partum hemorrhage during the third stage of labor.
                This was a randomized controlled trial of 864 singleton low-risk pregnant women. The outcomes were total blood loss, duration of the third stage of labor and peripartal change in hematocrit. Comparisons were by the chi2-test and Student t-test. Relative risks were calculated for side-effects profile. A P-value of less than 0.05 was statistically significant.
                The biodata of all the participants were similar. The mean blood loss for the misoprostol and methylergometrine groups was 191.6 +/- 134.5 mL and 246.0 +/- 175.5 mL, respectively (95% CI: -79.3 to -39.5 mL). The mean duration of the third stage of labor was 19.6 +/- 2.4 min and 9.4 +/- 3.3 min in the misoprostol and methylergometrine groups, respectively (95% CI: 9.82-10.58 min). More subjects had blood loss >500 mL, 42 (9.7%) versus 6 (1.4%), and peripartal hematocrit change greater than 10%, 38 (8.8%) versus 5 (1.2%), in the methylergometrine group than in the misoprostol group, respectively. Also, more subjects received additional oxytocic in the methylergometrine group, compared to the misoprostol group (80 [18.5%] versus 33 [7.6%] patients, respectively).
                Orally administered misoprostol was more effective in reducing blood loss during the third stage of labor than intramuscular methylergometrine. However, there were more subjects in the misoprostol group in whom duration of the third stage of labor was greater than 15 min and who also had manual placental removal than in the methylergometrine group. To compare the efficacy and adverse effects of sublingual misoprostol, intravenous oxytocin, and intravenous methylergometrine in active management of the third stage of labor (AMTSL).
                A double-blind randomized trial of 300 women with a healthy singleton pregnancy allocated into 4 groups to receive either: 400 microg or 600 microg of sublingual misoprostol, 5 IU of intravenous oxytocin, or 200 microg of intravenous methylergometrine. The primary outcome measure was blood loss in the third and fourth stage of labor; secondary measures were duration of the third stage of labor, changes in hemoglobin levels, and adverse effects.
                Patients who received 600 microg of misoprostol had the lowest blood loss (96.05+/-21.1 mL), followed by 400 microg of misoprostol (126.24+/-49.3 mL), oxytocin (154.7+/-45.7 mL), and methylergometrine (223.4+/-73.7 mL) (P<0.01). Shortest mean duration of the third stage of labor (5.74 minutes) was with 600 microg of misoprostol, while methylergometrine had the longest (6.83 minutes) (P<0.05). Pyrexia was observed in the misoprostol groups, and raised blood pressure in the methylergometrine group (P<0.001). The 24-hour postpartum hemoglobin level was similar among the groups (P>0.05).
                Administration of 600 microg of sublingual misoprostol was more effective than 400 microg of misoprostol, intravenous oxytocin, and intravenous methylergometrine for AMTSL. To compare the efficacy and side effects of 0.2 mg methyl-ergometrine IM, 400 microg misoprostol sublingual and 125 microg 15 methyl PGF2alpha IM in active management of third stage of labor.
                Two hundred low risk pregnant women with induced or spontaneous labor were randomized to receive either 400 microg misoprostol sublingually or 0.2 mg methyl-ergometrine intramuscularly or 125 microg 15-methyl PGF2alpha intramuscularly, after the delivery of anterior shoulder of baby. The main outcome measures were: blood loss more than 500 ml, need for additional oxytoxic drug, change in hemoglobin level and side effects due to drugs.
                The median estimated blood loss, blood loss more than 500 ml, need for additional oxytocic drug and change in hemoglobin levels were similar in all three groups. The significant side effects in the misoprostol group were shivering, pyrexia (temperature > 38 degrees C) and vomiting, which were self-limiting. Diarrhea was significantly more in the 15 methyl PGF2alpha group. Three women in methyl-ergometrine group underwent manual removal of placenta. One woman in misoprostol group received blood transfusion.
                Sublingual misoprostol appears to be as effective as intramuscular methyl-ergometrine and intramuscular 15-methyl PGF2alpha in the prevention of postpartum hemorrhage. It can be a good alternative in resource poor setting. To compare active management of third stage of labour with 15-methyl prostaglandin F2alpha (PGF2alpha) and conventional management with methylergometrine as prophylaxis for postpartum hemorrhage, a randomised comparative study was carried out at Calcutta National Medical College and Hospital, Kolkata on 100 women. They were randomly allotted to one of the two groups. Group A included 50 women who received 15-methyl PGF2alpha (125 microg) intramusculary at the time of delivery of the anterior shoulder and group B included 50 women who underwent conventional management of the third stage of labour where methylergometrine 0.2 mg was given after delivery of placenta. Main outcome measured were duration of third stage, amount of bleeding and side-effects. The present study showed that there were significent reduction of the duration of third stage as well as reduction of amount of bleeding particularly when 125 microg of 15-methyl PGF2alpha was given intramuscularly at the time of delivery of the anterior shoulder in comparison to coventional method of management of third stage of labour with methylergometrine. Placental expulsion occurred within 4 minutes in group A and 16.5 minutes in group B. The amount of bleeding following delivery was 95.6 ml in average in group A and 249.6 ml in average in group B. 15-methyl PGF2alpha (125 microg) is certainly effective in prevention of postpartum haemorrhage particularly in developing country like India where this complication contributes a major factor for maternal mortality. To investigate whether orally administered misoprostol during the third stage of labor is efficient in reducing postpartum blood loss.
                In a double-masked trial, during vaginal delivery women were randomly assigned to receive a single oral dose of misoprostol (600 microg) or placebo in third stage of labor, immediately after cord clamping. The third stage of labor was managed routinely by early cord clamping and controlled cord traction; oxytocin was administered only if blood loss seemed more than usual. Blood loss was estimated by the delivering physician and differences in hematocrit were measured before and after delivery.
                Mean (+/- standard error of the mean) estimated blood loss (345 +/- 19.5 mL versus 417 +/- 25.9 mL, P = .031) and hematocrit difference (4.5 +/- 0.9% versus 7.9 +/- 1.2%, P = .014) were significantly lower in women who received misoprostol than those who received placebo. Fewer women in the misoprostol group had postpartum hemorrhage (blood loss of at least 500 mL), but that difference was not statistically significant (7% versus 15%, P = .43). Additional oxytocin before or after placental separation was used less often in the misoprostol group (16% versus 38%, P = .047). There were no differences in the length of third stage of labor (8 +/- 0.9 minutes versus 9 +/- 1 minutes, P = .947). There were no differences in pain during third stage of labor, postpartum fever, or diarrhea, but shivering was more frequent in the misoprostol group.
                Oral misoprostol administered in the third stage of labor reduced postpartum blood loss and might be effective in reducing incidence of postpartum hemorrhage. The purpose of this study was to compare misoprostol 600 microg intrarectally with conventional oxytocics in the treatment of third stage of labor.
                In a controlled trial, 1606 women were randomly grouped to receive (1) oxytocin 10 IU plus rectal misoprostol, (2) rectal misoprostol, (3) oxytocin 10 IU, and (4) oxytocin 10 IU plus methylergometrine. The main outcome measures were the incidence of postpartum hemorrhage and a drop in hemoglobin concentration from before delivery to 24 hours after delivery.
