Sublingual misoprostol for labor induction: a randomized clinical trial

OBJECTIVE: To compare the effectiveness of 50 microg compared with 100 microg of repetitive misoprostol dosages administered sublingually for labor induction. METHODS: Two hundred twelve women who presented with an indication for cervical ripening and labor induction were randomly assigned to 50 microg or 100 microg of misoprostol tablets administered sublingually with double masking of treatment group dose allocation. The primary outcome was the interval from start of induction to vaginal delivery. RESULTS: Among the 203 evaluable participants, 102 were randomly assigned to the 50-microg group and 101 to the 100-microg group. The proportion of patients who delivered vaginally in less than 12 hours and less than 24 hours was significantly higher in the 100-microg group: 28% and 63% in the 100-microg group compared with 15% and 36% in the 50-microg group, respectively (P = .01 and P = .001). The incidence of tachysystole was significantly higher in the 100-microg group (P = .02). The incidence of hyperstimulation syndrome was higher in the 100-microg group, but not statistically significant (P = .46). With respect to the proportion of patients delivered after a single dose, mode of delivery, and perinatal outcome, no significant differences between treatment groups were observed. Regarding the need for oxytocin augmentation, 61% required augmentation in the 100-microg group compared with 81% in the 50-microg group (P = .002). CONCLUSION: One hundred micrograms of sublingual misoprostol is more effective than 50 microg of sublingual misoprostol, but is associated with a higher incidence of tachysystole and uterine hyperstimulation syndrome. LEVEL OF EVIDENCE: I.     

Comparison of 25 and 50 microg vaginally administered misoprostol for preinduction of cervical ripening and labor induction.

Our purpose was to compare the efficacy of 25 microg and 50 microg intravaginally administered misoprostol tablets for cervical ripening and labor induction. Either 25-microg (n: 58) or 50-microg (n: 56) misoprostol tablets were randomly administered intravaginally to 114 subjects with an unripe cervix for labor induction. The physician was blinded to the medication. Intravaginal misoprostol was given every 4 h until the onset of labor. The mean Bishop score before misoprostol administration was 2.1 +/- 1.6 in the 25-microg group and 2.0 +/- 1.4 in the 50-microg group (p > 0.05). With the 25-microg dose the time until delivery was significantly longer (991.2 +/- 514.4 min vs. 703.12 +/- 432.6 min in the 50-microg group). The use of oxytocin augmentation was significantly higher in the 25-microg group (63.8%) than the 50-microg group (32.1%; p < 0.05). The proportions of patients with tachysystoles and hypersystoles were not significantly different between the two groups (19 and 6.9%, respectively, in the 25-microg group and 25 and 17.8%, respectively, in 50-microg group; p > 0.05). Overall, in the 25-microg group more women achieved vaginal delivery (79.3 vs. 60.7%; p < 0.05). The rate of cesarean sections due to non-reassuring fetal status was higher in the 50-microg misoprostol group (28.6 vs. 10.3%; p < 0.05). The number of neonates with a low 1-min Apgar score (<7) was significantly higher in the 50-microg misoprostol group (26.8 vs. 8.6%; p < 0.05), but 5-min Apgar scores and umbilical artery blood gas values at the time of delivery were not significantly different between the groups (p > 0.05). One patient in the 25-microg group suffered a ruptured uterus. Intravaginal administration of 25 microg of misoprostol is a clinically effective labor induction regimen and has the least adverse effects and complications.     

Misoprostol 50 microg sublingually versus vaginally for labor induction at term: a randomized study

