ObesityNCT05753124
Effect of Obesity, Diabetes and Bariatric Surgery on Pregnancy Outcomes
An observational study of Obesity and Pregnancy in Diabetic, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pregnancy in Diabetic, Pregnancy Complications
- What is being tested?
- Observational
- How many people
- 700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with a singleton pregnancy that resulted in the delivery of a live, phenotypically normal neonate.
Who may be able to join
- 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 join
- Pregnant women less than 18 years of age
- Pregnant women with twins/triplets
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
DAMON FOSTER contact
DORIS DABY contact
United Kingdom1 site, 1 recruiting
- Recruiting
Chelsea & Westminster Hospital Nhs Ft
London
MAKRINA SAVVIDOU, MD, m.savvidou@imperial.ac.uk
About this study
Official title: Investigation and Study of Pregnancy in Overweight or Diabetic Women and the Effect of 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:
- affected by maternal obesity and/or GDM/T2DM compared to pregnancies with normal maternal body mass index (BMI).
- with previous maternal bariatric surgery compared to pregnancies without previous bariatric surgery but matched for maternal pre-surgery and early pregnancy BMI.
Read the detailed description
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.
- Conditions
- Obesity, Pregnancy in Diabetic, Pregnancy Complications, Pregnancy Related, Bariatric Surgery Status Complicating Pregnancy
- Being tested
- Observational
- Keywords
- Pregnancy, Gastric sleeve, Gastric bypass, Bariatric surgery, Birth weight, Glucose intolerance
- Medical subject headings
- Obesity, Pregnancy in Diabetics, Pregnancy Complications, Birth Weight, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with obesity/GDM/T2DM | Pregnant women with obesity/GDM/T2DM | |
| Pregnant women with obesity/GDM/T2DM- Controls | Pregnant women with normal BMI/ no GDM orT2DM | |
| Post-bariatric pregnant women | Pregnant women with previous bariatric surgery Receives: Other: Observational | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight (in percentiles)
Birthweight percentiles will be compared in the groups studied
Measured: At the time of birth
Secondary outcomes (5)
Reported pregnancy complications
Compare the percentage of women that develop pre-eclampsia or other complications in the groups studied
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study startMay 2015
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAKRINA SAVVIDOU, MD, Principal investigator, CHELSEA & WESTMINSTER HOSPITAL NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753124
- Sponsor's protocol ID
- 142103
- Status last verified
- Mar 2023
- First submitted
- 4 Jul 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Study of Pregnancy in Overweight or Diabetic Women and the Effect of Bariatric Surgery on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT05753124
- Acronym / sponsor ID
- 142103
- Conditions
- Obesity, Pregnancy in Diabetic, Pregnancy Complications, Pregnancy Related, Bariatric Surgery Status Complicating Pregnancy
- Keywords
- Pregnancy, Gastric sleeve, Gastric bypass, Bariatric surgery, Birth weight, Glucose intolerance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- affected by maternal obesity and/or GDM/T2DM compared to pregnancies with normal maternal body mass index (BMI).
- with previous maternal bariatric surgery compared to pregnancies without previous bariatric surgery but matched for maternal pre-surgery and early pregnancy BMI.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with obesity/GDM/T2DM | – | –Pregnant women with obesity/GDM/T2DM |
| Pregnant women with obesity/GDM/T2DM- Controls | – | –Pregnant women with normal BMI/ no GDM orT2DM |
| Post-bariatric pregnant women | – | Other: ObservationalPregnant women with previous bariatric surgery |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with a singleton pregnancy that resulted in the delivery of a live, phenotypically normal neonate.
Key inclusion criteria (4 listed)
- Pregnant women with normal size (BMI <30)
- Pregnant women with obesity (BMI ≥30)
- Pregnant women with glucose disorders
- Pregnant women with previous bariatric surgery
Key exclusion criteria (2 listed)
- Pregnant women less than 18 years of age
- Pregnant women with twins/triplets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis is an observational study | Other | Post-bariatric pregnant women |
Primary outcome
Birth weight (in percentiles)
Time frame: At the time of birth
Birthweight percentiles will be compared in the groups studied
5 secondary outcomes
Reported pregnancy complications
Time frame: During pregnancy and up until the birth of the baby
Reported labour outcomes
Time frame: At birth
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
Maternal and infant blood pressure (in mmHg)
Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Maternal and infant blood and urine samples
Time frame: Following the birth: 6 weeks, 3 months, 12-24 months and 3-7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DAMON FOSTER contact
DORIS DABY contact
MAKRINA SAVVIDOU, MD principal investigator
CHELSEA & WESTMINSTER HOSPITAL NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Pregnancy in Diabetic, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAMON FOSTER (damon.foster2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (in percentiles) (time frame: At the time of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.