Vaginal misoprostol versus dinoprostone for the management of missed abortion. A prospective randomized study to compare the use of repeated doses of vaginal with sublingual misoprostol in the management of first trimester silent miscarriages. Intravaginal misoprostol 600 microg and 800 microg for the treatment of early pregnancy failure. Intravaginal 400 microg misoprostol for pregnancy termination in cases of blighted ovum: a randomised controlled trial. A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Oral misoprostol vs. vaginal misoprostol for termination of pregnancy with intrauterine fetal demise in the second-trimester. Randomised trial comparing expectant with medical management for first trimester miscarriages. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Comparative study of intravaginal misoprostol with gemeprost as an abortifacient in second trimester missed abortion. Misoprostol in the management of missed abortion. A randomized trial of saline solution-moistened misoprostol versus dry misoprostol for first-trimester pregnancy failure. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management: a randomized trial. Medical management of missed abortion: a randomized clinical trial. Medical management of non-viable early first trimester pregnancy. Randomized, double-blind, placebo-controlled trial of vaginal misoprostol for management of early pregnancy failures. Gemeprost for first trimester missed abortion. Mifepristone (RU 486) induces embryo expulsion in first trimester non-developing pregnancies: a prospective randomized trial. Early intrauterine pregnancy failure: a randomized trial of medical versus surgical treatment.
nan A randomized controlled trial comparing sublingual with vaginal administration of misoprostol for medical management of silent miscarriages.
                Eighty women who had silent miscarriages (<13 weeks) were randomized to receive 600 micro g of misoprostol every 3 h for a maximum of three doses either sublingually or vaginally.
                The success rates of medical management were the same in both groups (87.5%; 95% CI: 74-95%). There were no serious complications. The incidence of diarrhoea was higher in the sublingual (70%) than the vaginal route (27.5%) (P < 0.005). Other side effects were similar in each group, although fatigue was experienced by more women in the sublingual group than in the vaginal group (65 versus 40%: P = 0.043). The overall acceptability of medical management was good. Most women would choose the medical method if they were allowed to choose again and would recommend the method to others.
                The current regimen of misoprostol is useful for the management of silent miscarriage in terms of complete miscarriage rate and patient acceptability. Sublingual misoprostol may offer an alternative for women who do not like repeated vaginal administration of the drug. To compare the respective effectiveness and safety of 600 microg and 800 microg of intravaginal misoprostol for complete abortion in cases of early pregnancy failure (occurring in the first 12 weeks).
                A total of 114 women with a diagnosis of early pregnancy failure made by transvaginal ultrasonography at Rajavithi Hospital between November 25, 2002 and July 31, 2003, were assigned randomly to 2 groups of equal size. In one group the women received 600 microg of misoprostol and in the other 800 microg of misoprostol intravaginally.
                The rate of complete abortion within 24 h was significantly higher in the group that received 800 microg of misoprostol (68.4%) than in the other group (45.6%) (P<0.05). There were no significant differences between the 2 groups regarding time interval between misoprostol insertion and complete abortion or side effects.
                Intravaginal misoprostol 800 microg is significantly more effective than vaginal misoprostol 600 microg for the termination of an early pregnancy failure, with no significant differences in side effects. To investigate the effectiveness and side effects of intravaginal misoprostol 400 micrograms compared with a placebo for facilitating complete abortion in cases of blighted ovum.
                A prospective randomised placebo-controlled trial.
                Rajavithi Hospital, Thailand between 1 July 1998 and 31 January 1999.
                Fifty-four pregnant women with gestations of up to 12 weeks whose diagnosis of blighted ovum had been made by transvaginal ultrasound.
                The patients were assigned randomly into two equal groups; the study group received two tablets of vaginal misoprostol (200 micrograms/tablet), and the control group received two tablets of a vaginal placebo.
                The complete abortion rate was significantly higher in the women receiving misoprostol (63%) compared with those receiving the placebo (18.5%) (p < 0.05). Lower abdominal pain (74.1%) and fever (14.8%) were significantly higher in the study group than in the placebo group (22.2%) and (0%) respectively, (p < 0.05).
