Dataset Information

A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA).

ABSTRACT:

Background

We aimed at developing a core outcome and variables of interest set to investigate the effects of mediolateral episiotomy on Obstetric Anal Sphincter Injury (OASI) during and after operative delivery in nulliparous women in a large-scale one-year observational French study including 15,000 women (INSTRUMODA).

Methods

A list of outcomes and variables of interest was suggested to obstetricians participating in the INSTRUMODA study using online questionnaires divided into 7 categories: the woman's history and course of pregnancy, course of labor, modalities of operative delivery, episiotomy characteristics, immediate maternal morbidity, one-year maternal morbidity, immediate neonatal morbidity. We used a three-round DELPHI method to reach a consensus. In the first round, outcomes and variables considered as essential by 70% or more of obstetricians were included in the corpus whereas they were excluded when 70% rated them as "not important". In the second round, non-consensual outcomes and variables were reassessed and excluded or definitively included if considered as "not important" or essential by 50% or more of the obstetricians. During the first round, obstetricians were invited to suggest new outcomes and/or variables that were then assessed in the second and third round. We used the same method to develop a core outcome and variables of interest set in a population of women in the community recruited via an association of patients. At the end of the procedure the core outcome and variables of interest sets were merged to provide the final core outcome set for the INSTRUMODA study.

Results

Fifty-three obstetricians and 16 women filled out questionnaires. After the 3 rounds of Delphi procedure in each population, 74 outcomes and variables were consensually reported by obstetricians and 92 by women in the community. By mixing these two consensual corpora we reported a final consensual list of 114 variables of interest and outcomes for both obstetricians and women.

Conclusion

We established a core outcome and variables of interest set among obstetricians and women in the community to investigate the association between mediolateral episiotomy and OASI during operative delivery.

Trial registration

The INSTRUMODA study was registered on https://clinicaltrials.gov on June 25, 2020 ( NCT04446780 ).

SUBMITTER: Gachon B

PROVIDER: S-EPMC7993449 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe potential protective effect of mediolateral episiotomy for obstetrical anal sphincter injuries (OASIs) remains controversial during operative vaginal delivery because of the difficulties to take into account the risk factors and clinical conditions at delivery; in addition, little is known about the potential benefits of mediolateral episiotomy on neonatal outcomes. The objectives were to investigate the associations between mediolateral episiotomy and both OASIs and neonatal outcomes, using propensity scores.MethodsWe performed a retrospective population-based observational study from a perinatal registry that includes all births in a French region between 2010 and 2017. All nulliparous women with singleton pregnancy delivering by operative vaginal deliveries at 37 weeks gestational age or later were included. Inverse-probability-of-treatment weighting with propensity scores was used to minimize indication bias. OASIs was defined as third and fourth-degree tears according to Royal College of Obstetricians and Gynecologists. Two neonatal outcomes were studied: condition at birth (5-min Apgar score less than 7 and/or umbilical artery pH less than 7.10), and admission to neonatal intensive care unit.ResultsThe study population consisted of 7589 women; 2880 (38.0%) received mediolateral episiotomy. After applying propensity scores, episiotomy was associated with a lower rate of OASIs in forceps/spatula delivery (2.3 vs 6.8%, Risk Ratio (RR) 0.38, 95% Confidence Interval (CI) 0.28-0.52) and in vacuum delivery (1.3 vs 3.4%, RR 0.27, 95% CI 0.20-0.38) as compared with no episiotomy. Mediolateral episiotomy was associated with better condition at birth in case of forceps/spatula delivery (4.5 vs 8.8%, RR 0.56, 95% CI 0.39-0.81). In cases of fetal distress (40.7%), mediolateral episiotomy was associated with better condition of infant at birth in women who delivered by forceps/spatula (4.2 vs 13.5%, RR 0.52, 95% CI 0.31-0.89). No association was found with neonatal unit admission (RR 0.93, 95% CI 0.50-1.74).ConclusionsUse of mediolateral episiotomy was associated with a lower rate of OASIs during operative vaginal delivery, and in infants it was associated with better condition at birth following forceps/spatula delivery.

Project description:IntroductionObstetric anal sphincter injury (OASIS) occurs in 5%-7% of normal deliveries and increases with vacuum extraction (VE) to 12%-14% in nulliparous women in Sweden. Lateral/mediolateral episiotomy may reduce the prevalence of OASIS at VE in nulliparous women. The current use of episiotomy is restrictive. The protective effect and consequences are uncertain. This trial will investigate if lateral episiotomy can reduce the prevalence of OASIS and assess short-term and long-term effects.Methods and analysisThis is a multicentre randomised controlled trial of lateral episiotomy versus no episiotomy in nulliparous women with a singleton, live fetus, after gestational week 34+0 with indication for VE. A lateral episiotomy of 4 cm is cut at crowning, 1-3 cm from the midline, at a 60° angle. The primary outcome is OASIS by clinical diagnosis analysed according to intention to treat. To demonstrate a 50% reduction in OASIS prevalence (from 12.4% to 6.2%), 710 women will be randomised at a 1:1 ratio. Secondary outcomes are pain, blood loss, other perineal injuries, perineal complications, Apgar score, cord pH and neonatal complications. Web-based questionnaires at baseline, 2 months, 1 and 5 years will be used to assess pain, incontinence, prolapse, sexual function, quality of life and childbirth experience. A subset of women will receive follow-up by pelvic floor sonography and pelvic examination. Mode of delivery and recurrence of OASIS/episiotomy in subsequent pregnancies will be assessed at 5 and 10 years using register data.Ethics and disseminationThe trial is open for enrolment. The trial has received ethical approval from the Regional Ethical Review Board of Stockholm and full funding from the Swedish Research Council. Women are interested in participation. The predominant restrictive view on episiotomy may limit recruitment. Results are of global interest and will be disseminated in peer-reviewed journals and at international congresses.Trial registration numberNCT02643108; Pre-results.