OBJECTIVE: To compare the efficacy of misoprostol 50 mug vaginally and 50 mug sublingually for labor induction at term. MATERIALS AND METHODS: One hundred and sixty women were randomized to receive misoprostol 50 microg vaginally (n = 80) or 50 microg sublingually misoprostol (n = 80). The doses were given every 4 h (maximum 6 doses). Primary outcome measure was number of cesarean deliveries. Induction to delivery time, delivery within 24 h, the number of misoprostol doses given; the need for oxytocin augmentation, tachysystole and uterine hyperstimulation rates and neonatal outcomes were secondary outcome measures. RESULTS: The mean induction to delivery time was 748 +/- 379 min in the vaginal group and 711 +/- 425 in the sublingual group (p = 0.56). The number of women delivering within 24 h was 73 (91.3%) in the vaginal group and 74 (92.5%) in the sublingual group (p = 0.78). The mean number of misoprostol doses required was significantly higher in the sublingual group (1.9 +/- 1.2) compared with the vaginal group (1.1 +/- 0.4; p < 0.001). More women in the sublingual group experienced tachysystole (n = 14, 17.5%) compared with the vaginal group (n = 3, 3.8%; p = 0.005). Seven cases (8.8%) in the vaginal group and 12 cases in the sublingual group (15%) required emergent cesarean delivery for fetal heart rate abnormalities (p = 0.22). Other neonatal outcomes including umbilical artery pH, Apgar scores and intensive care unit admission were similar in the two groups. CONCLUSION: Sublingual misoprostol is as efficacious as vaginal misoprostol for induction of labor. More frequent tachysystole is observed with misoprostol 50 microg sublingually, but neonatal outcomes are similar.     

Oral misoprostol (100 microg) versus vaginal misoprostol (25 microg) in term labor induction: a randomized comparison

OBJECTIVE: To compare the efficacy of vaginal misoprostol (25 microg) to oral misoprostol (100 microg) in labor induction at term. METHODS: One hundred and one women at term, with indications for labor induction and cervical Bishop's scores of less than 8, were randomly assigned to receive 100 microg of oral misoprostol or 25 microg vaginal misoprostol after random allocation. This could be repeated every 4 h to a maximum of five doses. The number delivering vaginally within 24 h of the induction was the main outcome measure. RESULTS: Of those who delivered vaginally (74.5% in the oral group vs. 72% in the vaginal group), significantly fewer women delivered within 24 h of induction in the oral group (42.1% vs. 72.2%, RR 0.6, 95% CI 0.4-0.9), with more women receiving more than one dose (45.7% vs. 16.7%, RR 2.7, 95% CI 1.2-6.0). More women in the oral group received oxytocin (68.6% vs. 44%, RR 1.6, 95% CI 1.1-2.2), and the induction to delivery interval was shorter in the vaginal group, although this was not statistically significant [28.9 h (SD 20.2) vs. 20.6 h (SD 16.1), mean difference - 8.3 h, 95% CI - 16.8 to 0.2]. There were no differences in the modes of delivery, uterine hyperstimulation rates or in the neonatal outcomes. CONCLUSION: Vaginal misoprostol in its currently recommended dose of 25 microg seems to be more efficacious than the 100 microg oral dose.     

Labor induction with 25 microg versus 50 microg intravaginal misoprostol: a systematic review.

OBJECTIVE: To systematically review published randomized controlled trials (RCTs) to compare the safety and efficacy of 25 microg versus 50 microg of intravaginal misoprostol for cervical ripening and labor induction. DATA SOURCES: We supplemented a search of entries in electronic databases with references cited in original studies and review articles to identify RCTs of misoprostol for cervical ripening and labor induction, which compared repeated doses of 25 microg and 50 microg. STUDY SELECTION: We evaluated, abstracted data, and assessed the quality of RCTs to compare the safety and efficacy of 25 microg versus 50 microg of intravaginal misoprostol for cervical ripening and labor induction. TABULATION, INTEGRATION, AND RESULTS: Five RCTs met inclusion criteria for meta-analysis. Odds ratios (OR) with 95% confidence intervals (CI) were calculated for each outcome (random- and fixed-effects models). In addition, we aggregated the results of two separate studies, permitting an indirect comparison of the two doses being analyzed. In the meta-analysis, tachysystole and hyperstimulation syndrome appear to occur less frequently among women who received 25 microg of misoprostol than with 50 microg. However, neonatal outcomes appear to be comparable with the two doses. Regarding efficacy, use of the 50-microg dose was associated with a shorter interval to vaginal delivery, greater proportion of deliveries within 24 hours, and less frequent need for oxytocin augmentation. The indirect comparison of two studies yielded similar results. CONCLUSION: Published data indicate that intravaginal misoprostol at doses of 50 microg for cervical ripening and labor induction is more efficacious but it is unclear whether it is as safe as the 25-microg dose.     