                Intravaginal 400 microg misoprostol is significantly more effective for termination of blighted ovum than placebo, but lower abdominal pain and fever are signifcantly higher in the misoprostol group. A prospective randomized control trial was designed to assess the effectiveness of single dose, 800 microg misoprostol administered p.v. compared with surgical evacuation for the treatment of early pregnancy failure. A total of 80 women with a diagnosis of early pregnancy failure were randomized to study (vaginal misoprostol) and control (surgical curettage) groups. Success of treatment, side-effects as assessed during, immediately after and 10 days after treatment, and patient satisfaction were compared. Intravaginal misoprostol was successful in 82.5% (33 out of 40) of the patients. None of the control group patients required a repeat evacuation. The number of patients who experienced significant abdominal pain following treatment did not differ between the groups. The duration of pain was shorter in the control group; however, they required more analgesics during this short period. The number of patients with significant vaginal bleeding, the duration or severity of bleeding did not show any significant difference between the groups. All 33 patients in the study group who had successful treatment expressed satisfaction, whereas only 58% of the control group did so. In conclusion this randomized control study demonstrated the efficacy and safety of the administration of 800 microg of misoprostol p.v. for the management of early pregnancy failure. We aimed to determine whether outpatient treatment of miscarriage with vaginal misoprostol is more effective than expectant management in reducing the need for surgical evacuation of retained products of conception (ERPC).
                Of 131 eligible women with first trimester miscarriage, 104 agreed to randomization to either 600 microg misoprostol or placebo intravaginally. They were assessed the following day and administered a second dose of their allocated treatment if miscarriage was not complete. Those not successful after two doses were seen on day 7, and, if miscarriage was not complete, an ERPC was performed.
                The success rate of medical management was 88.5% (46/52) compared with 44.2% (23/52) for expectant management. There was no significant difference in success rate (100 versus 85.7%) in women treated with an incomplete miscarriage. Women with early pregnancy failure had a success rate of 87% with misoprostol compared with 29% with expectant management [odds ratio (OR) 15.96; 95% confidence interval (CI) 5.26, 48.37]. The complete miscarriage rate was achieved quicker in the medical group than the expectant group by day 1 (32.7 versus 5.8%) and by day 2 (73.1 versus 13.5%) of treatment. There were no differences in side-effects, bleeding duration, analgesia use, pain score and satisfaction with treatment. Women in the expectant group made more outpatient visits (5.06 versus 4.44%; OR = -0.62, 95% CI -1.04, -0.19). More women in the medical group (90.4 versus 73.1%; OR 1.26, 95% CI 1.05, 1.50) would elect the same treatment in the future.
                Medical management using 600 microg misoprostol vaginally is more effective than expectant management of early pregnancy failure. Misoprostol did not increase the side-effect profile and patient acceptability was superior to expectant management. nan To compare the efficacy of antiprogesterone (mifepristone) in combination with a synthetic prostaglandin E1 analogue (misoprostol) for outpatient treatment of miscarriages.
                One hundred and twenty-two women with first trimester miscarriages.
                The women were randomised to treatment with mifepristone 400 mg orally followed by a single oral dose of 400 microg misoprostol 48 hours later (n = 60) or expectant management (n = 62). Women were re-evaluated five days later. If retained intrauterine products of conception were found with an antero-posterior diameter above 15 mm on transvaginal ultrasound, surgical evacuation was performed.
                Eighty-two percent of the women randomised to pharmacological treatment and 76% of those randomised to expectant management had an empty uterine cavity after five days. Convalescence time was 1.8 days longer for women randomised to pharmacological treatment. Pain, bleeding, complications, and satisfaction with the treatment did not differ between the groups.
                Most cases of spontaneous incomplete miscarriage will become a complete miscarriage without intervention. This study shows that outpatient treatment with a combination of antiprogesterone and a prostaglandin E1 analogue did not increase the rate of complete miscarriage, compared with expectancy alone, by a clinical important degree. Our purpose was to determine whether intracervical placement of laminaria tents would improve the effectiveness of the prostaglandin analog misoprostol for the elective termination of pregnancies in the second trimester.
