Mifepristone in second-trimester medical abortion: a randomized controlled trial. Vaginal versus oral misoprostol for second-trimester pregnancy termination: a randomized trial. A prospective, randomized comparison of vaginal misoprostol versus intra-amniotic prostaglandins for midtrimester termination of pregnancy. Use of prostaglandin, hypertonic saline and oxytocin for second-trimester abortion. Mid-trimester termination of pregnancy--a randomised controlled trial of two prostaglandin regimens. A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation. A comparison of low-dose and high-dose protocols of vaginal misoprostol for second trimester termination of pregnancy. A prospective randomised comparison of sublingual and vaginal misoprostol in second trimester termination of pregnancy. A prospective randomized comparison of sublingual and oral misoprostol when combined with mifepristone for medical abortion at 12-20 weeks gestation. Comparison of extra-amniotic instillation of rivanol and PGF2alpha either separately or in combination followed by oxytocin for second trimester abortion. Comparison of ethacridine lactate and prostaglandin E2 in second trimester medical abortion. A randomised controlled trial of 6 and 12 hourly administration of vaginal misoprostol for second trimester pregnancy termination. A randomised comparative study on sublingual versus vaginal administration of misoprostol for termination of pregnancy between 13 to 20 weeks. A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion. A comparison of two regimens of intravaginal misoprostol for termination of second trimester pregnancy: a randomized comparative trial. Intra-amniotic injection of oxytetracycline hydrochloride for termination of mid-trimester pregnancy. Comparison of vaginal and sublingual misoprostol for second trimester abortion: randomized controlled equivalence trial. A comparison of 600 and 200 mg mifepristone prior to second trimester abortion with the prostaglandin misoprostol. A randomised study of two doses of gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy. A randomised study of misoprostol and gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy. Induction of abortion in the second trimester by a combination of misoprostol and mifepristone: a randomized comparison between two misoprostol regimens. Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy. A randomized trial of 2 regimens for the administration of vaginal prostaglandins (gemeprost) for the induction of midtrimester abortion. Vaginal misoprostol compared with vaginal gemeprost in termination of second trimester pregnancy. A randomized trial. Randomized controlled trial of misoprostol for second-trimester pregnancy termination associated with fetal malformation. Prostaglandin F2alpha and oxytocin compared with hypertonic saline and oxytocin for the induction of second trimester abortion. A comparison between two doses of intravaginal misoprostol and gemeprost for induction of second-trimester abortion. The abortifacient effect of misoprostol in the second trimester. A randomized comparison with gemeprost in patients pre-treated with mifepristone (RU486). Randomized study on the effect of adding oxytocin to ethacridine lactate or misoprostol for second-trimester termination of pregnancy. Randomized comparison of dry tablet insertion versus gel form of vaginal misoprostol for second trimester pregnancy termination. Mid-trimester abortion by extraamniotic Emcredil versus normal saline. Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy. Second-trimester abortion by intramuscular 15-methyl-prostaglandin F2 alpha or intravaginal prostaglandin E2 suppositories: a randomized trial. Misoprostol is as effective as gemeprost in termination of second trimester pregnancy when combined with mifepristone: a randomised comparative trial. A randomized controlled trial comparing two protocols for the use of misoprostol in midtrimester pregnancy termination. Randomized trial of intracervical prostaglandin E2 gel and intraamniotic prostaglandin F2 alpha for induction of second trimester abortion. Second-trimester pregnancy termination: comparison of three different methods. Second-trimester termination with 16,16 dimethyl-PGE1-methyl ester (gemeprost), compared with a regimen that included intra-amniotic PGF2 alpha and hypertonic saline.
To investigate the adjunctive use of mifepristone in second-trimester induction abortions using misoprostol 1 day after feticidal digoxin.
                This is a randomized, placebo-controlled, double-blind trial of mifepristone in second-trimester induction termination using misoprostol after feticidal digoxin. Women seeking abortion between 18 and 23 weeks of gestation were offered enrollment. At the time of digoxin amnioinfusion, participants received a randomly allocated, identical-appearing capsule containing either mifepristone, 200 mg, or placebo. Patients returned the following day for induction with buccal misoprostol. The primary outcome was the time interval from the first misoprostol dose to abortion. Analysis utilized survival curves with log-rank testing.
                Of 64 women, 32 received mifepristone and 32 received placebo. The groups did not differ by ethnicity, age, parity, reason for termination, or gestational age. Median procedure time was significantly shorter for those who received mifepristone, 10 hours (95% confidence interval [CI] 8-12), than those who did not, 18 hours (95% CI 15-22), P<.01, and those parous, 10 hours (95% CI 9-14), compared with nulliparous, 16 hours (95% CI 12-22, P=.02). Other findings in the mifepristone compared with placebo group included rates of placental retention, 3.1% compared with 6.3% (P=.61), length of hospitalization, 0.66 days compared with 0.8 days (P=.23), and analgesic requirements, 27.2 mg compared with 39.3 mg morphine (P=.22). Side effects during induction were similar between groups.
                Addition of mifepristone in second-trimester termination inductions using misoprostol significantly reduces the abortion time interval.
                Clinicaltrials.gov, www.clinicaltrials.gov, NCT00382538
                I. The purpose of this study was to compare the efficacy and side effects of two different misoprostol regimens for second-trimester pregnancy termination. Sixty women in second trimester of gestation with indications for pregnancy termination were randomly assigned in two equal groups to receive either vaginal or oral misoprostol. The dosing regimen was 400 microg as the initial dose followed by 400 microg up to 3 doses (1200 microg) if needed in each group. Efficacy and side effects were compared. The percentage of women who delivered was significantly higher in vaginal group than the oral group (86.7 vs. 43.3 p = 0.0006). No significant differences in complication rates and induction to delivery interval were noted between the two groups. Vaginal administration of misoprostol resulted in a higher success rate for second trimester pregnancy termination, whereas, no significant differences in induction to delivery time and complication rates were noted between vaginal and oral groups. The purpose of this study was to compare the efficacy and adverse effects of vaginal misoprostol and intra-amniotic PGF2alpha for midtrimester abortion.
