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PubMed2000

Vaginal misoprostol for cervical ripening and labour induction in late pregnancy.

BACKGROUND: Although not yet registered for such use, misoprostol has been widely used for obstetric and gynaecological indications, such as induction of abortion and of labour. OBJECTIVES: The objective of this review was to assess the effects of vaginal misoprostol for third trimester cervical ripening or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and reference lists of articles were searched. SELECTION CRITERIA: Randomised trials comparing vaginal misoprostol with other methods of cervical ripening or labour induction, placebo or no treatment in women due for third trimester induction of labour. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done by both reviewers. MAIN RESULTS: Twenty-six studies were included. Compared to placebo, misoprostol was associated with increased cervical ripening (relative risk of unfavourable or unchanged cervix after 12 to 24 hours with misoprostol 0.20, 95% confidence interval 0.07 to 0.61). It was also associated with a reduced need for oxytocin (relative risk 0.47, 95% confidence interval 0.23 to 0.96). Misoprostol was more effective than prostaglandin E2 for labour induction (relative risk of failure to achieve vaginal delivery in 24 hours 0.70, 95% confidence interval 0.62 to 0.79). Oxytocin augmentation was used less often with misoprostol than with prostaglandin E2 (relative risk 0.64, 95% confidence interval 0.58 to 0.71). Uterine hyperstimulation and meconium stained liquor were more common with misoprostol than with prostaglandin E2. Lower doses of misoprostol compared to higher doses did not show significant differences except for more need for oxytocin augmentation and less uterine hyperstimulation without fetal heart rate changes. REVIEWER'S CONCLUSIONS: Vaginal misoprostol appears to be more effective in inducing labour than conventional methods of cervical ripening and labour induction. The apparent increase in uterine hyperstimulation is of concern. The studies were not large enough to exclude the possibility of rare but serious adverse effects.

Cervical Ripening↗
PubMed2000

Oral misoprostol for induction of labour with a viable fetus.

BACKGROUND: Misoprostol is a synthetic prostaglandin which has been used to induce labour. Oral use of the drug misoprostol may be convenient, but an overdose could cause uterine hyperstimulation and precipitate labour which may be life-threatening for both mother and fetus. OBJECTIVES: The objective of this review was to assess the effects of oral misoprostol used for labour induction in women with a viable fetus. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. SELECTION CRITERIA: Randomised trials of oral misoprostol versus any other method, placebo or no treatment given to women with a viable fetus for induction of labour. DATA COLLECTION AND ANALYSIS: The selection of trials and data extraction were undertaken by one reviewer and independently checked by two other reviewers. MAIN RESULTS: Five trials were included. In one placebo trial, oral misoprostol reduced the need for oxytocin infusion and shortened delivery time in women with prelabour rupture of membranes at term. In another trial, compared to vaginal prostaglandins, oral misoprostol reduced the need for oxytocin (relative risk 0.62, 95% confidence interval 0.47 to 0.82). Based on two trials, the caesarean section rate with oral misoprostol was 20. 2% (55/272) compared with 15.5% (42/270) for vaginal prostaglandins (relative risk 1.29, 95% confidence interval 0.90 to 1.86). Different doses (100 micrograms three hourly and 200 micrograms six hourly) were used in the two trials that compared oral with vaginal misoprostol. The caesarean section rate was 21.8% in the oral misoprostol group compared with 13.5% for vaginal misoprostol (relative risk 1.62, 95% confidence interval 0.85 to 3.09). The uterine hyperstimulation rate with oral misoprostol was 37.5% (36/96) compared with 28% (25/89) for vaginal misoprostol (relative risk 1.32, 95% confidence interval 0.86 to 2.04). There was significant heterogeneity between these two trials. REVIEWER'S CONCLUSIONS: Oral misoprostol may be an effective method for labour induction. However clinically effective oral regimens may have an unacceptably high incidence of uterine hyperstimulation and possibly uterine rupture.

Female↗
PubMed2005

Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol.

