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NCT Number: NCT05753124

Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes

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.

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Key information

Conditions

Obesity Bariatric Surgery Status Complicating Pregnancy Birth Weight Body Weight Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Related Pregnancy in Diabetic Pregnancy in Diabetics Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Chelsea & Westminster Hospital Nhs Ft

London, United Kingdom

Location status: Recruiting

Location contact

MAKRINA SAVVIDOU, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

This is an observational study

Primary outcomes

  1. Birth weight (in percentiles)

    Time frame: At the time of birth

    Birthweight percentiles will be compared in the groups studied

Secondary outcomes

  1. Reported pregnancy complications

    Time frame: During pregnancy and up until the birth of the baby

    Compare the percentage of women that develop pre-eclampsia or other complications in the groups studied

  2. Reported labour outcomes

    Time frame: At birth

    The percentage of women who deliver by instrumental deliveries or Caesarean section, in the groups studied

  3. Maternal and infant weight (in kg) and height (in cm)

    Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

    Weight and height will be combined to report BMI in kg/m^2, in the groups of women studied

  4. Maternal and infant blood pressure (in mmHg)

    Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

    Compare the maternal and infant biophysical profile in the groups of women studied

  5. Maternal and infant blood and urine samples

    Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years

    Compare the maternal and infant metabolic profile in the groups of women studied

Study contacts

Contact information is provided by the study sponsor or research team.

DAMON FOSTER

CONTACT

[email protected]

DORIS DABY

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Official study title

Investigation and Study of Pregnancy in Overweight or Diabetic Women and the Effect of Bariatric Surgery on Pregnancy Outcomes

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2023
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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