Mifepristone for preinduction cervical ripening beyond 41 weeks' gestation: a randomized controlled trial

OBJECTIVE: To compare the effect of mifepristone with placebo on cervical ripening before labor induction in prolonged pregnancies. METHODS: One hundred eighty women with pregnancies beyond 41 weeks and undilated, uneffaced cervices were assigned randomly to receive mifepristone 200 mg or placebo and observed for 24 hours. We then gave intravaginal misoprostol 25 microg every 4 hours or intravenous oxytocin. We expected 60% of placebo-treated and 80% of mifepristone-treated women to deliver vaginally within 48 hours. RESULTS: Among 180 subjects, 97 received mifepristone and 83 received placebo. The mean interval (+/- standard deviation [SD]) from start of induction to delivery was 2209 +/- 698 minutes for mifepristone-treated subjects and 2671 +/- 884 minutes for placebo-treated subjects (P <.001, log-transformed data). Twelve (13. 6%) mifepristone-treated women and seven (10.8%) placebo-treated women delivered vaginally on day 1 (P =.60). After 24 hours, the median Bishop score for both groups was 3 (0-11) (P =.51). One hundred thirty-one subjects required misoprostol, 65 (67.0%) were mifepristone-treated women, and 66 (79.5%) placebo-treated women (P =.06). The median (range) oxytocin dose was 871.5 (0-22,174) mU for mifepristone-treated women and 2021.0 (0-24,750) mU for placebo-treated women (P =.02). Seventy-seven (87.5%) mifepristone-treated women and 46 (70.8%) placebo-treated women delivered vaginally 48 hours after the start of treatment (P =.01). There were nine cesareans in the mifepristone group and 18 in the placebo group (P =.02). More nonreassuring fetal heart rate patterns and uterine contractile abnormalities occurred in mifepristone-treated subjects. There were no statistically significant differences in neonatal outcomes between groups. CONCLUSION: Mifepristone had a modest effect on cervical ripening when given 24 hours before labor induction, appearing to reduce the need for misoprostol and oxytocin compared with placebo.     

Comparing two dinoprostone agents for preinduction cervical ripening at term. A randomized trial.

OBJECTIVE: To compare the safety, efficacy and cost of two methods of administering commercially available dinoprostone for preinduction cervical ripening at term. STUDY DESIGN: Sixty-nine women admitted for labor induction were randomized to receive one of two commercially available agents for cervical ripening. Half the patients received a gel containing 0.5 mg of dinoprostone placed intracervically every four hours. The other half received a polymer insert containing 10 mg of dinoprostone intravaginally. After 12 hours of cervical ripening, oxytocin was given and amniotomy performed to induce labor. RESULTS: Among 69 women randomized, 35 received the gel and 34 the polymer. No significant differences were noted between the two groups in starting characteristics or indication for induction. Both groups were similar with respect to change in Bishop score, start-to-delivery interval, amount of oxytocin required, mode of delivery and success of induction. A slightly higher rate of hyperstimulation was noted in the polymer group, although this did not lead to fetal or maternal morbidity. The average costs per patient for the two agents were similar. CONCLUSION: The two dinoprostone agents are similar with respect to efficacy. The polymer group had slightly more complications but without adverse fetal or maternal outcomes. A larger, multicenter trial would be required to determine actual differences in the efficacy, safety and cost of these two agents.     

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.     

Oral misoprostol vs. intravaginal prostaglandin E2 for preinduction cervical ripening. A randomized trial

OBJECTIVE: To compare orally administered misoprostol with intravaginal prostaglandin E2 for cervical ripening and labor induction. STUDY DESIGN: Patients presenting with medical or obstetric indications for labor induction whose Bishop's score was < or = 6 were randomly allocated to receive either 50 micrograms of oral misoprostol or 4 mg of intravaginal prostaglandin E2. If adequate cervical ripening (Bishop score of 9 or cervical dilatation of 3) or active labor did not ensue, repeat doses of each medication were administered every four hours. A maximum of six doses of either oral misoprostol or intravaginal prostaglandin E2 was permitted. Intravenous oxytocin was subsequently administered according to a standardized infusion protocol. RESULTS: Sixty patients were enrolled, with 29 randomized to the oral misoprostol arm and 31 to the prostaglandin E2 group. The data on 58 patients were eligible for analysis. Delivery occurred within 48 hours in 96.4% (27/28) of those administered oral misoprostol as compared to 76.7% (23/30) of those who received intravaginal prostaglandin E2 (P = .03). The mean time intervals from the start of induction to delivery were similar between the two groups (1,496 +/- 120 vs. 1,723 +/- 230 minutes, P = .40). No statistically significant differences existed between the two groups with respect to intrapartum complications, tachysystole, uterine hyperstimulation or adverse neonatal outcomes. CONCLUSION: Oral administration of misoprostol is an effective alternative to intravaginal prostaglandin E2 for preinduction cervical ripening.     