                The incidence of postpartum hemorrhage was 9.8% in the group that received only rectal misoprostol therapy compared with 3.5% in the group that received oxytocin and methylergometrine therapy (P =.001). There were no significant differences among the 4 groups with regard to a drop in hemoglobin concentrations. Significantly more women needed additional oxytocin in the group that received only rectal misoprostol therapy, when compared with the group that received oxytocin and methylergometrine therapy (8.3% vs 2.2%; P <.001). The primary outcome measures were similar in the group that received only rectal misoprostol therapy and the group that received only oxytocin therapy.
                Rectal misoprostol is significantly less effective than oxytocin plus methylergometrine for the prevention of postpartum hemorrhage. To compare oral misoprostol with conventional oxytocics in the management of the third stage of labor. In a controlled trial, 1574 women were randomized into four groups, as follows: Group 1 received intravenous infusion of oxytocin 10 IU plus oral misoprostol 400 micro g, followed by two doses of oral misoprostol 100 micro g 4 hours apart; group 2 received oral misoprostol 400 micro g, followed by two doses of oral misoprostol 100 micro g 4 hours apart; group 3 received intravenous infusion of oxytocin 10 IU; and group 4 received intravenous infusion of oxytocin 10 IU plus intramuscular administration of methylergonovine maleate (Methergine) 0.2 mg. The incidence of postpartum hemorrhage and decrease in hemoglobin concentration from before delivery to 24 hours postpartum were the main outcome measures.
                The primary outcome measures were similar in groups 2 and 3. The incidence of postpartum hemorrhage was 9% in group 2, compared with 3.2% in group 1 and 3.5% in group 4 (P <.01, and P =.01, respectively). There were no significant differences among the four groups regarding hemoglobin concentrations. Significantly more women needed additional oxytocin in group 2, when compared with group 4 (5.9% versus 2.2%; P =.01). The proportion of women requiring additional methylergonovine maleate was 4.8% in group 2, compared with 0.7% in group 1 and 1% in group 4 (P <.01 and P =.01, respectively).
                Oral misoprostol alone is as effective as oxytocin alone for the prevention of postpartum hemorrhage; it is less effective than oxytocin plus methylergonovine maleate and oral misoprostol plus oxytocin. To compare the effectiveness of 400 microg rectal misoprostol in 5 cm(3) of saline with oxytocin 10 IU, i.m., in reducing bleeding during the third stage of labor.
                A double blind, randomized, clinical trial including 663 women with uncomplicated vaginal delivery who received misoprostol (n=324) or oxytocin (n=339).
                Changes in hemoglobin and hematocrit from before to 72 h postpartum; blood loss during the third stage; duration of the third stage of labor; need for additional oxytocic drug; frequency of requisition and of administration of blood; changes in blood pressure; and occurrence of side effects.
                No significant differences were observed between groups, before and 72 h postpartum, in mean hemoglobin and hematocrit, on volume of blood loss and duration of third stage of labor. The incidence of shivering and mean temperature (P<0.01) was significantly greater among women receiving misoprostol than oxytocin.
                Misoprostol administered as a micro-enema, 400 microg in 5 ml of saline during the third stage of labor, appears to be as effective as oxytocin 10 IU, i.m., but misoprostol produced more side effects than oxytocin. To compare the effectiveness of sublingual misoprostol administered immediately after delivery of the neonate at cesarean section, with intravenous oxytocin infusion in prevention of uterine atony and thereby reducing blood loss at cesarean section.
                One hundred women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. They were randomly allocated to receive either misoprostol 400 mug sublingually or intravenous infusion of 20 units of oxytocin soon after delivery of the neonate. The main outcome measures were blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related side effects.
                The mean blood loss estimated was significantly lower in misoprostol group compared to oxytocin group (819 ml versus 974 ml; p = 0.004). The number of women who had blood loss exceeding 500 ml and the change in hemoglobin, however, was comparable between the two groups. There was a need for additional oxytocic therapy in 16% and 18% after use of misoprostol and oxytocin respectively (p = 0.673). The incidence of side effects such as pyrexia, shivering and metallic taste was significantly higher in misoprostol group compared to oxytocin group.
                Sublingual misoprostol appears to be as effective as intravenous infusion of oxytocin in reducing blood loss at cesarean section. However, occurrence of transient side effects such as shivering and pyrexia were noted more frequently with the use of misoprostol. To evaluate whether routine administration of sublingual misoprostol 600 microg after delivery reduces postpartum haemorrhage.
                Randomised double blind placebo controlled trial.
                Primary health centre in Bissau, Guinea-Bissau, West Africa.
                661 women undergoing vaginal delivery.
                Misoprostol 600 mug or placebo administered sublingually immediately after delivery.
                Postpartum haemorrhage, defined as a loss of > or = 500 ml and decrease in haemoglobin concentration after delivery.
                The incidence of postpartum haemorrhage was not significantly different between the two groups, the relative risk being 0.89 (95% confidence interval 0.76 to 1.04) in the misoprostol group compared with the placebo group. Mean blood loss was 10.5% (-0.5% to 20.4%) lower in the misoprostol group than in the control group. Severe postpartum haemorrhage of > or = 1000 ml or > or = 1500 ml occurred in 17% (56) and 8% (25) in the placebo group and 11% (37) and 2% (7) in the misoprostol group. Significantly fewer women in the misoprostol group experienced a loss of > or = 1000 ml (0.66, 0.45 to 0.98) or > or = 1500 ml (0.28, 0.12 to 0.64). The decrease in haemoglobin concentration tended to be less in the misoprostol group, the mean difference between the two groups being 0.16 mmol/l (-0.01 mmol/l to 0.32 mmol/l).
                Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage. To compare the efficacy of intravenous ergometrine, intramuscular oxytocin, and oral misoprostol in the control of postpartum hemorrhage.
                Mean blood loss, rates of blood loss between 500 and 1000 ml, hematocrit fall greater than 10%, and need for additional oxytocic agents and nature and rates of adverse effects were assessed in this prospective, randomized, controlled study.
                All outcomes were similar in the 3 groups. The main adverse effects in the misoprostol group were temperatures higher than 99 degrees F, which normalized within 2 h and shivering, which was mild and self-limiting.
                Oral misoprostol is as effective as conventional oxytocic agents in preventing postpartum hemorrhage and can be recommended for use in low-resource settings. To compare the efficacy and side effects of sublingual misoprostol and intravenous methylergometrine for active management of third stage of labor.
                One hundred twenty low risk pregnant women at term with spontaneous onset of labor were included in the study. The women were randomized to receive either two tablets of misoprostol (200 microg/tablet) sublingually or 1 ml of methylergometrine (200 microg) intravenous injection, after the delivery of the anterior shoulder of the baby. The main outcome measures were: need for additional oxytocic drugs, blood loss >or=500 ml, change in hemoglobin levels and side effects.
                Postpartum hemorrhage as defined by hemorrhage >or=500 ml occurred in 3.1% of the women in the sublingual misoprostol group but none of the women in the methylergometrine group (P > 0.05). There was a need for additional oxytocic drugs in 5.0% and 8.3% after methylergometrine and misoprostol, respectively (P > 0.05). The change in hemoglobin levels at 24 h postpartum were 0.8 and 0.7 gm% in methylergometrine and misoprostol group, respectively(P > 0.05). In the misoprostol group, 6.6% women developed fever >or=38 degrees C and 21.6% had shivering while in methylergometrine group none experienced these side effects. However, the incidence of other side effects like nausea, vomiting, headache and giddiness were similar in both groups.