OBJECTIVE: The purpose of this study was to compare the efficacy and safety of stepwise oral misoprostol vs vaginal misoprostol for cervical ripening before induction of labor. STUDY DESIGN: Two hundred and four women between 32 to 42 weeks of gestation with an unfavorable cervix (Bishop score < or = 6) and an indication for labor induction were randomized to receive oral or vaginal misoprostol every 4 hours up to 4 doses. The oral misoprostol group received 50 microg initially followed by 100 microg in each subsequent dose. The vaginal group received 25 microg in each dose. The primary outcome was the interval from first misoprostol dose to delivery. Patient satisfaction and side effects were assessed by surveys completed after delivery. RESULTS: Ninety-three (45.6%) women received oral misoprostol; 111 (54.4%) received vaginal misoprostol. There was no difference in the average interval from the first dose of misoprostol to delivery in the oral (21.1 + 7.9 hrs) and vaginal (21.5 + 11.0 hrs, P = NS) misoprostol groups. The incidence of hyperstimulation in the oral group was 2.2% vs 5.4% in the vaginal group, P = NS. Eighteen patients in the oral group (19.4%) and 36 (32.4%) in the vaginal group underwent cesarean section (P < .05). This difference was attributed to better tolerance of more doses of misoprostol by the women in the oral group. There was no difference in side effects (nausea, vomiting, diarrhea, shivering) between groups. Fourteen percent of women in the vaginal group versus 7.5% in the oral group were dissatisfied with the use of misoprostol (P = NS). CONCLUSION: Stepwise oral misoprostol (50 microg followed by 100 microg) appears to be as effective as vaginal misoprostol (25 microg) for cervical ripening with a low incidence of hyperstimulation, no increase in side effects, a high rate of patient satisfaction, and is associated with a lower cesarean section rate.

Abortifacient Agents, Nonsteroidal↗
PubMed1998

Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. Omeprazole versus Misoprostol for NSAID-induced Ulcer Management (OMNIUM) Study Group.

BACKGROUND: Misoprostol is effective for ulcers associated with the use of nonsteroidal antiinflammatory drugs (NSAIDs) but is often poorly tolerated because of diarrhea and abdominal pain. We compared the efficacy of omeprazole and misoprostol in healing and preventing ulcers associated with NSAIDs. METHODS: In a double-blind study, we randomly assigned 935 patients who required continuous NSAID therapy and who had ulcers or more than 10 erosions in the stomach or duodenum (or both) to receive 20 mg or 40 mg of omeprazole orally in the morning or 200 microg of misoprostol orally four times daily. Patients were treated for four weeks or, in the absence of healing, eight weeks. Treatment success was defined as the absence of ulcers and the presence of fewer than five erosions at each site and not more than mild dyspepsia. We then randomly reassigned 732 patients in whom treatment was successful to maintenance therapy with 20 mg of omeprazole daily, 200 microg of misoprostol twice daily, or placebo for six months. RESULTS: At eight weeks, treatment was successful in 76 percent of the patients given 20 mg of omeprazole (233 of 308), 75 percent of those given 40 mg of omeprazole (237 of 315), and 71 percent of those given misoprostol (212 of 298). The rates of gastric-ulcer healing were significantly higher with 20 mg of omeprazole (but not 40 mg of omeprazole) than with misoprostol. Healing rates among patients with duodenal ulcers were higher with either dose of omeprazole than with misoprostol, whereas healing rates among patients with erosions alone were higher with misoprostol. More patients remained in remission during maintenance treatment with omeprazole (61 percent) than with misoprostol (48 percent, P=0.001) and with either drug than with placebo (27 percent, P<0.001). There were more adverse events during the healing phase in the misoprostol group than in the groups given 20 mg and 40 mg of omeprazole (59 percent, 48 percent, and 46 percent, respectively). CONCLUSIONS: The overall rates of successful treatment of ulcers, erosions, and symptoms associated with NSAIDs were similar for the two doses of omeprazole and misoprostol. Maintenance therapy with omeprazole was associated with a lower rate of relapse than misoprostol. Omeprazole was better tolerated than misoprostol.

Adult↗
PubMed2002

A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy.

BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 250 women with gestations < or = 56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 microg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05). CONCLUSIONS: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies < or = 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

A randomized controlled trial of laminaria, oral misoprostol, and vaginal misoprostol before abortion.

