BEYOND- Bariatrics and EmbrYONic Development: The influence of bariatric surgery on maternal periconception health, embryonic growth and fetal development.
- Conditions
- Obesity
- Registration Number
- NL-OMON24076
- Lead Sponsor
- Erasmus MC, University Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 190
In order to be eligible to participate in this study, a case must meet all of the following criteria:
Women:
1)Women = 18 and 45 = years of age, <12 weeks pregnant of a singleton pregnancy.
2)Understanding of Dutch in speaking and reading.
3)Willingness to give written informed consent.
4)Having undergone bariatric surgery prior to inclusion (any type of bariatric surgery is included, except for having undergone a gastric banding procedure that has been deflated or removed)
Men:
1)Partner of a woman who is eligible for inclusion.
2)Understanding of Dutch in speaking and reading.
3)Willingness to give written informed consent.
In order to be eligible to participate in this study, a control must meet all of the following criteria:
Women
1)=18 and 45 = years of age, <12 weeks pregnant of a singleton pregnancy.
2)Understanding of Dutch (Erasmus MC) in speaking and reading.
3)Willingness to give written informed consent.
4)Not having undergone bariatric surgery prior to inclusion.
5)Participant in the PREDICT study
Men:
1)Partner of a woman who is eligible as a control
2)=18 and 45 = years of age
3)Understanding of Dutch (Erasmus MC) in speaking and reading.
4)Willingness to give written informed consent.
5)Participant in the PREDICT study
A potential case or control who meets any of the following criteria will be excluded from participation in this study:
1)Unable or unwilling to give informed consent.
2)Multiple pregnancy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relationship between bariatric surgery and embryonic growth measured by embryonic volume offline on 3D ultrasound scans and Virtual Reality-techniques.
- Secondary Outcome Measures
Name Time Method The relationship between bariatric surgery and:<br>a)Maternal biomarkers such as vitamin status (blood)<br>b)Vaginal and faecal microbiome<br>c)(Pre)clinical maternal outcomes (e.g. pregnancy outcome, preeclampsia, gestational diabetes)<br>d)(Pre)clinical embryonic/foetal outcomes (e.g. growth trajectories in the first, second and third trimester, miscarriage, birth weight)<br>e)Maternal conditions and lifestyle (e.g. medication use, intoxications, infections, physical activity, working activities, body mass index (BMI), blood pressure, nutrition, smoking, alcohol, folic acid supplement use, vitamin supplement use)<br>f)Placental development<br>