NCT05753124 Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes
| NCT ID | NCT05753124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chelsea and Westminster NHS Foundation Trust |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2015-05 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2015-05 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
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
Contact & Investigator
DAMON FOSTER
✉ damon.foster2@nhs.netMAKRINA SAVVIDOU, MD
PRINCIPAL INVESTIGATOR
CHELSEA & WESTMINSTER HOSPITAL NHS FT
Frequently Asked Questions
Who can join the NCT05753124 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05753124 currently recruiting?
Yes, NCT05753124 is actively recruiting participants. Contact the research team at damon.foster2@nhs.net for enrollment information.
Where is the NCT05753124 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05753124 clinical trial?
NCT05753124 is sponsored by Chelsea and Westminster NHS Foundation Trust. The principal investigator is MAKRINA SAVVIDOU, MD at CHELSEA & WESTMINSTER HOSPITAL NHS FT. The trial plans to enroll 700 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.