                Sublingual misoprostol appears to be as effective as intravenous methylergometrine in the prevention of postpartum hemorrhage. However, larger randomized studies are needed to advocate its routine use. To assess the effectiveness and safety of the administration of misoprostol, an orally active prostaglandin, in addition to routine uterotonic therapy as part of the active management of the third stage of labor.
                The present study was a hospital-based, decentralized, multi-center, randomized, placebo-controlled, double-blind trial. We enrolled 1103 women (out of a target sample size of 1180) at 4 hospitals in South Africa, Uganda, and Nigeria. Participants received a sublingual dose of 400 μg of misoprostol or a placebo, in addition to standard active management of the third stage of labor, after vaginal birth.
                The baseline characteristics of the participants were comparable. The difference in the primary outcome of blood loss of 500 mL or more within 1 hour of randomization was not significant between the 2 groups (misoprostol 22/546 [4.0%] versus placebo 35/553 [6.3%]; relative risk, 0.64; 95% confidence interval, 0.38-1.07). Shivering and pyrexia occurred more frequently in the misoprostol group. No maternal deaths occurred.
                The present study did not confirm a beneficial effect of administering 400 μg of misoprostol, in addition to routine uterotonic therapy, during the third stage of labor, but was consistent with other trials showing a cumulative modest benefit. Where routine uterotonics are available for prophylactic use, any potential benefit of misoprostol might not outweigh the likelihood of adverse effects.
                Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. Delivery-induced hemorrhage is defined as a blood loss greater than 500 ml within the first 24 hours after delivery. Loss of more than 1000 ml is a sign of gravity. For certain authors, 40% of these hemorrhages could be avoided with systematic preventive measures using uterotonic agents to control the third phase of labor. The aim of our work was to assess the preventive efficacy of active management measures during the third phase of labor and to determine which agents are most effective.
                We compared two protocols for controlled deliver: a conventional method using ocytocin (2.5 IU i.v. bolus), and a more recent method using a prostaglandin E1 analog: misoprostol (Cytotec, 3 tablets per os). We compared the two methods with a control group where no preventive measures were used, the standard procedure in our maternity unit.
                Six hundred two women participated in the study. They were divided into 3 homogeneous groups (ocytocin group misoprostol group, control group). There was a 46% reduction in delivery-induced hemorrhage in the ocytocin group but only a minimal preventive effect against severe hemorrhage. Misoprostol did not demonstrate any efficacy in our study.
                It would appear appropriate to take preventive measures against delivery-induced hemorrhage for all deliveries. A bolus intravenous injection of ocytocin immediately after delivery should bed used. The dose should be greater than that used in this study in order to prevent the development of severe hemorrhage. The most satisfactory results can be obtained with 5 IU (1 ampoule of Syntocinon). It is important to obtain a precise quantification of excessive blood loss in order to institute appropriate care rapidly. Misoprostol should be assessed with other prospective studies because of its easy administration, its low cost and easy storage, important advantages in countries with limited resources. To characterize the pharmacokinetics and adverse-effect profile of rectally administered misoprostol.
                To assess absorption of rectally administered misoprostol, 20 women were randomized to receive misoprostol 600 microg by either oral or rectal administration after delivery. Blood samples were obtained at 0, 7.5, 15, 30, 45, 60, 90, 120, and 240 minutes and analyzed for serum concentrations of misoprostol free acid by enzyme-linked immunosorbent assay. Additionally, 275 women were randomized to receive rectal 400 microg, rectal 600 microg, or oral 600 microg misoprostol after delivery. Self-assessment questionnaires were used to ascertain the adverse-effect profiles.
                Misoprostol tablets are absorbed rectally even though they are formulated for oral use. The area under the curve (integral of concentration and time graph) for rectal misoprostol was higher by 121 pg.h/mL (95% confidence interval [CI] -4.2, 246.2) than for oral misoprostol. The rectal route group had a mean maximum serum concentration 144 pg/mL lower than that for the oral route (95% CI 63, 225). This maximum was achieved on average 23 minutes later than in the oral group (95% CI 10, 35). Shivering was reported by 76% of the patients in the oral 600-microg arm, 56% of the patients in the rectal 400-microg arm, and 54% of the patients in the rectal 600-microg arm. The relative risk of shivering in the combined rectal groups is 73% that of the oral group (95% CI 61%, 86%). Severe shivering reported by patients was significantly reduced, by 72%, in rectal groups compared with the oral group (95% CI 60%, 81%).
                Misoprostol administered rectally is associated with lower peak levels and a reduction in adverse effects compared with the oral route. Increasing rectal doses may achieve higher efficacy without reducing the acceptability of the treatment. The aim of this study was to compare the efficacy and safety of oral misoprostol 400 mug with intramuscular syntometrine in the management of the third stage of labor.
                This was a double-blind randomized controlled trial conducted in a tertiary care hospital. Three hundred and fifty-five women randomized to receive either oral misoprostol 400 mug or intramuscular syntometrine in the third stage of labor were studied. The change in hemoglobin level from before to 48 h after delivery, use of additional oxytocics and treatment related side effects were the main outcome measures.
                There were no significant differences between the two groups in terms of the change in hemoglobin level and mean blood loss. The incidence of shivering was significantly higher in the misoprostol group whilst that of vomiting was significantly higher in the syntometrine group. There were no differences in the incidence of nausea, headache, diarrhea and pyrexia between the two groups.
                Orally administered misoprostol at a dose of 400 mug is an acceptable alternative in preventing post-partum blood loss, as measured by the peri-partum change in hemoglobin level and was not associated with an increased incidence of side effects. To compare misoprostol with standard oxytocic regimens in the prevention of postpartum haemorrhage.
                Randomised controlled trial.
                Obstetric unit in a large teaching hospital.
                One thousand women randomised to 500 microg misoprostol given orally or to standard oxytocic regimens of oxytocin, oxytocin with ergometrine, or ergometrine.
                Incidence of postpartum haemorrhage and the incidence and severity of side effects.
                Postpartum haemorrhage occurred in 12% of women given misoprostol and in 11% of women given standard oxytocic drugs (relative risk (RR) 1.10, 95% confidence interval (CI) 0.79, 1.55). Blood loss of 1000 mL or more occurred in 2% of women in each group. Nausea, headache, dizziness and tiredness were less frequent with misoprostol (RR (95% CI) 0.71 (0.59, 0.84); 0.53 (0.38, 0.74); 0.73 (0.61, 0.87) and 0.88 (0.83, 0.94) respectively). The main side effects of misoprostol were shivering (RR 1.95, 95% CI 1.69, 2.25) and a rise in temperature (difference in mean rise 0.34 degrees C, 95% CI 0.26, 0.42).
