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.     

Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction

Objective

To characterize the incidence and timing of cardiotocographic (CTG) abnormalities associated with misoprostol and dinoprostone vaginal inserts during labor induction.

Study design

This was a secondary analysis of data collected during the misoprostol vaginal insert (MVI) trial, a multi-site, double-masked, randomized trial of women requiring cervical ripening before induction of labor. The timing, incidence and clinical outcomes associated with CTG abnormalities were analyzed among three study groups.

Results

1308 subjects were randomized to receive dinoprostone pessary, misoprostol 50 mcg (MVI 50) or 100 mcg (MVI 100) vaginal insert. 6.8% of MVI 50-treated women had a uterine contractile abnormality (hyperstimulation, hypertonus and/or tachysystole) while the study drug was in situ, compared to 17.4% with dinoprostone insert (p < 0.001) and 17.3% with MVI 100 (p < 0.001). There was no significant difference in incidence of fetal heart rate (FHR) abnormalities that occurred with the study drug—11.2% with dinoprostone, compared to 9.9% with MVI 50 and 10.7% with MVI 100. Cardiotocographic (CTG) abnormalities while the study drug was in situ occurred later in women treated with MVI 50 (7.5 h [6.2-9.8]) compared to dinoprostone (5.5 h [4.2-6.6], p = 0.003) and MVI 100 (7.0 h [5.7-7.9], p = 0.13). Eight participants in MVI 50 group underwent cesarean section secondary to a CTG event that was initially noted with the study drug in situ, compared to eight dinoprostone-treated participants and 16 in the MVI 100 group, but these differences were not statistically significant.

Conclusion

Cardiotocographic abnormalities were less frequent and occurred after longer exposure with MVI 50 than MVI 100 or dinoprostone. Clinical outcomes were similar among the groups.     

Six hourly vaginal misoprostol versus intracervical dinoprostone for cervical ripening and labor induction

AIM: Prospective clinical trials were conducted to assess the safety and efficacy of 6-hourly vaginal misoprostol versus intracervical dinoprostone for induction of labor. METHODS: A total of 120 pregnant women requiring induction of labor were recruited. Cases were randomized to receive either 50 microg vaginal misoprostol 6 hourly (group 1, n = 60) or 0.5 mg intracervical dinoprostone 6 hourly (group II, n = 60). Outcome measures, such as change in Bishop's score, need of oxytocin, induction delivery interval; complications like tachysystoly, hyperstimulation, abnormal fetal heart rate, and meconium passage were compared between two groups. Statistical analysis was performed by Wilcoxan's Rank sum and Student's t-test. RESULTS: Bishop score rise, after 6 h of initiation of therapy was significantly higher in the misoprostol group than dinoprostone, 2.98 +/- 2.57 versus 2.05 +/- 1.83 (P = 0.04). The need of oxytocin augmentation was reduced in misoprostol versus dinoprostone group, 16.6% versus 78.3% (P = <0.001). Induction delivery interval was shorter in misoprostol; 12.8 +/- 6.4 h versus 18.53 +/- 8.5 h in dinoprostone group (P = <0.01). One case (1.6%) in misoprostol group, but none in dinoprostone had tachystole (P = 1.00). Abnormal heart rate pattern was found more in misoprostol than dinoprostone 16.6% versus 4.9% (P = 0.14) and so was the incidence of cesarean section, 26.6 versus 15%, respectively (P = 0.47). Meconium passage was the same in both groups, 10% in each group. CONCLUSION: Vaginal misoprostol 50 microg 6-hourly is safe and effective for induction of labor with lesser need of oxytocin augmentation and shorter induction delivery interval.     

