{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T01:48:16Z","timestamp":1789177696217,"version":"build-2803163510"},"reference-count":18,"publisher":"BMJ","issue":"12","funder":[{"DOI":"10.13039\/501100004690","name":"Minist\u00e8re de la Sant\u00e9","doi-asserted-by":"publisher","award":["PHRC 2005 05.09"],"award-info":[{"award-number":["PHRC 2005 05.09"]}],"id":[{"id":"10.13039\/501100004690","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,11,8]]},"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4\u2005weeks post partum.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation \u22657\u2005cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study was approved by a French Institutional Review Board (Comit\u00e9 de Protection des Personnes Sud Est 6:N\u00b0AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be useful for counselling pregnant women before and during labour.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      Agence national de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM): 150099B-22 and IDRCB: 2014-A01920-47.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\" ext-link-type=\"uri\">ClinicalTrials.gov: NCT02474745<\/jats:ext-link>\n                      . Pre-result stage.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-012290","type":"journal-article","created":{"date-parts":[[2016,12,24]],"date-time":"2016-12-24T13:35:38Z","timestamp":1482586538000},"page":"e012290","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial\u2014the EOLE study protocol"],"prefix":"10.1136","volume":"6","author":[{"given":"Chlo\u00e9","family":"Barasinski","sequence":"first","affiliation":[{"name":"P\u00f4le Femme et Enfant, The Clermont-Ferrand University Hospital, Clermont-Ferrand, France"},{"name":"EA 4681, PEPRADE (Perinatalogy, pregnancy, Environment, medical care PRActices and DEvelopment), Clermont University, University of Auvergne, Clermont-Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7oise","family":"Vendittelli","sequence":"additional","affiliation":[{"name":"P\u00f4le Femme et Enfant, The Clermont-Ferrand University Hospital, Clermont-Ferrand, France"},{"name":"EA 4681, PEPRADE (Perinatalogy, pregnancy, Environment, medical care PRActices and DEvelopment), Clermont University, University of Auvergne, Clermont-Ferrand, France"},{"name":"The AUDIPOG Sentinel Network (Association des Utilisateurs de Dossiers informatis\u00e9s en P\u00e9diatrie, Obst\u00e9trique et Gyn\u00e9cologie), RTH Laennec Medical University, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2016,12,20]]},"reference":[{"key":"2025121602075414000_6.12.e012290.1","unstructured":"Calais-Germain B . Le p\u00e9rin\u00e9e f\u00e9minin et l'accouchement [The Female Perineum and Childbirth] (in French.). M\u00e9olans-Revel: D\u00e9siris, 1996."},{"key":"2025121602075414000_6.12.e012290.2","unstructured":"de Gasquet B . Pour une pouss\u00e9e moins traumatique [For less traumatic pushing]. In: Schaal JP , Riethmuller D , Maillet R , et al . M\u00e9caniques & techniques obst\u00e9tricales [Obstetrical Mechanics and Techniques ]. 3rd edn. (in French). Montpellier: Sauramps Medical, 2007:289\u201393."},{"issue":"1","key":"2025121602075414000_6.12.e012290.3","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1515\/jpme.1981.9.s1.63","article-title":"The bearing-down efforts and their effects on fetal heart rate, oxygenation and acid base balance","volume":"9","author":"Caldeyro-Barcia","year":"1981","journal-title":"J Perinat Med"},{"key":"2025121602075414000_6.12.e012290.4","doi-asserted-by":"crossref","first-page":"162","DOI":"10.1016\/S0022-4804(03)00125-2","article-title":"Effect of straining on perineal muscles and their role in perineal support: identification of the straining-perineal reflex","volume":"112","author":"Shafik","year":"2003","journal-title":"J Surg Res"},{"key":"2025121602075414000_6.12.e012290.5","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1111\/j.1523-536X.1982.tb01667.x","article-title":"Infant outcome in relation to second stage labor pushing method","volume":"9","author":"Barnett","year":"1982","journal-title":"Birth"},{"key":"2025121602075414000_6.12.e012290.6","doi-asserted-by":"crossref","first-page":"31","DOI":"10.3109\/00016349309013345","article-title":"Pushing method in the expulsive phase of labor. 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