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Open Access 01-12-2021 | Episiotomy | Research article

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)

Authors: Bertrand Gachon, Thomas Schmitz, France Artzner, Olivier Parant, Renaud De Tayrac, Guillaume Ducarme, Camille Le Ray, Anne Cécile Pizzoferrato, Charles Garabedian, Didier Riethmuller, Fabrice Pierre, Stephanie Ragot, Xavier Fritel, the GROG (Groupe de Recherche en Gynécologie Obstétrique)

Published in: BMC Pregnancy and Childbirth | Issue 1/2021

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).

Available only for authorised users

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Title: 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)
Authors: Bertrand Gachon
Thomas Schmitz
France Artzner
Olivier Parant
Renaud De Tayrac
Guillaume Ducarme
Camille Le Ray
Anne Cécile Pizzoferrato
Charles Garabedian
Didier Riethmuller
Fabrice Pierre
Stephanie Ragot
Xavier Fritel
the GROG (Groupe de Recherche en Gynécologie Obstétrique)
Publication date: 01-12-2021
Publisher: BioMed Central
Keyword: Episiotomy
Published in: BMC Pregnancy and Childbirth / Issue 1/2021
Electronic ISSN: 1471-2393
DOI: https://doi.org/10.1186/s12884-021-03603-0

2024 ASCO Annual Meeting

Springer Medicine

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

Methods

Results

Conclusion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration

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