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.     

A prospective, randomized, controlled trial comparing vaginal misoprostol and osmotic dilator in achieving cervical ripening before operative hysteroscopy

The purpose of this study was to compare the effectiveness of vaginal misoprostol and an osmotic dilator in achieving cervical ripening before operative hysteroscopy in pre-menopausal women. One hundred patients undergoing operative hysteroscopies with a 9-mm hysteroscope were prospectively and randomly assigned to two groups. In group 1 (the misoprostol group), 53 patients received 400 μg of vaginal misoprostol 12 h before the operation. In group 2 (the osmotic dilator group), 47 patients had an osmotic dilator inserted into the cervical canal 12 h before the operation. The primary outcome measure in this study was cervical width, assessed by the largest number of Hegar dilators that could be inserted into the cervix without resistance. The secondary outcome measure was the subjective assessments of the ease of dilatation to 9 mm by the surgeon. Adverse effects experienced including preoperative pain and vaginal bleeding were recorded for each group. There was no difference between the two groups with regard to demographic variables. The spontaneous cervical dilatation (mean ± SD) in the osmotic dilator group (9.6±2.2 cm) was significantly (P<0.01) greater than that in the misoprostol group (8.0±1.8 cm). In addition, the proportion of difficult dilatation in the osmotic dilator group (8 out of 47, 17.0%) was significantly less than that in the misoprostol group (22 out of 53, 41.5%). The occurrence of vaginal bleeding in the misoprostol group (77.4%) was significantly (P<0.01) higher than that in the osmotic dilator group (31.9%). The osmotic dilator is more effective than misoprostol at achieving cervix ripening prior to operative hysteroscopy.     

Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial

Objective To compare the efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labour induction. Methods We carried out an experimental clinical trial in which we enrolled 130 cervical consecutive patients with cervical ripening, randomly assigned to one of the following two treatment groups: (1) intravaginal misoprostol and (2) intracervical dinoprostone gel. A total of 50 μm of misoprostol was placed in the posterior vaginal fornix every 6 h for a maximum period of 24 h and 0.5 mg of dinoprostone was administrated in the uterine cervix every 6 h, for a maximum period of 24 h. The primary outcome measure was the number (rate) of women who went to vaginally deliver within 24 h of the protocol initiation. Results Among 130 patients evaluated, 65 were allocated to the misoprostol group and 65 to the dinoprostone group. The proportion of vaginal delivery within 24 h was significantly higher in the misoprostol group (75%) than in the dinoprostone group (53.8%) (RR = 1.40, 95% CI [1.07–1.45], P = 0.02). There was no significant difference between the mean time interval of delivery in the misoprostol group and the dinoprostone group (14.9 vs.15.8 h) (P = 0.51). The Bishop score was significantly higher in the misoprostol group, 6 h after the onset of the study (1.38; relative risk, 95% CI [1.02–1.85], P = 0.03). The Caesarean delivery rate for fetal distress was higher in the dinoprostone group (21 vs. 10.8%, P = 0.15). The tachysystole (Misoprostol 6.1% vs. dinoprostone 4.6%, relative risk 1.15, 95% CI [0.6–2.24]) and hyperstimulation syndrome rates (Misoprostol 7.6% vs. dinoprostone 4.6%, relative risk 1.26, 95% CI [0.72–2.24]) were slightly increased in the misoprostol group than in the dinoprostone group without reaching the level of statistical signification. Conclusion Misoprostol as used in this protocol is more effective than cervical dinoprostone gel application in the cervical ripening and labour induction. There is a tendency for an increase in the rate of tachysystole and hyperstimulation syndrome.     

Cervical ripening with oral misoprostol at term.

OBJECTIVES: To determine the efficacy of 200 microg single dose oral misoprostol as a cervical priming agent at term. METHODS: In this double-blind randomized trial, 156 pregnant women requiring induction of labor with gestational age of 37-42 weeks and Bishop score < or =5, were randomized to receive either 200 microg of misoprostol or a placebo, orally. Labor was induced with intravenous oxytocin infusion 12 h after oral medication if the patient did not go into labor. The primary outcome was the change in the Bishop score 12 h after oral medication. The secondary outcomes were the timings starting from the drug administration to the onset of uterine activity, interval between oral medication and delivery, oxytocin need for induction, mode of delivery, frequency of side effects, and neonatal and maternal outcome. The chi-square or Fisher exact test, Student's t-test, and Mann-Whitney U-test were used for analysis of the data. RESULTS: There were no significant differences in maternal characteristics or indications of induction. The Bishop score 12 h after oral medication significantly improved in the misoprostol group compared with the control group [55 (70%)>8 vs. 4 (5%)>8; P<0.001]. The induction rate was significantly reduced in the misoprostol group (P<0.001). The interval between oral medication and the onset of uterine activity was significantly shorter in the misoprostol group (P<0.001). The interval between oral medication and delivery was also significantly shorter in the misoprostol group (P<0.001). The cesarean delivery rate was significantly lower in the misoprostol group (P<0.001). There were no differences between the groups with respect to the incidence of tachysystole, hyperstimulation, adverse neonatal or maternal outcome. CONCLUSIONS: Oral administration of 200 microg single dose of misoprostol is an effective agent not only for cervical priming but also for induction of labor at term. Furthermore, it reduces the rate of cesarean deliveries.     