A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction

Objective: Our purpose was to compare the effect of vaginal administration of misoprostol (Cytotec) with that of dinoprostone (Cervidil) on cervical ripening and labor induction. Study design: Two hundred patients with indications for induction of labor and unfavorable cervical examinations were randomly assigned to receive vaginally administered misoprostol (prostaglandin E₁) or the dinoprostone (prostaglandin E₂) vaginal insert. Twenty-five microgram tablets of misoprostol were placed in the posterior vaginal fornix every 4 hours for a maximum of six doses. Additional misoprostol was not given after either spontaneous rupture of membranes, adequate cervical ripening (Bishop score of ≥8 or cervical dilatation of ≥3 cm), or beginning of active labor. The vaginal insert, Cervidil, containing 10 mg of dinoprostone in a timed-release preparation was placed in the posterior vaginal fornix for a maximum period of 24 hours. The vaginal insert was removed for spontaneous rupture of membranes, entry into active labor, adequate cervical ripening, or abnormality of uterine contractile pattern or fetal cardiac activity. Results: Of the 200 patients enrolled, 99 were randomized to misoprostol and 101 to dinoprostone. The average interval from start of induction to vaginal delivery was 1 hour shorter in the misoprostol group (1296.7 ± 722.1 minutes) than in the dinoprostone group (1360.0 ± 792.0 minutes), but this difference was not statistically significant (p = 0.97). Oxytocin augmentation of labor was used in 50 (50.5%) misoprostol-treated patients and 43 (43.5%) dinoprostone-treated patients (relative risk 1.14, 95% confidence interval 0.86 to 1.51, p = 0.35). There were no significant differences between routes of delivery with misoprostol or dinoprostone. Overall, 38 patients (19.3%) had cesarean deliveries. There was a significantly lower prevalence of tachysystole (six or more uterine contractions in a 10-minute window for two consecutive 10-minute periods) in the misoprostol group (7.1%) than in the dinoprostone group (18.4%) (relative risk 0.52, 95% confidence interval 0.31 to 0.89, p = 0.02). There were no significant differences in frequency of uterine hyperstimulation or hypertonus. Abnormal fetal heart rate tracings were found in 23 (23.2%) of misoprostol-treated patients and 35 (35.7%) of dinoprostone-treated patients (relative risk 0.73, 95% confidence interval 0.52 to 1.01, p = 0.0546). No significant differences were found in meconium passage, 1- or 5-minute Apgar scores <7, neonatal resuscitations, or admissions to the neonatal intensive care unit between the two groups. CONCLUSIONS: Vaginally administered misoprostol is as effective as dinoprostone for cervical ripening and the induction of labor. Mean time intervals to delivery, need for oxytocin augmentation, and routes of delivery were similar between the two groups. Incidence of uterine tachysystole with misoprostol every 4 hours was significantly less than with dinoprostone.     

Factors affecting the likelihood of successful induction after intravaginal misoprostol application for cervical ripening and labor induction

OBJECTIVE: Our purpose was to determine whether maternal age, height and weight, parity, duration of pregnancy, cervical dilatation or Bishop score, and birth weight could be used to predict the likelihood of successful induction in women given intravaginal misoprostol. STUDY DESIGN: A computerized database was compiled of 1373 pregnancies in which intravaginal misoprostol was given for cervical ripening and labor induction. Most of these women were placed on investigational protocols in which the dose of misoprostol administered was 25 to 50 microg and the dosing intervals ranged from 3 to 6 hours. No more than 24 hours of administration was permitted. Induction was undertaken in women with unfavorable cervical examinations (Bishop scores of 4 or less) and without spontaneous labor or ruptured membranes. Univariate and stepwise multiple regression analyses were performed to identify those factors associated with successful induction, defined as vaginal delivery within 24 hours of induction. RESULTS: Six hundred fifty-seven (48%) had successful induction. Parity (odds ratio [OR] 2.5, 95% CI 2.0-2.9, P <.0001), initial cervical dilatation (OR 1.9, 95% CI 1.6-2.3, P <.0001), Bishop score (OR 1.6, 95% CI 1.3, 1.8, P <.0001), and gestational age at entry (OR 1.3, 95% CI 1.1-1.5, P =.002) were significant at the.05 level for predicting successful induction. A multivariate stepwise logistic regression was then performed to evaluate each of these as independent predictors. Parity (OR 2.4, 95% CI 2.0-3.0, P <.0001), initial cervical dilatation (OR 1.7, 95% CI 1.4-2.1, P <.0001), and estimated gestational age (OR 1.3, 95% CI 1.1-1.6, P =.003) are significant independent predictors for successful induction, but initial Bishop score is not significant (P =.19) after adjustment for other significant predicting factors. CONCLUSIONS: The clinical characteristics of parity, initial cervical dilatation, and gestational age at entry are predictors of the likelihood of success of cervical ripening and labor induction with intravaginal misoprostol administration.     

