Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

NCT05753124 | Recruiting

• 1 other identifier: 142103
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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. 1.affected by maternal obesity and/or GDM/T2DM compared to pregnancies with normal maternal body mass index (BMI).
2. 2.with previous maternal bariatric surgery compared to pregnancies without previous bariatric surgery but matched for maternal pre-surgery and early pregnancy BMI.

Conditions

Obesity; Pregnancy in Diabetic; Pregnancy Complications; Pregnancy Related; Bariatric Surgery Status Complicating Pregnancy

Keywords

Pregnancy; Gastric sleeve; Gastric bypass; Bariatric surgery; Birth weight; Glucose intolerance

Outcome Measures

Primary Outcomes (1)

• Birth weight (in percentiles)

  Birthweight percentiles will be compared in the groups studied

  At the time of birth

Secondary Outcomes (5)

• Reported pregnancy complications

  During pregnancy and up until the birth of the baby

• Reported labour outcomes

  At birth

• Maternal and infant weight (in kg) and height (in cm)

  Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

• Maternal and infant blood pressure (in mmHg)

  Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

• Maternal and infant blood and urine samples

  Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

Study Arms (4)

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

Other: Observational

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.

Interventions

Observational OTHER

This is an observational study

Post-bariatric pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female and pregnant. Only looking at singleton pregnancies.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with a singleton pregnancy that resulted in the delivery of a live, phenotypically normal neonate.

You may qualify if:

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

You may not qualify if:

• Pregnant women less than 18 years of age
• Pregnant women with twins/triplets

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea & Westminster Hospital Nhs Ft

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood, urine, stool samples and vaginal swabs. Neonatal cord blood, urine and meconium samples. Maternal (after the delivery) and infant blood, urine and stool samples.

MeSH Terms

Conditions

Obesity; Pregnancy in Diabetics; Pregnancy Complications; Birth Weight; Glucose Intolerance

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• MAKRINA SAVVIDOU, MD

  CHELSEA & WESTMINSTER HOSPITAL NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAMON FOSTER

CONTACT

damon.foster2@nhs.net

DORIS DABY

CONTACT

doris.daby1@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: March 3, 2023
• Study Start: May 1, 2015
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

GB (1)