Oral misoprostol and intracervical dinoprostone for cervical ripening and labor induction: a randomized comparison

OBJECTIVE: To compare efficacy, safety, and tolerance of oral misoprostol with intracervical dinoprostone for cervical ripening and labor induction. METHODS: Two hundred women were randomized to receive single doses of oral misoprostol 200 microg or 0.5 mg of dinoprostone intracervically every 6 hours for a maximum four doses. RESULTS: The intervals from administration of the drug to active phase of labor (11.1 hours [7-24] versus 15.8 hours [7.5-29.62], P =. 01), to delivery (14.0 hours [8.42-27.61] versus 20.2 hours [16.7-32. 8], P =.01), and to rupture of membranes (10.0 hours [4.95-24.7] versus 15.6 hours [8.2-29.2], P =.003) were significantly shorter in the misoprostol group. All those variables were not distributed normally, so results are presented as median and interquartile range. The rates of women who needed oxytocin (68% versus 52%, P =.03) and cesarean for failed induction (9% versus 1%, P =.01) were higher in the dinoprostone group. CONCLUSION: A single dose of 200 microg oral misoprostol was more effective for cervical ripening and labor induction than 0.5 mg of dinoprostone intracervically every 6 hours, with a maximum of four doses.     

Oral misoprostol or vaginal dinoprostone for labor induction: a randomized controlled trial

OBJECTIVE: The objective of the study was to compare the effectiveness, safety, and side effects of low-dose oral misoprostol with vaginal dinoprostone for cervical ripening and labor induction. STUDY DESIGN: Women with Bishop score 6 or less admitted for labor induction at term were eligible for this randomized controlled trial. Exclusion criteria were multiple pregnancy, breech, fetal distress, or previous uterine scar. The allocation to the oral misoprostol group (20 microg given every 2 hours increased to 40 microg depending on uterine contractions) or to the vaginal dinoprostone group (2 mg twice, 6 hours apart) was contained in a sealed, opaque, and consecutively numbered envelope. RESULTS: Two hundred women (100 in each group) were included. The proportion of vaginal delivery within 24 hours was 56% in the misoprostol group and 62% in the dinoprostone group (relative risk 0.90, 95% CI 0.72-1.14). The risk of cesarean section was 18% and 19%, respectively. The median interval to delivery, calculated from survival analysis, was longer in the misoprostol group (1305 minutes) compared with the dinoprostone group (1080 minutes). The log-rank test was not significant (P =.35). Uterine hyperstimulation occurred in 9% of women in the misoprostol group compared with 14% in the dinoprostone group (P =.27). The only significant difference in neonatal outcomes was a more frequent presence of thick meconium in the misoprostol group (P =.03). CONCLUSION: We found no difference in terms of effectiveness and safety between low-dose oral misoprostol and vaginal dinoprostone used for induction of labor. This regimen avoids the excessive uterine contractility noted in previous studies, where higher doses of misoprostol were administered at longer intervals.     

A randomized controlled trial comparing low dose vaginal misoprostol and dinoprostone gel for labor induction

Objectives

To compare the safety and efficacy of low dose misoprostol and dinoprostone for cervical ripening and labor induction

Methods

It was an open label randomized controlled trial conducted at department of Obstetrics & Gynecology, Dr TMA Pai Rotary Hospital, Karkala. The main outcome measure was induction-to-vaginal delivery interval. Secondary outcome measures were the labor characteristics, maternal complications and neonatal outcomes.

Results

Out of 320 eligible women included for final analysis, 159 received misoprostol and 161 dinoprostone. There was no significant difference between the two groups in induction-to-vaginal delivery interval, mode of delivery, number of women delivering within 24 hours and neonatal outcomes. The efficacies of the two prostaglandins were similar.