Excessive uterine activity accompanying induced labor

OBJECTIVE: To estimate the incidence and timing of excessive uterine activity accompanying induction of labor with misoprostol using different routes (oral or vaginal) and forms (intact tablet or crushed) and to compare these with dinoprostone gel, oxytocin, and spontaneous labor. METHODS: This retrospective cohort study included 519 women at term who had labor induced and 86 women at term in spontaneous labor. Induction agents included misoprostol, dinoprostone, or oxytocin. Fetal heart rate and uterine activity tracings were analyzed independently by three maternal-fetal medicine physicians. The diagnosis of tachysystole or hyperstimulation required the agreement of two or more reviewers. RESULTS: The incidence of tachysystole was highest with misoprostol administered by vaginal tablet (misoprostol vaginal tablet 50 microg every 4 hours, 48.6%; vaginal tablet crushed 50 microg and suspended in hydroxyethyl gel every 4 hours, 30.7%, P =.009; oral tablet 50 microg every 4 hours, 22.2%, P =.001; oral tablet crushed 50 microg every 4 hours, 15.5%, P <.001; dinoprostone gel, 33.0%, P =.022; intravenous oxytocin, 30.2%, P =.027; and spontaneous onset of labor, 23.3%, P <.001). Hyperstimulation occurred more often with dinoprostone gel (16.5%) than with other forms of induction or spontaneous labor. Hyperstimulation occurred significantly more often with vaginal misoprostol crushed tablet (7.9%) and vaginal misoprostol intact tablet (7.6%) than with crushed oral misoprostol (1.0%) (P =.016 and.018, respectively). There was a shorter time to tachysystole with increasing doses of vaginal misoprostol tablet (P =.01). CONCLUSION: The incidence of tachysystole and hyperstimulation, and time to tachysystole, varied depending on the route and form of misoprostol given.     

Comparison of oral and vaginal misoprostol for induction of labor at term: a randomized controlled trial

OBJECTIVE: To compare the efficacy of oral with vaginal misoprostol for induction of labor at term. METHODS: One hundred and fifty-three pregnant women at term with indications for induction of labor and Bishop score < or = 6 were randomly assigned to receive misoprostol either 100 microg orally or 50 microg vaginally every 6 h for 48 h. Repeated doses were given until Bishop score > or = 8 was achieved or spontaneous rupture of membranes occurred. Those who were not in labor after 48 h had labor induced with amniotomy and oxytocin. The main outcome measure was induction to delivery time. RESULTS: The median induction to vaginal delivery time in the oral group (14.3 h) was not significantly different from that of the vaginal group (15.8 h). The median number of doses was also not significantly different in the oral group compared with the vaginal group. There was a significant higher incidence of uterine tachysystole in the vaginal group compared to the oral group (17.1% vs 5.3%, P = 0.032). There was no hyperstimulation in either group. There were no significant differences between the groups with respect to oxytocin augmentation, cesarean section rate, analgesic requirement, and neonatal outcomes. CONCLUSION: Oral administration of 100 microg misoprostol has similar efficacy to intravaginal administration of 50 microg misoprostol for labor induction with less frequent abnormal uterine contractility. 100 microg of misoprostol orally can be used as an alternative to the vaginal route for labor induction.     

A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor

OBJECTIVE: The purpose of this study was to compare the efficacy of different routes of misoprostol administration for cervical ripening and the induction of labor. STUDY DESIGN: Three hundred thirty women at > or = 32 weeks gestation with a Bishop score < or = 6 and an indication for induction were randomized to 1 of 3 double-blinded groups: (1) 25 microg orally administered misoprostol plus 25 microg vaginally administered misoprostol, (2) orally administered placebo plus 25 microg vaginally administered misoprostol, or (3) 25 microg orally administered misoprostol plus vaginally administered placebo. Doses were repeated every 4 hours until onset of labor or a maximum of 12 doses were given. The primary outcome of the trial was vaginal delivery within 24 hours of the initiation of induction. Secondary outcomes were the time from induction to delivery, need for oxytocin augmentation, mode of delivery, frequency of side effects, and neonatal and maternal outcome. Analysis of variance, chi-square test, and logistic regression were used for analysis. RESULTS: There were no significant differences in maternal characteristics or indications for induction. The percentage of women who achieved vaginal delivery within 24 hours was highest in the vaginally administered misoprostol group: 67% compared with 53% in the oral-plus-vaginal group (P < .05) and 36% in the oral group (P < .05). The median time to vaginal delivery was shorter in the vaginal and oral-plus-vaginal misoprostol groups, 13.5 hours and 14.3 hours, respectively, when compared with 23.9 hours in the oral group (P < .05). The rate of cesarean delivery was lowest in the vaginal misoprostol group (17% compared with 30% in the oral-plus-vaginal group and 32% in the oral group; P < .05). Uterine tachysystole occurred least frequently in the oral misoprostol group (10% compared with 32% in the vaginal group and 34% in the oral-plus-vaginal group; P < .05). Uterine hyperstimulation also occurred least frequently in the oral misopro-stol group (4% compared with 15% in the vaginal group and 22% in the oral-plus-vaginal group; P < .05). CONCLUSION: At the doses studied, induction of labor with vaginally administered misoprostol is more efficacious than either oral-plus-vaginal or oral-only route of administration.     

