At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Observational (other)
- How long the study runs
- Study runs about 149 months (dates as stated)
- About the drug or intervention
- Observational — other: This is an observational study
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 50 Years
- Who
- Female
- Number of participants
- 700
- Started
- 2015-05
- Last checked
- 2023-03
Plain English Summary
What is this study?
- • Testing a new treatment for obesity
- • Clinical study - 700 participants
- • The obesity epidemic is growing worldwide and in the UK this is perpetuated with a third of women classified as overweight/obese in 2020
Who can take part?
- • Ages 18 Years to 50 Years
- • Diagnosed with obesity
- • Female only
Where?
- • London - Chelsea & Westminster Hospital Nhs Ft
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
This is an observational study. The investigators are planning to study pregnant women with normal BMI or overweight (BMI\<30), obesity (BMI ≥30) and glucose disorders (GDM and T2DM). The investigators will also study pregnant women with previous bariatric surgery (gastric band, sleeve gastrectomy or gastric bypass) and compare them with pregnant women of similar pre-surgery and early pregnancy BMI, but no hisotry of weight loss surgery. For all the participants and serially during pregnancy (at 12-14, 20-24, 26-28, 30-32, 35-37 weeks gestation and postnatally (at 6 weeks, 3 months, 12-24 months and 3-7 years of age), the investigators will perform the following investigations: Maternal investigations: Demographics and medical history will be recorded, weight, height, waist to hip ratio and blood pressure will be measured, blood, urine, stool samples and vaginal swabs will be obtained, cervical length (by trans-vaginal ultrasound) will be measured and maternal echocardiography will be performed. Maternal glucose homeostasis will be assessed at 26-28 weeks of gestation, by a full oral glucose tolerance test, HOMA, home glucose monitoring and/ or continuous glucose monitoring (CGM), depending on the group the women belong to. Fetal investigations: Fetal growth and well being will be assessed by 2D, 3D and Doppler ultrasound, fetal echocardiography will be performed. At and following delivery: Maternal blood and urine samples and subcutaneous and omental fat (if Caesarean section is performed) will be obtained, placental tissue will be stored. Neonatal cord blood will be obtained, birthweight (percentiles), anthropometric characteristics will be measured, meconium and urine samples will be obtained and neonatal MRI (to assess body fat distribution) will be arranged. Postnatal follow up visits for the mother and the infant (at 6 weeks, 3 months, 12-24 months, 3-7 years old) will be arranged and maternal and infant blood and urine samples will be requested and obtained.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 50 Years
- Who can join: Female only
What the study is looking for
- ✓Pregnant women with normal size (BMI \<30)
- ✓Pregnant women with obesity (BMI ≥30)
- ✓Pregnant women with glucose disorders
- ✓Pregnant women with previous bariatric surgery
Who cannot take part
- ✗Pregnant women less than 18 years of age
- ✗Pregnant women with twins/triplets
See the full criteria
Where Is This Study? (1 UK site)
Chelsea & Westminster Hospital Nhs Ft
London, United Kingdom
How to Get in Touch
DAMON FOSTER
Sponsor contactCONTACT
DORIS DABY
Sponsor contactCONTACT