OBJECTIVE: To compare the efficacy and acceptability of oral misoprostol, vaginal misoprostol, and laminaria tents for cervical dilation before surgical abortion. METHODS: We conducted a randomized, double-blind, placebo-controlled trial comparing oral misoprostol 400 microg, vaginal misoprostol 400 microg, and one medium laminaria for dilating the cervix over 4 hours before surgical abortion. The study sample consisted of 106 women at 7-14 weeks' gestation who presented to San Francisco General Hospital requesting abortion. The primary outcome was the amount of cervical dilation measured by Pratt dilators. Secondary outcomes were the proportion of subjects needing further manual dilation, difficulty of dilation, duration of the procedure, blood loss, and side effects. RESULTS: The vaginal-misoprostol group had a significantly greater mean dilation (28.0 mm) than the oral misoprostol group (24.2 mm; P < .05) and a greater mean dilation than the laminaria group (25.9 mm), although this difference did not reach significance. Women who received laminaria reported significantly more pain at the time of placement (85.7% reported at least "a little" pain) compared with women who received misoprostol by either route (28.9% of oral-misoprostol and 34.0% of vaginal-misoprostol subjects reported "a little" pain; P < .01). The proportion of subjects who required further manual dilation, ease of dilation, duration of the procedure, and blood loss were not significantly different among the groups. There was no difference in side effects during the 4-hour waiting period among the three groups, and gastrointestinal side effects were rare in all groups. CONCLUSION: Vaginal misoprostol is superior to oral misoprostol and is an acceptable alternative to laminaria tents for cervical dilation before surgical abortion in pregnancies of 7-14 weeks' gestation. It is inexpensive and easy to administer, and achieves equal or greater dilation with less pain on insertion and no increase in side effects compared with laminaria.

Abortifacient Agents, Nonsteroidal↗
PubMed1991

Expression of gastric antisecretory and prostaglandin E receptor binding activity of misoprostol by misoprostol free acid.

In enriched canine parietal cell preparations, misoprostol, an analog of prostaglandin E1 methyl ester, was rapidly deesterified to misoprostol free acid. Under this circumstance, misoprostol and misoprostol free acid exhibited equal antisecretory potency against histamine-stimulated acid secretion and bound equally well to prostaglandin E receptors. When the deesterification of misoprostol was inhibited by paraoxon, an esterase inhibitor, the antisecretory and receptor binding activity of misoprostol was markedly reduced, with potency much less than misoprostol free acid. These results indicate that misoprostol free acid is the active biological form of misoprostol that binds to prostaglandin E receptors and mediates the antisecretory action of misoprostol.

Alprostadil↗
PubMed2004

Does the route of administration of misoprostol make a difference? The uterotonic effect and side effects of misoprostol given by different routes after vaginal delivery.

OBJECTIVE: To compare the postpartum uterotonic effect and side effects of misoprostol administered by different routes. STUDY DESIGN: Fifty women were given misoprostol 400 microg either by the oral solution, oral tablet, rectal or vaginal route, or intramuscular syntometrine 1 ml after spontaneous vaginal delivery. Pre- and post-treatment uterine activity were measured with intrauterine pressure catheters. RESULTS: Uterine activity produced by oral solution misoprostol 400 microg was significantly higher than that of oral tablet, rectal and vaginal misoprostol (P = 0.004, 0.002, respectively). Onset of action after oral solution misoprostol was faster than by the oral tablet (P = 0.01), rectal (P < 0.001) and vaginal (P< 0.001) routes. Shivering and pyrexia were most common with oral solution misoprostol. Maximum body temperature recorded was significantly higher with oral solution misoprostol than with oral tablet, rectal and vaginal misoprostol (P = 0.009, 0.001, respectively). CONCLUSION: Different routes of administering misoprostol greatly influence the effects achieved. Oral solution misoprostol produces the fastest and strongest uterotonic effect, with the most side effects.

Administration, Intravaginal↗
PubMed1999

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.

OBJECTIVE: 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. DESIGN: Randomised pilot trial, double-blinded with the use of double placebos. SETTING: 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. POPULATION: Women during second stage of labour about to be delivered vaginally. METHODS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.

Adult↗
PubMed1994

Methotrexate and misoprostol vs misoprostol alone for early abortion. A randomized controlled trial.

