1. Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery
- Author
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Paul Berveiller, Marie-Victoire Senat, Elodie Guilbert, Dominique Luton, Christophe Vayssière, Marie Caputo, Muriel Doret-Dion, Sylvie Deghilage, Nicolas Sananès, Marie Pigeyre, Philippe Deruelle, Carla Chatelet, Emmanuel Roth, Loïc Sentilhes, Denis Gallot, Elodie Lorio, Alain Duhamel, Franck Perrotin, Emmanuelle Couturier, Oumar Timbely, Céline Chauleur, Sophie Lelorain, and Julien Couster
- Subjects
Neonatal intensive care unit ,medicine.medical_treatment ,law.invention ,Obesity, Maternal ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,Pregnancy ,law ,Birth Weight ,Multicenter Studies as Topic ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,030219 obstetrics & reproductive medicine ,Obstetrics ,Postpartum Period ,Cesarean delivery ,Obstetrics and Gynecology ,Gestational age ,Extraction, Obstetrical ,Prenatal Care ,Gestational Weight Gain ,Treatment Outcome ,Premature birth ,Female ,Instrumental delivery ,Apgar score ,Internet-Based Intervention ,Adult ,Postnatal Care ,medicine.medical_specialty ,Birth weight ,Macrosomia ,lcsh:Gynecology and obstetrics ,03 medical and health sciences ,Fetus ,medicine ,Humans ,Caesarean section ,Healthy Lifestyle ,Obesity ,lcsh:RG1-991 ,Nutrition ,Cesarean Section ,Physical activity ,business.industry ,Infant, Newborn ,medicine.disease ,Obstetric Labor Complications ,Apgar Score ,Patient Compliance ,business ,Risk Reduction Behavior ,Follow-Up Studies - Abstract
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.govIdentifier:NCT02924636/ October 5th 2016.
- Published
- 2020