Dataset Information

A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

ABSTRACT:

Objective

To compare the impact of 1000 microg 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.

Design

Randomised, double-blind, placebo-controlled sequential trial.

Setting

Norwegian university teaching hospital.

Population

Sixty-seven postmenopausal women referred for day-care operative hysteroscopy.

Methods

The women were randomised to receive either 1000 microg of self-administered vaginal misoprostol or self-administered vaginal placebo on the evening before day-care operative hysteroscopy. All women had administered a 25-microg vaginal estradiol tablet daily for 14 days prior to the operation.

Main outcome measures

Primary 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.

Results

The 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 microg at home on the evening before day-care hysteroscopy is safe and highly acceptable, although a small proportion of women experienced lower abdominal pain.

Conclusions

One 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.

SUBMITTER: Oppegaard KS

PROVIDER: S-EPMC2805871 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

Oppegaard K S KS Lieng M M Berg A A Istre O O Qvigstad E E Nesheim B-I BI

BJOG : an international journal of obstetrics and gynaecology 20100101 1

<h4>Objective</h4>To compare the impact of 1000 microg 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.<h4>Design</h4>Randomised, double-blind, placebo-controlled sequential trial.<h4>Setting</h4>Norwegian university teaching hospital.<h4>Population</h4>Sixty-seven postmenopausal women referred for day-ca ...[more]

PMID: 20002369

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Project description:ObjectiveTo compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo on preoperative cervical ripening after pre-treatment with estradiol vaginal tablets at home in postmenopausal women prior to day-care operative hysteroscopy.DesignRandomised double-blind placebo-controlled sequential trial. The boundaries for the sequential trial were calculated on the primary outcomes of a difference of cervical dilatation > or = 1 millimetre, with the assumption of a type 1 error of 0.05 and a power of 0.95.SettingNorwegian university teaching hospital.PopulationPostmenopausal women referred for day-care operative hysteroscopy.MethodsThe women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before day-care operative hysteroscopy. All women had administered a 25-microgram vaginal estradiol tablet daily for 14 days prior to the operation.Main outcome measuresPreoperative cervical dilatation (difference between misoprostol and placebo group, primary outcome), difference in dilatation before and after administration of misoprostol or placebo, number of women who achieve a preoperative cervical dilatation > or = 5 millimetres, acceptability, complications and side effects (secondary outcomes).ResultsIntra-operative findings and distribution of cervical dilatation in the two treatment groups: values are given as median (range) or n (%). Difference in dilatation before and after administration of misoprostol and placebo: values are given as median (range) of intraindividual differences. Percentage of women who achieve a cervical dilatation of > or = 5 mm, percentage of women who were difficult to dilate. Acceptability in the two treatment groups: values are given as completely acceptable n (%), fairly acceptable n (%), fairly unacceptable n (%), completely unacceptable n (%). Pain in the two treatment groups: pain was measured with a visual analogue scale ranging from 0 (no pain) to 10 (unbearable pain): values are given as median (range). Occurrence of side effects in the two treatment groups. Values are given as n (%). Complications given as n (%).Funding sourcesNo pharmaceutical company was involved in this study. A research grant from the regional research board of Northern Norway has been awarded to finance Dr K.S.O.'s leave from Hammerfest hospital as well as travel expenses between Hammerfest and Oslo, and research courses. The research grant from Prof B.I.N. (Helse Øst) funded the purchase of estradiol tablets, the manufacturing costs of misoprostol and placebo capsules from the hospital pharmacy, as well as the costs incurred for preparing the randomisation schedule and distribution of containers containing capsules to hospital. Prof B.I.N.'s research grant also funded insurance for the study participants.ConclusionsEstimated completion date 31 December 2008.

Project description:ObjectiveInduction of labor concerns about 29 % of women in Unites States and 33 % in Europe. Among the various methods for cervical ripening, the efficacy and safety profiles of oral misoprostol and balloon catheter are comparable, but data in the literature on maternal satisfaction during induction of labor are few. The objective of this study was to assess the satisfaction of women who chose the method of cervical ripening, i.e. either balloon catheter or oral misoprostol, for induction of labor.Study designThis retrospective study asked women who had undergone induction of labor between February 1, 2020 and February 28, 2021. After receiving verbal and written information, the choice of method between oral misoprostol and balloon catheter was left to the patient's free appreciation. Satisfaction was assessed by means of a questionnaire distributed to all women during their stay in the maternity unit. The principal assessment criterion was based on women' inclination to choose the same cervical ripening method if induction of labor were to prove necessary in a future pregnancy, and their willingness to recommend this method to a friend. Univariate analyses were conducted using Student's t-test, Chi-2 test or Fisher's exact test.ResultsOn 575 women eligible for analysis, 365 (63.5 %) of these women replied to the satisfaction questionnaire. Of this number, 236 (64.7 %) chose cervical ripening by balloon catheter, and 129 (35.3 %) by oral misoprostol. No significant difference was found between the two groups: 68.2 % of women in the balloon catheter group would opt for the same method of cervical ripening if it proved necessary in a future pregnancy and 64.7% would recommend it to a pregnant friend, versus 65.9 % and 63.6 % in the oral misoprostol group, respectively. Women were overall pleased to be able to choose their method of cervical ripening: 90.5 % of patients in the balloon catheter group and 95.3 % in the oral misoprostol group.ConclusionsWhen women choose the method of cervical ripening, satisfaction is overall good, irrespective of the method, whether by balloon catheter or misoprostol.

