Comparison of vaginal misoprostol, laminaria, and isosorbide dinitrate on cervical preparation and labor duration of term parturient: a randomized double-blind clinical trial (original) (raw)
Related papers
Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol
International Journal of Gynaecology and Obstetrics, 2003
Objectives: To compare the effectiveness of 25 mg vs. 50 mg 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 G5, and Bishop score -5. Women were randomized to receive either 25 mg (ns60) or 50 mg (ns60) 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 inductionvaginal delivery interval (685"201 min in the 25 mg group vs. 627"177 min in the 50 mg group, Ps0.09). The proportion of women delivering vaginally with one dose of vaginal misoprostol was significantly greater in the 50 mg group (0y49 vs. 41y47, 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 mg of misoprostol appears to be as effective as 50 mg for cervical ripening and labor induction beyond 41 weeks' gestation.
A Comparison of 25 μg with 50 μg Misoprostol for Cervical Ripening and Induction of Labor
Journal of Womens Health Care
Background: Misoprostol is increasingly being accepted as a standard agent for cervical ripening and induction of labor. The lowest effective dose is still not known. Materials and Methods: This was an open label clinical trial of one hundred and eighty four women with obstetrics or medical indications for induction of labor at University of Abuja Teaching Hospital, Abuja. Women were grouped to receive either 25 µg or 50 µg of intravaginal misoprostol. The main outcome measure was inductionvaginal delivery interval while the secondary outcome measures were requirements for oxytocin augmentation, mode of delivery, frequency of tachsystole/hyperstimulation, as well as feto-maternal outcomes. Data was analyzed using SPSS version 21.0. Chi-square test was used to compare categorical variables. Mann-Whitney test was used to analyze continuous variables of the two treatment groups. P-value of less than 0.05 was accepted as indicating statistical significance. Results: Mean induction delivery interval was 13.8 ± 5.9 and 14.0 ± 5.7 hours (P=0.842) with the 25 µg and 50 µg misoprostol respectively. The delivery rate within 24 hours of 66.3% (61/92,) in 25 µg group was lower than 67.4% (62/92) recorded in the 50 µg group but the difference was not statistically significant (P=0.156). The rates of caesarean section and operative vaginal delivery were similar in both groups. There were no significant difference in maternal side effects and neonatal outcomes among the women in the two groups. Conclusion: There were no statistically significant differences in the effectiveness and safety of either of the dose regimen over the other. The choice may therefore be guided by the physician's experience, availability and/or departmental protocol.
Randomization of vaginal and sublingual misoprostol for cervical ripening and labor induction
Tropical Journal of Obstetrics and Gynaecology, 2020
Background: Planned induction of labor for various indications has become an established part of modern Obstetric practice. While the efficacy of misoprostol, a prostaglandin E1 analog as a cervical ripening labor induction agent has been established, the appropriate route and dosage are still objected to ongoing research. Objective: This study aims at comparing the efficacy of vaginally administered with sublingual misoprostol for cervical ripening and labor induction. Methodology: One hundred (100) pregnant women at term who fulfill the inclusion criteria were equally randomized into the two arms of the study to receive either 25 µg of misoprostol sublingually or 25µg vaginally. The induction delivery interval and fetal outcomes were compared in the two arms of the study. Results: The vaginal group required more doses of misoprostol than the sublingual group (1.68 ± 0.74 versus 1.26 ± 0.44, P = 0.005). Time from the administration of the first dose of misoprostol to the achievement of a Bishop score of 7 or active phase labor was shorter in the sublingual group than the vaginal route group (5.04 ± 1.77 hours versus 6.32 ± 1.36 hours, P = 0.001). Induction-delivery interval was shorter in the sublingual group than the vaginal route (10.02 ± 2.37 hours versus 11.12 ± 3.97 hours) although the difference was not statistically significant (P = 0.098). The mean Apgar scores at 1 min and 5 min were slightly better in the vaginal group than the sublingual group but the difference did not assume statistical significance (Apgar scores at 1 minute: 7.62 ± 0.83 versus 7.72 ± 0.88, at 5 minutes: 8.94 ± 1.23 versus 9.22 ± 0.46 for the sublingual versus the vaginal group, respectively, P = 0.561). Conclusions: The two routes of sublingual and vaginal administration showed comparable safety and effectiveness for cervical ripening and induction of labor in low-risk pregnancies at term. However, the sublingual route appears to be superior in terms of easy administration and patients' satisfaction.
2023
Objective: To compare the effectiveness and safety of 50μg of sublingual misoprostol administered six (6) hourly to that of 50μg of vaginal misoprostol administered four (4) hourly. Methodology: A non-blinded, randomized controlled trial conducted from Sept 1, 2014, to Nov 31, 2014, at a tertiary hospital in Ghana. Hundred and sixty women with medical or obstetric indications for labour induction were randomized into two groups. Results: The rate of vaginal delivery, caesarean section, uterine tachysystole and uterine hyperstimulation were similar in both groups. Sixty-three (78.8%) and 66 (82.5%) mothers in the vaginal and sublingual groups delivered vaginally. More (10.0%) mothers in the vagina group required emergency caesarean for foetal distress. Six (vaginal group) and 8 (sublingual group) of the mothers required emergency caesarean for cephalopelvic disproportion. Three mothers from each group had an emergency caesarean section due to failed labour induction. Almost the same number of mothers had uterine tachysystole in both groups. More (3.8%) mothers in the vaginal group had uterine hyperstimulation. Differences in the mean induction delivery interval and the need for oxytocin augmentation were not significant. No differences were found in the intrapartum passage of meconium, blood loss in the third stage of labour, 5-minute Apgar score <7, and neonatal intensive care unit admissions. Conclusion: The sublingual regimen was as effective and safe as the vaginal regimen in achieving vaginal delivery.
