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Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

ConditionsObesityPregnancy in DiabeticPregnancy ComplicationsPregnancy RelatedBariatric Surgery Status Complicating Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorChelsea and Westminster NHS Foundation Trust

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women with normal size (BMI <30)

Pregnant women with obesity (BMI ≥30)

Pregnant women with glucose disorders

Pregnant women with previous bariatric surgery

Disqualifiers

Pregnant women less than 18 years of age

Pregnant women with twins/triplets

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    This is an observational study

Treatment groups

700 Participants
are divided into 4 treatment groups
Group A: Pregnant women with obesity/GDM/T2DM0 interventions
Group B: Pregnant women with obesity/GDM/T2DM- Controls0 interventions
Group C: Post-bariatric pregnant women1 intervention
Group D: Pregnant no bariatric women- Controls0 interventions

Trial outcomes

Primary outcomes

1

Birth weight (in percentiles)

Birthweight percentiles will be compared in the groups studied

Time frame
At the time of birth

Secondary outcomes

1

Reported pregnancy complications

Compare the percentage of women that develop pre-eclampsia or other complications in the groups studied

Time frame
During pregnancy and up until the birth of the baby
2

Reported labour outcomes

The percentage of women who deliver by instrumental deliveries or Caesarean section, in the groups studied

Time frame
At birth
3

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

Weight and height will be combined to report BMI in kg/m\^2, in the groups of women studied

Time frame
Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
4

Maternal and infant blood pressure (in mmHg)

Compare the maternal and infant biophysical profile in the groups of women studied

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chelsea and Westminster NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov
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