                One hundred thirty-two women between 12 and 24 weeks' gestation, seeking abortion in a tertiary hospital, were randomized to receive vaginal misoprostol (400 microg every 3 hours) or intra-amniotic PGF2alpha (carboprost 1.5 mg). Main outcome measures were induction-to-abortion interval, success rates at 24 and 48 hours, and adverse effects.
                Successful abortion rates at 24 and 48 hours between intra-amniotic PGF2alpha and vaginal misoprostol were not statistically different. However, vaginal misoprostol results in a significantly shorter mean induction-to-abortion interval, compared with intra-amniotic PGF2alpha (misoprostol: 16.2 hours; intra-amniotic PGF2alpha: 20.8 hours; P = .006), particularly among multiparous women (misoprostol: 13.1 hours; intra-amniotic PGF2alpha 18.3 hours; P = .011) and for gestation below 130 days (misoprostol: 14.6 hours; intra-amniotic PGF2alpha: 20.2 hours; P = .015). Fever and shivering were commoner with vaginal misoprostol.
                Vaginal misoprostol should be the regimen of choice for midtrimester abortion, particularly for multiparous women and women in the early second trimester. The management of second-trimester abortion is still not satisfactory with respect to safety and side-effects; it is considered to be in a state of evolution. The goal of this investigation has been to combine, in reduced quantity, prostaglandin and hypertonic saline in order to minimize the complications and side-effects associated with the separate administration of each component. This study documents the results of a random sample of 385 abortions performed in the second trimester, induced by intra-amniotic instillation of prostaglandin (20 mg) and NaCl 5 and 10 g in different volumes and concentrations augmented with oxytocin. In a series of 20 patients, the coagulation profile is presented and the clinical characteristics of 4 groups are compared. This study demonstrated no coagulation defects. The gastrointestinal side-effects were reduced. In spite of the reduced dosage of each component, the instillation abortion interval still remained 17.08 h on the average. Incomplete abortion ranged from 32% to 48.78%. The data presented in this report suggests that combination of prostaglandin, hypertonic saline and oxytocin is feasible for midtrimester abortion. To determine the more applicable of two ways of prostaglandin induction currently in use in second trimester induced abortions for congenital or chromosomal abnormalities.
                A prospective randomised controlled trial.
                Department of Obstetrics and Gynaecology, Tygerberg Hospital, CP.
                Twenty consecutive patients admitted for termination of pregnancy for congenital or chromosomal abnormalities between 14 and 26 weeks' pregnancy duration.
                Patients were randomly selected to receive either 1.5 mg prostaglandin E2 (PGE2) gel extra-amniotically or 25 mg prostaglandin F2 alpha (PGF2 alpha) intra-amniotically. Patients in both groups received oxytocin to a maximum dosage of 120 mU per minute if they had not aborted 18 hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 hours after commencement of treatment, management was considered unsuccessful.
                Proportion of successful inductions and complications.
                Complications of management were rare and did not differ between the two management groups. However, there were significantly more failures in the group who received intra-amniotic PGF2 alpha (7 v. 2 patients) as well as a significantly higher need for oxytocin in this group (10 v. 4 patients).
                With promising drugs such as prostaglandin analogues and anti-progesterones not universally available, methods of induction suitable to the local situation should be sought. Extra-amniotic PGE2 seems more suitable than intra-amniotic PGF2 alpha because of a shorter induction-to-delivery time without increased morbidity. Several studies have now reported the successful use of the sublingual administration of misoprostol for medical abortion in the first trimester. The objective of this study was to assess the acceptability to women, the efficacy of the regimen, as well as the acceptability to staff of sublingual versus vaginal administration of misoprostol following mifepristone for medical abortion at 13-20 weeks gestation.
                Women were randomized by opening consecutive sealed envelopes generated using random number tables. Mifepristone (200 mg) was followed 36-48 h later by sublingual administration of misoprostol 600 microg or vaginal misoprostol 800 microg. This was followed by 3 hourly doses of misoprostol 400 microg administered sublingually or vaginally.
                A total of 76 women were randomized. Of women in the sublingual group, 24 (66.7%) expressed satisfaction with the route of misoprostol administration compared with 25 (62.5%) in the vaginal group. A higher proportion in the sublingual group used intramuscular opiates. There was no significant difference in the surgical evacuation rate between the sublingual (three out of 36 women, 8.3%) and vaginal groups (one out of 40, 2.5%), (P=0.26) and acceptability to staff was the same for both methods.
                Sublingual administration of misoprostol following mifepristone is an acceptable and effective alternative to vaginal administration for medical abortion at 13-20 weeks gestation. However, women should be advised about the greater likelihood of requiring stronger analgesia. Sixty patients were randomized to low-dose and high-dose groups, receiving a maximum total dose 1400 g of misoprostol by the vaginal route to compare the efficacy of the protocols for second trimester termination of pregnancy. Outcome measures to be compared between the groups were success rates, time to termination, blood loss, complications and side-effects. Yet time to termination was significantly shorter in the high-dose than in the low-dose group (923 +/- 571 vs 1307 +/- 828 min; p < 0.05). The distance between the internal cervical os and the placenta was positively correlated with the duration of the termination process (r = 0.508, p < 0.001). Induction to the fetal expulsion period is shorter with the higher dose without any significant increase in morbidity. A shorter distance between the internal cervical os and the placenta may forecast a shorter termination process. To compare the efficacy, side effects and acceptability of sublingual and vaginal misoprostol for second trimester medical abortion.
                Prospective randomised controlled trial.
                Tertiary referral unit and a teaching hospital.