                Oral misoprostol for the prevention of postpartum haemorrhage was comparable to standard oxytocics. Many side effects were less common with misoprostol but shivering and pyrexia were more common. Larger randomised trials are needed before establishing the equivalence between misoprostol and standard oxytocic drugs in the prevention of postpartum haemorrhage. Our objective was to compare oral misoprostol with intramuscular oxytocin in the prevention of postpartum haemorrhage. Four hundred and ninety-six women were randomised to receive either 600 microg misoprostol orally or 10 IU oxytocin intramuscularly after delivery. There were no significant differences between the misoprostol and oxytocin groups with regard to the incidence of postpartum haemorrhage (1% vs. 0% respectively, relative risk (RR) 3.02, 95% confidence interval (CI) 0.32-28.88) or drop in haemoglobin concentration (0.71 g/dl vs. 0.68 g/dl, respectively, P = 0.699). The length of the third stage of labour and the percentage of women requiring manual removal of placenta, further oxytocics or blood transfusion were also similar. Shivering was significantly higher with misoprostol (57% vs. 14%; RR 4.06, CI 2.93-5.62), but there were no differences in other side effects. We conclude that oral misoprostol can replace intramuscular oxytocin in reducing postpartum haemorrhage in low-risk women, in developing countries, especially as it is administered orally and it is thermostable in tropical conditions. The search for an effective, easily stored, affordable uterotonic agent in preventing postpartum hemorrhage is of importance, especially in the developing world. The objective of this study was to randomly compare the effectiveness of rectal misoprostol with Syntometrine in the management of the third stage of labor.
                Four hundred and ninety-one low risk women in labor were randomly allocated to receive either misoprostol 400 microgram rectally or Syntometrine 1 ampuole intramuscularly, and postpartum blood loss was estimated as the principal end point. Comparisons were by the chi-square test or Fisher's test and relative risks with 95% confidence intervals for categorical data, and the Mann-Whitney test for ranked continuous variables.
                The baseline characteristics in terms of hemoglobin estimation in antenatal clinic, mean age, parity, and duration of labor in the 250 patients who received Syntometrine and 241 patients who received misoprostol were similar. However, there was a significant difference in the pre-delivery blood pressure of the two groups because of the non-protocol exclusion of women with elevated blood pressure allocated to receive Syntometrine. Duration of third stage of labor, blood loss postpartum and hemoglobin estimation post partum were all similar. Postpartum diastolic hypertension was more common in the Syntometrine group (p= 0.002). No other apparent side effect was noted in either group.
                Misoprostol rectally for management of the third stage of labor merits further investigation. To compare sublingual misoprostol with intravenous syntometrine use during third stage of labor by measuring the blood loss.
                Sixty women were randomized to receive either 600 micro g misoprostol sublingually or 1 ml syntometrine intravenously during the third stage of labor after spontaneous vaginal delivery. For those with risk factors of postpartum hemorrhage such as medical induction or augmentation of labor, previous third stage complications were excluded. The blood loss in labor was measured by the alkaline-hematin method, and differences in hemoglobin before and after delivery were compared.
                There was no significant difference in the median measured blood loss between the misoprostol group and the syntometrine group (280 versus 226 ml, p = 0.45). The change in hemoglobin was comparable between the two groups. There were more women in the misoprostol group who required additional oxytocics, but the difference was not statistically significant. A major complication occurred in one patient in the misoprostol group with blood loss in excess of 1000 ml. The incidence of side effects such as shivering and pyrexia in women receiving misoprostol was significantly higher than that in the syntometrine group.
                The use of sublingual misoprostol or intravenous syntometrine in spontaneous vaginal delivery resulted in a comparable amount of blood loss. Transient side effect such as fever and shivering which resolved within a day occurred more frequent to those who received sublingual misoprostol. This study investigated the effectiveness of rectal misoprostol in preventing postpartum hemorrhage.
                In a randomized, placebo-controlled study, 550 women were randomly allocated to rectally receive 400 microg misoprostol or nonidentical placebo after normal vaginal delivery. Any excessive bleeding was actively managed with conventional oxytocic agents. Blood loss was measured directly.
                The baseline variables were similar. Blood loss of > or = 1000 mL occurred in 4.8% (13/270) of the misoprostol group and 7% (19/272) of the placebo group. Additional oxytocic therapy was required by 3.3% and 4.7%, respectively. No predominance of side effects, particularly shivering, was noted in the misoprostol group.
                Postpartum use of 400 microg rectal misoprostol was well tolerated and associated with a statistically nonsignificant trend toward less postpartum hemorrhage. The early active management of excessive bleeding with conventional oxytocic agents may have reduced the potential of the study to detect differences between the groups. To assess the efficacy of buccal misoprostol to decrease bleeding after vaginal delivery.
                This was a randomized study of patients between 22 weeks and 42 weeks of gestation with anticipated vaginal delivery. Patients were given either a 200-mug misoprostol tablet or placebo in the buccal space at the time of cord clamping. A continuous dilute intravenous oxytocin infusion was given to all patients at delivery of the placenta. Postpartum hemorrhage was defined as blood loss exceeding 500 mL. Sample size calculations based on previous studies assumed a 13% incidence of postpartum hemorrhage in the control group. To show a statistically significant reduction of postpartum hemorrhage a total of 1,604 patients would be required in each group.
                A total of 848 patients were enrolled and 756 randomly assigned, 377 in the misoprostol group and 379 in the placebo group. Demographic, antepartum, and intrapartum characteristics were similar between the groups. The incidence of postpartum hemorrhage, 3% compared with 5%, (relative risk 0.65, 95% confidence interval 0.33-1.29, P = .22), mean estimated blood loss, 322 compared with 329 mL, (P = .45), and mean minutes of the third stage of labor, 6.7 compared with 6.9 (P = .52) were similar between the groups, misoprostol and placebo, respectively. Hemoglobin difference before and after delivery, need for second or third uterotonic agent, and all measured neonatal variables including birth weights, and umbilical cord pH were similar between the groups.
                Buccal misoprostol at cord clamping is no more effective than placebo in reducing postpartum hemorrhage. The purpose of this study was to assess the efficacy of buccal misoprostol to decrease uterine atony, hemorrhage, and the need for additional uterotonic agents during cesarean delivery.
                Patients who underwent cesarean delivery were assigned randomly to either 200-microg misoprostol or placebo placed in the buccal space. A dilute intravenous oxytocin infusion was given to all patients at delivery of the placenta. The primary outcome variable was the need for additional uterotonic agents.
                A total of 352 women received random assignments. Demographic and intrapartum characteristics were similar between the groups. More women in the placebo group required 1 additional uterotonic agent (43% vs 26%; P < .01; relative risk, 1.3; 95% CI, 1.10, 1.50). There was not a difference between the groups in the incidence of postpartum hemorrhage or a difference in preoperative and postoperative hemoglobin level.
                Buccal misoprostol reduces the need for additional uterotonic agents during cesarean delivery. to determine if misoprostol is safe and efficacious in preventing postpartum haemorrhage (PPH) when administered by trained traditional birth attendants (TBA) at home deliveries.
                a randomised, double-blind, placebo-controlled trial.
                Chitral, Khyber Pakhtunkhwa Province, Pakistan.
                a total of 1119 women giving birth at home.
                from June 2006 to June 2008, consenting women were randomised to receive 600 microg oral misoprostol (n = 534) or placebo (n = 585) after delivery to determine whether misoprostol reduced the incidence of PPH (≥ 500 ml).
                the primary outcomes were measured blood loss ≥ 500 ml after delivery and drop in haemoglobin >2 g/dl from before to after delivery.
                oral misoprostol was associated with a significant reduction in the rate of PPH (≥ 500 ml) (16.5 versus 21.9%; relative risk 0.76, 95% CI 0.59-0.97). There were no measurable differences between study groups for drop in haemoglobin >2 g/dl (relative risk 0.79, 95% CI 0.62-1.02); but significantly fewer women receiving misoprostol had a drop in haemoglobin >3 g/dl, compared with placebo (5.1 versus 9.6%; relative risk 0.53, 95% CI 0.34-0.83). Shivering and chills were significantly more common with misoprostol. There were no maternal deaths among participants.
                postpartum administration of 600 microg oral misoprostol by trained TBAs at home deliveries reduces the rate of PPH by 24%. Given its ease of use and low cost, misoprostol could reduce the burden of PPH in community settings where universal oxytocin prophylaxis is not feasible. Continual training and skill-building for TBAs, along with monitoring and evaluation of programme effectiveness, should accompany any widespread introduction of this drug. To evaluate efficacy of misoprostol by intrauterine route for the prevention of the obstetrical hemorrhage and to know its effects collaterals.
