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Objective

To assess the efficacy of an electronic-personalized program including antenatal dietary and lifestyle during pregnancy to reduce the rate of labour procedures and interventions in comparison to standard care.

Study design: randomized controlled trial

Study population

Obese pregnant women (30 ≤ BMI < 40 kg/m2), age from 18 to 45 years old
Singleton pregnancy between 12+0 to 19+6 weeks of pregnancy
Having an email address, an Internet access and a cell phone

Intervention

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 behavioural strategies delivered by emails, text message on mobile phone and a web site. This program will be developed with the French start-up “Be Patient”.

Outcome measures

Primary endpoint: rate of obstetrical interventions during labour and delivery including Caesarean section and instrumental delivery (forceps and vacuum extractor).

Power/data analysis

The main objective of this study is to show the superiority of an electronic-personalized program over standard care to reduce the rate of delivery interventions (defined as caesarean section and instrumental (vacuum extractor and forceps) extractions) in obese pregnant patients. In the AUDIPOG database of the French maternities, the rate of delivery interventions is 50% among pregnant women with a BMI> 30 kg/m2. We believe that the electronic-personalized program could reduce this rate to 40% (i.e. a relative risk reduction of 20%). To detect this difference, using a 2-sided Chi-square test with an alpha risk of 5% and a power of 80%, we calculated that a total of 774 subjects (i.e. 387 subjects in each group) would be required.

Coordinator:
Philippe Deruelle. CHRU de Lille
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Founding: PHRCnational 2014

Puma Rihanna
Catégorie : Études en cours

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