Objective To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women before operative hysteroscopy.Design Two separate but identical parallel, randomised, double-blind, placebo-controlled sequential trials, one in premenopausal women and one in postmenopausal women. The boundaries for the sequential trials were calculated on the primary outcomes of a difference of cervical dilatation ‡1 mm, with the assumption of a type 1 error of 0.05 and a power of 0.95.Setting Norwegian university teaching hospital.Sample Eighty-six women referred to outpatient operative hysteroscopy.Methods The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient operative hysteroscopy.Main outcome measures Preoperative cervical dilatation (primary outcome), number of women who achieve a preoperative cervical dilatation ‡5 mm, acceptability, complications and adverse effects (secondary outcomes).Results In premenopausal women, the mean cervical dilatation was 6.4 mm (SD 2.4) in the misoprostol group and 4.8 mm (SD 2.0) in the placebo group, the mean difference in cervical dilatation being 1.6 mm (95% CI 0.5-2.7). Among the premenopausal women receiving misoprostol, 88% achieved a cervical dilatation of ‡5 mm compared with 65% in the placebo group. Twelve percent of the women who received misoprostol were difficult to dilate compared with 32% who received placebo. Dilatation was also quicker in the misoprostol group. Misoprostol had no effect on cervical ripening in postmenopausal women compared with placebo, and 43% of the women were difficult to dilate. The trials were terminated after analysis of 21 postmenopausal women and 65 premenopausal women after reaching a conclusion on the primary outcome with only 28% of the number of women needed in a fixed sample size trial. Three of 45 women who received misoprostol experienced severe lower abdominal pain, and there was an increased occurrence of light preoperative bleeding in the misoprostol group. Most women did not experience misoprostol-related adverse effects. The majority (83% of premenopausal and 76% of postmenopausal women) found self-administered vaginal misoprostol at home to be acceptable. There were two serious complications in the premenopausal misoprostol group: uterine perforation with subsequent peritonitis and heavy postoperative bleeding requiring blood transfusion, but these were not judged to be misoprostol related. Complications were otherwise comparatively minor and distributed equally between the two dosage groups.Conclusions One thousand micrograms of self-administered vaginal misoprostol 12 hours prior to operative hysteroscopy has a significant cervical ripening effect compared with placebo in premenopausal but not in postmenopausal women. Self-administered vaginal misoprostol of 1000 micrograms at home the evening be...
ObjectiveTo compare the impact of 1000 μg of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after 2 weeks of pretreatment with estradiol vaginal tablets in postmenopausal women prior to day-care operative hysteroscopy.DesignRandomised, double-blind, placebo-controlled sequential trial.SettingNorwegian university teaching hospital.PopulationSixty-seven postmenopausal women referred for day-care operative hysteroscopy.MethodsThe women were randomised to receive either 1000 μg of self-administered vaginal misoprostol or self-administered vaginal placebo on the evening before day-care operative hysteroscopy. All women had administered a 25-μg vaginal estradiol tablet daily for 14 days prior to the operation.Main outcome measuresPrimary outcome: preoperative cervical dilatation at hysteroscopy. Secondary outcomes: difference in dilatation at recruitment and before hysteroscopy, number of women who achieved a preoperative cervical dilatation of 5 mm or more, acceptability, complications and adverse effects.ResultsThe mean cervical dilatation was 5.7 mm (SD, 1.6 mm) in the misoprostol group and 4.7 mm (SD, 1.5 mm) in the placebo group, the mean difference in cervical dilatation being 1.0 mm (95% CI, 0.2–1.7 mm). Self-administered vaginal misoprostol of 1000 μg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.ConclusionsOne thousand micrograms of self-administered vaginal misoprostol, 12 hours prior to day-care hysteroscopy, after 14 days of pretreatment with vaginal estradiol, has a significant cervical ripening effect compared with placebo in postmenopausal women.
Introduction: Induction of labor has become an increasingly common obstetric procedure, but in nulliparous women or women with a previous cesarean section, it can pose a clinical challenge. Despite an overall expansion of medical indications for labor induction, there is little international consensus regarding the criteria for induction, or for the recommended methods among nulliparous women. In this light, we assessed variations in the practice of induction of labor among 21 birth units in a nationwide cohort of women with no prior vaginal birth. Material and methods: We carried out a prospective observational pilot study of women with induced labor and no prior vaginal birth, across 21 Norwegian birth units. We registered induction indications, methods and outcomes from 1 September to 31 December 2018 using a web-based case record form. Women were grouped into "Nulliparous term cephalic", "Previous cesarean section" and "Other Robson" (Robson groups 6, 7, 8 or 10). Results: More than 98% of eligible women (n=1818) were included and a wide variety of methods was used for induction of labor. In nulliparous term cephalic pregnancies, cesarean section rates ranged from 11.1% to 40.6% between birth units, whereas in the previous cesarean section group, rates ranged from 22.7% to 67.5%. The indications "large fetus" and "other fetal" indications were associated with the highest cesarean rates. Failed inductions and failure to progress in labor contributed most to the cesarean rates. Uterine rupture occurred in two women (0.11%), both in the previous cesarean section group. In neonates, 1.6% had Apgar <7 at 5 minutes, and 0.4% had an umbilical artery pH <7.00. Conclusions: Cesarean rates and applied methods for induction of labor varied widely in this nationwide cohort of women without a prior vaginal birth. Neonatal outcomes were similar to those of normal birth populations. Results could indicate the need to move towards more standardized induction protocols associated with optimal outcomes for mother and baby. | 1701 SØRBYE Et al.
Objective To compare the impact of 200 and 400 Ag oral misoprostol on pre-operative cervical priming in both primi-and multigravidae prior to first trimester termination of pregnancy. Pre-operative cervical dilatation and bleeding were assessed. Design Randomised controlled trial.Setting Norwegian university teaching hospital.Sample Five hundred and fifty-one women undergoing surgical termination of pregnancy between 7 and 12 weeks of gestation. Methods Patients were randomised to either 200 or 400 Ag of oral misoprostol 10 -16 hours before vacuum aspiration. The degree of cervical dilatation prior to abortion by vacuum aspiration was measured. Preoperative bleeding and pain were recorded and vaginal bleeding was measured. Main outcome measures Degree of pre-operative cervical dilatation and pre-operative bleeding.Results The mean cervical dilatation was 5.8 mm (SD 1.7) for the women who received 400 Ag misoprostol and 5.4 mm (SD 1.4) for those who received 200 Ag ( P ¼ 0.004). The pre-operative dilatation was larger in multigravidae than in primigravidae in both dosage groups. The odds ratio (OR) of pre-operative bleeding was 3.3 (95% confidence interval [CI] 2.1 -5.0) in the 400 Ag dosage group, as compared with the group receiving 200 Ag misoprostol. The occurrence of bleeding was dose-dependent. Frequency of bleeding was similar in multigravidae compared with primigravidae in the 400 Ag dosage group, whereas the occurrence of bleeding was less in primigravidae than multigravidae in the 200 Ag dosage group. Only 89 out of 551 patients bled one or more grams. The volumes measured were not statistically significantly different.Complications were minor, and were distributed equally between the two dosage groups. Conclusions The 200 Ag oral misoprostol compared with the 400 Ag oral misoprostol given 10-16 hours before first trimester surgical abortions results in less pre-operative vaginal bleeding and in a statistically, although not clinically significant reduction in cervical dilatation.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.