Bertrand Gachon1,2,3, Thomas Schmitz4, France Artzner5, Olivier Parant6, Renaud De Tayrac7, Guillaume Ducarme8, Camille Le Ray9, Anne Cécile Pizzoferrato10, Charles Garabedian11, Didier Riethmuller12, Fabrice Pierre13, Stephanie Ragot14, Xavier Fritel13,14. 1. Poitiers University Hospital, Department of Obstetrics and Gynecology, Poitiers, France. bertrand.gachon@gmail.com. 2. INSERM CIC-P 1402, Poitiers University Hospital, Poitiers, France. bertrand.gachon@gmail.com. 3. Nantes University, Movement - Interactions - Performance, MIP, EA4334, Nantes, France. bertrand.gachon@gmail.com. 4. Robert Debre Hospital, Department of Obstetrics and Gynecology, Paris, France. 5. Patients representative. CIANE, Collectif inter associatif autour de la naissance, Paris, France. 6. Paule de Viguier Maternity, Toulouse University Hospital, Toulouse, France. 7. Caremeau University Hospital, Department of Obstetrics and Gynecology, Nimes, France. 8. Centre Hospitalier Départemental de La Roche sur Yon, Department of Obstetrics and Gynecology, La Roche sur Yon, France. 9. Port Royal maternity unit, Cochin Hospital, APHP, Paris, France. 10. Caen University Hospital, Department of Obstetrics and Gynecology, Caen, France. 11. Jeanne de Flandres maternity unit, Lille University Hospital, Lille, France. 12. Grenoble University Hospital, Department of Obstetrics and Gynecology, Grenoble, France. 13. Poitiers University Hospital, Department of Obstetrics and Gynecology, Poitiers, France. 14. INSERM CIC-P 1402, Poitiers University Hospital, Poitiers, France.
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 ).
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 ).
Authors: A H Sultan; R Thakar; K M Ismail; V Kalis; K Laine; S H Räisänen; J W de Leeuw Journal: Eur J Obstet Gynecol Reprod Biol Date: 2019-07-09 Impact factor: 2.435
Authors: Joey de Vogel; Anneke van der Leeuw-van Beek; Dirk Gietelink; Marijana Vujkovic; Jan Willem de Leeuw; Jeroen van Bavel; Dimitri Papatsonis Journal: Am J Obstet Gynecol Date: 2012-03-15 Impact factor: 8.661
Authors: G Ducarme; A C Pizzoferrato; R de Tayrac; C Schantz; T Thubert; C Le Ray; D Riethmuller; E Verspyck; B Gachon; F Pierre; F Artzner; B Jacquetin; X Fritel Journal: J Gynecol Obstet Hum Reprod Date: 2018-12-12
Authors: Jamie J Kirkham; Sarah Gorst; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; David Moher; Jochen Schmitt; Peter Tugwell; Sean Tunis; Paula R Williamson Journal: PLoS Med Date: 2016-10-18 Impact factor: 11.069