Project description:Currently, there is no meta-analysis comparing intravaginal misoprostol plus intracervical Foley catheter versus intravaginal misoprostol alone for term pregnancy without identifying risk factors. Therefore, the purpose of this study is to conduct a systematic review and meta-analysis of randomized control trials (RCTs) comparing concurrent intravaginal misoprostol and intracervical Foley catheter versus intravaginal misoprostol alone for cervical ripening. We systematically searched Embase, Pubmed, and Cochrane Collaboration databases for randomized controlled trials (RCTs) comparing intracervical Foley catheter plus intravaginal misoprostol and intravaginal misoprostol alone using the search terms "Foley", "misoprostol", "cervical ripening", and "induction" up to 29 January 2019. Data were extracted and analyzed by two independent reviewers including study characteristics, induction time, cesarean section (C/S), clinical suspicion of chorioamnionitis, uterine tachysystole, meconium stain, and neonatal intensive care unit (NICU) admissions. Data was pooled using random effects modeling and calculated with risk ratio (RR) and 95% confidence interval (CI). Pooled analysis from eight studies, including 1110 women, showed that labor induction using a combination of intracervical Foley catheter and intravaginal misoprostol decreased induction time by 2.71 h (95% CI -4.33 to -1.08, p = 0.001), as well as the risk of uterine tachysystole and meconium staining (RR 0.54, 95% CI 0.30-0.99 and RR 0.48, 95% CI 0.32-0.73, respectively) significantly compared to those using intravaginal misoprostol alone. However, there was no difference in C/S rate (RR 0.93, 95% CI 0.78-1.11) or clinical suspicion of chorioamnionitis rate (RR 1.22, CI 0.58-2.57) between the two groups. Labor induction with a combination of intracervical Foley catheter and intravaginal misoprostol may be a better choice based on advantages in shortening induction time and reducing the risk of uterine tachysystole and meconium staining compared to intravaginal misoprostol alone.

Project description:BackgroundThe safest, most effective and fastest combined approaches to induction of labor is unknown. In an open-label randomized clinical trial we evaluated the efficacy of combination of extra-amniotic Foley's catheter and vaginal misoprostol compared to vaginal misoprostol alone for cervical ripening and induction of labor on the incidence of failed induction, induction-to-delivery interval and adverse maternal and perinatal outcomes.MethodsPregnant women at gestational age of 28 weeks or greater admitted at Kenyatta National Hospital, Kenya for induction of labor were enrolled then randomized to either a combination of extra-amniotic Foley's catheter inflated by 30 cm3 of normal saline and 25 micrograms of vaginal misoprostol or 25 micrograms of vaginal misoprostol alone. Women underwent 6 hourly reviews and additional misoprostol inserted if required. The primary outcome was incidence of failed induction. Secondary outcomes were induction-to-delivery interval and adverse maternal and perinatal outcomes. We conducted an intent-to-treat analysis and compared means or medians using t-test or Wilcoxon rank, proportions using Chi-square or Fishers test as appropriate. Induction-to-delivery interval were compared using the log-rank test. P-values of < 0.05 and 95% confidence intervals that excluded the null were considered statistically significant.ResultsBetween February and May 2016, we enrolled 180 of 237 pregnant women admitted for induction of labor and randomized them to either a combination of extra-amniotic Foley's catheter and vaginal misoprostol (n = 90) or vaginal misoprostol alone (n = 90). The socio-demographic and obstetric characteristics were similar between the two groups. Failed induction rates were lower but not statistically significant following combined extra-amniotic Foley's catheter and vaginal misoprostol (8.9%) versus vaginal misoprostol alone (11.1%). The mean induction-to-delivery time was 4.8 h shorter in the combined extra-amniotic Foley's catheter and vaginal misoprostol (mean 18.9, standard deviation (SD) 7.2 h) compared to misoprostol only group (mean 14.1, SD 6.9 h) (log-rank test, p < 0.001). Maternal and perinatal complications were similar between the two groups.ConclusionsExtra-amniotic Foley's catheter and vaginal misoprostol for cervical ripening and induction of labor did not significantly lower the incidence of failed induction but safely shortened induction-to-delivery time compared to vaginal misoprostol only.Trial registrationTrial was retrospectively registered on 14-03-2016 PACTR201604001535825.

Project description:BackgroundEvery year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared.MethodsThis pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women's experience are also planned.DiscussionAvoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman's care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin.Trial registrationClinical Trials.gov, NCT03749902 , registered on 21st Nov 2018.

Dataset Information

A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

Objective

Design

Setting

Population

Methods

Main outcome measures

Primary outcome

Secondary outcomes

Results

Conclusions

Publications

A combination of misoprostol and estradiol for preoperative cervical ripening in postmenopausal women: a randomised controlled trial.

Similar Datasets

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