Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery

BMC Pregnancy and Childbirth

Marie Victoire Sénat¹  Franck Perrotin²  Dominique Luton³  Loïc Sentilhes⁴  Julien Couster⁵  Carla Chatelet⁶  Marie Caputo⁷  Oumar Timbely⁸  Christophe Vayssière⁹  Paul Berveiller^1,10  Elodie Lorio^1,11  Marie Pigeyre^1,12  Muriel Doret-Dion^1,13  Céline Chauleur^1,14  Denis Gallot^1,15  Emmanuel Roth^1,16  Nicolas Sananes^1,17  Alain Duhamel^1,18  Elodie Guilbert^1,19  Emmanuelle Couturier^1,19  Sylvie Deghilage^1,19  Philippe Deruelle^2,20  Sophie Lelorain^2,21 

[1] Assistance Publique-Hôpitaux de Paris, Department of Gynecology-Obstetrics, Bicêtre Hospital, University of Paris-Sud, University of Medicine Paris- Saclay Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France;Department of Gynecology and Obstetrics, Inserm U1253 « Imaging and Brain » (iBrain). CHU Bretonneau, Tours, France;Department of Obstetrics and Gynecology, AP-HP, Bichat hospital, Paris, France;Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux, France;Department of Obstetrics and Gynecology, Boulogne general hospital, Boulogne, France;Department of Obstetrics and Gynecology, Béthune general hospital, Béthune, France;Department of Obstetrics and Gynecology, Lens general hospital, Lens, France;Department of Obstetrics and Gynecology, Meaux general hospital, Meaux, France;Department of Obstetrics and Gynecology, Paule de Viguier Hospital, CHU Toulouse, Toulouse, France;Department of Obstetrics and Gynecology, Poissy Saint Germain hospital, Poissy, France;Department of Obstetrics and Gynecology, Valenciennes general hospital, Valenciennes, France;Department of medicine, endocrinology division, Mc Master university, Hamilton, Canada;Department of obstetrics and gynecology surgery, Femme mere enfant university hospital, hospices civils de Lyon, Bron, France;INSERM, SAINBIOSE, U1059, Dysfonction Vasculaire et Hémostase, Université Jean-Monnet, CIC1408, F- 42055, Saint-Etienne, France;Pôle Femme Et Enfant, CHU Estaing, Clermont-Ferrand cedex 1, France;R2D2-EA7281, Université d’Auvergne, Faculté de Médecine, Place Henri Dunant, Clermont-Ferrand, France;Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France;Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France;Maternal Fetal Medicine Department, INSERM 1121 “Biomaterials and Bioengineering”, Strasbourg University Hospital, Strasbourg, France;Univ. Lille, CHU Lille, EA 2694 - Santé publique : épidémiologie et qualité des soins, F-59000, Lille, France;Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France;Univ. Lille, CHU Lille, EA 4489 - Environnement Périnatal et Santé, F-59000, Lille, France;Pôle Gynécologie, Obstétrique et Fertilité, Hôpitaux Universitaires de Strasbourg, 67200, Strasbourg cedex, France;Univ. Lille, CNRS, CHU Lille, UMR 9193 – SCALab – Cognitive and Affective Sciences, Lille, France;

关键词: Obesity;    Pregnancy;    Cesarean delivery;    Instrumental delivery;    Physical activity;    Nutrition;    Fetus;    Macrosomia;   

DOI  :  10.1186/s12884-020-03288-x

来源: Springer

【 摘 要 】

BackgroundPre-pregnancy obesity and excessive gestational weight gain (GWG) are established risk factors for adverse pregnancy, delivery and birth outcomes. Pregnancy is an ideal moment for nutritional interventions in order to establish healthier lifestyle behaviors in women at high risk of obstetric and neonatal complications.MethodsElectronic-Personalized Program for Obesity during Pregnancy to Improve Delivery (ePPOP-ID) is an open multicenter randomized controlled trial which will assess the efficacy of an e-health web-based platform offering a personalized lifestyle program to obese pregnant women in order to reduce the rate of labor procedures and delivery interventions in comparison to standard care. A total of 860 eligible pregnant women will be recruited in 18 centers in France between 12 and 22 weeks of gestation, randomized into the intervention or the control arm and followed until 10 weeks of postpartum.The intervention is based on nutrition, eating behavior, physical activity, motivation and well-being advices in which personalization is central, as well as the use of a mobile/tablet application. Inputs includes data from the medical record of participants (medical history, anthropometric data), from the web platform (questionnaires on dietary habits, eating behavior, physical activity and motivation in both groups), and adherence to the program (time of connection for the intervention group only). Data are collected at inclusion, 32 weeks, delivery and 10 weeks postpartum. As primary outcome, we will use a composite endpoint score of obstetrical interventions during labor and delivery, defined as caesarean section and instrumental delivery (forceps and vacuum extractor). Secondary outcomes will consist of data routinely collected as part of usual antenatal and perinatal care, such as GWG, hypertension, preeclampsia, as well as fetal and neonatal outcomes including premature birth, gestational age at birth, birth weight, macrosomia, Apgar score, arterial umbilical cord pH, neonatal traumatism, hyperbilirubinemia, respiratory distress syndrome, transfer in neonatal intensive care unit, and neonatal adiposity. Post-natal outcomes will be duration of breastfeeding, maternal weight retention and child weight at postnatal visit.DiscussionThe findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy.Trial registrationClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.

【 授权许可】

CC BY