An observational study in Obesity, Pregnancy in Diabetic and Pregnancy Complications, sponsored by Chelsea and Westminster NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-03.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational
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:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 700 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women with a singleton pregnancy that resulted in the delivery of a live, phenotypically normal neonate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with obesity/GDM/T2DM
Pregnant women with normal BMI/ no GDM orT2DM
Pregnant women with previous bariatric surgery
Other: Observational
There will be two control groups of women with no previous bariatric surgery: 1. Pregnant women with booking BMI similar to the booking BMI of the post-bariatric ones and 2. Pregnant women with booking BMI similar to the pre-surgery BMI of the post-bariatric ones.
This is an observational study
Birth weight (in percentiles)
Birthweight percentiles will be compared in the groups studied
Time frame: At the time of birth
Reported pregnancy complications
Compare the percentage of women that develop pre-eclampsia or other complications in the groups studied
Time frame: During pregnancy and up until the birth of the baby
Reported labour outcomes
The percentage of women who deliver by instrumental deliveries or Caesarean section, in the groups studied
Time frame: At birth
Maternal and infant weight (in kg) and height (in cm)
Weight and height will be combined to report BMI in kg/m\^2, in the groups of women studied
Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Maternal and infant blood pressure (in mmHg)
Compare the maternal and infant biophysical profile in the groups of women studied
Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Maternal and infant blood and urine samples
Compare the maternal and infant metabolic profile in the groups of women studied
Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
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Chelsea and Westminster NHS Foundation Trust