Conclusion

Low dose misoprostol is as efficient as dinoprostone in achieving active labor and delivering with in 24 hours. The maternal and neonatal outcomes associated with each group were similar. It is a cheaper alternative for labor induction.     

Cardiotocographic abnormalities associated with dinoprostone and misoprostol cervical ripening

OBJECTIVE: To characterize the frequency and timing of cardiotocographic abnormalities associated with the use of 3 commercially available prostaglandin analogues, misoprostol, dinoprostone gel, and dinoprostone pessary, as labor preinduction agents. METHODS: One-hundred and eleven women undergoing induction of labor with an unfavorable cervix were randomized to receive either misoprostol 50 microg every 6 hours x 2 doses, dinoprostone gel 0.5 mg every 6 hours x 2 doses, or dinoprostone pessary 10 mg x 1 dose for 12 hours intravaginally. Oxytocin induction was initiated per standardized protocol. Cardiotocographic tracings were blindly reviewed, with abnormalities coded using established definitions. RESULTS: Fifty-five percent of women treated with misoprostol demonstrated an abnormal tracing event within the initial 24 hours of induction, compared with 21.1% with dinoprostone pessary and 31.4% with the dinoprostone gel. The mean (+/- standard deviation) number of abnormal events was significantly greater in women treated with misoprostol (5.0 +/- 5.9) versus the dinoprostone pessary (1.6 +/- 2.5) and gel (2.2 +/- 3.1) (P < .05). In addition, these events occurred earlier after initial misoprostol dosing (5.0 +/- 4.0 hours), compared with the dinoprostone pessary (9.4 +/- 5.6 hours) and gel (7.7 +/- 6.6). Thirty-nine percent of the misoprostol-treated women had abnormal patterns within 6 hours of initial dosing, compared with those treated with the dinoprostone pessary (7.9%) and gel (17.1%). CONCLUSION: Cardiotocographic abnormalities are more frequent after misoprostol administration compared with the dinoprostone analogues. The early onset and frequent nature of the tracing abnormalities associated with misoprostol raises concern for the potential use of misoprostol for outpatient cervical ripening.     

A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening

OBJECTIVE: To compare the efficacy of intravaginal misoprostol tablets with transcervical Foley catheter for preinduction cervical ripening. METHODS: Pregnant women who presented for induction of labor with unfavorable cervices (Bishop score less than 6) were assigned randomly to intravaginal misoprostol (50 microg tablet every 4 hours for a maximum of six doses) or 30-mL Foley catheter placed transcervically with maintenance of traction. RESULTS: Among 111 women, 53 were allocated to misoprostol and 58 to Foley bulb. Contractile abnormalities were more frequent in the misoprostol group (20.4%) than the Foley group (0%) (P <.001). No statistically significant differences were noted between groups in change in Bishop score, preinduction cervical ripening times, and total induction times. There were no statistically significant differences in mode of delivery or adverse neonatal outcomes. Uterine rupture occurred in one woman with two previous cesarean deliveries in the misoprostol group. CONCLUSION: Intravaginal misoprostol and transcervical Foley catheter are equivalent for cervical ripening. Uterine contractile abnormalities and meconium passage are more common with misoprostol.     

Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial

OBJECTIVE: To compare the 50-microgram (misoprostol vaginal insert 50) and 100-microgram (misoprostol vaginal insert 100) dose reservoirs of the misoprostol vaginal insert to 10-mg dinoprostone vaginal insert for time to vaginal delivery and rate of cesarean delivery. METHODS: A total of 1,308 women requiring cervical ripening (modified Bishop score less than or equal to 4) before induction of labor were randomly assigned to receive misoprostol vaginal insert 100 (n=428), misoprostol vaginal insert 50 (n=443) or 10-mg dinoprostone vaginal insert (n=436). The primary outcomes were time to vaginal delivery and rate of cesarean births. Safety was also assessed by comparing frequency of adverse events. RESULTS: Median time to vaginal delivery was 1,596, 2,127, and 1,650 minutes for misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal insert, respectively (P=.97 and 0.01 compared with dinoprostone vaginal insert, respectively). Of those who delivered in first admission, cesarean deliveries occurred in 119 of 421 (28.3%), 124 of 429 (28.9%), and 115 of 424 (27.1%) of participants treated with misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal inserts, respectively (relative risk 1.04, 95% confidence interval 0.84-1.30 for misoprostol vaginal insert 100 and relative risk 1.06, 95% confidence interval 0.86-1.32 for misoprostol vaginal insert 50 compared with dinoprostone vaginal insert). Medication-related adverse events included hyperstimulation syndrome in 17 of 428 (4.0%), 6 of 443 (1.4%), and 21 of 436 (4.8%); and nonreassuring fetal heart rate patterns in 63 of 428 (14.7%), 54 of 443 (12.2%), and 67 of 436 (15.4%) of participants treated with the misoprostol vaginal insert 100, misoprostol vaginal insert 50, and dinoprostone vaginal inserts, respectively. CONCLUSION: The misoprostol vaginal insert 100 and the dinoprostone vaginal insert had similar median time intervals to vaginal delivery, whereas the misoprostol vaginal insert 50 had a significantly longer time to vaginal delivery. The three products had similar cesarean rates and safety profiles.     

