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Misoprostol for Labour Induction after Previous Caesarean Section - Forever a "No Go"?

ABSTRACT: Misoprostol in oral or vaginal form is an established method of labour induction worldwide. Its use after previous caesarean section is associated with a high rate of uterine rupture; according to international guidelines it is therefore contraindicated in this setting. However the evidence base for this recommendation comprises case reports, one randomised trial that was discontinued prematurely, and numerous low quality retrospective data analyses published between 1997 and 2004. New insights into e.g. resorption kinetics, dosage and application intervals, dose dependant uterine hyperstimulation rates, as well as increasing clinical experience with misoprostol have lead to a critical reappraisal of these "historical" studies. Accordingly the evidence supporting a ban on vaginal and particularly oral misoprostol for labour induction in the context of a scarred uterus is currently insufficient for a convincing guideline recommendation. In view of the clear advantages of misoprostol over prostaglandin E₂ (cheaper, more effective) a retrospective review of registry data should be conducted to determine the incidence of uterine rupture following misoprostol and the circumstances in which it occurs. A prospective, randomised trial could then be conducted on the basis of these findings (e.g. oral misoprostol vs. vaginal prostaglandin E₂); known risk factors for uterine rupture including the type of uterine scar would need to be taken into account when selecting patients for vaginal delivery. Until new data from well-designed studies are available, misoprostol will continue to be contraindicated in clinical guidelines for use in labour induction after previous caesarean section.

SUBMITTER: Rath W

PROVIDER: S-EPMC4678051 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Misoprostol for Labour Induction after Previous Caesarean Section - Forever a "No Go"?

Rath W W Tsikouras P P

Geburtshilfe und Frauenheilkunde 20151101 11

Misoprostol in oral or vaginal form is an established method of labour induction worldwide. Its use after previous caesarean section is associated with a high rate of uterine rupture; according to international guidelines it is therefore contraindicated in this setting. However the evidence base for this recommendation comprises case reports, one randomised trial that was discontinued prematurely, and numerous low quality retrospective data analyses published between 1997 and 2004. New insights ...[more]

PMID: 26719597

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Project description:BackgroundFull dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown.MethodsThere are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG).Craft-obsObservational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth.Craft-rctRandomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section.Craft-imgImaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche.DiscussionThe CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies.Trial registrationCRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry ( https://doi.org/10.1186/ISRCTN15068651 ).

Project description:BackgroundElective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.MethodsUsing a decision analytic model, a cost-effectiveness analysis (CEA) was performed where the measure of health gain was quality-adjusted life years (QALYs) over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC) and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations.ResultsMaternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively), and QALYs were modestly higher (0.84 versus 0.70). Our findings were supported by probabilistic sensitivity analysis.ConclusionsClinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single comprehensive decision model.

Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

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Misoprostol for Labour Induction after Previous Caesarean Section - Forever a "No Go"?

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Misoprostol for Labour Induction after Previous Caesarean Section - Forever a "No Go"?

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