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NCT05753124Recruiting

Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

Investigation and Study of Pregnancy in Overweight or Diabetic Women and the Effect of Bariatric Surgery on Pregnancy Outcomes

Source: ClinicalTrials.gov · Last updated 3 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
700 (estimated)
First submitted
4 Jul 2022
Start date
1 May 2015
Primary completion date
31 Oct 2027
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Diseases
Obesity
NCT number
NCT05753124

What you commit to

  • Study type: Observational
  • Planned participants: 700
  • From 1 May 2015 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Pregnant women less than 18 years of age

Other

  • Pregnant women with twins/triplets

Who the study is looking for

  • Pregnant women with normal size (BMI \<30)
  • Pregnant women with obesity (BMI ≥30)
  • Pregnant women with glucose disorders
  • Pregnant women with previous bariatric surgery

Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chelsea & Westminster Hospital Nhs Ft
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.