Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes
NCT ID: NCT05753124
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2015-05-31
2027-10-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pregnant women with obesity/GDM/T2DM
Pregnant women with obesity/GDM/T2DM
No interventions assigned to this group
Pregnant women with obesity/GDM/T2DM- Controls
Pregnant women with normal BMI/ no GDM orT2DM
No interventions assigned to this group
Post-bariatric pregnant women
Pregnant women with previous bariatric surgery
Observational
This is an observational study
Pregnant no bariatric women- Controls
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.
No interventions assigned to this group
Interventions
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Observational
This is an observational study
Eligibility Criteria
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Inclusion Criteria
* Pregnant women with obesity (BMI ≥30)
* Pregnant women with glucose disorders
* Pregnant women with previous bariatric surgery
Exclusion Criteria
* Pregnant women with twins/triplets
18 Years
50 Years
FEMALE
Yes
Sponsors
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Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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MAKRINA SAVVIDOU, MD
Role: PRINCIPAL_INVESTIGATOR
CHELSEA & WESTMINSTER HOSPITAL NHS FT
Locations
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Chelsea & Westminster Hospital Nhs Ft
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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142103
Identifier Type: -
Identifier Source: org_study_id
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