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。     

Addition of isosorbide mononitrate to misoprostol for cervical ripening in post-term pregnancy: A randomized controlled trial

ObjectiveThe purpose of this paper is to compare the effect of vaginal isosorbide mononitrate added to misoprostol versus misoprostol alone in cervical ripening and labor induction in post-term pregnancy.MethodsIn this double-blind controlled trial study, 150 pregnant women in post-term pregnancy who were candidates for labor induction were selected. The participants were assigned randomly to receive either vaginal isosorbide mononitrate (IMN) (40 mg) or placebo. Misoprostol (25 mg) was added to both groups as needed. Time to full cervical ripening, time to delivery, and the amount of misoprostol used in each group were assessed.ResultsThe time interval from the administration of IMN to full cervical ripening was shown to be significantly lower in the IMN+ misoprostol groups versus the comparison group (p = .032). The adjusted analysis of this time interval after controlling for age, BMI, gravidity, and Bishop score on administration remained significantly less (p = .045),the mean difference being ?4.85 h, CI 95% ?9.58 to ?.12. Isosorbide treatment resulted in significantly less misoprostol used versus misoprostol alone (2.37 ± 1.02 versus 3.08 ± 1.29), adjusted p-value = .001, CI 95% ?1.09 to ?.32. We found no significant increase in maternal–fetal outcomes or side effects of the IMN+ misoprostol group compared with the misoprostol group.ConclusionThis study found that intravaginal IMN added to misoprostol is more effective in reducing time to full cervical ripening versus misoprostol alone in post-term pregnancy. It also reduces the need for more misoprostol.     

Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial

Objective  To compare efficacy and safety of vaginal misoprostol (PGE₁ analog) with dinoprostone (PGE₂ analog) vaginal insert for labor induction in term pregnancies. Study design  A total of 112 women with singleton pregnancies of ≥37 weeks of gestation, and low Bishop scores underwent labor induction. The subjects were randomized to receive either 50 μg misoprostol intravaginally every 4 h to a maximum of five doses or a 10 mg dinoprostone vaginal insert for a maximum of 12 h. Time interval from induction to vaginal delivery, vaginal delivery rates within 12 and 24 h, requirement of oxytocin augmentation, incidence of tachysystole and uterine hyperstimulation, mode of delivery, rate of cesarean section due to fetal distress and neonatal outcome were outcome measures. Student’s t test, Chi square test, Fischer’s exact test were used for statistical analysis. Results  Time interval from induction to vaginal delivery was found to be significantly shorter in misoprostol group when compared to dinoprostone subjects (680 ± 329 min vs. 1070 ± 435 min, P < 0.001). Vaginal delivery rates within 12 h were found to be significantly higher with misoprostol induction [n = 37 (66%) vs. n = 25 (44.6%); P = 0.02], whereas vaginal delivery rates in 24 h did not differ significantly between groups [n = 41 (73.2%) vs. n = 36 (64.2%); P = 0.3]. More subjects required oxytocin augmentation in dinoprostone group [n = 35 (62.5%) vs. n = 20 (35.7%), P = 0.005] and cardiotocography tracings revealed early decelerations occurring more frequently with misoprostol induction (10.7 vs. 0%, P = 0.03). Tachysystole and uterine hyperstimulation, mode of delivery, rate of cesarean sections due to fetal distress and adverse neonatal outcome were not demonstrated to be significantly different between groups (P = 1, P = 0.5, P = 0.4, P = 0.22, P = 0.5). Conclusion  Using vaginal misoprostol is an effective way of labor induction in term pregnant women with unfavorable cervices, since it is associated with a shorter duration of labor induction and higher rates of vaginal delivery within 12 h. Misoprostol and dinoprostone are equally safe, since misoprostol did not result in a rise in maternal and neonatal morbidity, namely, tachysystole, uterine hyperstimulation, cesarean section rates and admission to neonatal intensive care units as reported previously in literature.     

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.     