                Two hundred and twenty-four women at 12 to 20 weeks of gestation.
                The women were randomised to receive either sublingual or vaginal misoprostol 400 microg every 3 hours for a maximum of five doses. The course of misoprostol was repeated if the woman did not abort within 24 hours.
                The success rate at 48 hours, induction-to-abortion interval and the side effects.
                There was no significant difference in the success rate at 48 hours (sublingual: 91%; vaginal: 95%). However, the success rate at 24 hours was significantly higher in the vaginal group (85%) compared with the sublingual group (64%). There was no difference in the median induction-to-abortion interval (sublingual: 13.8 hours; vaginal: 12.0 hours). Significantly more women in the sublingual group preferred the route to which they were assigned when compared with the vaginal group. The incidence of fever was also less in the sublingual group.
                The use of vaginal misoprostol for second trimester medical abortion resulted in a higher success rate than sublingual misoprostol at 24 hours but the abortion rate was similar at 48 hours. Vaginal misoprostol should be the regimen of choice but sublingual misoprostol is also an effective alternative. Sublingual misoprostol has been shown to be effective in medical abortion. A prospective double-blinded placebo-controlled trial was done to compare the efficacy and side-effects of sublingual to oral misoprostol when used with mifepristone for medical abortion from 12 to 20 weeks gestation.
                A total of 120 women at 12-20 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either sublingual or oral misoprostol 400 mg every 3 h for a maximum of five doses 36-48 h later. The course of misoprostol was repeated if the woman did not abort within 24 h.
                There was no significant difference (P = 0.43) in the success rate at 24 h [relative risk = 1.075; 95% confidence interval (CI): 0.94-1.19]. Abortion occurred in 91.4% in the sublingual group (95% CI: 81.0-96.7%) as compared to 85.0% (95% CI: 73.7-92.1%) in the oral group. The median induction-to-abortion interval was significantly shorter (P = 0.009) in the sublingual group (5.5 h) as compared to the oral group (7.5 h). The incidence of fever was higher in the sublingual group (P < 0.0001). The incidences of other side-effects were similar.
                Sublingual misoprostol, when combined with mifepristone, is effective for medical abortion in the second trimester. The induction-to-abortion interval is shorter when sublingual misoprostol is used when compared to oral misoprostol. Second trimester abortion was induced in 92 women by extra-amniotic instillation of Rivanol and/or PGF2alpha followed by intravenous oxytocin after 24 hours. All instillations were made via a catheter with a balloon filled with 30 ml and left in place until abortion, but never for more than 24 hours. Induction was started by Rivanol alone (n = 23), PGF2alpha alone (n = 23), Rivanol combined with PGF2alpha (n = 23), or Rivanol combined with half dose PGF2alpha (n = 23) and the patients were allotted to the different groups in a random manner. The Rivanol solution was instilled as a single dose but PGF2alpha was instilled every 2nd hour for 24 hours. The mean induction-abortion time was similar in all 4 groups but a number of patients given PGF2alpha alone or in combination with Rivanol aborted earlier than patients induced by Rivanol alone, during the period before intravenous oxytocin was administered. Gastrointestinal side effects were equally common after Rivanol as after PGF2alpha. With the methods and doses used in the present investigation PGF2alpha alone or combined with Rivanol with subsequent oxytocin had no over-all advantage over Rivanol. A comparison of ethacridine lactate and prostaglandin E2 (PGE2) with or without oxytocin infusion in second trimester medical abortion cases.
                A prospective study was performed on 151 women requiring second trimester medical abortions between 1989 and 1995. Patients were randomly assigned to PGE2 group (n = 30), ethacridine lactate group (n = 48), ethacridine lactate combined with oxytocin infusion group (n = 49) and PGE2 combined with oxytocin infusion group (n = 24). Rates of successful abortion (i.e., complete evacuation of fetal and placental tissues from the uterus) within 24 hours for each group were determined and compared by chi2 and the Student t-test.
                Statistically significant difference concerning successful abortion rates was observed between ethacridine lactate and PGE2 groups, PGE2 and PGE2+oxytocin infusion groups, and ethacridine lactate+oxytocin infusion and PGE2 groups, while there was no significant difference between ethacridine lactate and ethacridine lactate+oxytocin infusion groups, ethacridine lactate and PGE2+oxytocin infusion groups, and PGE2+oxytocin infusion and ethacridine lactate+oxytocin infusion groups.
                Extra-amniotic ethacridine lactate instillation alone and intracervical PGE2 gel application are effective and safe methods for second trimester abortion. To compare the effectiveness of vaginal misoprostol administered 6 or 12 hourly for second trimester pregnancy termination.
                A randomised controlled trial.
                University teaching hospital.
                Two hundred and seventy-nine pregnant women at gestations between 14 and 26 weeks undergoing pregnancy termination.
                Women were randomised to receive 600-microg misoprostol tablets vaginally either every 6 hours or every 12 hours until abortion occurred.
                Induction-abortion interval, success rate within 24 and 48 hours and adverse effects.
                There was no significant difference in the median induction to abortion interval 6 hours (16 hours) and 12 hours (16 hours; P= 0.80). The total dose of misoprostol was higher in the 6-hour group (1800 vs 1200 microg). The cumulative abortion rates within 24 hours were 74% and 67% and within 48 hours 94% and 92%, in the 6- and 12-hour groups, respectively. Fever was more common in the 6-hour group (53%) versus the 12-hour group (31%; P < 0.001). The incidence of nausea, vomiting, diarrhoea, severe bleeding and abdominal pain were similar.
                Misoprostol (600 microg) administered at 12-hour intervals was associated with fewer adverse effects and was as effective as a 6-hour interval. Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration.
                To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion.
