Actively Recruiting

Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID05753124

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

Led by Chelsea and Westminster NHS Foundation Trust · Updated on 2023-03-03

700

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how obesity, diabetes, and previous bariatric surgery affect pregnancy outcomes. The study focuses on pregnant women with normal weight, overweight, obesity, and glucose disorders like gestational diabetes and type 2 diabetes. It also compares pregnancies of women who have had bariatric surgery to those without surgery but with similar body mass index (BMI) before and during pregnancy. This research aims to understand the maternal and fetal environment and health during and after pregnancy. This observational study involves multiple groups: pregnant women with obesity or glucose disorders, women with normal BMI without diabetes, women with prior bariatric surgery, and matched control groups without surgery. Participants will be followed during pregnancy at several time points between 12 and 37 weeks gestation, and after birth at 6 weeks, 3 months, 12-24 months, and 3-7 years. Various tests including ultrasounds, echocardiography, blood and urine sampling, and neonatal MRI will be performed. Participants will have their medical history recorded and undergo measurements such as weight, height, blood pressure, and blood sugar testing. Fetal growth and wellbeing will be assessed using ultrasound techniques. Samples from mother and baby will be collected at delivery and during postnatal visits. The main outcome measured is birth weight percentiles, with additional monitoring of pregnancy complications, labor outcomes, and long-term health of mother and child. The study lasts several years with follow-up visits scheduled up to 7 years after birth.

CONDITIONS

Brief Title

Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women with normal body mass index (BMI less than 30)
  • Pregnant women with obesity (BMI 30 or higher)
  • Pregnant women diagnosed with glucose disorders such as gestational diabetes or type 2 diabetes
  • Pregnant women who have had previous bariatric surgery
Not Eligible

You will not qualify if you...

  • Pregnant women under 18 years of age
  • Pregnant women expecting twins or triplets

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From early pregnancy until delivery (up to 40 weeks)

Participants are observed and assessments are performed throughout pregnancy to study maternal and fetal health, including blood tests, ultrasounds, and other sample collections.

Visits at approximately 12-14, 20-24, 26-28, 30-32, and 35-37 weeks gestation

Diagnostic Evaluation

Duration - At delivery and immediate postnatal period

At and following delivery, maternal and neonatal samples are collected and neonatal MRI is performed to assess body fat distribution and other outcomes.

1 visit at delivery and immediate postnatal assessments

Long-term Monitoring

Duration - From 6 weeks to up to 7 years after birth

Participants and their infants are followed postnatally to assess growth, health, and sample collection over several years.

Visits at 6 weeks, 3 months, 12-24 months, and 3-7 years postnatal

Trial Site Locations

Total: 1 location

1

Chelsea & Westminster Hospital Nhs Ft

London, United Kingdom

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Research Team

D

DAMON FOSTER

D

DORIS DABY

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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