Cervical ripening: A randomized comparison between intravaginal misoprostol and an intracervical balloon catheter combined with intravaginal dinoprostone

OBJECTIVES: Our purpose was to compare the efficacy of intravaginal misoprostol and intracervical Foley catheter/intravaginal dinoprostone for cervical ripening. STUDY DESIGN: Patients admitted for induction of labor were randomized to receive intravaginal misoprostol 25 μg every 4 hours or intracervical Foley catheter/intravaginal dinoprostone 4 mg every 4 hours. Patients not entering active labor and having ruptured membranes or arrest of dilatation received intravenous oxytocin. RESULTS: Sixty-five patients received Foley catheter/dinoprostone gel and 62 patients received misoprostol. The mean time until cervical ripening was less in the catheter/gel group (7.5 ± 3.4 vs 12.0 ± 5.9 hours, p < 0.01). The mean time until vaginal delivery was less in the catheter/gel group (17.4 ± 6.9 vs 21.2 ± 7.5 hours, p = 0.004). Among vaginal deliveries, more patients in the catheter/gel group delivered within 24 hours (90% vs 69%, p = 0.013). CONCLUSIONS: Intracervical Foley catheter/intravaginal dinoprostone was associated with more rapid cervical ripening, shorter induction to vaginal delivery interval, and greater number of vaginal deliveries within 24 hours. (Am J Obstet Gynecol 1998;178:1333-40.)     

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.     

Vaginal misoprostol administration for cervical ripening and labor induction

Intravaginal misoprostol has been shown to be an effective agent for cervical ripening and induction of labor. Vaginal application of misoprostol has been reported in over 9000 women worldwide and seems to have safety profile similar to that of endocervically and intravaginally administered dinoprostone. Concern arises with the use of higher doses of intravaginal misoprostol (50 mcg or more) and the association with uterine contractile abnormalities and for this reason, use of low-dose misoprostol regimen has been recommended by the American College of Obstetricians and Gynecologists. The recommendation is use of a 25-mcg dose of misoprostol inserted into the posterior vaginal fornix and repeated every 3 to 6 hours as needed. Misoprostol administration to women with prior cesarean births seems to increase the likelihood of uterine scar disruption and should not be used in these women. There are reports of uterine rupture in women with unscarred uteri treated with vaginally applied misoprostol. Therefore, all patients need to be monitored adequately after misoprostol administration. Although there is a growing body of data regarding the ambulatory use of intravaginal misoprostol for cervical ripening, its use for this purpose cannot be recommended outside of investigational protocols at this time because of concerns for maternal and neonatal safety.     

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.     

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- &#119 g suppositories, or misoprostol 50- &#119 g 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.     

Induction of labor with intravaginal misoprostol versus intracervical dinoprostone

Sixty five pregnant women who had the indication for labor induction were randomized in a clinical trial to receive 100 μg. intravaginal misoprostol or intracervical gel of 0.5 mg dinoprostone. The mean time from induction to delivery for the misoprostol group was 7.6±1.9 versus 8.2±5.9 (hours±SD) for the dinoprostone group. There were no significant differences between groups in gestational age, induced labor rates, type of delivery, fetal outcome and maternal complications. We found that intravaginal misoprostol tablet is as effective as intracervical dinoprostone for inducing second and third trimester labor. Received: 15 July 1996 / Accepted: 10 September 1996     

A comparison of obstetrical outcomes and costs between misoprostol and dinoprostone for induction of labor

Objective: The objective of this study is to compare resource utilization (efficiency) and obstetrical/cost outcomes of single dose misoprostol versus dinoprostone for induction of labor (IOL) at term.

Methods: Retrospective cohort of induced deliveries 37–41 weeks gestation presenting with a Bishop score?≤4 using single-dose-50?mcg vaginal misoprostol or 10?mg-dinoprostone vaginal-inserts. Dinoprostone patients were compared (5:1) with misoprostol patients. The primary outcome variable was length of L&D stay (proxy for resource utilization). Baseline characteristics, clinical outcomes, and costs were compared.

Results: Three-hundred thirty-one patients were included, 276 received dinoprostone and 55 received misoprostol. The misoprostol group had statistically significant decreased time to active labor [median 8?h (1.6,24) versus 12(0.8,52)], time-to-delivery [median 11?h (4,31) versus 17(2.8,56)] and L&D stay [median 16?h (13,28) versus 24(18,30)]. Differences remained significant after adjustment for race, method of delivery, birth weight, gravidity/parity, gestational age, and BMI (adjusted p values?<0.001, <0.01, and?<?0.05, respectively). There were no statistical differences in Apgar scores, tachysystole rate, cesarean section rate, and composite maternal/neonatal morbidity. A policy of using misoprostol would result in annual cost savings of approximately $242 500 at our institution as compared with dinoprostone.

Conclusion: Single-dose misoprostol is more efficient in IOL at term with respect to L&D utilization and cost and its use is not associated with increased adverse obstetrical outcomes.     

Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor.

