Selected Cochrane Systematic Reviews: Oral Misoprostol for Induction of Labour with a Viable Fetus

Alfirević, Z̄arko; Howarth, Graham; Gaußmann, A.

doi:10.1046/j.1523-536x.2000.00286.x

Cited by 8 publications

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“…Misoprostol, an inexpensive and stable prostaglandin E1 analogue, has been shown to stimulate uterine contractility in early pregnancy 2 and at term. 3 Administered orally or vaginally, it is effective for inducing abortion 4,5 and labour, [6][7][8] though it poses certain risks. 9,10 Administration of this drug on a wide scale at the community level to prevent and treat postpartum haemorrhage is of major public health importance.…”

Section: Introductionmentioning

confidence: 99%

Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects

Hofmeyr¹,

Gülmezoglu²,

Novikova³

et al. 2009

Bull World Health Org

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Objective To review maternal deaths and the dose-related effects of misoprostol on blood loss and pyrexia in randomized trials of misoprostol use for the prevention or treatment of postpartum haemorrhage. Methods We searched the Cochrane Controlled Trials Register and Pubmed, without language restrictions, for "(misoprostol AND postpartum) OR (misoprostol AND haemorrhage) OR (misoprostol AND hemorrhage)", and we evaluated reports identified through the Cochrane Pregnancy and Childbirth Group search strategy. Randomized trials comparing misoprostol with either placebo or another uterotonic to prevent or treat postpartum haemorrhage were checked for eligibility. Data were extracted, tabulated and analysed with Reviewer Manager (RevMan) 4.3 software. Findings We included 46 trials with more than 40 000 participants in the final analysis. Of 11 deaths reported in 5 trials, 8 occurred in women receiving ³ 600 µg of misoprostol (Peto odds ratio, OR: 2.49; 95% confidence interval, CI: 0.76-8.13). Severe morbidity, defined as the need for major surgery, admission to intensive care, organ failure or body temperature ³ 40 °C, was relatively infrequent. In prevention trials, severe morbidity was experienced by 16 of 10 281 women on misoprostol and by 16 of 10 292 women on conventional uterotonics; in treatment trials, it was experienced by 1 of 32 women on misoprostol and by 1 of 32 women on conventional uterotonics. Misoprostol recipients experienced more adverse events than placebo recipients: 8 of 2070 versus 5 of 2032, respectively, in prevention trials, and 5 of 196 versus 2 of 202, respectively, in treatment trials. Meta-analysis of direct and adjusted indirect comparisons of the results of randomized trials showed no evidence that 600 µg are more effective than 400 µg for preventing blood loss ³ 1000 ml (relative risk, RR: 1.02; 95% CI: 0.71-1.48). Pyrexia was more than twice as common among women who received ³ 600 µg rather than 400 µg of misoprostol (RR: 2.53; 95% CI: 1.78-3.60). Conclusion Further research is needed to more accurately assess the potential beneficial and harmful effects of misoprostol and to determine the smallest dose that is effective and safe. In this review, 400 µg of misoprostol were found to be safer than ³ 600 µg and just as effective.Une traduction en français de ce résumé figure à la fin de l'article. Al final del artículo se facilita una traducción al español. ‫املقالة.‬ ‫لهذه‬ ‫الكامل‬ ‫النص‬ ‫نهاية‬ ‫يف‬ ‫الخالصة‬ ‫لهذه‬ ‫العربية‬ ‫الرتجمة‬

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Section: Introductionmentioning

confidence: 99%

Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects

Hofmeyr¹,

Gülmezoglu²,

Novikova³

et al. 2009

Bull World Health Org

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“…Replacing dinoprostone with misoprostol would allow considerable cost savings. Although misoprostol can be administered vaginally, orally or rectally, the vaginal route appears, at present, to offer the most benefits in terms of efficacy and minimising side effects 4–6 . Danielian et al 7 found that 50 μg of misoprostol was more effective than dinoprostone gel and had a similar side effect profile, but others have demonstrated that a dosing regimen of 50 μg or higher is associated with an increased incidence of uterine contraction abnormalities 8,9 .…”