                A randomised comparative trial where 300 women at 13-20 weeks gestation, requiring medical abortion, were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of 400 microg three-hourly, up to a maximum five doses over 24 h. The same doses were repeated for another 24 h in non-responders. Primary outcome measure was complete abortion rate at 24 and 48 h, and the secondary outcome measures were induction-abortion interval, failure rate, side-effects and patients' preference to the route.
                No statistically significant differences in the complete abortion rates were observed at 24 h (64.03% vs 61.59%, P = 0.767) and at 48 h (79.14% vs 82.01%, P = 0.651) when sublingual and vaginal groups were compared. Mean induction-abortion intervals in sublingual and vaginal groups were 14.1 and 14.5 h, respectively (P = 0.066). Other outcome measures were also more or less similar in both groups. Differences in the incidence of side-effects were also statistically insignificant when both groups were compared. Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration (P < 0.0001).
                Both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients. The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion.
                Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects.
                There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group.
                Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval. A prospective randomized trial was conducted in 148 women to compare the efficacy of two regimens of vaginal misoprostol for termination of second trimester pregnancy. Women aged 16-40 years requesting termination of second trimester pregnancy were randomized into two groups. Women in group 1 were given vaginal misoprostol 400 microg every 3 h for a maximum of five doses in 24 h. Women in group 2 were given vaginal misoprostol 400 microg every 6 h for a maximum of three doses in 24 h. If women did not abort in 24 h, the same regimen was repeated. The median induction-abortion interval in group 1 (15.2 h) was significantly shorter (P < 0.01) than that in the group 2 (19.0 h). The percentage of women who achieved successful abortion within 48 h in group 1 (90.5%) was also significantly higher (P < 0.02) than that in group 2 (75.7%). The incidence of fever was more common in group 1 (P = 0.01). It is concluded that the regimen of vaginal misoprostol 400 microg every 3 h with maximum of five doses in 24 h was more effective than the regimen of misoprostol every 6 h in termination of second trimester pregnancy. Seventy-eight women underwent induced mid-trimester abortion. Fifty-two women aborted after an intra-amniotic injection of 1 g oxytetracycline hydrochloride. The control group comprised 16 women who received an intra-amniotic injection of hypertonic saline and 9 women with prostaglandin F2 alpha. All but 2 women aborted after one injection. Thirty-five women of the oxytetracycline hydrochloride group received intravenous oxytocin after the appearance of uterine contractions, 17 did not. The mean injection abortion interval in the women who received intravenous oxytocin was 38.6 +/- 2.7 h, whereas in the group without oxytocin it was 31.3 +/- 2.3 h. There is no statistically significant difference between these two groups (p less than 0.2). The mean injection abortion interval in the hypertonic saline group was 18.4 +/- 2.2 h. In the F2 alpha group it was 13.2 +/- 1.3 h. There is no statistically significant difference between hypertonic saline and prostaglandins (p less than 0.2). The mean injection abortion interval is significantly shorter in the F2 alpha and hypertonic saline groups as compared to the oxytetracycline hydrochloride group (p less than 0.001). It is advisable therefore to use oxytetracycline hydrochloride only in cases when the use of F2 alpha or hypertonic saline is contraindicated. To identify an effective misoprostol-only regimen for the termination of second trimester pregnancy, we compared sublingual and vaginal administration of multiple doses of misoprostol in a randomized, placebo-controlled equivalence trial.
                Six hundred and eighty-one healthy pregnant women requesting medical abortion at 13-20 weeks' gestation were randomly assigned within 11 gynaecological centres in seven countries into two treatment groups: 400 microg of misoprostol administered either sublingually or vaginally every 3 h up to five doses, followed by sublingual administration of 400 microg misoprostol every 3 h up to five doses if abortion had not occurred at 24 h after the start of treatment. We chose 10% as the margin of equivalence. The primary end-point was the efficacy of the treatments to terminate pregnancy in 24 h. Successful abortion within 48 h was also considered as an outcome along with the induction-to-abortion-interval, side effects and women's perceptions on these treatments.
                At 24 h, the success (complete or incomplete abortion) rate was 85.9% in the vaginal administration group and 79.8% in the sublingual group (difference: 6.1%, 95% CI: 0.5 to 11.8). Thus, equivalence could not be concluded overall; the difference, however, was driven by the nulliparous women, among whom vaginal administration was clearly superior to sublingual administration (87.3% versus 68.5%), whereas no significant difference was observed between vaginal and sublingual treatments among parous women (84.7% versus 88.5%). The rates of side effects were similar in both groups except for fever, which was more common in the vaginal group. About 70% of women in both groups preferred sublingual administration.
                Equivalence between vaginal and sublingual administration could not be demonstrated overall. Vaginal administration showed a higher effectiveness than sublingual administration in terminating second trimester pregnancies, but this result was mainly driven by nulliparous women. Fever was more prevalent with vaginal administration. Registered with International Standard Randomized Controlled Trial number ISRCTN72965671. To compare the use of 600 and 200 mg mifepristone prior to second trimester termination of pregnancy with the prostaglandin misoprostol.
                A randomised study.
                A Scottish teaching hospital.
                Seventy women undergoing legal induced abortion between 13 and 20 weeks of gestation.
                Administration of either 600 or 200 mg mifepristone 36 to 48 hours prior to prostaglandin.
                Induction-abortion interval.
                The geometric mean induction abortion interval was 6.9 (95% CI 5.8-8.4) h and 6.9 (95% CI 5.8-8.2) h in the 600 and 200 mg groups, respectively (no significant difference). The median dose of misoprostol was 1600 micrograms (three doses) in each group. Analgesic requirements and prostaglandin-related side effects were similar between groups. Overall, 11.4% of women required surgical evacuation of the uterus as a result of retained placenta.
