The promote study, a pilot: The characterization of the microbiome in pregnancy and prediction of pregnancy outcomes.
- Conditions
- Darmdysbiose: ongunstige verstoring van het microbioom van de darmen.ongunstige samenstelling van darmmicroben.zwangerschapssuikerziekteZwangerschapsvergiftiging1001027310057166
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
• Participation in Predict study
• Preconceptional women who wish to become pregnant or pregnancy <13 weeks of
gestational age.
• BMI > 30 kg/m2 or 18-25 kg/m2
• Understanding of Dutch in speaking and reading
• Willingness to give written informed consent
Exclusion Criteria
• Age < 18 years and > 45 years.
• >=13 weeks of gestational age
• Multiple pregnancy
• Smoking
• Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney
diseases.
• Use of antibiotics < 2 weeks before sampling
• Pre-existent diabetes mellitus
• Unable or unwilling to give informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The composition of the maternal gut and vaginal microbiome (in obese women (BMI<br /><br>>30 kg/m2) and non-obese women (BMI 18-25 kg/m2)). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The associations between the composition of the microbiome and:<br />1) Clinical maternal outcomes (e.g. pregnancy outcome, gestational age at<br />delivery, preeclampsia, hypertension, gestational diabetes)<br />2) Clinical fetal outcomes (e.g. fetal growth trajectories in first, second and<br />third trimester, birthweight)<br />3) Maternal (and fetal) immune response and one-carbon metabolism (e.g.<br />inflammatory and biomarkers)<br />4) Placental function (e.g. placental vascular architecture and volume during<br />the 1st trimester, placental weight, inflammatory status)</p>