Rationale and design of ePPOP-ID: a multicenter randomized controlled trial using an electronic-personalized program for obesity in pregnancy to improve delivery.
Adult
Apgar Score
Birth Weight
Cesarean Section
/ statistics & numerical data
Extraction, Obstetrical
/ statistics & numerical data
Female
Follow-Up Studies
Gestational Weight Gain
Healthy Lifestyle
Humans
Infant, Newborn
Internet-Based Intervention
Multicenter Studies as Topic
Obesity, Maternal
/ complications
Obstetric Labor Complications
/ epidemiology
Patient Compliance
Postnatal Care
/ methods
Postpartum Period
Pregnancy
Prenatal Care
/ methods
Randomized Controlled Trials as Topic
Risk Factors
Risk Reduction Behavior
Treatment Outcome
Cesarean delivery
Fetus
Instrumental delivery
Macrosomia
Nutrition
Obesity
Physical activity
Pregnancy
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
07 Oct 2020
07 Oct 2020
Historique:
received:
18
02
2020
accepted:
27
09
2020
entrez:
8
10
2020
pubmed:
9
10
2020
medline:
18
5
2021
Statut:
epublish
Résumé
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. 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. The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy. ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
The findings of the ePPOP-ID trial will help design e-health intervention program for obese women in pregnancy.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier: NCT02924636 / October 5th 2016.
Identifiants
pubmed: 33028261
doi: 10.1186/s12884-020-03288-x
pii: 10.1186/s12884-020-03288-x
pmc: PMC7542973
doi:
Banques de données
ClinicalTrials.gov
['NCT02924636']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
602Subventions
Organisme : Ministère de la Santé et des Services sociaux
ID : 590780193
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