OBJECTIVE: To compare the safety and efficacy of early abortion by administration of methotrexate and misoprostol vs administration of misoprostol alone. DESIGN: Randomized controlled trial. SETTING: San Francisco (Calif) General Hospital. PATIENTS: Pregnant women at 56 days' gestation or less seeking elective abortion. Sixty-three women volunteered for the trial; 61 completed the study and are included in the analysis. INTERVENTION: Intramuscular administration of 50 mg of methotrexate per square meter of body surface area followed 3 days later by vaginal administration of 800 micrograms of misoprostol (group 1) or the same dose of misoprostol given alone (group 2). The misoprostol dose was repeated 24 hours later if abortion had not occurred. MAIN OUTCOME MEASURES: Successful abortion, duration of vaginal bleeding, side effects, and change in beta-human chorionic gonadotropin (beta-hCG) level. An abortion was considered successful if the pregnancy ended without requiring a surgical procedure. RESULTS: Complete abortion occurred in 28 (90%) of 31 patients in group 1 and 14 (47%) of 30 patients in group 2 (P < .001). Seventeen (61%) of the 28 women in group 1 who aborted did so the same day as misoprostol administration; vaginal bleeding lasted a mean (+/- SD) of 10 (+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a mean of 31 (+/- 6) days after methotrexate administration. The 11 other women in group 1 who aborted did so after a mean delay of 29 (+/- 11) days; vaginal bleeding lasted 7 (+/- 4) days, and beta-hCG level was less than or equal to 10 IU/L by a mean of 24 (+/- 11) days after the abortion. There were three treatment failures in group 1: two ongoing pregnancies (6%) and one incomplete abortion (3%). For the 14 women with successful abortions in group 2, vaginal bleeding lasted a mean of 10 (+/- 6) days and beta-hCG level was less than or equal to 10 IU/L by mean of 39 (+/- 18) days after the misoprostol. There were 16 treatment failures in group 2: eight ongoing pregnancies (27%), and eight incomplete abortions (27%). Methotrexate side effects were minimal. Misoprostol side effects were diarrhea in 18% and nausea and vomiting in 5%. CONCLUSIONS: Methotrexate and vaginal misoprostol are more effective than misoprostol alone. Both drugs are available throughout the United States, and both drugs are inexpensive. This combination may offer an alternative to the use of antiprogestin and prostaglandin for medical abortion.

Abortion, Induced↗
PubMed1999

A comparison of orally administered misoprostol with vaginally administered misoprostol for cervical ripening and labor induction.

OBJECTIVE: Our purpose was to compare orally administered with vaginally administered misoprostol for cervical ripening and labor induction. MATERIAL AND METHODS: Two hundred twenty subjects with medical or obstetric indications for labor induction and undilated, uneffaced cervices were randomly assigned to receive orally administered or vaginally administered misoprostol. Fifty micrograms of oral misoprostol or 25 microgram of vaginal misoprostol was given every 4 hours. If cervical ripening (Bishop score of >/=8 or cervical dilatation of >/=3) or active labor did not occur, repeated doses were given to a maximum of 6 doses or 24 hours. Thereafter, oxytocin was administered intravenously by a standardized incremental infusion protocol to a maximum of 22 mU/min. RESULTS: Of the 220 subjects evaluated, 110 received orally administered misoprostol and 110 received vaginally administered misoprostol. Fewer subjects who received the oral preparation (34/110, 30.9%) were delivered vaginally within 24 hours of initiation of induction, in comparison with those who received the vaginal preparation (52/110, 47.3%) (P =.01). The average interval from start of induction to vaginal delivery was nearly 6 hours longer in the oral treatment group (mean and SD 1737.9 +/- 845.7 minutes) than in the vaginal treatment group (mean and SD 1393.2 +/- 767.9) (P =.005, log-transformed data). Orally treated patients required significantly more doses than vaginally treated patients (orally administered doses: mean and SD 3.3 +/- 1.7; vaginally administered doses: mean and SD 2.3 +/- 1.2) (P <.0001). Oxytocin administration was necessary in 83 (75.4%) of 110 orally treated subjects and in 65 (59.1%) of 110 vaginally treated subjects (P =.01, relative risk 1. 28, 95% confidence interval 1.06-1.54). Vaginal delivery occurred in 95 (86.4%) orally treated subjects and in 85 (77.3%) vaginally treated subjects (P =.08, relative risk 1.12, 95% confidence interval 0.99-1.27), with the remainder undergoing cesarean delivery. There was no difference in the incidence of uterine contractile abnormalities (tachysystole, hypertonus, or hyperstimulation), intrapartum complications, or neonatal outcomes between the 2 groups. CONCLUSIONS: Oral administration of 50-microgram doses of misoprostol appears less effective than vaginal administration of 25-microgram doses of misoprostol for cervical ripening and labor induction. Further investigation is needed to determine whether orally administered misoprostol should be used for cervical ripening and labor induction.

