Skip to content

BEYOND- Bariatrics and EmbrYONic Development: The influence of bariatric surgery on maternal periconception health, embryonic growth and fetal development.

Bariatrics and EmbrYONic Development

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24076
Enrollment
190
Registered
2019-12-05
Start date
2020-01-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

- Transvaginal ultrasound (preconceptional and in the first trimester) - Transabdominal ultrasound (in the second and third trimester) - Biomarkers

Sponsors

Erasmus MC, University Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The relationship between bariatric surgery and embryonic growth measured by embryonic volume offline on 3D ultrasound scans and Virtual Reality-techniques.

Secondary

MeasureTime frame
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

Contacts

Public ContactSam Schoenmakers

Erasmus MC

beyondstudie@erasmusmc.nl0107043599

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)