                The dose of mifepristone used in second trimester abortion can be reduced from 600 to 200 mg. Two regimens of the prostaglandin E1 analogue, gemeprost, in combination with mifepristone were compared in a randomised trial for termination of pregnancy between 12-19 weeks. Thirty-six hours after treatment with 200 mg mifepristone, women were allocated at random to receive either 4 x 1 mg (Group I) or 4 x 0.5 mg (Group II) gemeprost by vaginal pessary every 6 hours (n = 50 in each group). If abortion had not occurred after 24 h, 5 x 1 mg of gemeprost was administered every 3 h to both groups of women. Although the median abortion interval was slightly shorter in the 1 mg group (7.8 h vs. 8.4 h, p = 0.5), the cumulative abortion rates at 24 h were similar (98% vs. 96%). Women in Group I required significantly more gemeprost to induce abortion than Group II (p < 0.0001). Parous women in both groups required significantly less of the prostaglandin to induce abortion. In Group II, the median abortion interval was significantly longer in primigravidae than multigravidae (9.5 h vs. 6.1 h; p < 0.02). There were no significant differences between the groups in the incidence of vomiting, diarrhoea or the request for analgesia. The results suggest that in parous women, the dose of gemeprost can be reduced to 0.5 mg every 6 h within the first 24 h without loss of clinical efficacy. To compare the effectiveness of gemeprost and misoprostol as prostaglandins used in combination with mifepristone for induction of mid-trimester termination.
                Randomised trial.
                Scottish teaching hospital.
                One hundred women undergoing abortion between 12 and 20 weeks.
                Each woman received 200 mg mifepristone and 36-48 hours later either 1 mg gemeprost vaginal pessary every 6 hours for 18 hours or 4 x 200 microg misoprostol tablets vaginally followed by 2 x 200 microg misoprostol tablets orally every 3 hours for 12 hours. Success was defined as the percentage of women aborted within 24 hours of the first administration of prostaglandin.
                Prostaglandin-abortion interval and side effects.
                There were no significant differences in median prostaglandin-abortion interval between gemeprost (6.6 hours 95% CI 6.0-10.7) and misoprostol (6.1 hours 95% CI 5.5-7.5) (P = 0.22). The cumulative abortion rates at 24 hours (96% vs 94%, respectively), the surgical evacuation rates (12% and 10%) and the incidence of vomiting, diarrhoea and pain were similar.
                Two hundred milligrammes of mifepristone followed 36-48 hours later by either vaginal gemeprost or misoprostol is a highly effective way of inducing abortion in the second trimester of pregnancy. The combination of mifepristone (RU486) and prostaglandin is effective in the induction of abortion in the second trimester. The optimal regimen is still under development, but is likely to be characterized by a short induction-to-abortion interval, low incidence of side-effects and high acceptability. We have investigated further whether misoprostol, a synthetic prostaglandin E1 analogue, can reliably induce second trimester abortion in 70 women pre-treated with mifepristone, and whether different routes of administration affect the induction-to-abortion interval. Abortion was achieved in 97% [95% confidence interval (CI) 90-100%] of cases without resort to other prostaglandin agents. The mean induction abortion time for the studied population was 6.4 h (95% CI 5.6-7.0 h). No significant difference was found between two different routes of administration, namely vaginal versus a combination of vaginal and oral. Misoprostol has a number of advantages over other prostaglandin preparations. We recommend that, following pre-treatment with mifepristone, misoprostol is used as the prostaglandin of choice to induce abortion in the second trimester. It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment, the vaginal route is more effective than the oral route. However, women prefer the oral route. This randomized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone. A total of 142 patients was randomly assigned to group 1 (200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses) or group 2 (200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses). The incidence of side-effects and the preference study were assessed through a standardized questionnaire during and after the abortion. For the oral group, both the incidence of diarrhoea (40.0 versus 23.2%, P = 0.03) and the amount of drug used (1734 compared with 812 microg, P < 0.0001) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower (not significant). There was no significant difference in complete abortion rate: 81.4% in the oral group and 75.4% in the vaginal group. The median induction-abortion interval was similar in the two groups (10.4 versus 10.0 h). The percentage of women who aborted in 24 h was also similar: 57/70 (81.4%) in the oral group and 58/69 (87.0%) in the vaginal group. Overall, 82.0% of women preferred the oral route. Oral misoprostol (400 microg) given every 3 h up to five doses, when combined with mifepristone, was as effective as the vaginal (200 microg) route in second trimester termination of pregnancy. This regimen could also be offered to those women who found repeated vaginal administration unacceptable. The most frequently used method for second trimester termination of pregnancy is administration of gemeprost (16, 16-dimethyl-trans delta 2-prostaglandin E1methyl ester) as a vaginal pessary. This provides a safe and effective method for achieving abortion. The current prescribing advice is to insert the pessaries into the posterior vaginal fornix every 3 hours. This study compares this to a 6-hourly regimen. The median abortion interval in the 6-hour group was shorter than the 3-hour group (15 versus 16 hours respectively) but the cumulative abortion rates were similar (98% in the 3-hour group and 91.8% in the 6-hour group). The 6-hour group required a significantly lower total dose of gemeprost to induce abortion. There was no difference in the rates of side-effects in the 2 groups but those receiving pessaries every 6 hours required less analgesia. This study finds no advantage in giving gemeprost every 3 hours. A prospective randomized trial was conducted in 140 women to compare the efficacy of vaginal gemeprost with vaginal misoprostol for termination of second trimester pregnancy. Women requesting termination of second trimester pregnancy were randomized into two groups. Group A women were given 1 mg vaginal gemeprost every 3 h for a maximum of five doses in the first 24 h, whereas group B women were given 400 micrograms vaginal misoprostol every 3 h for a maximum of five doses in 24 h. The median induction-abortion interval in the vaginal misoprostol group (14.1 h) was significantly shorter than that in the gemeprost group (19.5 h). The percentage of women who achieved successful abortion within 24 h in the misoprostol group (80.0%) was significantly higher than that in the gemeprost group (58.6%). There was no significant difference in the incidence of side effects between the two groups except for diarrhea, which was more common in the gemeprost group. The incidence of fever was more common in the misoprostol group. It is concluded that vaginal misoprostol is more effective than gemeprost in termination of second trimester pregnancy. Our purpose was to compare the effectiveness, women's views of the termination procedure, and success of umbilical cord culture for vaginal and oral misoprostol versus intra-amniotic prostaglandin PGF(2alpha) for second-trimester pregnancy termination (STPT).