                Sixty-eight women between 12 and 22 weeks of gestation with either an intrauterine fetal death (n = 40) or medical or genetic indications for pregnancy termination (n = 30) were randomized to receive 200 micrograms of misoprostol administered vaginally every 12 hours with or without intracervical placement of laminaria concurrently with the first dose of misoprostol.
                The rate of abortion 24 hours after initiation of treatment was 69.7% in the 33 women receiving misoprostol alone and 68.6% in the 35 women treated with misoprostol and laminaria. The abortion rates 48 hours after initiation of treatment were 84.8% and 91.4%, respectively, an insignificant difference. The complete abortion rate was also similar between women receiving misoprostol alone (39.3%) and the group receiving misoprostol and laminaria (37.5%). There were no significant differences in the incidence of fever, vomiting, diarrhea, or pain. The mean interval from initiation of treatment to abortion was also similar, 15.7 hours in those receiving misoprostol alone and 17.4 hours in those treated with misoprostol and laminaria. In both groups women who had live fetuses at the start of the procedure had a higher failure rate of abortion and a longer time interval to abortion than women whose fetus was dead.
                Laminaria tents inserted concurrently with the first dose of misoprostol do not significantly improve the abortifacient effect of vaginal misoprostol in the second trimester of pregnancy. This prospective, randomized study compared the efficacy of intravaginal misoprostol (Cytotec) and gemeprost (Cervagem) as an abortifacient for intrauterine deaths in second trimester pregnancy. Side-effects, complications and the cost-effectiveness associated with each drug were assessed. 21 out of 25 patients (84%) in the misoprostol group aborted whereas only 17 out of 25 patients (68%) in the gemeprost group aborted within 24 hours after the initiation of therapy. In the misoprostol group, the abortion rate was influenced by the gestational age with 100% abortion rate for those > 17 weeks' gestation compared to 67% for those with a gestational age of 13-16 weeks. Side-effects were rare in either group and no major complications were reported in either group. Misoprostol was definitely more cost-effective compared to gemeprost as the mean cost of inducing an abortion using misoprostol was RM 1.08 whereas that of gemeprost was RM 105. We thus concluded that misoprostol was at least as effective as gemeprost as an abortifacient for intrauterine death in second trimester pregnancy. Moreover, it was less costly, with very few side-effects. To compare the effect of vaginal misoprostol with that of placebo when used prior to dilation and aspiration in women with a missed abortion.
                Eighty-four pregnant women with a missed abortion were randomized to receive either vaginal misoprostol (200 micrograms) or placebo the day before the planned dilatation and aspiration under inhalation anesthesia.
                Thirty-five women (83.33%) in the misoprostol group and 6 women (17.14%) in the placebo group aborted spontaneously prior to the scheduled dilatation and aspiration, P < 0.0001. The mean insertion to spontaneous expulsion time was 11.63 +/- 6.14 h in the misoprostol group compared to 11.95 +/- 5.43 h in placebo. In the misoprostol group two women required intramuscular pethidine for analgesia. In the placebo group there were two cases of blood loss in excess of 500 ml and one woman with a uterine perforation.
                Vaginal administration of misoprostol to women with a missed abortion produced spontaneous expulsion of the pregnancy and reduced the need for surgical treatment. The purpose of this study was to estimate whether the efficacy of treatment with intravaginal misoprostol for first-trimester pregnancy failure is enhanced by the addition of saline solution.
                Eighty women with embryonic/fetal death or anembryonic pregnancy were assigned randomly to receive either 800 microg of misoprostol with saline solution (group I, 41 women) or without (group II, 39 women). Treatment was repeated on day 3 if the gestational sac remained. Curettage was performed if the gestational sac remained on day 8 or as necessary during at least 30 days of follow-up. Data were analyzed with the Student t test and the chi(2) or Fisher exact test.
                By the first follow-up visit, 73% (group I) and 64% (group II) of women passed the gestational sac (P=.38). By the second follow-up visit, expulsion rates were 83% and 87%, respectively (P=.59). Five subjects in each group underwent curettage.
