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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• Pregnant women with normal size (BMI \<30)

• Pregnant women with obesity (BMI ≥30)

• Pregnant women with glucose disorders

• Pregnant women with previous bariatric surgery

Locations
Other Locations
United Kingdom
Chelsea & Westminster Hospital Nhs Ft
RECRUITING
London
Contact Information
Primary
DAMON FOSTER
damon.foster2@nhs.net
Backup
DORIS DABY
doris.daby1@nhs.net
Time Frame
Start Date: 2015-05
Estimated Completion Date: 2027-10
Participants
Target number of participants: 700
Treatments
Pregnant women with obesity/GDM/T2DM
Pregnant women with obesity/GDM/T2DM
Pregnant women with obesity/GDM/T2DM- Controls
Pregnant women with normal BMI/ no GDM orT2DM
Post-bariatric pregnant women
Pregnant women with previous bariatric surgery
Pregnant no bariatric women- Controls
There will be two control groups of women with no previous bariatric surgery:~1\. Pregnant women with booking BMI similar to the booking BMI of the post-bariatric ones and 2. Pregnant women with booking BMI similar to the pre-surgery BMI of the post-bariatric ones.
Sponsors
Leads: Chelsea and Westminster NHS Foundation Trust

This content was sourced from clinicaltrials.gov