                We randomized 217 women, 15 to 24 weeks' gestation, into 3 groups. Oral (OM) and vaginal (VM) misoprostol groups received 400 microg of misoprostol every 4 hours for 24 hours. The intra-amniotic PGF(2alpha) (IAPG) group received 40 mg of PGF(2alpha) followed by oxytocin infusion. Women completed self-administered questionnaires 3 weeks after the termination procedure. Umbilical cord samples were collected at delivery for karyotype analysis. The primary outcome was the time from start of the procedure to placental delivery. Secondary outcomes were maternal complications, women's acceptance of the termination procedure, and success rates of umbilical cord culture.
                The time was longer for the OM group (30.5+/-14.4 hours) compared with the VM group (18.3+/-8.2 hours) and the IAPG group (21.1+/-10.2 hours), P<.001 for both comparisons. Women in the VM group reported being more willing to repeat the termination method in the future and reported fewer side effects than those in the other groups, P<.001. Failure rates for umbilical cord cultures were 9.6%, 17.0%, and 45.6% for the VM, OM, and IAPG groups, respectively.
                Oral misoprostol is less effective than intra-amniotic PGF(2alpha) or vaginal misoprostol for STPT. Women report vaginal misoprostol more acceptable than other methods. Umbilical cord culture failure rate is highest in the IAPG group. Second trimester abortion was induced in a randomized investigation using a single dose of prostaglandin F2alpha (PGF2alpha) in combination with oxytocin in one group of patients, and hypertonic saline (20%) in combination with oxytocin in another group of patients. Oxytocin was administered in order to induce a rapid abortion, and was given intravenously in a glucose drip (100 I.U. oxytocin added to 1 litre of 5% glucose). Administration rate was 10 I.U./hour. The PG-group consisted of 16 patients. The mean induction-abortion interval for this group was 14.2 hours, and all patients aborted within 24 hours. In three cases the bleeding exceeded 200 ml. In one of these cases infection occurred. Only mild side effects occurred. The saline group also consisted of 16 patients. The mean induction-abortion interval in this group was 21.5 hours. Eleven patients aborted within 24 hours. In two cases the bleeding exceeded 200 ml. No side effects occurred. Intraamniotic instillation of PGF2alpha seems to be a good alternative to hypertonic saline for termination of second trimester pregnancies. To compare the abortifacient efficacies of two intravaginally administered misoprostol doses and gemeprost in termination of second-trimester pregnancy.
                Eighty-one women between 12 and 24 weeks' gestation requesting abortion were randomized to receive intravaginally either 100 micrograms of misoprostol at 6-hour intervals (n = 27), 200 micrograms of misoprostol at 12-hour intervals (n = 26), or 1.0 mg of gemeprost at 3-hour intervals (n = 28). The regimen was continued until abortion, or for 36 hours, with assessment of the rate of complete and incomplete abortions as well as side effects within 48 hours from the start of the treatment.
                The final rates of terminations were 74% in the 100-microgram misoprostol group, 92% in the 200-microgram misoprostol group, and 89% in the gemeprost group. Abortion was complete in 37%, 61%, and 32% in each group, respectively (P = .03, when the 200-microgram misoprostol group was compared with the two other groups). The induction-to-abortion interval was longer (P = .001) in the misoprostol groups (mean 23.1 hours for the 100-microgram and 27.8 hours for the 200-microgram dose) than in the gemeprost group (14.5 hours). There was less pain (P = .01), diarrhea (P = .001), and vomiting (P = .01) in the misoprostol groups than in the gemeprost group. The mean blood loss in the misoprostol groups was lower than in the gemeprost group (P = .001).
                Intravaginal application of 200 micrograms of misoprostol at 12-hour intervals in induction of second-trimester abortion is equally effective to a standard gemeprost regimen. Misoprostol causes fewer side effects and is cheaper and more practical to use. The objective of this work was to study the abortifacient effects of misoprostol, an orally active prostaglandin E1 (PGE1) analogue, in the second trimester. A randomized study of two prostaglandin regimens in women pre-treated with the antiprogesterone mifepristone was carried out in the gynaecological wards of Aberdeen Royal Hospitals, NHS Trust, and included 60 women at 13-20 weeks' gestation, in whom termination of pregnancy had been agreed. Following pre-treatment with mifepristone 600 mg women were randomly allocated to one of two prostaglandin regimens which started 36-48 h later. The first misoprostol 400 micrograms orally (up to three doses) followed by gemeprost vaginal pessary 1 mg up to two doses. The second was gemeprost vaginal pessary 1 mg up to five doses. The main outcome measures were success rate induction-to-abortion interval and side-effects. There were no significant differences between the two groups in any of the main outcome measures. We conclude that misoprostol is a stable, cheap PGE1 analogue with demonstrable efficacy and acceptable side-effects in the management of second trimester abortion. Further work is needed to establish the optimum dose and regimen. To compare effectiveness of misoprostol and ethacridine lactate with or without oxytocin in second-trimester medical abortions.
