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

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.

Impact of gestational weight gain on perinatal outcomes after a bariatric surgery.

BACKGROUND: Recommendations by the Institute of Medicine (IOM) on gestational weight gain (GWG) for women with histories of bariatric surgery have yet to be studied. OBJECTIVES: To describe GWG in women with histories of bariatric surgery and to investigate the relationship between GWG and maternal and neonatal outcomes. STUDY DESIGN: A bicentric retrospective study on the medical charts of pregnant women with histories of bariatric surgery who delivered between 2003 and 2017 in two level III maternity units. In accordance with IOM guidelines, GWG was classified as insufficient, adapted, or excessive. RESULTS: At least 337 pregnancies from 264 patients were included in this study. Of these pregnancies, 154 (45.7%) occurred after gastric banding, 135 (40.1%) after Roux-en-Y gastric bypass, and 48 (14.2%) after sleeve gastrectomy. GWG was adapted in 90 of the pregnancies (26.7%), insufficient in 11 of the pregnancies (35%), and excessive in 129 of pregnancies (38.3%). Gestational age at birth was significantly lower when GWG was insufficient (37.7 ± 4.2 weeks vs. 38.8 ± 2.9 weeks for adequate GWG and 39.4 ± 1.8 weeks for excessive GWG). When compared to normal GWG, insufficient GWG was indicated to be a risk factor for preterm labor (adjusted OR, 3.05, 95% CI 1.30-7.17). When compared to excessive GWG, insufficient GWG increased the rates of small for gestational age (SGA) newborns (OR, 1.96, 95% CI 1.04-3.68), preterm labor (OR, 4.13, 95% CI 1.84-9.24), and preterm delivery (OR, 6.40, 95% CI 2.41-17.0). CONCLUSION: In our study, adequate GWG was associated with better obstetrical outcomes, resulting in the conclusion that IOM recommendations applied to pregnant women who had undergone bariatric surgery. Our findings suggest that the large proportion of women with insufficient GWG may account for increased rates of SGA and preterm birth.