                Misoprostol is effective for the treatment of failed first-trimester pregnancy. The expulsion rate is not improved by adding saline solution. Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject.
                Women with early pregnancy failure, who had been managed expectantly for at least 1 week, were assigned randomly (using a computer-generated list) to receive either vaginal misoprostol 800 microg or curettage. If, after 24 h, there had not been complete evacuation, a further 800 microg of misoprostol was administered. In the absence of complete evacuation after > days, curettage was performed. The primary end-point was the complete evacuation of the products of conception, with secondary end-points being the occurrence of side effects, pain intensity, need for analgesics, and intensity and duration of bleeding.
                In the misoprostol group, 47% (37/79) required curettage due to incomplete evacuation. After 1 week, evacuation was complete in 85% (67 out of 79) of the misoprostol group and 93% (70 out of 75) of the curettage group. Severity of pain, bleeding and emergency evacuation was higher in the misoprostol group. The complication rate was 0% for misoprostol and 4% for curettage.
                Curettage is superior to misoprostol in the evacuation of early pregnancy failure after failed expectant management. However, misoprostol could be clinically useful since it reduces the need for curettage by half and has a lower complication rate, at the expense of increased pain, vaginal bleeding and emergency evacuation.
                Copyright 2004 European Society of Human Reproduction and Embryology To estimate the efficacy of vaginal misoprostol for medical management of missed abortion.
                Fifty women with missed abortion were randomized to treatment with up to two 800 microg [DOSAGE ERROR CORRECTED] doses of misoprostol vaginally or a placebo. Participants were reviewed daily for 2 days, then again at 1 week. A blood sample for hemoglobin and serum beta-human chorionic gonadotropin (beta hCG) was obtained on day 1 and the hemoglobin level checked again on day 7. Complete abortion was defined as expulsion of the products of conception without dilation and curettage (D&C) and a negative follow-up urine beta hCG test after 4 weeks, or as no products of conception obtained at D&C in cases of suspected incomplete abortion.
                The rate of complete abortion was 80% (20 of 25) in the misoprostol group and 16% (four of 25) in the placebo group, relative risk 0.20 (0.08, 0.50), P <.001. The rate of D&C was 28% (seven of 25) in the misoprostol group and 84% (21 of 25) in the placebo group, relative risk 0.33 (0.17, 0.64), P <.001. One participant in the misoprostol group had an emergency D&C for heavy bleeding. No participants required blood transfusion. The mean reduction in hemoglobin from day 1 to day 7 was 3.2 g/L in the misoprostol group versus 4.3 g/L in the placebo group, P = .72. Patient satisfaction with misoprostol treatment was high with 19 of 21 participants reporting they would try medical management again if they experienced another missed abortion.
                Medical management of missed abortion is effective, reduces the need for D&C, and is associated with high levels of patient satisfaction. To compare the efficacy of intramuscular methotrexate plus vaginal misoprostol to vaginal misoprostol alone in completing abortion in women with non-viable early first trimester pregnancy.
                Twenty-one women with non-viable pregnancy up to 49 days gestation were randomized to receive intramuscular methotrexate, followed 2 days later by vaginal misoprostol or misoprostol alone. We also collected patient satisfaction information.
                Complete abortion occurred in all 12 (100%) women in the combined group and eight of nine (89%, RR = 1.13, CI 0.89-1.42) women in the misoprostol only group. Of the women, 75% rated their experience as good and would choose medical management again.
                Either methotrexate plus misoprostol or misoprostol alone effectively completed abortion in women with non-viable early pregnancy and represent acceptable medical alternatives to surgery or expectant management. To determine whether misoprostol medical management of early pregnancy failures is more effective than expectant management.
                Patients diagnosed with early pregnancy failures, closed cervix, and minimal vaginal bleeding were randomized to 800 microg of misoprostol or placebo placed vaginally. Patients were evaluated by ultrasound imaging 24 hours and 48 hours after study drug administration, with repeat administration if 24-hour imaging showed a persistent gestational sac. Treatment success was defined as expulsion of uterine contents within 48 hours. Patient follow-up occurred 2 weeks after expulsion of uterine contents.