                Clinical and randomized test with 200 patients to those who one took place to them Caesarean. The Group A was applied placebo and the group B misoprostol (group B; 800 microg) intrauterine, after the birth of its newborns. The necessity of additional uterotonics was compared, loss of hemoglobin and hematocrit, and the effects collaterals.
                In group B it diminished the necessity of additional uterotonics to 50% and the loss of hemoglobin in 39.6%. In the group greater loss of 3 was registered g of hemoglobin in 13 versus 3% of the patients. With respect to the hematocrit, its loss was reduced in 40.6%. The patients in those who the hematocrit in more fell than 10%, registered themselves in 7 versus 1% cases. The effects collaterals were few and not so serious.
                The intrauterine combination of misoprostol and oxitocin diminishes the postcaesarean sanguineous loss and has brings about few effects collaterals. To compare carboprost trometamol with methylergometrine in managing the third stage of labor.
                One hundred and fifty parturient women were randomly assigned to use carboprost trometamol or methylergometrine immediately after delivery.
                Both the duration of the third stage and the mean blood loss were significantly less in the carboprost group than the methergine group (P < 0.001).
                Carboprost trometamol is a more potent uterotonic drug than methylergometrine. Reducing blood loss in parturient women is very important especially in cases where there is the likelihood of anemia. We conducted a double-blind randomized controlled trial to compare a conventional regimen of oxytocin and ergometrine with administration of the prostaglandin E2 analogue, sulprostone, for prophylaxis of postpartum hemorrhage in high-risk women.
                Women with a history of postpartum hemorrhage > or = 1000 were assigned to two coded prophylactic regimens. Drugs, given respectively at delivery of the anterior shoulder and after delivery of the placenta, were oxytocin and ergometrine in the control group, and sulprostone and placebo in the experimental group. Eighty-one women, 69 of whom actually participated in the trial, were investigated. Both the women and the caregivers were unaware of treatment allocation.
                Although the trial was terminated prematurely there was a slight, but not statistically significant, preference for the sulprostone regimen in terms of blood loss and use of blood transfusion. No serious adverse effects were noted with either of the two regimens.
                Prostaglandins may be more effective for preventing recurrence of severe postpartum hemorrhage than the oxytocin and ergometrine combination, but they do not eliminate the risk entirely. To compare the efficacy and side-effects of low-dose sublingual misoprostol and i.v. methylergometrine for active management of the third stage of labor.
                The study subjects were three hundred low-risk women with term pregnancy and spontaneous onset of labor. These women received either one (100 microg/tablet) or two tablets of misoprostol (200 microg) sublingually or 1 mL (200 microg) of methylergometrine, i.v. injection, after the delivery of the anterior shoulder of the baby. The main outcome measures were the need for additional oxytocic drugs, blood loss >or=500 mL, change in hemoglobin levels and side-effects.
                Post-partum hemorrhage (>or=500 mL blood loss) did not occur in any of the women, but above-average bleeding occurred in 2.0% of cases in groups I, II (sublingual misoprostol 100 microg and 200 microg respectively) and III (methylergometrine), despite additional oxytocics used in 5.0%, 4.0% and 3.0% cases in groups I, II and III respectively (P>0.05). The change in hemoglobin levels at 24 h post-partum were 0.8%, 0.7% and 0.8% in groups I, II and III respectively (P>0.05).
                A low dose of sublingual misoprostol appears to be as effective as a low dose of i.v. methylergometrine in the prevention of post-partum hemorrhage in low-risk cases. So given the advantages of its stability at room temperature, low cost and easy route of administration, misoprostol appears to be a better choice, and a low dose is enough. However, larger studies in low-risk as well as high-risk cases are needed to advocate routine use of a low dose at the primary level. To compare the effect of 400 mug of oral misoprostol with 5 U of intravenous oxytocin in the reduction of postpartum blood loss and prevention of postpartum hemorrhage.
                In a prospective, double-blind, randomized controlled trial conducted in a tertiary maternity hospital 622 women received either 400 mug of oral misoprostol or 5 U of intravenous oxytocin after delivery of the anterior shoulder or within 1 min of delivery. The primary outcome was a hematocrit drop of 10% or greater 24 h postpartum. The secondary outcomes were a hemoglobin drop of 30 mg/L or greater, the use of additional oxytocin, an estimated blood loss greater than 1000 mL, manual removal of the placenta, a blood transfusion, and shivering and fever (>or=38 degrees C) as adverse effects of misoprostol.
                There was no difference between the 2 groups regarding the primary outcome (a >or=10% hematocrit drop occurred in 3.4% and 3.7% of the participants in the oxytocin and misoprostol groups, P=0.98). The rate of use of additional oxytocin was higher in the misoprostol group (51% versus 40.5%, P=0.01). Shivering was confined to the misoprostol group (6.8%), and fever occurred in 12.5% of the women in the misoprostol group and 0.3% of the women in the oxytocin group.
                The routine use of 400 microg of oral misoprostol was no less effective than 5 U of intravenous oxytocin in reducing blood loss after delivery, as assessed by change in postpartum hematocrit. The adverse effects of misoprostol were mild and self-limiting. To compare rectal misoprostol with oxytocin for routine management of the third stage of labour.
                A total of 240 parturient women were randomized, at three University of Toronto teaching hospitals, to receive either rectal misoprostol (400 microg) after delivery of the infant or parenteral oxytocin (5 units i.v. or 10 units i.m.) with the delivery of the anterior shoulder, when possible, or 5 units i.v. or i.m after the delivery of the placenta. The primary outcome measure was change in hemoglobin (Delta[Hgb]) from admission in early labour to day one postpartum.
                The labour ward of three University of Toronto teaching hospitals: St. Michael's, Toronto General, and Mount Sinai.
                Labouring women either nulliparous or multiparous with no known risk for excessive third stage blood loss; vertex presentation; no previous Caesarean delivery; induced, spontaneous, or augmented labour.
                No difference in Delta[Hgb] was observed between the two groups; the Delta[Hgb] in the oxytocin and misoprostol groups were 1.43 g/L (95% confidence interval [CI], 1.2-1.6 g/L) and 1.59 g/L (95% CI, 1.4-1.8 g/L) respectively (p = 0.35). Secondary outcome measures (excessive third stage bleeding, duration of third stage of labour, need for manual removal of the placenta or the need for additional oxytocics) did not differ between the two groups.