                A randomized prospective study. A total of 388 women with genetic indications for termination of pregnancy at 13-24 weeks of gestation were recruited. Group I (n=85) were treated with extra-amniotic ethacridine lactate, 10 ml instilled per gestational week, to a maximum of 200 ml. Group II (n=93) were treated with misoprostol administered intravaginally (200 microg), followed by 100 microg of oral misoprostol 4 hourly for 24 h. Group III (n=102) were treated with a combination of ethacrine lactate and oxytocin. An initial dose of 6 mU/min oxytocin was given, followed by additional 6 mU/min doses every 20 min. Group IV (n=96) were treated with a combination of misoprostol and oxytocin administered in a similar way as in group III. The main outcome measures were time to induce abortion, side effects, and failure/success rates.
                The mean time to induce abortion was 14.2+/-3.6, 13.2+/-3.4, 10.8+/-2.6, and 9.9+/-2.4 h in groups I, II, III, and IV, respectively (p<0.001). Addition of oxytocin to ethacridine lactate did not decrease the risk of prolongation of induction beyond 24 h but use of oxytocin with misoprostol did reduce the risk of induction beyond 24 h (OR: 0.46, 95%CI: 0.21-1, p<0.05). The occurrence of minor side effects was similar in all groups.
                Addition of oxytocin to ethacridine lactate or misoprostol significantly decreases the length of time to induce abortion without supplementary side effects. To compare the effectiveness of vaginal misoprostol between dry tablet insertion and gel form for second trimester pregnancy termination.
                A non-blinded block randomized controlled trial was conducted on 148 pregnant women with live fetuses in the second trimester undergoing pregnancy termination. They were randomly allocated to receive vaginal misoprostol (400 microg) either dry tablet insertion (n=72) or gel form (n=76). The same dose was then repeated every 3 h if adequate uterine contraction was not achieved until 48 h after the initiation of misoprostol. If abortion did not occur within this period, the treatment was considered a failure and other technique of termination was then given based on the decision of the attending physicians and the cervical status.
                The mean induction-abortion interval in group 1 (20.9+/-12.3 h) was not significantly different from that in group 2 (17.7+/-10.2 h). The mean total dose of misoprostol was also not significantly different between the two groups (group 1, 1556.9 microg; group 2, 1350.9 microg), but the adverse effects of misoprostol (chill and diarrhoea) were more common in the gel group.
                Tablet insertion or gel form of vaginal misoprostol have similar effectiveness but the gel form was associated with more common adverse effects. Data is presented for 40 mid-trimester abortions, induced by 0.1% Emcredil (Group 1--20 cases) and normal saline (Group 2--20 cases) by instillation in the extraamniotic space. It was observed that the 2 groups were comparable for age, parity and period of gestation. The mean induction-abortion interval was 18 hours 9 minutes in Group 1 and 19 hours 19 minutes in Group 2. Abortion was complete in 45% and 65% in Group 1 and Group 2, respectively. With a cutoff time of 30 hours, there were 3 failures, 1 in Group 1 and 2 in Group 2. The induction-abortion interval was significantly less in the more advanced pregnancies in the saline group. There was no complication in either of the 2 groups. It is hypothesized that normal saline also acts by damage of the decidual cells with liberation of prostaglandins locally. Also since normal saline is a cheap and easily available commodity with no contraindication for its use and no side-effects, it seems to hold a lot of promise for induction of mid-trimester abortion. To compare the efficacy of vaginal with oral misoprostol in termination of second-trimester pregnancy after pretreatment with mifepristone.
                Women requesting termination of second-trimester pregnancy were randomized into two groups. Thirty-six to 48 hours after oral administration of 200 mg of mifepristone, women were given either oral or vaginal misoprostol 200 microg every 3 hours for a maximum of five doses in the first 24 hours. Women receiving oral misoprostol also were given a vaginal placebo (vitamin B6), whereas those receiving vaginal misoprostol were given an oral placebo. If they failed to abort, a second course was given by the same route.
                The median induction-abortion interval in the vaginal group (9 hours) was significantly shorter than that in the oral group (13 hours). The percentage of women aborting within 24 hours in the vaginal group (90%) was significantly higher than that in the oral group (69%). The median amount of misoprostol used in the vaginal group (600 microg) also was significantly less than that in the oral group (1000 microg). There was no significant difference in the incidence of side effects between the two groups except for fatigue and breast tenderness, which were more common in the oral group. Seventy-six percent of the women preferred the oral route, and 24.5% of the women preferred the vaginal route.
                Vaginal misoprostol is more effective than oral misoprostol in termination of second-trimester pregnancy after pretreatment with mifepristone, but more women preferred the oral route. To compare intramuscular (IM) prostaglandin 15 methyl-F2 alpha (15M-PGF2 alpha) with prostaglandin E2 (PGE2) vaginal suppositories for second-trimester abortion in terms of efficacy and side effects.
                Fifty-one women were randomized to receive either 15M-PGF2 alpha IM injections or PGE2 intravaginal suppositories for second-trimester abortion. Efficacy and side effects of the two agents were analyzed by two-tailed t tests, chi 2 analysis with Fisher exact test, and survival analysis.
                The mean times to rupture of membranes, delivery of fetus, and delivery of placenta were significantly less for women receiving PGE2 vaginal suppositories. The cumulative abortion rate after 24 hours for the PGE2 group was 96%, compared with 69% for the 15M-PGF2 alpha group. Although there were few differences in side effects, the 15M-PGF2 alpha group had significantly fewer headaches, fevers, and chills.
                Intravaginal PGE2 is superior to IM 15M-PGF2 alpha for second-trimester abortion. A prospective randomized study was conducted to compare the efficacy of misoprostol with gemeprost when combined with mifepristone for termination of second trimester pregnancy. Patients requesting termination of second trimester pregnancy were randomized into two groups. In both groups of patients, 200 mg of mifepristone was given 36 to 48 hours before the administration of prostaglandins. In Group 1, the women were given 400 micrograms of oral misoprostol every 3 hours up to 5 doses. In Group 2, patients were given 1 mg of vaginal gemeprost every 6 hours up to 4 doses. The main outcomes measured were the induction-abortion intervals (the interval between the first dose of prostaglandin and abortion) and the incidence of side effects. Altogether, 50 subjects were recruited with 25 women in each group. The mean age and parity of the women and the mean gestational age of the two groups of women were comparable. There was no significant difference in the median induction-abortion intervals (8.7 hours in Group 1 and 10.8 hours in Group 2) or the incidence of side effects between the two groups of patients. We conclude that misoprostol is as effective as gemeprost in termination of second trimester pregnancy when combined with mifepristone. Our purpose was to compare the efficacy of oral misoprostol with that of vaginal misoprostol for midtrimester termination of pregnancy.
