Clinical Trial

Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

Recruiting
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Summary
The obesity epidemic is growing worldwide and in the UK this is perpetuated with a third of women classified as overweight/obese in 2020. Many of these woman are of childbearing age and go on to have high risk pregnancies which are often complicated by gestational or pre-existing (type 2 diabetes mellitus (GDM, T2DM). Bariatric surgery is the most successful treatment of sustainable weight loss and is associated with a reduction in rates of GDM, pre-eclampsia, delivery of large babies but increased risk of delivery of small babies and preterm delivery. The aims of the study are to investigate the maternal and fetal/neonatal, biophysical and biochemical, intra-uterine environment and postnatal profile of pregnancies: 1. affected by maternal obesity and/or GDM/T2DM compared to pregnancies with normal maternal body mass index (BMI). 2. with previous maternal bariatric surgery compared to pregnancies without previous bariatric surgery but matched for maternal pre-surgery and early pregnancy BMI.
Trial Details
NCT Number NCT05753124
Lead Sponsor Chelsea and Westminster NHS Foundation Trust
Conditions Obesity, Pregnancy in Diabetic, Pregnancy Complications, Pregnancy Related, Bariatric Surgery Status Complicating Pregnancy
Enrollment 700 participants
Start Date 2015-05
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2023-03-03