                Rectal misoprostol is of equivalent efficacy to parenteral oxytocin for the prevention of primary postpartum hemorrhage. Rectal misoprostol is an appropriate uterotonic agent for routine management of the third stage of labour. In a prospective, open-label, assessor-blind, randomised parallel group study the efficacy and safety of Hemabate (Pharmacia-Upjohn Pharmaceuticals, Milton Keynes, Buckinghamshire) an analogue of 15-methyl-prostaglandin (PGF2alpha) analogue was compared with Syntometrine (Alliance Pharmaceuticals, Chippenham, Wilts) the standard combination of ergometrine and syntocinon used for the active management of the third stage of labour and the prevention of primary postpartum haemorrhage (PPH). The study was set in a district general hospital with approximately 4,000 deliveries annually. The study was discontinued at the time of the interim analysis because of unacceptable gastrointestinal side effects. At the time of the interim analysis, a total of 529 women had completed the study with 263 randomised to receive PGF2alpha and 266 to receive ergometrine and syntocinon. In a pre-specified subgroup analysis, women delivered vaginally were further subdivided into those considered to be at high or low risk of primary PPH. The measured blood loss and incidence of PPH was similar in both treatment groups whether delivered by caesarean section or vaginally independent of whether women were considered to be at high or low risk. Adverse gastrointestinal events were recorded more often in the Hemabate group. The most common symptom was diarrhoea which occurred in 21% of women who received Hemabate compared to only 0.8% of Syntometrine users. PGF2alpha is as effective as Syntometrine in the prophylaxis of primary PPH in all groups studied but there was a statistically significantly increased risk of diarrhoea among users of PGF2alpha. The objective of this trial was to investigate whether 500 microg oral misoprostol given immediately after delivery of the neonate at Caesarean section is as effective as a bolus intravenous injection of 10 iu Syntocinon in stimulating uterine contractions and thereby reducing blood loss. Forty women undergoing elective or emergency Caesarean section were included in a placebo-controlled randomised trial. Group 1 received oral misoprostol and a placebo intravenous bolus and Group 2 received intravenous Syntocinon and oral placebo tablets. The main outcome measures were estimated blood loss at Caesarean section, drop in serum haemoglobin, and the need for additional uterotonic agents. We found that there was no significant difference (p = 0.75) in estimated blood loss between the two groups. No differences were observed in the decrease in haemoglobin, requirement for additional oxytocics, the need for blood transfusion or the degree of shivering in each group (p > 0.05 in each case). We concluded that oral misoprostol could be used as an alternative oxytocic agent for the third stage at Caesarean section. However, there is an obvious need for a larger randomised controlled trial to be undertaken. Previous published studies have concentrated on vaginal births and further studies should be extended to Caesarean deliveries. To assess the effectiveness of 800 microg of rectal misoprostol compared with an intravenous infusion of 5 IU of oxytocin as prophylaxis against postpartum hemorrhage (PPH).
                A total of 514 women in labor were randomized into two groups (257 women in each). Within 1 minute of delivery of the anterior shoulder participants in group 1 received 800 microg of rectal misoprostol and 1 ampoule of normal saline in 5 mL lactated Ringer solution intravenously; group 2 received a rectal placebo tablet and 5 IU of oxytocin in 5 mL lactated Ringer solution intravenously.
                Both groups were comparable regarding the need for uterotonics, blood transfusion, and hematocrit drop of 10% or greater, 24 hours post partum (P=0.54, P=0.25, and P=0.85, respectively). Fever was significantly higher among misoprostol patients (18.7% vs 0.8%, P<0.001).
                Routine use of 800 microg of rectal misoprostol was effective in reducing blood loss after delivery. We recommend the regimen for low-resource, busy obstetric settings. nan a) To compare the clinical effect of rectal misoprostol with intramuscular syntometrine in reducing blood loss in the third stage of labour b) to determine the severity and incidence of side effects of both drugs and c) to measure blood loss, patient tolerance and acceptance of rectal misoprostol.
                One hundred and forty parturients were randomly allocated to receive intramuscular syntometrine (syntocinon 10 IU + ergometrine 0.5 mg) or rectal misoprostol 400 microg within five minutes of the delivery of the anterior shoulder Blood loss was measured by the use of a plastic collection drape. Additional oxytocic therapy was instituted for uterine atony or if blood loss was in excess of one litre.
                There was no significant difference in patient demographics of each treatment group (Table 1). There was no difference in mean duration of the third stage of labour (8.4 +/- 14 min vs 7.8 +/- 6.6 min). The mean blood loss from those parturients receiving misoprostol (180.1 +/- 120 mls) was not significantly different (p = 0.5) from those receiving syntometrine (197 +/- 176.97 mls) for the active management of the third stage of labour Treatment with syntometrine was associated with a significant elevation of post-partum systolic blood pressure compared with misoprostol treatment (mean increase 0.57 +/- 18.79 mmHg vs -1.43 +/- 14.17 mmHg, (mean +/- SD), p < 0.04). Rectal misoprostol was well tolerated in 88.5% of participants, 11.4% reported that insertion was uncomfortable, of which 2.8% reported that they would have preferred parenteral drug administration.
                The clinical effect of rectal misoprostol and intramuscular syntometrine were not different at the doses used in the active management of the third stage of labour in this study. Rectal misoprostol was well tolerated by the patients and had a low side effect profile. Blood loss assessment using the blood collection drape is of invaluable benefit in resource-poor settings. To compare the impact of a dinoprostone vaginal insert and intravenous oxytocin in reducing blood loss of women undergoing vaginal or cesarean delivery.
                This study was conducted among term singleton pregnancies delivered vaginally or by elective cesarean section. In the vaginally delivered cases, active management of the third stage of labor was conducted. During cesarean delivery, 20 IU of intravenous oxytocin was administered. Women, who either delivered via the vaginal or abdominal route, were then randomly allocated to receive 10 mg vaginal dinoprostone insert for 12 hours (group I, n: 100) or intravenous oxytocin (group II, n: 100), respectively.
                Mean blood loss and need for additional uterotonics and postpartum hemoglobin and hematocrit levels at 24 and 36 hours after delivery did not differ between the two groups. Women allocated to the dinoprostone vaginal insert arm experienced more nausea and vomiting.
                Dinoprostone vaginal insert was as effective as intravenous oxytocin in the prevention of postpartum blood loss. The objective of this study was to compare a Tibetan traditional medicine (the uterotonic Zhi Byed 11 [ZB11]) to oral misoprostol for prophylaxis of postpartum hemorrhage (PPH). We conducted a double-blind randomized controlled trial at three hospitals in Lhasa, Tibet, People's Republic of China. Women (N = 967) were randomized to either ZB11 or misoprostol groups. Postpartum blood loss was measured in a calibrated blood collection drape. The primary combined outcome was incidence of PPH, defined as measured blood loss (MBL) > or = 500 mL, administration of open label uterotonics, or maternal death. We found that the rate of the combined outcome was lower among the misoprostol group (16.1% versus 21.8% for ZB11; P = .02). Frequency of PPH was lower with misoprostol (12.4% versus 17.4%; P = .02). There were no significant differences in MBL > 1000 mL or mean or median MBL. Fever was significantly more common in the misoprostol group (P = .03). The rate of combined outcome was significantly lower among women receiving misoprostol. However, other indices of obstetric hemorrhage were not significantly different. nan To compare the effect of rectal misoprostol with intramuscular oxytocin in the routine management of the third stage in a rural developing country.