OBJECTIVE: To compare the efficacy and safety of 100 microg of intravaginal misoprostol with intracervical Foley catheter for cervical ripening and induction of labor. METHOD: One hundred women being induced in the Lagos University Teaching Hospital, Nigeria, were randomized to receive a single 100 microg dose of misoprostol intravaginally or intracervical insertion of Foley catheter. Data analyses were by the Student's t-test and chi-square test. RESULT: Misoprostol was more effective in terms of induction to delivery interval (11.84+/-5.43 versus 20.03+/-4.68 h, P<0.05), change in Bishop score, and number delivered within 24 h, in patients with a one-time successful induction. Uterine hyperactivity and rupture were more frequent in the misoprostol group. CONCLUSION: A single 100 microg dose of intravaginal misoprostol is more efficacious than intracervical insertion of Foley catheter for cervical ripening and induction of labor. Further studies using lower doses are needed to determine the safest dose.     

Buccal versus intravaginal misoprostol administration for cervical ripening

OBJECTIVE: The purpose of this study was to compare the efficacy of misoprostol that is administered in the buccal pouch with the intravaginal route of administration. STUDY DESIGN: One hundred fifty-seven pregnant women with a singleton live gestation, Bishop score of <7, estimated fetal weight of <4500 g, and gestational age of >24 weeks were randomized to receive misoprostol that would be placed either in the buccal pouch or vagina every 6 hours. In the buccal group, after the first 2 doses of 200 microg, the dose was increased to 300 microg for the duration of the study (up to a total of 1600 microg). In the vaginal group, after the first 2 doses of 50 microg, the dose was increased to 100 microg for the duration of the study (up to a total of 500 microg). The primary outcome variable was the interval from the first dose to vaginal delivery. Power calculations indicated the need to enroll 71 patients in each arm of the study, which would allow for the detection of a 4-hour reduction in vaginal birth interval for buccal misoprostol. RESULTS: The hours from drug administration to vaginal delivery were similar between the buccal and vaginal groups (23.5 +/- 20.8 hours versus 21.3 +/- 13.4 hours), respectively. Thirty-five women (63%) versus 34 women (67%) delivered vaginally within 24 hours (P = not significant). The incidence of tachysystole was higher in the buccal group, 28 occurrences (38%) versus 15 occurrences (19%; P =.01). CONCLUSION: Buccal misoprostol is effective for cervical ripening but results in a higher incidence of tachysystole than does intravaginal administration.     

Oral misoprostol versus intracervical dinoprostone for induction of labor.

OBJECTIVES: To compare oral misoprostol with dinoprostone for induction of labor and their effects on the fetal heart rate patterns. METHODS: In a randomized controlled trial, 200 patients received either misoprostol 50 mug orally for every 4 h, or dinoprostone 0.5 mg intracervically for every 6 h. Cardiotocographic recordings, in 10-min windows 30, 60, and 80 min after prostaglandin administration during induction and continuously during labor, were compared between the two groups. Primary outcome for effectiveness and safety was assessed in terms of the number of vaginal deliveries within 24 h and fetal heart rate abnormalities during induction and labor respectively. RESULTS: Data from 96 patients in the misoprostol group and 95 in the dinoprostone group were analyzed. There were no significant differences in respect of the number of vaginal deliveries within 24 h (RR 1.12; 95% CI 0.88-1.42). The frequency of suspicious and pathological fetal heart rate patterns did not differ significantly but significantly more cardiotocographs in the dinoprostone group had non-reassuring baseline variability 60 min after dose administration (RR 0.33; 95% CI 0.14-0.77). Maternal and neonatal outcomes did not differ significantly. CONCLUSION: Oral misoprostol is as effective as intracervical dinoprostone for induction of labor with no difference in the frequency of fetal heart rate abnormalities.     

地诺前列酮、米索前列醇及缩宫素用于促宫颈成熟及引产的对比研究

目的:对比地诺前列酮(普贝生)、米索前列醇及缩宫素促宫颈成熟及引产的效果。方法:随机将200例单活胎、具备引产指征的初产妇分为3组:(1)实验组100例,阴道后穹窿放置普贝生;(2)对照1组50例,阴道后穹窿放置米索前列醇;(3)对照2组50例,静脉输注缩宫素。结果:用药24h后,普贝生组宫颈成熟度明显优于缩宫素组,平均临产时间、破膜时间以及分娩时间均明显短于缩宫素组。24h内分娩率:普贝生组为57.0%,明显高于缩宫素组的4.0%(P<0.01);引产成功率:普贝生组为75.0%,明显高于缩宫素组的20.0%(P<0.01)。普贝生组促宫颈成熟及引产效果与米索前列醇组相近,米索前列醇组出现高张宫缩1例(2%),胎盘早剥1例(2%),普贝生组无上述情况。结论:普贝生是一种安全、有效、方便的促宫颈成熟和引产药物,对母儿无明显不良影响。