Exploring the role of gut microbiome in pregnancy outcomes related to obesity
The PROMOTE Study, a Pilot: The Characterization of the Microbiome in Pregnancy and Prediction of Pregnancy Outcomes
This study looks at how the gut bacteria of pregnant women with obesity might affect their health and their baby's health during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05754645 on ClinicalTrials.gov |
What this trial studies
This observational research investigates how maternal obesity affects pregnancy outcomes and long-term health for both mothers and their children by examining the gut microbiome. It focuses on the relationship between gut dysbiosis and complications such as preeclampsia and gestational diabetes. The study will analyze differences in gut and vaginal microbiomes, immune responses, and one-carbon metabolism in obese versus normal-weight pregnant women. Blood samples will be collected to assess these factors and their implications for maternal and fetal health.
Who should consider this trial
Good fit: Ideal candidates include preconceptional women wishing to become pregnant or those who are less than 13 weeks pregnant with a BMI greater than 30 kg/m2 or between 18-25 kg/m2.
Not a fit: Patients over 45 years old, those with multiple pregnancies, or individuals with certain pre-existing health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of pregnancy complications associated with maternal obesity.
How similar studies have performed: While the role of the microbiome in health is a growing area of interest, this specific focus on maternal obesity and pregnancy outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nicole Schenkelaars, MD
- Email: n.schenkelaars@erasmusmc.nl
- Phone: +31627530793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.