Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

March 1, 2023 updated by: Chelsea and Westminster NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an observational study. The investigators are planning to study pregnant women with normal BMI or overweight (BMI<30), obesity (BMI ≥30) and glucose disorders (GDM and T2DM). The investigators will also study pregnant women with previous bariatric surgery (gastric band, sleeve gastrectomy or gastric bypass) and compare them with pregnant women of similar pre-surgery and early pregnancy BMI, but no hisotry of weight loss surgery.

For all the participants and serially during pregnancy (at 12-14, 20-24, 26-28, 30-32, 35-37 weeks gestation and postnatally (at 6 weeks, 3 months, 12-24 months and 3-7 years of age), the investigators will perform the following investigations:

Maternal investigations: Demographics and medical history will be recorded, weight, height, waist to hip ratio and blood pressure will be measured, blood, urine, stool samples and vaginal swabs will be obtained, cervical length (by trans-vaginal ultrasound) will be measured and maternal echocardiography will be performed. Maternal glucose homeostasis will be assessed at 26-28 weeks of gestation, by a full oral glucose tolerance test, HOMA, home glucose monitoring and/ or continuous glucose monitoring (CGM), depending on the group the women belong to.

Fetal investigations: Fetal growth and well being will be assessed by 2D, 3D and Doppler ultrasound, fetal echocardiography will be performed.

At and following delivery: Maternal blood and urine samples and subcutaneous and omental fat (if Caesarean section is performed) will be obtained, placental tissue will be stored. Neonatal cord blood will be obtained, birthweight (percentiles), anthropometric characteristics will be measured, meconium and urine samples will be obtained and neonatal MRI (to assess body fat distribution) will be arranged.

Postnatal follow up visits for the mother and the infant (at 6 weeks, 3 months, 12-24 months, 3-7 years old) will be arranged and maternal and infant blood and urine samples will be requested and obtained.

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
This is an observational study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth weight (in percentiles)
Time Frame: At the time of birth
Birthweight percentiles will be compared in the groups studied
At the time of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reported pregnancy complications
Time Frame: During pregnancy and up until the birth of the baby
Compare the percentage of women that develop pre-eclampsia or other complications in the groups studied
During pregnancy and up until the birth of the baby
Reported labour outcomes
Time Frame: At birth
The percentage of women who deliver by instrumental deliveries or Caesarean section, in the groups studied
At birth
Maternal and infant weight (in kg) and height (in cm)
Time Frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Weight and height will be combined to report BMI in kg/m^2, in the groups of women studied
Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Maternal and infant blood pressure (in mmHg)
Time Frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Compare the maternal and infant biophysical profile in the groups of women studied
Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Maternal and infant blood and urine samples
Time Frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Compare the maternal and infant metabolic profile in the groups of women studied
Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Investigators

  • Principal Investigator: MAKRINA SAVVIDOU, MD, Chelsea & Westminster Hospital Nhs Ft

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Anticipated)

October 1, 2027

Study Completion (Anticipated)

October 1, 2027

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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