Section: Introductionmentioning

confidence: 99%

A randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term

Gregson¹,

Waterstone²,

Norman

et al. 2005

BJOG

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Objective To compare the efficacy of low dose vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term. Design A single-blind randomised controlled trial.Setting Antenatal and labour ward of a UK district general hospital.Participants Two hundred and sixty-eight women requiring induction of labour at term (>37 weeks of gestation) with no significant fetal or medical condition, no previous uterine surgery and no contraindication to prostaglandin. Methods Misoprostol 25 Ag (one-quarter of a 100 Ag tablet) was inserted into the posterior vaginal fornix every 4 hours (to a maximum of six doses) or dinoprostone vaginal gel 1 -2 mg 6 hourly (maximum of 3 mg in 24 hours). Main outcome measure Induction-to-vaginal delivery interval.Secondary outcome measures Requirements for oxytocin, mode of delivery, number of women delivering <24 hours, incidence of uterine contraction abnormalities, incidence of abnormal cardiotocograph (CTG) recordings, 5-minute Apgar scores, umbilical cord pH recordings, analgesia requirements, admission to NICU and blood loss at delivery. Results There were no significant differences between the two groups in induction-to-vaginal delivery interval, mode of delivery, number of women delivering within 24 hours and neonatal outcomes. The incidence of uterine contraction abnormalities (tachysystole and hyperstimulation) and the incidence of abnormal CTG recordings were also similar for both groups. Conclusion Low dose vaginal misoprostol is as effective as dinoprostone gel for inducing labour at term.There would be substantial cost savings, estimated at around £3.9 million per annum, for maternity services if low dose misoprostol became the agent of choice for inducing labour in the UK.

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“…The manufacturers have acknowledged the role of doctors in prescribing an approved pharmaceutical product for use outside its approved indication 12 . The Cochrane Review 13 on the topic remains inconclusive because widely varying dosage regimens have been used and the studies to date have been far too small to address the issue of safety. We have emphasised the dangers of misoprostol, particularly in larger dosages, and the need for large studies to confirm safety.…”

Section: Introductionmentioning

confidence: 99%

Titrated oral misoprostol solution for induction of labour: a multi‐centre, randomised trial

Hofmeyr

Alfirević

Matonhodze

et al. 2001

BJOG

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Objectives To determine the effects of titrated oral misoprostol solution, compared with vaginal dinoprostone.Study design Open, randomised clinical trial. Setting Academic hospitals in South Africa and Liverpool, UK.Methods Women undergoing induction of labour after 34 weeks of pregnancy were allocated by randomised, sealed opaque envelopes, to induction of labour with titrated oral misoprostol solution, or two doses of vaginal dinoprostone (2mg) administered six hours apart. Failure to deliver within 24 hours of randomisation was the primary outcome on which the sample size was based. The data were analysed by intention-to-treat. Results Six hundred and ninety-®ve women were randomly allocated: 346 to oral misoprostol and 349 to vaginal dinoprostone. There were no signi®cant differences in substantive outcomes. Vaginal delivery within 24 hours was not achieved in 38% of women in the oral misoprostol group and 36% in the vaginal dinoprostone group (RR 1.08; 95% CI 0.89-1.31). The caesarean section rates were 16% and 20%, respectively (RR 0.80; 95% CI 0.58-1.11). Hyperstimulation with fetal heart rate changes occurred in 4% of women in the oral misoprostol group and 3% after vaginal dinoprostone (RR 1.32, 95% CI 0.59±2.98). The response to induction of labour in women with unfavourable cervices was somewhat slower with misoprostol when membranes were intact, and with dinoprostone when membranes were ruptured. There were no differences in neonatal outcome between the two groups. Conclusions This new approach to oral misoprostol administration was successful in minimising the risk of uterine hyperstimulation, which has been a feature of misoprostol use for induction of labour, at the expense of a somewhat slower response in women with intact membranes and unfavourable cervices. Misoprostol is not registered for use in pregnant women, and further research is needed to con®rm optimal and safe dosages.

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Selected Cochrane Systematic Reviews: Oral Misoprostol for Induction of Labour with a Viable Fetus

Cited by 8 publications

References 0 publications

Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects

Misoprostol to prevent and treat postpartum haemorrhage: a systematic review and meta-analysis of maternal deaths and dose-related effects

A randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term

Titrated oral misoprostol solution for induction of labour: a multi‐centre, randomised trial

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