A randomized trial that compared intravaginal misoprostol and dinoprostone vaginal insert in pregnancies at high risk of fetal distress

OBJECTIVE: The purpose of this study was to compare the safety and efficacy of misoprostol and dinoprostone in pregnancies at high risk of fetal distress. STUDY DESIGN: Medical indications for the induction of labor with postdate pregnancy or intrauterine growth restriction were randomized. A sequential design that was based on the triangular test was used. RESULTS: At the fourth interim analysis, which included 140 patients, the trial was stopped because no significant difference was found in neonatal safety between misoprostol and dinoprostone, which was assessed on arterial cord pH <7.20 (14.3% vs 10.0%, respectively; P=.60). Neonatal tolerance was similar in the 2 groups, with no difference in the cesarean delivery rate for fetal distress or in the incidence of meconium-stained amniotic fluid. Time to vaginal delivery was shortened by misoprostol (P=.03). CONCLUSION: Misoprostol and dinoprostone are equally safe for the induction of labor in pregnancies that are at high risk of fetal distress; however, misoprostol allowed the earlier induction of labor than did dinoprostone.     

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.     

The nurse's role in misoprostol induction: a proposed protocol

The use of misoprostol (PGE 1) for induction of labor has been studied in the United States since 1993. The current medical literature contains studies of this non-FDA-approved indication for misoprostol. The data reveal that misoprostol is as effective or more effective in inducing labor as are oxytocin and prostaglandin E2 (PGE 2), with less cost. Nurses need to understand the physiology of prostaglandins and management of misoprostol in labor. Nurses often must assess the safety of mother and fetus during a misoprostol induction without a protocol based on research findings. This article presents a sample protocol.     

Foley尿管水囊促宫颈成熟用于足月妊娠引产的前瞻性随机对照研究

目的 比较Foley尿管水囊与普贝生栓促宫颈成熟用于足月妊娠引产的安全性和有效性. 方法 采用前瞻性随机对照研究方法,选择2009年6月至12月在本院待产的孕足月、单胎头位、有引产指征、阴道清洁度≤Ⅱ度、胎膜完整、官颈Bishop评分＜6分的初产妇,签署随机对照研究知情同意书后,随机分为2组,最终纳入分析的共126例,分别予Foley尿管水囊(64例)和普贝生栓(62例)促官颈成熟,Foley尿管水囊组与普贝生栓组孕妇的孕周、引产前宫颈评分、引产指征差异无统计学意义.采用t、x2检验或Fisher精确概率法比较2组孕妇的引产成功率、分娩方式、产程时间及母儿结局. 结果 Foley尿管水囊组与普贝生栓组宫颈评分改善、引产成功率、阴道分娩率、总产程、产后出血量差异均无统计学意义(P＞0.05).Foley尿管水囊组较普贝生栓组引产24 h内阴道分娩率低[28.1％(18/64)与56.5％(35/62),t=10.37,P＜0.05],宫缩过频过强发生率也较低[0.0％(0/64)与17.7％(11/62),P＜0.05],但缩宫素使用率高[87.5％(56/64)与21.0％(13/62),x2 =56.27,P＜0.05].2组新生儿Apgar评分、羊水胎粪污染发生率、新生儿体重差异均无统计学意义(P＞0.05).2组孕妇无一例发生产褥感染. 结论 严格掌握Foley尿管水囊促宫颈成熟的指征及执行无菌操作规程,可以取得与普贝生栓相似的促官颈成熟效果及引产母婴结局,未发生过频过强官缩,具有安全性高及成本低廉等优点.     

Isosorbide mononitrate vaginal gel versus misoprostol vaginal gel versus Dilapan-S for cervical ripening before first trimester curettage

OBJECTIVE: To compare the efficacy and safety of vaginal applications of three different principles of cervical priming prior to first trimester curettage, isosorbide mononitrate (ISMN), misoprostol and Dilapan-S, a hygroscopical cervical dilator. STUDY DESIGN: Pregnant women with missed abortion between 6 and 12 gestational weeks were included and randomly assigned to receive either 80 mg ISMN vaginal gel (group 1) or 200 microg of misoprostol vaginal gel (group 2) or Dilapan-S, a hygroscopical cervical dilator (group 3), for cervical ripening before curettage. Outcome parameters were cervical dilation at the time of operation and maximum dilation reached with Hegar's dilator and the degree of difficulty in mechanical dilation as well as safety and side effects of the preparations. RESULTS: Sixty-five pregnant women with missed abortion were included and assigned to the three study groups (n=22 for group 1, n=22 for group 2, n=21 for group 3). Misoprostol vaginal gel and Dilapan-S were significantly more effective than ISMN vaginal gel in cervical dilation reached with priming (p<0.005 and p<0.005) and in the degree of difficulty in cervical dilation assessed by the surgeon (p<0.001 and p<0.01). Mild discomfort was indicated by all patients after Dilapan insertion, whereas no patient complained about discomfort after misoprostol or ISMN insertion (p<0001). Three patients suffered from mild hypotension and headache after ISMN treatment, and two had increased vaginal bleeding due to uterine atony during surgery (p<0.05). CONCLUSION: A vaginal gel of ISMN is less effective for cervical ripening prior to first trimester curettage compared to misoprostol vaginal gel or Dilapan-S. The latter could be an effective and safe alternative to prostaglandin priming avoiding preoperative contractions caused by prostaglandin preparations.