A randomized clinical trial comparing vaginal misoprostol versus cervical Foley plus oral misoprostol for cervical ripening and labor induction

We compared labor induced by vaginal misoprostol versus a supracervical Foley catheter and oral misoprostol. Singleton pregnancies at > or = 24 weeks' gestation were randomized to either an initial 25-microg dose of intravaginal misoprostol, followed by 50-microg intravaginal doses at 3- to 6-hour intervals, or a supracervical Foley balloon and 100 microg of oral misoprostol at 4- to 6-hour intervals. Primary outcome was time from induction to delivery. One hundred twenty-six women were randomized to vaginal misoprostol alone (group I) and 106 women to Foley and oral misoprostol (group II). The groups were similar in age, weight, gestational age, parity, indication for induction of labor, and oxytocin use. Cesarean delivery rates at 37% and cesarean indications were similar ( P = 0.25). The time from induction to delivery in group II (12.9 hours) was significantly shorter than that in group I (17.8 hours, P < 0.001). Uterine tachysystole occurred less often in the vaginal misoprostol group (21% versus 39%, P = 0.015). Compared with vaginal misoprostol, delivery within 24 hours was significantly more likely with a Foley balloon and oral misoprostol. The use of terbutaline and peripartum outcomes were similar in the two groups.     

Oral versus vaginal misoprostol for induction of labor: a double-blind randomized controlled trial

OBJECTIVE: To determine the efficacy of oral misoprostol (50 microg) administered every 3 hours compared to vaginal misoprostol (50 microg) administered every 6 hours for induction of labor. STUDY DESIGN: In this double-blind randomized trial, 126 women received misoprostol (50 microg) either orally every 3 hours or vaginally every 6 hours for induction of labor. Outcomes included time from induction to delivery, oxytocin augmentation, incidence of hyperstimulation and tachysystole, mode of delivery, and neonatal outcomes. RESULTS: Median time to delivery was shorter in those women who were receiving vaginal misoprostol (vaginal 14.3 hours vs oral 23.1 hours; P =.0004) and more women in the oral group required oxytocin augmentation of labor (73% vs 42%) (RR, 1.98; 95% CI, 1.29 to 3.06). The incidence of hyperstimulation was similar between the groups, but there was an increased incidence of tachysystole in the vaginal group (26.5% vs 9.7%)(RR, 2.74; 95% CI, 1.16 to 6.51). There was no difference between the groups with respect to mode of delivery or neonatal outcome. CONCLUSION: Vaginal misoprostol administered every 6 hours is more effective for induction of labor than oral misoprostol administered every 3 hours. The higher rates of tachysystole with use of vaginal misoprostol in the current study warrant further investigation.     

Controlled-release misoprostol vaginal insert in parous women for labor induction: a randomized controlled trial

OBJECTIVE: To assess the ability of a controlled-release misoprostol vaginal insert to induce labor using dose reservoirs of 25, 50, 100, and 200 microg. METHODS: This double-blind, dose ranging, randomized study was carried out in parous women requiring induction of labor at term. Each woman was randomly assigned to receive a single misoprostol vaginal insert that could remain in place for up to 24 hours and was removed for onset of active labor, an adverse event, or having reached 24 hours in situ. The primary outcome measure was time from insertion of the misoprostol vaginal insert to vaginal delivery of the neonate. RESULTS: A total of 124 women participated in the study. The median time to vaginal delivery was 27.5, 19.1, 13.1, and 10.6 hours for the 25-, 50-, 100-, and 200-microg doses, respectively. The percentage of women who delivered vaginally within 12 hours was 9%, 14%, 47%, and 53% (P<.001 using the 25-microg group as the comparator) and within 24 hours was 42%, 79%, 81%, and 70% (P=.003). Uterine hyperstimulation syndrome occurred in one woman who received the 25-mug, two women who received the 100-microg, and three women who received the 200-microg dose reservoirs. CONCLUSION: Misoprostol vaginal inserts effectively induced labor in pregnant parous women at term. LEVEL OF EVIDENCE: I.     