                Women seen for midtrimester pregnancy termination were randomly assigned to receive either misoprostol orally in a dose of 200 microg every hour for 3 hours followed by 400 microg every 4 hours or vaginally in a dose of 400 microg every 4 hours. The protocol was followed for 24 hours, after which time further management was at the discretion of the attending physician. The primary outcome measure was the induction-to-delivery interval. Sample size was calculated a priori. Statistical analysis was performed with the t test for continuous variables and the chi(2) test for categorical variables. P <.05 was considered significant.
                One hundred fourteen women were randomized, with 49 receiving vaginal misoprostol and 65 receiving oral misoprostol. The two groups were comparable with respect to maternal age, parity, indication for pregnancy termination, gestational age, and maternal weight. The mean induction-to-delivery interval was significantly shorter for the vaginal group (19.6 +/- 17.5 hours vs 34.5 +/- 28.2 hours, P <.01). Length of stay was also shorter in the vaginal group (32.3 +/- 17.3 hours vs 50.9 +/- 27.9 hours, P <.01). Significantly more patients in the vaginal group were delivered within 24 hours (85.1% vs 39.5%, P <.01), and more patients in the oral group required changes in the method of induction when they were undelivered after 24 hours (38.2% vs 7%, P <.01). The only complication was an increase in febrile morbidity in the vaginal group (25% vs 6.7%, P =.046). This did not result in an increased use of antibiotics, and all the fevers resolved post partum without further complications.
                Vaginal administration of misoprostol resulted in a shorter induction-to-delivery interval. The shorter length of stay should result in improved patient care. For the purpose of reducing the side effects and complication rate when inducing second trimester abortion, intracervically administered PGE2 gel was tested for the first time and compared with a single intraamniotic instillation of PGF2 alpha by a randomized allocation of 41 consecutive patients in the 13th to 24th week of gestation. In both groups the treatment was supplemented with oxytocin 5 - 6 hours after starting the induction. The methods proved of equal value as regards the abortion success rate and the induction-abortion interval, whereas the incidence of gastrointestinal side effects on intracervical application of PGE2 gel was only half as high and the occurrence of diarrhea significantly lower (p less than 0.05) with this non-invasive method than with intraamniotic PGF2 alpha. Intracervical PGE2 gel also possessed other advantages, being int. al. more acceptable by the patients and technically easier to administer. The object of this study was to compare intravaginal misoprostol and dinoprostone (prostaglandin E2) for second-trimester pregnancy termination, and to examine the role of the nitric oxide donor, glyceryl trinitrate, as a possible alternative to prostaglandins to induce cervical ripening in second-trimester pregnancy termination. This was a randomised clinical trial. The trial involved pregnant women between 13 and 28 weeks' gestation admitted with clear medical or obstetric indications for pregnancy termination, and was carried out in the department of obstetrics and gynecology, Assiut University Hospital, Egypt. Patients were classified into Group A, where pregnancy termination was induced by vaginal misoprostol 100 micrograms every 4 hours with a maximum dose of 500 micrograms; Group B, where induction was by vaginal dinoprostone 6 mg every 6 hours with a maximum dose of 24 mg; and Group C, where induction involved vaginal glyceryl trinitrate 500 micrograms every 6 hours with a maximum dose of 2.5 mg. Twenty-four hours after the start of induction, the rate of complete abortion in the three groups was 100%, 66.67% and 0%, respectively. The rate of complete abortion was 100% in the nitric oxide (glyceryl trinitrate)-induced group after introducing a complementary procedure. The induction-abortion interval was significantly shorter, the number of doses needed was less and the maximum Bishop score reached was greater with misoprostol than with dinoprostone. A higher rate of side effects occurred with the misoprostol-induced group (74%) compared with the other two groups (46.6% and 0%). Misoprostol is a cheap, effective drug for second-trimester pregnancy termination with short induction abortion intervals but a higher rate of side effects. Prostin E2 is also effective in termination of second-trimester pregnancy but is expensive and may require high doses to be administered. Glyceryl trinitrate is an effective drug for cervical ripening (softening) but it has no role in the stimulation of uterine contractions. The use of gemeprost (16,16 dimethyl-PGE1-methyl ester) pessaries was compared in an open, randomized single-centre trial with the intra-amniotic injection of PGF2 alpha combined with hypertonic saline, intravenous oxytocin and a hygroscopic cervical dilator (Dilapan) for the termination of pregnancy between 14 and 20 weeks. There was no significant difference in the induction-delivery interval for the two groups. With the exception of an increased incidence of diarrhoea in the gemeprost group, there was no significant difference in other side effects, analgesic requirements or retained placentae. Gemeprost pessaries are an effective alternative to the more invasive methods previously used for the induction of second-trimester termination.
Medical abortion in the second trimester using the combination of mifepristone and misoprostol appeared to have the highest efficacy and shortest abortion time interval. Where mifepristone is not available, misoprostol alone is a reasonable alternative. The optimal route for administering misoprostol is vaginally, preferably using tablets at 3-hourly intervals. Apart from pain, the side-effects of vaginal misoprostol are usually mild and self limiting. Conclusions from this review are limited by the gestational age ranges and variable medical regimens, including dosing, administrative routes and intervals of medication, of the included trials.