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ID
Source
Brief title
Health condition
Obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relationship between bariatric surgery and embryonic growth measured by embryonic volume offline on 3D ultrasound scans and Virtual Reality-techniques.
Secondary outcome
The relationship between bariatric surgery and:
a) Maternal biomarkers such as vitamin status (blood)
b) Vaginal and faecal microbiome
c) (Pre)clinical maternal outcomes (e.g. pregnancy outcome, preeclampsia, gestational diabetes)
d) (Pre)clinical embryonic/foetal outcomes (e.g. growth trajectories in the first, second and third trimester, miscarriage, birth weight)
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)
f) Placental development
Background summary
The worldwide obesity epidemic has resulted in more frequent bariatric surgery (BS) in women of reproductive age over the past decades. Maternal health in the periconception period is crucial for embryonic and foetal development. BS can lead to maternal vitamin deficiencies, a change in maternal lifestyle and possibly an increased risk of prematurity and foetal growth restriction, thereby also affecting health in later life for both the future mother and her offspring.
We hypothesize that BS impairs embryonic growth and leads to more vitamin deficiencies before and during pregnancy.
This study will initially start with creating an overview of health status based on retrospective medical record review concerning health status of both pre- and postbariatric surgery status as well as pre- and postconceptional status. A prospective, observational cohort study will be performed embedded within the Rotterdam Periconception cohort (Predict study), a hospital-based birth cohort study from preconception onwards. At four moments women will undergo blood measurements and at three moments women will undergo ultrasound examination and
With this study we aim to provide:
1) More knowledge about embryonic, foetal and placental growth trajectories by serial assessments of sizes and volumes and foetal morphology during the first, second and third trimester of pregnancy. 2) Information about whether BS influences embryonic growth compared to women who have not undergone BS.
3) Whether BS influences foetal and placental growth compared to women who have not undergone BS 4) More insights into the relationship between BS and periconception maternal lifestyle, health and vitamin status, and the influence of these determinants on embryonic, foetal and placental development.
Study objective
Bariatric surgery leads to vitamin deficiencies and a malabsorptive state that impairs embryonic growth.
Study design
- Preconceptional (maximum one year before conception)
- First trimester
- Second trimester
- Third trimester
Intervention
- Transvaginal ultrasound (preconceptional and in the first trimester)
- Transabdominal ultrasound (in the second and third trimester)
- Biomarkers
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8217 |
| CCMO | NL OZBS72.19167 |