International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 2018
Induction of labour is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby. 1 There are many indications for term labour induction, including post dated pregnancy, preeclampsia, diabetes mellitus, oligohydramnios, intrauterine fetal growth retardation and abnormal ante partum fetal surveillance results. 2 With more than 15% of all gravid women requiring aid in cervical ripening and labour induction, there is widespread interest in, and demand for, an effective and safe method of assistance. The immature cervix is the greatest barrier to labour induction. As oxytocin affects mostly uterine contractions and minimally cervical ripening, prostaglandin agents are the first choice for labour inductions as they exert a local effect on the ABSTRACT Background: With more than 15% of all gravid women requiring prostaglandins in cervical ripening and labour induction. However, evidence is not clear about the preferred route or dose of the drug. So this study was designed with objectives to compare the induction delivery interval and safety of titrated oral misoprostol solution with vaginal misoprostol for labour induction in term primigravida women. Methods: In this randomised controlled trial out of 576 eligible women, 220 women as per inclusion criteria between 37 and 42 weeks of gestation with an unfavourable cervix (Bishop score <6) with indication for labour induction were randomly assigned (110each) to receive titrated oral solution of 20 mL misoprostol solution (1 mcg/mL) every 1 hour for four doses and then were titrated against individual uterine response or vaginal misoprostol 25 mcg every 4 hours. Vaginal delivery within 12 hours was the primary outcome. The data were analyzed by intention-to-treat. Results: Vaginal delivery occurred within 12 hours in 56 (50.9%) women in the titrated oral group and 24 (21.8%) women in the vaginal group with significant p-value (<0.001). The incidence of caesarean, hyper stimulation, low apgar score was less in the titrated oral group. More women experienced nausea in the titrated oral group. Conclusions: Titrated oral misoprostol is safe and effective for labour induction in primigravida patients with unfavourable cervix.
A masked randomized comparison of oral and vaginal administration of misoprostol for labor induction
Obstetrics and gynecology, 1998
To test the null hypothesis that administering misoprostol orally or vaginally will result in no difference in time to vaginal birth, and to determine whether different frequencies of tachysystole and hyperstimulation are associated with route of administration. Two hundred six women after 37 completed weeks' gestation who presented with an indication for induction were randomly assigned to receive misoprostol (50 microg) either orally or vaginally every 4 hours as needed to induce labor. Placebo use and allocation concealment accomplished blinding until data analysis was completed. Sample size was calculated to allow a two-tailed alpha of .05 and power (1-beta) of 80%. All fetal heart rate and uterine activity graphs were classified according to Curtis' criteria before induction groups were unmasked. Analysis involved 104 women in the oral group and 102 in the vaginal group. The mean time (+/-standard deviation) to vaginal birth with oral misoprostol was 1072 (+/-593) minut...
Quarterly of Horizon of Medical Sciences, 2016
Danforths obstetrics and gynecology [2] William's obstetrics [3] Sublingual misoprostol for labor induction: A randomized clinical trial [4] High risk pregnancy: Management options [5] Comparison of vaginal misoprostol and dinoprostone for cervical ripening before diagnostic hysteroscopy in nulliparous women [6] A randomized clinical trialcomparing vaginal misoprostol versus cervical Foleyplus oral misoprostol for cervical ripening andlabor induction [7] Misoprostol: Pharmacokinetic profiles, effects on the uterus and sideeffects [8] Use ofmisoprostol in first and second trimester abortion [9] Absorption kinetics of misoprostol with oral or vaginaladministration [10] A randomized controlled trial comparing twoprotocols for the use of misoprostol in midtrimester pregnancytermination [11] Comparison of Vaginal Misoprostol and Oral Misoprostol with intracervicalDinoprostone gel for labour induction at term [12] A Comparison of Vaginal vs. Oral Misoprostol for Induction of Labor-Double Blind Randomized Trial [13] A benefit-risk assessment of misoprostol for cervical ripening and labour induction [14] The effect of vaginal misoprostol and intravenous oxytocin for labor induction [15] Labour induction with randomized comparison of oral and intravaginal misoprostol in post date multigravida women [16] Oral misoprostol vs vaginal dinoprostone for labor induction in nulliparous women at term [17] A doubleblind randomized trial of two dose regimensof misoprostol for cervical ripening and labor induction [18] Comparing the effects of vaginal misoprostol and oxytocin in successful induction of labor [19] Oral misoprostol for induction of labour [20] Induction of labour in nulliparous and multiparous women: A UK, multicentre, openlabel study of intravaginal misoprostol in comparison with dinoprostone [21] O673 comparative study of oral vs vaginal misoprostol for induction of labour [22] Misoprostol versus prostaglandin E2 gel for labor induction in premature rupture of membranes after 34 weeks of pregnancy [23] Off-label use of misoprostol for labor induction in Germany: A national survey [24] Randomized clinical trial between hourly titrated oral misoprostol and vaginal dinoprostone for induction of labor
Acta Obstetricia et Gynecologica Scandinavica, 2006
Objective. The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25 mg and one-eighth of a 200-mg oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that. Methods. A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t , Mann ÁWhitney, x 2 , Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis. Results. There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3 h in the vaginal tablet group and 30.1 h in the oral tablet group, a difference that was not statistically significant. Conclusion. The results showed that the 25-mg vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-mg oral tablets.