Vaginal misoprostol for induction of labor: 25 vs. 50 microg dose regimen.

OBJECTIVE: To compare the efficacy and safety of two regimens of vaginal misoprostol for induction of labor. METHOD: In a randomized study, 185 women undergoing induction of labor were allocated to Group A (n=93), to be given 25 microg misoprostol and Group B (n=92), to be given 50 microg misoprostol. Intravaginal misoprostol was given every 4 h until the onset of labor. A maximum of six doses was administered. RESULTS: Abnormal uterine contractions were more common in Group B compared to Group A: 33 (35.86%) vs. 10 (10.75%) cases, and significantly more women in Group B required tocolysis (9.78 vs. 3.23%). The induction-delivery interval (mean+/-S.D.) was 17.18+/-8.48 h in Group A and 9.37+/-5.87 h in Group B (P<0.05). Oxytocin infusion was used in 37.63% of women in Group A and 26.08% in Group B (P>0.05). The cesarean section rate was 17.20% in Group A and 14.13% in Group B (P>0.05). Cesarean for failed IOL was more common in Group A: 7 of 16 (43.8%) vs. 3 of 13 (23.1%) cesarean deliveries (P<0.05). Postpartum hemorrhage occurred in 9.78% of women in Group B compared to 2.15% in Group A (P<0.05). There was a trend for more neonatal complications in Group B, but this did not reach significance. CONCLUSIONS: Although a dose of 50 microg of misoprostol results in a significantly shorter induction-delivery interval with less need for labor augmentation, there was an increased risk of uterine contractile abnormalities and postpartum hemorrhage. A regime using 25 microg of misoprostol every 4 h can induce labor safely and effectively.     

A comparison of oral and vaginal misoprostol for induction of labor

OBJECTIVE: The aim of the study is to compare the efficacy and safety of oral (100 microg) and vaginal (50 microg) misoprostol for labor induction. STUDY DESIGN: Ninety-nine patients with indications for labor induction randomly received 100 microg oral misoprostol every 4 h or 50 microg vaginal misoprostol every 4 h, using maximum six doses. Mean induction to delivery interval, mode of delivery, rates of tachysystole, hypertonus and hyperstimulation syndrome, oxytocin use, number of doses used, failed induction rate and neonatal outcomes were compared for the two groups. RESULTS: Mean dose of misoprostol used for oral and vaginal misoprostol groups were 2.17+/-1.35 and 1.91+/-0.94, respectively (p=0.65). There were two failed inductions in the oral (4%) and one failed induction (2.5%) in the vaginal group after a total of six doses of misoprostol (p=0.58). There was no significant difference for the mean induction to delivery interval, to the beginning of active phase interval, active phase duration, second stage duration and the number of women who received oxytocin for induction or augmentation between the two groups (p>0.05). There were also no significant differences for intrapartum complications and neonatal outcomes between the oral and vaginal misoprostol groups (p>0.05). CONCLUSION: Our findings indicate that, in a closely supervised hospital setting with adequate monitoring, 100 microg oral misoprostol has the potential to induce labor as safely and effectively as its 50 microg vaginal analogue. As oral use of the drug is easier for both the patient and the doctor, oral misoprostol will probably be more preferable than the vaginal route.     

Intracervical misoprostol as an effective method of labor induction at term.

