Impact of obesity, diabetes, and bariatric surgery on pregnancy outcomes
Investigation and Study of Pregnancy in Overweight or Diabetic Women and the Effect of Bariatric Surgery on Pregnancy Outcomes
This study looks at how being overweight, having diabetes, or having had weight-loss surgery affects pregnancy outcomes for women compared to those with a normal weight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Chelsea and Westminster NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05753124 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of maternal obesity, diabetes, and previous bariatric surgery on pregnancy outcomes. It compares pregnancies in women with normal BMI to those who are overweight or obese, as well as those with gestational or type 2 diabetes. The study will assess various maternal and fetal health parameters throughout pregnancy and postnatally, including biophysical and biochemical profiles. Participants will undergo a series of investigations at multiple gestational ages and post-delivery to gather comprehensive data on their health and pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with normal BMI, obesity, glucose disorders, or a history of bariatric surgery.
Not a fit: Patients under 18 years of age or those carrying multiples (twins/triplets) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing pregnancies affected by obesity and diabetes, potentially improving maternal and neonatal health outcomes.
How similar studies have performed: Other studies have shown success in understanding the impacts of obesity and diabetes on pregnancy, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Chelsea & Westminster Hospital Nhs Ft — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Makrina Savvidou, Md — Chelsea & Westminster Hospital Nhs Ft
- Study coordinator: Damon Foster
- Email: damon.foster2@nhs.net
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.