                Treatment success occurred in 15 of 18 (83%) misoprostol patients and 2 of 16 (13%) placebo patients (P < .0001). Side effects were similar between groups except for vaginal bleeding, which was more common in the misoprostol group (P = .001). Patient satisfaction and pain perception were similar between groups.
                Misoprostol appears to be highly effective for treating early pregnancy failures, with few side effects and high patient satisfaction. In 87 patients with a missed abortion prior to 13 weeks, the application of a prostaglandin (PG) E1 derivative (1 mg gemeprost, Cergem) was compared to conventional surgical termination of pregnancy by cervical dilatation and curettage. In 33 patients with PGE1 application, complete expulsion of the abnormal pregnancy occurred after an average of 2.8 +/- 1.5 vaginal suppositories. PGE1 treatment was effective in 76.7%, and surgical management was effective in 90.9% of patients. Sixty percent of the patients in the PGE1 group required analgesia because of uterine pain in comparison to 4.5% in the surgical group. The possibility of medical termination with synthetic PG derivatives should be further investigated. This study was designed to investigate the use of oral mifepristone (RU 486) for the induction of natural expulsion of concepti in women with spontaneously interrupted pregnancy in the first trimester. It consisted of a double-blind placebo-controlled study of mifepristone (600 mg) against placebo. A total of 46 women consulting for interrupted pregnancy were diagnosed at ultrasound with no clinical sign of miscarriage. Measurements were made of the occurrence of natural expulsion, the frequency of complete expulsion, the need for subsequent surgical evacuation, analgesia and the need for transfusion. Natural expulsion occurred within 5 days in 82% of patients receiving mifepristone treatment versus 8% of placebo-treated patients (P < 0.001). All patients experienced bleeding after RU 486 and two needed emergency aspiration for haemorrhagic expulsion. The treatment failed in four patients, who underwent evacuation under local anaesthesia. In the control group, 19 patients underwent evacuation under local (n = 10) or general (n = 9) anaesthesia. It was concluded that a standard oral pilot dose of 600 mg of mifepristone induces natural expulsion in 82% of women with non-developing first trimester intrauterine pregnancies. The purpose of this study was to determine whether medical treatment of early pregnancy failure represents a reasonable alternative to surgical therapy.
                Patients who were diagnosed with pregnancy failure before 12 weeks of gestation were randomly assigned to receive either medical (intravaginal misoprostol) or surgical therapy (dilatation and curettage). In the medical arm of the study, 800 microg of misoprostol was placed within the posterior vaginal fornix. Patients subsequently were seen 24 and 48 hours after the initial dosing; intravaginal misoprostol was readministered only if ultrasound images revealed evidence of persistent pregnancy tissue. By 72 hours after initial study entry, if either a gestational sac or placental tissue was present, the medical treatment was considered a failure, and uterine curettage was performed. Statistical analysis was performed with the two-tailed unpaired t test, chi(2) analysis, Fisher exact test, and Mann-Whitney U test; a probability value of <.05 was considered statistically significant.
                A total of 50 women were enrolled, with 2 patients in the surgical arm experiencing spontaneous pregnancy loss before their scheduled procedures. Twenty-five women received medical therapy; 25 women were randomized to surgical procedure. Fifteen patients in the medical group (60%; 95% CI, 0.41-0.79) had successful pregnancy termination and did not require curettage. There were no significant differences between the medical and surgical groups with respect to either posttreatment hematocrit level or the time needed to achieve negative human chorionic gonadotropin test results.
                Intravaginal misoprostol is an effective agent for the treatment of early pregnancy failure. Medical treatment of early pregnancy failure represents a reasonable alternative to immediate surgical therapy.
Available evidence from randomised trials supports the use of vaginal misoprostol as a medical treatment to terminate non-viable pregnancies before 24 weeks. Further research is required to assess effectiveness and safety, optimal route of administration and dose. Conflicting findings about the value of mifepristone need to be resolved by additional study.
[Note: the 108 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]