To assess 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 with the aim to examine whether BS influences embryonic growth…
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
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. Foetal growth and volume, as well as placental growth and diverse
foetal structures can be measured by ultrasound techniques.
Study objective
To assess 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 with the aim to examine whether BS influences
embryonic growth compared to women who have not undergone BS.
Furthermore, we want to explore whether BS influences foetal and placental
growth compared to women who have not undergone BS.
Moreover, we want to explore 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 design
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.
Study burden and risks
For all cases the risks involve primarily the burden of participating in a
study, which usually means additional hospital visits and assessments. There
will be a maximum of 6 hospital visits, which will take approximately 30-45
minutes each. There will be three first trimester vaginal ultrasound
examinations (as part of the Predict study, METC 2004-227) and one abdominal
ultrasound examination during both second and third trimester. At 4 of the
appointments (preconceptionally and in the first, second and third trimester)
blood will be taken and vaginal and faecal swabs will be taken by the patients
themselves. The weight, height and blood pressure of the male partners will be
measured (preconceptionally and during the first trimester) and blood will be
taken from the male partner at 1 appointment (in the first trimester). The
risks of participation are considered to be minor and the potential benefit
outweighs the risks. From the above, it is clear that there are no obvious
risks associated with participation in the study. After each visit, the patient
will receive a picture of their child obtained by 3D or 2D ultrasound. The
controls have already been included and do not undergo any extra measurements
pertaining to the BEYOND study.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71108.078.19 |