OBJECTS: The purpose of this study was to evaluate the safety and effectiveness of intracervical misoprostol for the induction of labor at term. METHODS: Eighty-nine term pregnancies requiring induction of labor were treated intracervically with 50 microg of misoprostol. The dose was repeated every 4 h until adequate uterine contraction and cervical dilatation were achieved. Status of cervical ripening, uterine contraction, cervical dilatation, labor course and side effects were recorded and analyzed. RESULTS: Among the 89 patients, 58 had an unfavorable cervix (Bishop score < or = 4) and 31 had a favorable cervix (Bishop score > 4). Labor was successfully induced in all cases, most (93.3%) of which required a single dose of misoprostol. Seventy-two patients (81%) proceeded to spontaneous vaginal delivery, and 61 (85%) deliveries were achieved within 12 h. The other 17 cases received cesarean delivery with indications of fetopelvic disproportion (six cases), failure of induction (seven cases) and acute fetal distress (four cases). The mean duration from induction to regular uterine contraction and to delivery was 483+/-537 min and 79.2+/-38.2 min, respectively, with no significant difference between the two groups with differing status of cervical ripening. Complications of uterine contraction, including tachysystole (15 cases), hypertonus (one case) and hyperstimulation (10 cases) were more common in the group of unfavorable cervix (45%) than that of favorable cervix (23%) (P < 0.05). CONCLUSION: In addition to the oral and intravaginal routes of administration, intracervical misoprostol at a single dose of 50 microg appears to be an effective method for induction of labor at term, but caution should be taken with cases with unfavorable cervix.     

Sublingual compared with vaginal misoprostol for labour induction at term: a randomised controlled trial

OBJECTIVE: To compare the efficacy and safety of 50 microg of sublingual misoprostol with 25 microg of vaginal misoprostol administered for labour induction at term.Design Double-blinded, randomised controlled trial.Setting University Hospital, Kaunas, Lithuania.Sample A total of 140 women at term with indications for labour induction.Methods Women were randomised to receive either 50 microg of sublingual misoprostol with vaginal placebo (n = 70) or sublingual placebo with 25 microg of vaginal misoprostol (n = 70) every 4 hours (maximum six doses).Main outcome measures The number of women delivering vaginally within 24 hours of labour induction.Results Fifty-eight women (83%) in the sublingual misoprostol group and 53 (76%) in the vaginal misoprostol group delivered vaginally within 24 hours [relative risk (RR) 1.1, 95% confidential interval (CI) 0.9-1.3]. However, the induction to vaginal delivery time was significantly shorter in the sublingual group (15.0 +/- 3.7 hours) compared with the vaginal group (16.7 +/- 4.1 hours, P = 0.03). The incidence of tachysystole was more than three-fold higher in the sublingual than in the vaginal group (14 versus 4.3%; RR 3.3, 95% CI 0.9-11.6), but this was not statistically significant. There were no significant differences in the incidence of hypertonus or hyperstimulation syndrome, mode of delivery, interventions for fetal distress or neonatal outcomes between the two groups.Conclusion A 50 microg of sublingual misoprostol 4 hourly for labour induction at term seems to have similar efficacy as 25 microg of vaginal misoprostol. Further studies on safety with larger numbers of women need to be conducted before routine sublingual misoprostol use in this setting.     

A comparison of intermittent vaginal administration of two different doses of misoprostol suppositories with continuous dinoprostone for cervical ripening and labor induction.

PURPOSE: To compare the efficacy of a vaginal insert administering continuous dinoprostone with vaginal suppositories containing two different doses of misoprostol for cervical ripening and induction of labor. STUDY DESIGN: In this prospective, randomized, double-blinded study, 118 patients with indications for induction of labor and an unfavorable Bishop score were randomly assigned to receive either continuous dinoprostone, misoprostol 35-microg suppositories, or misoprostol 50-microg suppositories. RESULTS: No significant differences were noted among the three groups in the change of Bishop score, induction of active labor or the time from initial treatment to delivery. Active labor occurred in roughly two-thirds of the patients in an average of about 5.7-6.7 h regardless of treatment assignment. When the two misoprostol groups were combined, a shorter interval from insertion to vaginal delivery was observed in the nulliparous women receiving misoprostol than those receiving continuous dinoprostone (21.3 vs. 27.2 h, p = 0.019). Except for the significantly lower incidence of tachysystole observed in the combined misoprostol group (3.8% vs. 15.4%, p = 0.036), there were no other significant differences between the groups in mode of delivery or in adverse maternal, fetal, or neonatal effects. CONCLUSION: Misoprostol suppositories appeared to be as effective and safe as continuous dinoprostone in inducing cervical ripening in this sample.     

Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol.