Administration, Intravaginal↗
PubMed2000

The misoprostol third stage of labour study: a randomised controlled comparison between orally administered misoprostol and standard management.

OBJECTIVE: To compare misoprostol with standard oxytocic regimens in the prevention of postpartum haemorrhage. DESIGN: Randomised controlled trial. SETTING: Obstetric unit in a large teaching hospital. METHODS: One thousand women randomised to 500 microg misoprostol given orally or to standard oxytocic regimens of oxytocin, oxytocin with ergometrine, or ergometrine. MAIN OUTCOME MEASURES: Incidence of postpartum haemorrhage and the incidence and severity of side effects. RESULTS: 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). CONCLUSION: 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.

Administration, Oral↗
PubMed2005

The true cost differential between mifepristone and misoprostol and misoprostol-alone regimens for medical abortion.

Our objective was to evaluate relative differences in direct and total (direct and indirect) costs for medical abortion regimens using mifepristone and misoprostol or misoprostol alone. We created formulas to evaluate relative differences in costs in the United States, Chennai (Madras), India, and a hypothetical developing country based on published protocols and efficacy data. Follow-up visits and suction aspiration procedures in the United States were evaluated over a range of costs. American indirect costs were estimated using earning data. Indirect costs in India and the hypothetical developing country were based on mifepristone cost differences between the United States and India. Although mifepristone costs US dollar 83.33 for every 200-mg tablet in the United States, the actual excess cost of using a mifepristone regimen, as compared with a misoprostol-alone regimen, is only US dollar 22 to US dollar 32. The actual cost of a mifepristone regimen is lower than that of a misoprostol-alone regimen in India. In a hypothetical developing country, a mifepristone regimen is likely to be less expensive than regimens using misoprostol alone. Because of the higher efficacy of medical abortion regimens using mifepristone and misoprostol and the need for fewer follow-up evaluations, such regimens are less expensive or only minimally more expensive than those using misoprostol alone.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

Early pregnancy termination with intravaginally administered sodium chloride solution-moistened misoprostol tablets: historical comparison with mifepristone and oral misoprostol.

OBJECTIVE: The purpose of this study was to compare the abortifacient effect of intravaginally administered moistened misoprostol tablets with that of the combination regimen of mifepristone and oral misoprostol. STUDY DESIGN: One hundred women at </=56 days' gestation received 800 microg misoprostol intravaginally in the form of sodium chloride solution-moistened tablets. The dose was repeated 24 hours later if a gestational sac persisted on ultrasonographic examination. These 100 subjects (group 1) were then matched with 100 subjects who had received 600 mg mifepristone followed by 400 microg misoprostol orally as part of a large multicenter American trial (group 2). Subjects were monitored for abortion success, adverse side effects, and bleeding characteristics. Abortion failure was defined as persistence of an intrauterine sac or the need to perform a surgical evacuation of the uterus for hemorrhage, for incomplete abortion, or at the subject's request. RESULTS: In 88 of the 100 women in group 1 and 94 of the 100 women in group 2, abortion occurred and a surgical procedure was not required. Abortion rates were not influenced by gestational age in either group. Prostaglandin-related side effects of fever and chills, vomiting, diarrhea, and uterine pain were all significantly higher in group 1. Excessive uterine bleeding was uncommon in both groups, and no subjects received blood transfusions. CONCLUSION: The abortion rate with intravaginally administered moistened misoprostol tablets is similar to that with the combination of mifepristone and oral misoprostol. However, intravaginal administration of misoprostol is associated with significantly more prostaglandin-related side effects.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Vaginal misoprostol compared with oral misoprostol in termination of second-trimester pregnancy.

OBJECTIVE: To compare the efficacy of vaginal with oral misoprostol in termination of second-trimester pregnancy after pretreatment with mifepristone. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone.