                A randomized controlled trial was performed at two district hospitals in Ghana, West Africa. Four hundred fifty women in advanced labour were enrolled. The only exclusion criterion was a known medical contraindication to prostaglandin administration. Women were randomized to receive rectal misoprostol 800 microg or intramuscular oxytocin 10 IU with delivery of the anterior shoulder. The main outcome measure was change in hemoglobin concentration from before to after delivery. Secondary outcomes included the need for additional uterotonics, estimated blood loss, transfusion, and medication side effects.
                Demographic characteristics were similar in each treatment group. There was no significant difference between treatment groups in change in hemoglobin (misoprostol 1.19 g/dL and oxytocin 1.16 g/dL; relative difference 2.6%; 95% confidence intervals [CI]-16.8% to 19.4%; P = 0.80). The only significant secondary outcome was shivering, which was more common in the misoprostol group (misoprostol 7.5% vs. oxytocin 0.9%; relative risk 8.0; 95% CI 1.86-34.36; P = 0.001).
                Rectal misoprostol 800 microg is as effective as 10 IU intramuscular oxytocin in minimizing blood loss in the third stage of labour. Rectal misoprostol has a lower incidence of side effects than the equivalent oral dose. This confirms the utility of misoprostol as a safe and effective uterotonic for use in the rural and remote areas of developing nations where other pharmacologic agents may be less feasible. The influence of intramyometrial injection of 125 micrograms of 15-s-15-methyl prostaglandin F2 alpha (carboprost tromethamine, Prostin/15M) versus 20 U of oxytocin immediately after delivery of placenta on blood loss at cesarean section was investigated by means of a double-blinded, randomized trial. Hematocrit decrease from the day before operation to the third postoperative day was used as an index of blood loss. Decreases in hematocrit were comparable for the oxytocin and carboprost tromethamine groups. Excess blood loss (hematocrit decrease more than 6 vol. %) was significantly associated with the indication for cesarean section (three of four for cephalopelvic disproportion versus 9 of 42 others, p less than 0.01), but not with age, parity, number of prior cesarean sections, or birthweight. Carboprost tromethamine does not appear to be more effective than oxytocin when given by intramyometrial injection at this dose for routine cesarean section; its prophylactic utility in higher doses or in cases at risk for hemorrhage from uterine atony remains to be investigated. To compare the effect on post partum bloodloss of the postpartum prophylactic administration of oxytocin or sulprostone in low risk women having an expectant management of the third stage.
                Randomized, placebo controlled, double-blind trial.
                Radboud University Hospital, Nijmegen (67 women) and Lievensberg Hospital, Bergen op Zoom (10 women).
                77 women entered the trial (three were excluded).
                The intramuscular injection, immediately after the birth of the baby, of either oxytocin 5 IU, sulprostone 500 micrograms or 0.9% saline.
                Quantitative postpartum blood loss and length of third stage.
                Postpartum blood loss was reduced almost equally, by about 35%, by oxytocin (P = 0.02), or sulprostone (P = 0.05). The mean length of the third stage was shorter in both groups receiving the active treatment, this effect was significant in the sulprostone group (P = 0.01).
                Prophylactic administration of oxytocin or sulprostone directly after delivery followed by expectant management of the third stage reduces post partum blood loss and shortens the third stage. A double blind randomized controlled trial was performed at the tertiary hospital in Harare, Zimbabwe to compare oral misoprostol with intramuscular oxytocin in the management of third stage of labor.
                A total of 499 women were randomized to receive either 400 microg misoprostol orally or 10 IU oxytocin intramuscularly. The incidences of postpartum hemorrhage and side effects were examined.
                The demographic and labor characteristics were comparable. Postpartum hemorrhage occurred in 15.2% of women given misoprostol and in 13.3% of those given oxytocin (P=0.534). Measured blood loss of more than 1000 ml occurred in 3.7% of the misoprostol group compared with 2% in the oxytocin group (P=0.237). There was no significant difference in the need for additional oxytocic drugs or blood transfusion in women given misoprostol (P values 0.137 and 0.600, respectively). Significant side effects of misoprostol were shivering [RR=1.32 (95% CI 1.11-1.58); P=0.002) and a rise in temperature [RR=2.02 (95% CI 1.75-2.33); P<0.001].
                Oral misoprostol is as effective as intramuscular oxytocin in the prevention of PPH. Shivering and transient pyrexia were specific side effects of misoprostol. Misoprostol has potential in reducing the high incidence of PPH in developing countries. To compare rectally administered misoprostol to intravenously administered oxytocin for the management of third-stage labor.
                Subjects were randomized to receive two, 200-microg misoprostol tablets rectally (study medication) plus 2 mL saline in Ringer's lactate intravenously or two lactose tablets rectally plus 20 units oxytocin in Ringer's lactate intravenously (control medication). Blood loss was determined by estimation, measurement, and change in hematocrit values from admission to postpartum day 1. Subjects were excluded if cesarean delivery was required.
                A total of 325 women underwent analysis. By estimation, 21% of subjects and 15% of controls had postpartum hemorrhage (P =.17). By using measured blood loss, we determined that 70 of 154 (46%) study subjects and 61 of 161 (38%) control subjects had postpartum hemorrhage (P =.17). For 36 (23%) misoprostol subjects and 18 (11%) oxytocin subjects at least one additional agent was required to control bleeding (P =.004).
                Rectal misoprostol (400 microg) was no more effective than intravenous oxytocin in preventing postpartum hemorrhage. Postpartum haemorrhage is a major cause of maternal mortality in the developing world. Although effective methods for prevention and treatment of such haemorrhage exist--such as the uterotonic drug oxytocin--most are not feasible in resource-poor settings where many births occur at home. We aimed to investigate whether oral misoprostol, a potential alternative to oxytocin, could prevent postpartum haemorrhage in a community home-birth setting.
                In a placebo-controlled trial undertaken between September, 2002, and December, 2005, 1620 women in rural India were randomised to receive oral misoprostol (n=812) or placebo (n=808) after delivery. 25 auxiliary nurse midwives undertook the deliveries, administered the study drug, and measured blood loss. The primary outcome was the incidence of acute postpartum haemorrhage (defined as > or =500 mL bleeding) within 2 h of delivery. Analysis was by intention-to-treat. The trial was registered with the US clinical trials database (http://www. clinicaltrials.gov) as number NCT00097123.
                Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage (12.0% to 6.4%, p<0.0001; relative risk 0.53 [95% CI 0.39-0.74]) and acute severe postpartum haemorrhage (1.2% to 0.2%, p<0.0001; 0.20 [0.04-0.91]. One case of postpartum haemorrhage was prevented for every 18 women treated. Misoprostol was also associated with a decrease in mean postpartum blood loss (262.3 mL to 214.3 mL, p<0.0001). Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group. Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control.
                Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss. The drug's low cost, ease of administration, stability, and a positive safety profile make it a good option in resource-poor settings. Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour.
                In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labour. The primary outcomes were measured postpartum blood loss of 1000 mL or more, and the use of additional uterotonics without an unacceptable level of side-effects. We chose an upper limit of a 35% increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat.
                9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 mL or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% CI 1.19-1.63], p<0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p<0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15-3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery.