OBJECTIVES: To compare the effectiveness of 25 microg vs. 50 microg of intravaginal misoprostol for cervical ripening and labor induction beyond 41 weeks' gestation. METHODS: The study population consisted of 120 women not in active labor with a gestational age >41 weeks, singleton pregnancy with vertex presentation, reactive fetal heart rate tracing, amniotic fluid index >/=5, and Bishop score <5. Women were randomized to receive either 25 microg (n=60) or 50 microg (n=60) of intravaginal misoprostol. The dose was repeated every 4 h (maximum number of doses limited to six) until the patient exhibited three contractions in 10 min. The main outcome measure was the induction-vaginal delivery interval. RESULTS: There was no significant difference between the two groups with regard to the induction-vaginal delivery interval (685+/-201 min in the 25 microg group vs. 627+/-177 min in the 50 microg group, P=0.09). The proportion of women delivering vaginally with one dose of vaginal misoprostol was significantly greater in the 50 microg group (0/49 vs. 41/47, P<0.001). There were no differences in the rates of cesarean and operative vaginal delivery rates, or in the incidences of tachysystole and hyperstimulation syndrome in the two treatment groups. Neonatal outcomes were also similar. CONCLUSIONS: Intravaginal administration of 25 microg of misoprostol appears to be as effective as 50 microg for cervical ripening and labor induction beyond 41 weeks' gestation.     

The effect of tablet moistening on labor induction with intravaginal misoprostol: a randomized trial

OBJECTIVE: To estimate whether a dosage of 50 microg of misoprostol tablets moistened with 3% acetic acid and administered intravaginally is more efficacious for labor induction than a similar dosage regimen using dry tablets. METHODS: A total of 177 women who presented with an indication for cervical ripening and labor induction were randomly assigned to one of two treatment groups: 1) intravaginal misoprostol in dry tablet form, or 2) intravaginal misoprostol moistened with 1 mL of 3% acetic acid solution. The primary outcome assessed was the interval from start of induction to vaginal delivery. To detect at least a 3.5-hour difference in the primary outcome with 80% power, 87 subjects were required in each group. RESULTS: Among 162 patients evaluated, 80 were allocated to the misoprostol dry group and 82 to the misoprostol moistened group. No significant difference was noted for the mean +/- standard deviation interval to vaginal delivery: 1130 +/- 636 minutes for the group who received dry tablets and 1004 +/- 636 minutes for those who received moistened misoprostol tablets (P =.25). Additionally, no statistically significant differences were noted between the groups with respect to need for oxytocin, proportion of patients delivered after a single dose, intrapartum complications (including tachysystole and uterine hyperstimulation), mode of delivery, or perinatal outcomes. CONCLUSION: Tablet moistening with 3% acetic acid solution does not seem to improve the efficacy of intravaginally administered misoprostol for labor induction.     

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.     

Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial

OBJECTIVE: To evaluate the efficacy of oral and vaginal misoprostol compared with the standard regimen using dinoprostone for induction of labor. METHODS: We conducted a multicenter, randomized controlled trial in Cape Town, South Africa. A total of 573 women admitted for induction of labor were randomized to receive oral misoprostol, vaginal misoprostol, or the control, dinoprostone. Misoprostol was given orally or vaginally as a 50-microg dose at 6-hour intervals to a maximum of four doses. The dinoprostone gel was given as a 1-mg dose in the posterior fornix every 6 hours (maximum two doses). RESULTS: There was no significant difference in vaginal delivery rate in 24 hours between the vaginal misoprostol and dinoprostone groups. However, significantly fewer women delivered vaginally in the oral misoprostol group compared with those in the dinoprostone group (relative risk 0.71, 99% confidence interval 0.51, 0.99). The median induction to vaginal delivery time in the vaginal misoprostol, oral misoprostol, and dinoprostone groups was 12 hours, 23 hours, and 14 hours, respectively. The cesarean rate was approximately 33% in all the groups. There were more cesareans performed for fetal distress in the vaginal misoprostol group compared with the dinoprostone group (relative risk 2.86, 99% confidence interval 1.49, 5.46). There was a higher incidence of tachysystole in the vaginal misoprostol group (5.8%) compared with the other two groups: oral misoprostol (0.8%) and dinoprostone (0.8%), but this difference was not statistically significant. There were no differences in maternal or fetal complications. CONCLUSION: Vaginal misoprostol is as effective as dinoprostone in induction of labor, but it is associated with more tachysystole and cesarean sections for fetal distress compared with dinoprostone. Oral misoprostol results in fewer vaginal deliveries in 24 hours, but it is not associated with increased tachysystole or fetal distress.