Electronic-personalized Program for Obesity in Pregnancy to Improve Delivery - ePPOP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 857
- 试验地点
- 1
- 主要终点
- rate of obstetrical interventions
研究概览
简要总结
The purpose of this study is to assess the efficacy of an electronic-based intervention to help pregnant overweight and obese women gain an appropriate amount of weight and improve their delivery i.e. to reduce the rate of labour procedures and interventions. We chose a composite outcome including instrumental delivery and Caesarean section, as clinically relevant outcomes because the mode of delivery is one of the major goals of the obstetrical management and is is strongly associated with body mass index and gestational weight gain.
详细描述
Our study is an open, multicenter, randomized, parallel-group, controlled trial. This study will include obese pregnant women recruited in 11 French university hospitals. Patients will be randomized into two-parallel groups. One group underwent the electronic-personalized program (the interventional group) and the other underwent standard care (the control group). Due to the intervention by itself, a blind study would not be achievable.
Intervention group (the electronic-personalized program) The intervention will be presented as a comprehensive dietary and lifestyle intervention called "e-PPOP-ID" (electronic Personalized Programmed for Obesity in Pregnancy to Improve Delivery), including a combination of dietary, exercise, and behavioral strategies delivered on a web site.
The intervention will start at the latest by 20 weeks of pregnancy throughout the pregnancy and 8 weeks post-partum.
Pregnant women of the intervention group will be given an access to a personalized patient centric e-health platform. The platform we be specifically designed for this program. Various modules of this platform will be activated:
- An e-learning program: An e-Learning module will propose personalized content to each patient. Before the program, patients have to fill in questionnaires about food consumption (FFQ), Eating behavior (TFEQ) and physical activity (IPAQ). The answers of these questionnaires will be taken into account to define the e-learning lessons that patients must follow.Multi educational supports such as videos, fact sheets, quiz will be integrated into this program. Patient will be motivated to validate their program thanks to a reward system (access to new content by earning stars) and their knowledge can be estimated thanks to a quiz system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese pregnant women (30 ≤ BMI < 40 kg/m2)
- •Singleton pregnancy between 12+0 to 19+6 weeks of pregnancy
- •Having an email address and an Internet access
排除标准
- •BMI < 30 kg/m2 or BMI > 40 kg/m2
- •History of more than 2 miscarriages
- •Severe heart disease (arrhythmias, history of myocardial infarction)
- •Multiple pregnancy
- •Unstable thyroid disease
- •Uncontrolled hypertension
- •Pre-gestational diabetes
- •Bariatric surgery
- •Any medical condition that may interfere with physical activity during pregnancy
- •No access to Internet
- •Absence of health insurance
- •Guardianship
- •Refusal to participate in research
结局指标
主要结局
rate of obstetrical interventions
时间窗: at birth
Caesarean section and instrumental delivery (forceps and vacuum extractor)
次要结局
- Hemorrhage(1st week after delivery)
- Breastfeeding duration(8 weeks +/- 2 weeks after delivery)
- Total gestational weight gain(at birth)
- Gestational hypertension(at birth)
- Preeclampsia(at birth)
- Gestational diabetes mellitus(at birth)
- Premature birth(at birth)
- gestational age(at birth)
- Birth weight(at birth)
- Apgar score(at birth)
- Arterial umbilical cord pH(at birth)
- Neonatal traumatism(at birth)
- Hyperbilirubinemia(1st week after birth)
- Neonatal respiratory distress syndrome(1st week after birth)
- Transfer in neonatal intensive care unit(1st week after birth)
- Maternal fever(1st week after delivery)
- Thromboembolic event(1st week after delivery)
- Maternal weight(8 weeks +/- 2 weeks after delivery)
- child weight(8 weeks +/- 2 weeks after delivery)