RecruitingOBSERVATIONAL

Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

This UK study is all about understanding how being overweight, having diabetes, or having had weight loss surgery affects pregnancy. Many women today are overweight or have diabetes, which can make pregnancy more complicated. Weight loss surgery can help, but it might also bring different challenges for mothers and babies. Researchers will observe groups of pregnant women with different health backgrounds. They will look closely at their health during pregnancy, childbirth, and for several years afterwards, as well as the health of their babies. The aim is to learn more about how these factors influence pregnancy outcomes, helping doctors provide better care in the future.

At a glance

Status

Recruiting

Sponsor

Chelsea and Westminster NHS Foundation Trust

Enrolment target

700

Start

01 May 2015

Estimated completion

01 Oct 2027

Obesity Pregnancy in Diabetic Pregnancy Complications Pregnancy Related Bariatric Surgery Status Complicating Pregnancy

What is this study about?

This study wants to better understand how a mother's weight and whether she has diabetes affects her pregnancy. In the UK, many pregnant women are overweight or have diabetes, which can sometimes lead to complications for both the mother and the baby. This research aims to look closely at these potential issues.

We also want to compare pregnancies in women who have had weight loss surgery with those who haven't. While weight loss surgery can address some health problems, it's important to understand if it introduces any different challenges for pregnancy. By studying these different groups, we hope to gain a clear picture of how these factors influence the health of mothers and their babies.

The main goal is to find out more about how a mother's health before and during pregnancy affects her baby's development, the birth itself, and the health of both mother and child in the years that follow. This information will help doctors and midwives offer the best possible advice and care to pregnant women in the future.

Key takeaways

This study focuses on mothers' weight, diabetes, and previous weight loss surgery during pregnancy.
It's an 'observational' study, meaning no new treatments are given.
Participation involves multiple visits and health checks over several years.
The findings will help improve future pregnancy care for women and babies.
You can withdraw from the study at any time.
The study includes checks for both mother and baby, even after birth.

Who may be eligible?

To join this study, you need to be a pregnant woman who is 18 years old or older, but not older than 50. You can be of a healthy weight, overweight, or have diabetes.

Pregnant women who have had weight loss surgery, like a gastric band or a bypass, are also welcome to take part. However, if you are pregnant with twins or triplets, or are under 18, unfortunately, this study isn't suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant?
Are you between 18 and 50 years old?
Are you expecting only one baby (not twins or triplets)?
Are you comfortable with regular health checks and follow-up visits over several years?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have several visits during your pregnancy at around 12-14, 20-24, 26-28, 30-32, and 35-37 weeks. During these visits, we'll record your personal and health information, measure your weight, height, waist, and blood pressure. We'll also take samples of your blood, urine, poo, and some swabs. You might also have a special ultrasound to measure your cervix and an echo scan of your heart. At 26-28 weeks, we'll check your sugar levels with a special test.

For your baby, we'll use different types of ultrasound scans (2D, 3D, and Doppler) to check their growth and how well they are doing, including an echo scan of their heart.

At the time of birth, we will take more blood and urine samples from you, and if you have a C-section, we may also collect some fat samples. The baby's umbilical cord blood, weight, and other measurements will be taken, along with samples of their first poo and urine. Your baby might also have a special MRI scan to look at their body fat.

After your baby is born, there will be follow-up visits for both you and your baby at 6 weeks, 3 months, 12-24 months, and then again when your child is 3-7 years old. We'll ask for blood and urine samples from both of you during these visits. The total duration of your participation, including follow-up, could be up to 7 years.

Potential risks and benefits

Taking part in this study could offer useful insights into your pregnancy and your baby's health that you might not otherwise receive. All tests are standard and safe procedures. However, as with any medical test, there’s a small chance of minor discomfort from blood samples or ultrasounds, which are generally very safe. There are no direct medical treatments or recommendations given as part of this study. You are free to withdraw from the study at any time without giving a reason, and this will not affect the care you receive.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Chelsea & Westminster Hospital Nhs Ft
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the main goal of this study?

To understand how a mother's weight, diabetes, or past weight loss surgery affects pregnancy and the health of her baby.

Will I get any medicine as part of this study?

No, this is an observational study, which means we are only watching and collecting information, not giving any treatments or medicines.

How long will I need to be involved?

Your involvement could last up to 7 years, including follow-up visits for you and your child after birth.

Will this study affect the care I get from my doctor?

No, joining this study will not change the standard medical care you receive from your doctor or midwife.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

DAMON FOSTER

damon.foster2@nhs.net Official trial record

Always speak to your GP or specialist before deciding to take part in a study.