OBJECTIVES: To compare three methods of labour induction. DESIGN: Randomised controlled trial. SETTING: Academic hospitals in Johannesburg, South Africa. SUBJECTS: Women with intact membranes due for induction of labour. METHOD: Randomised, sealed opaque envelopes were used to allocate women to labour induction with extra-amniotic Foley catheter/titrated oral misoprostol solution (N = 174), titrated oral misoprostol solution alone (N = 176), or vaginal dinoprostone (N = 176). Misoprostol was dissolved in water and 20-40 g was given 2-hourly. OUTCOME MEASURES: These were failure to deliver vaginally within 24 hours, additional measures for induction or augmentation of labour, analgesia, and maternal and fetal complications. RESULTS: In the Foley catheter group, misoprostol was required in all but 1 case. Failure to deliver vaginally within 24 hours was similar for the three groups (79/174 v. 70/176 v. 70/176 respectively). Labour augmentation, caesarean section and instrumental delivery were used somewhat more frequently in the Foley/misoprostol group than in the misoprostol alone group, but these differences were not statistically significant. More analgesia was used in the Foley catheter/misoprostol group than in the misoprostol group (64/172 v. 46/175). Side-effects and neonatal complications were similar for the three groups. CONCLUSIONS: Use of extra-amniotic Foley catheter placement showed no measurable benefits over the use of oral misoprostol alone, or vaginal dinoprostone.

Administration, Intravaginal↗
PubMed2005

Comparison or oral versus vaginal misoprostol & continued use of misoprostol after mifepristone for early medical abortion.

BACKGROUND & OBJECTIVE: Medical abortion though legalized in India, is still not very popular. A disadvantage of medical abortion is the longer duration of bleeding compared with surgical abortion which may reduce acceptability. Due consideration needs to be given to the issues related to medical abortion for improving the reproductive health status of women suffering from consequences of unsafe and illegal surgical abortion. The present study compared the efficacy of oral and vaginal administration of misoprostol after a single dose of 200 mg of mifepristone and evaluated the influence of continuing misoprostol for one week on efficacy and side effects. METHODS: A double-blind randomized controlled trial with 150 healthy pregnant women requesting medical abortion with < 63 days of amenorrhoea was conducted in the gynecological and family planning clinic at All India Institute of Medical Sciences, New Delhi. Mifepristone (200 mg) was administered orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. Women in the oral group and one of the two vaginal groups continued 0.4 mg of oral misoprostol twice daily for seven days. RESULTS: Complete abortion rate in each of the groups was 96-100 per cent. The addition of misoprostol 0.4 mg twice a day from day 4-10 did not help in increasing successful outcome or shortening of duration or amount of bleeding. INTERPRETATION & CONCLUSION: Medical abortion for pregnancy up to 63 days using misoprostol 0.8 mg vaginal/oral after pretreatment with mifepristone 200 mg is a safe and successful procedure. No differences in efficacy or duration of bleeding were observed with addition of oral misoprostol for 1 wk after abortion.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

High-dose vaginal misoprostol versus concentrated oxytocin plus low-dose vaginal misoprostol for midtrimester labor induction: a randomized trial.

OBJECTIVE: This study was undertaken to compare the efficacy and side effects of a high-dose vaginal misoprostol regimen to concentrated intravenous oxytocin plus low-dose vaginal misoprostol for midtrimester labor induction. STUDY DESIGN: Women at 14 to 24 weeks, with obstetric or fetal indications for delivery and no prior cesarean, were randomly assigned to receive either vaginal misoprostol 600 microg x 1, then 400 microg every 4 hours x 5 (group 1) or escalating dose-concentrated oxytocin infusions (277-1667 mU/min) plus vaginal misoprostol 400 microg x 1, then 200 microg every 6 hours x 2, then 100 microg x 1 (group 2). Analysis was by intent to treat. Primary outcomes were live birth rate and induction-to-delivery interval. RESULTS: The intended sample size was 70 women per group; however, the trial was terminated at the initial interim analysis because of a highly significant difference in 1 of the primary study outcomes. Twenty women were assigned to group 1 and 18 were assigned to group 2. Median induction-to-delivery interval was significantly shorter in group 1 (12 hours, range 4-44 hours) versus group 2 (18 hours, range 7-36 hours; P = .01). Induction success rate at 12 hours was significantly higher in group 1 (60%) compared with group 2 (22%, P = .02). No significant difference was noted in the live birth rate between groups 1 and 2 (13%, 0%, P = .16). The incidence of retained placenta requiring curettage, chorioamnionitis, intrapartum fever, nausea, emesis, and diarrhea were similar between both groups. CONCLUSION: Compared with concentrated oxytocin plus low-dose vaginal misoprostol, high-dose vaginal misoprostol significantly shortens midtrimester labor inductions.

Abortifacient Agents, Nonsteroidal↗