Cervical ripening and induction of labor with misoprostol,dinoprostone gel,and a Foley catheter: a randomized trial of 3 techniques

OBJECTIVE: The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction. STUDY DESIGN: Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 microg oral doses of misoprostol, or (3) serial 100-microg oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified. RESULTS: There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH. CONCLUSION: Oral 100 microg serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor.     

Comparing two dinoprostone agents for cervical ripening and induction of labor: a randomized trial

OBJECTIVE: To compare dinoprostone gel and insert in achieving successful vaginal delivery in nulliparous and multiparous women. STUDY DESIGN: 220 nulliparous and 100 multiparous with a Bishop score < or =7 were randomized to receive dinoprostone either gel or insert for cervical ripening. The main outcome measures were the rate and latency of vaginal delivery. RESULTS: In nulliparous women no significant differences were found between the gel and insert groups in the rate of vaginal delivery (85.6% vs. 80.7%) delivery < or =12 (36.8% vs. 32.9%) and < or =24h (85.3% vs. 93.4%) regardless of the preinduction Bishop score. Nulliparous with Bishop score < or =4 treated with the insert had a decreased risk (p<0.05) of post partum hemorrhage (4.8%) when compared with nulliparous treated with gel (16.7%). On the contrary, in multiparous the time to delivery interval was significantly shorter in the gel treated group (9.9+/-4.9h vs. 13.1+/-5h; p<0.001) with more patients delivering vaginally < or =12h (75% vs. 37.5%, p<0.001), regardless of the preinduction Bishop score. CONCLUSION: Both dinoprostone gel and insert are efficient in achieving cervical ripening and successful labor in nulliparous and multiparous. In multiparous, however, the gel significantly reduces the time to vaginal delivery with more patients delivering vaginally < or =12h, regardless of the Bishop score.     

Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial

OBJECTIVE: To compare the efficacy and safety of titrated oral misoprostol and vaginal misoprostol for labor induction. METHODS: Women between 34 and 42 weeks of gestation with an unfavorable cervix (Bishop score less than or equal to 6) and an indication for labor induction were randomLy assigned to receive titrated oral or vaginal misoprostol. The titrated oral misoprostol group received a basal unit of 20 mL misoprostol solution (1 mcg/mL) every 1 hour for four doses and then were titrated against individual uterine response. The vaginal group received 25 mcg every 4 hours until attaining a more favorable cervix. Vaginal delivery within 12 hours was the primary outcome. The data were analyzed by intention-to-treat. RESULTS: Titrated oral misoprostol was given to 101 (48.8%) women and vaginal misoprostol to 106 (51.2%) women. Completed vaginal delivery occurred within 12 hours in 75 (74.3%) women in the titrated oral group and 27 (25.5%) women in the vaginal group (relative risk [RR] 8.44, 95% confidence interval [CI] 4.52-15.76). The incidence of hyperstimulation was 0.0% in the titrated oral group compared with 11.3% in the vaginal group (RR 0.08, 95% CI 0.01-0.61). Although more women experienced nausea (10.9%) in the titrated oral group (RR 27.07, 95% CI 1.57-465.70), fewer infants had Apgar scores of less than 7 at 1 minute in the titrated oral group than in the vaginal group (RR 0.10, 95% CI 0.01-0.76). CONCLUSION: Titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00529295 LEVEL OF EVIDENCE: I.