Bariatric surgery and EmbrYONic Development

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 190

Inclusion Criteria

Cases (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).

Cases (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.

Controls (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.
5) Has participated in the Predict study.

Controls (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.
4) Has participated in the Predict study.

Exclusion Criteria

1) Unable or unwilling to give informed consent.
2) Multiple pregnancy.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The relationship between bariatric surgery and embryonic growth measured by<br /><br>embryonic volume offline on 3D ultrasound scans and Virtual Reality-techniques.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The relationship between bariatric surgery and:<br /><br>a) Maternal biomarkers such as vitamin status (blood)<br /><br>b) Vaginal and faecal microbiome<br /><br>c) (Pre)clinical maternal outcomes (e.g. pregnancy outcome, preeclampsia,<br /><br>gestational diabetes)<br /><br>d) (Pre)clinical embryonic/foetal outcomes (e.g. growth trajectories in the<br /><br>first, second and third trimester, miscarriage, birth weight)<br /><br>e) Maternal conditions and lifestyle (e.g. medication use, intoxications,<br /><br>infections, physical activity, working activities, body mass index (BMI), blood<br /><br>pressure, nutrition, smoking, alcohol, folic acid supplement use, vitamin<br /><br>supplement use)<br /><br>f) Placental development</p><br>