A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction

OBJECTIVE: The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening. STUDY DESIGN: A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation >or=28 weeks and an unfavorable cervix (Bishop score 相似文献   

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.     

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.     

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.)     

Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction

Objective(S): To compare the effectiveness and safety of intra-cervical Foley catheter combined with intra-vaginal isosorbide mononitrate (IMN) versus intra-vaginal misoprostol for cervical ripening and labor induction in pregnant women with unripe cervices.

Methods: Open-labeled randomized controlled trial in Cairo university hospital, Cairo, Egypt during 2012–2014. Three hundred and ninety-five pregnant women at term or post-term with an indication for labor induction and unripe cervix were included in the study. The subjects were randomly divided into two groups. Vaginal misoprostol was used in group 1 (n?=?197) and intra-cervical Foley catheter plus vaginal IMN in group 2 (n?=?198). Our main outcome measure was cesarean section rate.

Results: Among the 395 included patients there were significantly lower duration of induction of labor (p?<?0.001) in group 1with lower cesarean section rates [22.8% in group 1versus 33.3% in group 2; RR 0.7 (0.6–0.9), (p?=?0.020)]. Whereas the uterine hyperstimulation (p?<?0.001) was significantly higher in group 1. There were no significant differences between both groups as regard patients’ demographic characteristics.

Conclusions(s): Vaginal misoprostol is more effective but less safe than Foley catheter combined with vaginal IMN for induction of labor in term and post-term pregnancy.     

Hyaluronidase versus Foley catheter for cervical ripening in high-risk term and post term pregnancies.

OBJECTIVE: To evaluate the effectiveness and safety of Foley catheter and hyaluronidase for cervical ripening. METHOD: Randomized controlled trial where 140 pregnant women, with gestational age > or = 37 weeks, indication for labor induction and an unripe cervix, were enrolled, allocated in two groups according to the method of cervical ripening before labor induction. Statistical analysis used Student's t-test, Mann-Whitney, Chi-square test, survival analysis, risk ratios and number needed to treat. RESULTS: Time of induction, dose of oxytocin and mode of delivery had better results in the Foley catheter group. Comfort with the method was higher in the hyaluronidase group. CONCLUSIONS: Both methods were effective and safe for cervical ripening. The Foley catheter group experienced a shorter period of induction, required a lower dose of oxytocin and had higher vaginal delivery rates, while the women who used hyaluronidase declared greater comfort with the method.     

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.     

Pregnancy outcomes after failed cervical ripening with prostaglandin E2 followed by Foley balloon catheter

Objective: To study pregnancy outcomes of cervical ripening with Foley catheter, in women who failed to respond to prostaglandin-E2 (PGE2).

Methods: A retrospective cohort study of all patients with a singleton pregnancy, who underwent cervical ripening with vaginal PGE2, between 2013 and 2014, was performed. Patients who failed to respond to a total dose of 6–9 mg PGE2, defined as no change in Bishop score, underwent subsequent ripening with Foley catheter (non-responders group). Data were compared to patients who achieved sufficient response to a total dose of up to 9 mg PGE2 (responders group).

Results: Compared with the responders group (n?=?813), patients in the non-responders group (n?=?49) had higher rates of nulliparity (p?<?0.001), pre-induction cervical dilation ≤1?cm (p?=?0.004), pre-induction cervical effacement?≤50% (p?=?0.01) and birth weight >4000?g (p?=?0.02). A significantly higher cesarean delivery rate was observed in the non-responders group (51 versus 12.3%, p?<?0.001). Failed ripening with PGE2 was found to be independently associated with cesarean delivery (aOR?=?5.11, 95% CI?=?2.72–9.62).

Conclusions: The need for an additional cervical ripening method after failure with PGE2 is associated with a very high risk of cesarean delivery. This is particularly significant in nulliparous women, women carrying large fetuses, and women presenting with a low Bishop score.     

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.     

Effect of vaginal pH on efficacy of misoprostol for cervical ripening and labor induction

OBJECTIVE: We sought to evaluate whether vaginal pH has an effect on the relative efficacy of misoprostol for cervical ripening and labor induction. STUDY DESIGN: Thirty-seven gravid women with an unfavorable cervix and indication for labor induction were enrolled in this prospective, double-blind, observational study. Baseline assessments of cervicovaginal pH and Bishop score were made at the time of enrollment by an independent examiner. All patients received 50 microg misoprostol intravaginally every 6 hours for 12 hours. After the initial 12 hours of preinduction, a repeat Bishop score assessment was made by the same initial examiner. Patients not in active labor at 12 hours were placed on a standardized oxytocin induction regimen. Labor was managed by the on-call obstetric team, who remained blinded to pH assessment. Clinical outcomes were evaluated. Statistical analyses were made by the Student t test, the Fisher exact test, and linear regression analysis. RESULTS: Average initial vaginal pH was 4.8 +/- 0.5 (range, 3.5-7.0) for the study cohort. No significant differences were noted between those patients with low vaginal pH (< or =4.5) compared with those with high pH vaginal (>4.5) with respect to maternal age, parity, gestational age, or initial Bishop score. Similarly, Bishop score change over preinduction interval (5.6 vs 4.9), time to active labor (16.3 vs 17. 1 hours), time to complete dilatation (20.0 vs 19.9 hours), and time to delivery (21.0 vs 21.6 hours) were not significantly different between the low and high pH groups, respectively. Linear regression analysis revealed no significant association between vaginal pH and Bishop score change during preinduction interval, time to active labor, time to complete dilatation, or time to delivery. CONCLUSION: Vaginal pH does not appear to influence the efficacy of intravaginally administered misoprostol for cervical ripening and labor induction.     

Nitric oxide donor isosorbide mononitrate for pre-induction cervical ripening at 41 weeks' gestation: A randomized controlled trial

OBJECTIVE: Nitric oxide donors have been shown to cause cervical ripening. The aim of this study was to determine whether sustained release isosorbide mononitrate (ISMN-SR) 60 mg administered vaginally is effective for pre induction cervical ripening at 41 weeks' gestation. METHODS: A double-blind randomised controlled trial was carried out at the University Obstetric Unit, Galle, Sri Lanka for a period of 9 months, commencing 1st August 2003. One hundred and fifty-six consecutive women with uncomplicated singleton pregnancies at 41 weeks' gestation with a modified Bishop Score <5 were allocated by stratified (primip/multip) block randomization to receive either ISMN-SR 60 mg (n = 78) or vitamin C 100 mg (n = 78) vaginally. Modified Bishop Score at 41 weeks + 2 days' gestation and the proportions establishing spontaneous labor or becoming favorable for induction of labor (IOL) by 41 weeks + 2 days' gestation were evaluated in each group. RESULTS: At the commencement of the study there were no differences between the mean age, parity or modified Bishop Score of the two groups. In the ISMN-SR group, there was a marked increase in the proportion establishing spontaneous labor (28% vs 7.5%, P < 0.01) and being favorable for IOL (40% vs 9% P < 0.001), 2 days after therapy. In the ISMN-SR group, there was a significantly higher increase in the mean modified Bishop Score (3.8, 95% CI 2.3-5.3 vs 1.3, 95% CI 0.3-2.2, P < 0.01) and a marked decrease in the proportion of subjects requiring further ripening of the cervix with a Foley catheter. (32% vs 79%, P < 0.001). The cesarean section rates were similar in both groups. CONCLUSION: Sustained release ISMN administered vaginally is effective for preinduction cervical ripening.     

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.