                10 IU oxytocin (intravenous or intramuscular) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm. This is a multicentre, blocked, randomized trial to compare the efficacy of oral misoprostol 400 microg with current injectable uterotonic agents (oxytocin/ Syntometrine) used prophylactically in the third stage of labour. Main outcome measures were blood loss, use of a second uterotonic agent and difference in haemoglobin level from antepartum to postpartum. Data analysis from 863 women showed a statistically significant increase in both the mean blood loss (p < 0.001) and the rate of postpartum haemorrhage > 500 mL, (RR 2.72: 95% C1 1.73-4.27) in the misoprostol group compared to the oxytocin/Syntometrine group. The use of a second uterotonic agent was higher in the misoprostol group (RR 2.89: 95% Cl 2.00-4.18) as well as a greater decrease in postpartum haemoglobin (p = 0.015). Oral misoprostol 400 microg is significantly less effective than the traditional intramuscular uterotonic agents currently used and therefore cannot be considered as a viable option to these agents in the management of the third stage of labour. To select the misoprostol dose to be used in a large multicentre randomised trial comparing misoprostol with oxytocin in the routine management of the third stage of labour.
                Randomised pilot trial, double-blinded with the use of double placebos.
                Two of the nine hospitals that will participate in the main multicentre trial. The hospitals were located in Johannesburg, South Africa and Khon Kaen, Thailand.
                Women during second stage of labour about to be delivered vaginally.
                The trial had three arms: misoprostol 400 microg versus misoprostol 600 microg versus intramuscular oxytocin 10 IU. Each group received an injection and three tablets immediately after the birth of the baby.
                Shivering and pyrexia rates were the main outcome measures. Data on other side effects and characteristics of the third stage of labour were also collected. Side effects were noted as none, mild, moderate or severe.
                Both shivering and pyrexia (temperature > 38 degrees C) were most common in the 600 microg misoprostol group (28% and 7.5% for shivering and pyrexia, respectively) compared with 400 microg misoprostol (19% and 2%), and the oxytocin group (12.5% and 3%). The increase in shivering in the misoprostol 600 microg group was due primarily to a higher rate of moderate shivering. None of the women had a temperature > 40 degrees C. There were no increases in severe side effects and other adverse events in the misoprostol 600 microg group.
                When used in the management of the third stage of labour oral misoprostol is associated with an increase in the rate of moderate shivering and pyrexia which seems to be dose-related. Based on the results of this pilot trial, the Steering Committee has decided to use 600 microg misoprostol in the main trial, comparing it with oxytocin, in order to achieve higher effectiveness. A randomized controlled study of 112 women with singleton pregnancies at term, and no antenatal complications, admitted in spontaneous labour were randomized to receive either an intramuscular injection of 0.5 mg of Syntometrine or an intramuscular injection of 125 ug of prostaglandin 15-methyl F2 alpha at delivery of the anterior shoulder of the baby. Blood lost in the first 2 hours, and subsequent 22 hours postdelivery were collected separately and measured by colourimetric measurement of haemoglobin content. Other parameters in the third stage were measured, including need for transfusion of blood or blood products, length of the third stage, and change in haemoglobin concentration before and 24 hours after delivery. The incidence of side-effects with administration of either prostaglandin 15-methyl F2 alpha or Syntometrine were documented. The prophylactic use of intramuscular prostaglandin 15-methyl F2 alpha (Carboprost) in the active management of the third stage of labour gave similar results to prophylactic intramuscular Syntometrine in terms of length of the third stage of labour, incidence of postpartum haemorrhage and total blood loss in the first 2 hours and subsequent 22 hours after delivery. However it has the disadvantage of higher cost, as well as statistically significant increase in the incidence of profuse and frequent diarrhoea. Based on these results intramuscular injection of prostaglandin 15-methyl F2 alpha offers no advantage over intramuscular Syntometrine for routine prophylactic use to reduce blood loss in the third stage of labour. Misoprostol, an inexpensive, stable, orally active prostaglandin analogue, has been suggested for use in the prevention of postpartum haemorrhage. Potential side-effects, however, need to be quantified.
                To compare the rate of postpartum shivering and pyrexia following oral misoprostol 600 micrograms and placebo.
                A double-blind placebo-controlled trial. Women in labour were randomly allocated to receive either misoprostol 600 micrograms orally or placebo after delivery. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Side-effects were recorded. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan.
                The labour ward of an academic hospital in Johannesburg, with 7,000 deliveries per annum.
                Shivering and pyrexia.
                The groups were well matched. Misoprostol use was associated with more shivering (44% versus 11%, relative risk (RR) 4.03, 95% confidence interval (CI) 2.85-5.70), pyrexia > or = 37.8 degrees C (38% v. 6%, RR 6.23, CI 3.89-9.97), 1-hour systolic blood pressure > or = 140 mmHg (33% v. 25%, RR 1.32, CI 1.03-1.70), and diastolic blood pressure > or = 90 mmHg (10.5% v. 3.0%, RR 3.44, CI 1.67-7.11). There were no other significant differences. The study was not designed to be large enough to assess a difference in blood loss > or = 1,000 ml (9% v. 9.7%, RR 0.93, CI 0.56-1.53). Possible effects on blood loss may have been obscured by the lesser use of additional oxytocics in the misoprostol group (14% v. 18%, RR 0.78, CI 0.54-1.13).
                This study has shown the association of postpartum oral misoprostol 600 micrograms with shivering, pyrexia and hypertension. The increased blood pressure, as for the trend towards increased abdominal pain, may be secondary to the uterotonic effect of misoprostol. Large randomised trials are needed to assess the effectiveness of misoprostol in the prevention of postpartum haemorrhage, against which the disadvantages demonstrated here can be weighed. nan To compare oral misoprostol 400 microg with placebo in the routine management of the third stage of labour.
                A double-blind placebo controlled trial. Setting The labour ward of an academic hospital in Johannesburg, South Africa with 7000 deliveries per annum.
                Low-risk women expected to deliver vaginally.
                Women in labour were randomly allocated to receive either misoprostol 400 microg orally or placebo after the birth. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan. Side effects were recorded.
                Measured blood loss > or = 1000 ml within the first hour after birth. Use of additional oxytocics.
                The groups were well matched. Measured blood loss > or = 1000 ml occurred in 15/250 (6%) after misoprostol and 23/250 (9%) after placebo (relative risk 0.65; 95% confidence interval 0.35-1.22). The difference may have been reduced by the greater use of conventional oxytocics in the placebo group, which was statistically significant for intravenous oxytocin infusion (2.8% vs 8.4%, relative risk 0.33, 95% confidence interval 0.14-0.77). Shivering was more common in the misoprostol group (19% vs 5%, relative risk 3.69; 95% confidence interval 2.05-6.64).
                Shivering has been shown in this study to be a specific side effect of misoprostol administered orally in the puerperium. No serious side effects were noted. Misoprostol shows promise as a method of preventing postpartum haemorrhage. Because of the potential benefits for childbearing women, particularly those in developing countries, further research to determine its effects with greater certainty should be expedited.
Oral or sublingual misoprostol shows promising results when compared with placebo in reducing blood loss after delivery. The margin of benefit may be affected by whether other components of the management of the third stage of labour are used or not. As side-effects are dose-related, research should be directed towards establishing the lowest effective dose for routine use, and the optimal route of administration.
Neither intramuscular prostaglandins nor misoprostol are preferable to conventional injectable uterotonics as part of the management of the third stage of labour especially for low-risk women; however, evidence has been building for the use of oral misoprostol to be effective and safe in areas with low access to facilities and skilled healthcare providers and future research on misoprostol use in the community should focus on implementation issues.