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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

Philippe Deruelle, Sophie Lelorain, Sylvie Deghilage, Emmanuelle Couturier, Elodie Guilbert, Paul Berveiller, Marie Victoire Sénat, Christophe Vayssière, Loïc Sentilhes, Franck Perrotin, Denis Gallot, Céline Chauleur, Nicolas Sananes, Emmanuel Roth, Dominique Luton, Marie Caputo, Elodie Lorio, Carla Chatelet, Julien Couster, Oumar Timbely, Muriel Doret-Dion, Alain Duhamel, and Marie Pigeyre

Subjects
Obesity, Pregnancy, Cesarean delivery, Instrumental delivery, Physical activity, Nutrition, Gynecology and obstetrics, RG1-991
Abstract

Abstract Background Pre-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. Methods Electronic-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. Discussion The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy. Trial registration ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.

Published
2020
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2. Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery

Author

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

3. Le fœtus et son environnement : rôle des professionnels pour préserver le capital santé des adultes de demain

Author

Vincent Prevot, Philippe Deruelle, Michel Cosson, Frédéric Gottrand, Sylvie Deghilage, Julia Tepel, Dominique Turck, and Laurent Storme

Subjects
03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, 030209 endocrinology & metabolism, General Medicine
Abstract

RESUME Le « Capital Sante » de chaque individu est influence par son environnement au cours des periodes critiques de la vie fœtale ou de la petite enfance. Ce concept est connu sous le terme « Origines Developpementales de la Sante et des Maladies » (Developmental Origins of Health and Disease — DOHaD). Une exposition a des toxiques comme les perturbateurs endocriniens, a un environnement nutritionnel et hormonal defavorable, a un stress « toxique », ou un desequilibre du microbiote intestinal notamment par une antibiotherapie perinatale inappropriee sont associes a la survenue de pathologies metaboliques (obesite, hypertension, diabete de type 2), au developpement de cancers, de maladies inflammatoires du tube digestif ou d’allergies, et peuvent conditionner le developpement cognitif ou psychologique. D’autres facteurs de l’environnement fœtal ont des effets protecteurs comme l’activite physique et la consommation d’acides gras de type omega-3 pendant la grossesse. Les mecanismes en cause impliquent des modifications epigenetiques susceptibles de modifier l’expression des genes a long terme, voire d’une generation a l’autre. L’objectif de cet article est de decrire l’impact de trois types de facteurs de l’environnement fœtal susceptibles de programmer des maladies chez l’adulte : les facteurs associes au petit poids de naissance, les toxiques de l’environnement et le stress « toxique ».

Published
2018

4. Early clindamycin for bacterial vaginosis in pregnancy (premeva): a multicentre, double-blind, randomised controlled trial

Author

Bruno Grandbastien, Rodrigue Dessein, Emma Tilloy, François Goffinet, Jean Louis Plennevaux, Eric Kipnis, Damien Subtil, Catherine Nolf, Karine Faure, Gilles Brabant, David Desseauve, Emmanuelle Joyez, Jean-Charles Dugimont, Marie-Christine Bissinger, Frédérique Canis, Marielle Jousse, Christine Delaeter, Patrick Devos, Anne Personne, Sophie Gautier, Elisabeth Guinard, Pierre-Yves Ancel, Annie Fruchart, Christophe Hacot, Jerome Chantrel, Sylvie Deghilage, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille, Hôpital Saint Vincent de Paul de Lille, Groupe Hospitalier de l'Institut Catholique de Lille (GHICL), Centre hospitalier [Valenciennes, Nord], Institut de Microbiologie [CHRU Lille], Pôle de Biologie Pathologie Génétique [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Lille, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Groupe Hospitalier Artois-Ternois Centre Hospitalier d’Arras, Hôpital Claude Huriez [Lille], CHU Lille, Centre Hospitalier de Calais, Recherche translationelle relations hôte-pathogènes, Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL), Université catholique de Lille (UCL)-Université catholique de Lille (UCL), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CNRS, Inserm, METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Santé publique : épidémiologie et qualité des soins - EA 2694, Troubles cognitifs dégénératifs et vasculaires - U1171, Recherche translationnelle : relations hôte-pathogènes - EA 7366, Troubles cognitifs dégénératifs et vasculaires - U 1171 [TCDV], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS], Centre hospitalier universitaire de Poitiers [CHU Poitiers], and Equipe 1 : EPOPé - Épidémiologie Obstétricale, Périnatale et Pédiatrique [CRESS - U1153]

Subjects
Adult, medicine.medical_specialty, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics, Placebo, Miscarriage, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Pregnancy, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Internal medicine, medicine, Very Preterm Birth, Humans, 030212 general & internal medicine, Pregnancy Complications, Infectious, 030219 obstetrics & reproductive medicine, Intention-to-treat analysis, business.industry, Clindamycin, Pregnancy Outcome, General Medicine, Vaginosis, Bacterial, medicine.disease, 3. Good health, Anti-Bacterial Agents, Abortion, Spontaneous, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Premature Birth, Female, Bacterial vaginosis, business, medicine.drug
Abstract

International audience; Background: Preterm delivery during pregnancy (

Published
2018

5. 3: Early clindamycin for bacterial vaginosis in low-risk pregnancy: the PREMEVA1 randomized, multicenter, double-blind, placebo-controlled trial

Author

Gilles Brabant, Marie-Christine Bissinger, Marielle Jousse, Emma Tilloy, Julia Salleron, Jerome Chantrel, François Goffinet, Rodrigue Dessein, Joyez Emmanuelle, Sylvie Deghilage, David Desseauve, Jean-Louis Plennevaux, Damien Subtil, Anne Personne, Frédérique Canis, Nolf Catherine, Jean-Charles Dugimont, Annie Fruchart, and Delaeter Christine

Subjects
Double blind, medicine.medical_specialty, Low risk pregnancy, business.industry, Internal medicine, medicine, Placebo-controlled study, Obstetrics and Gynecology, Clindamycin, Bacterial vaginosis, business, medicine.disease, medicine.drug
Published
2014

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