Investigating the role of maternal gut bacteria in preeclampsia
Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
This study is trying to see if differences in gut bacteria can help us understand why some pregnant women develop preeclampsia, which can be dangerous for both moms and babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Pieve Emanuele, Milan) |
| Trial ID | NCT06421493 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the differences in maternal gut microbiota between two phenotypes of preeclampsia: one linked to placental damage and the other to metabolic factors such as obesity. By analyzing the gut microbiome, the study seeks to identify potential early indicators of preeclampsia, which complicates a significant percentage of pregnancies and poses risks to both mothers and infants. The research will involve women with singleton pregnancies who are experiencing hypertensive disorders or fetal growth restrictions, as well as a control group of low-risk pregnancies. The findings could lead to improved prevention strategies for this serious condition.
Who should consider this trial
Good fit: Ideal candidates include women over 18 years old with singleton pregnancies experiencing hypertensive disorders or fetal growth restrictions.
Not a fit: Patients with multiple pregnancies or major fetal abnormalities identified early in pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early identification and prevention strategies for preeclampsia, potentially reducing maternal and fetal morbidity and mortality.
How similar studies have performed: While the connection between the microbiome and preeclampsia is an emerging area of research, this specific approach to differentiate between phenotypes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Singleton pregnancy * Live fetus at 11-13 weeks of gestation * Pregnancies complicated by hypertensive disorders (HDP) and fetal growth restriction (FGR) Women with pregnancies complicated by HDP and a fetus with appropriate weight for gestational age (AGAf) * Women with pregnancies complicated solely by early fetal growth restriction (before 34 weeks) * Women with pregnancies complicated solely by late fetal growth restriction (after 34 weeks) * Women identified as high-risk in first-trimester screening for preeclampsia Women identified as high-risk in first-trimester screening for fetal growth restriction * Low-risk pregnancies in first-trimester screening for preeclampsia and fetal growth restriction, with physiological follow-up visits until delivery (homogeneous control sample) Exclusion Criteria: * Multiple pregnancies * Pregnancies complicated by major fetal abnormalities identified during the 11-13 week gestational assessment * Women who are unconscious or severely ill, women with learning difficulties, and those with severe psychiatric disorders * Age \<18 years * Women who have not provided informed consent for the study * Women with HIV, HBV, HCV infection * Women with a history of leukemia and lymphoma * Women with immunodeficiency * Women who have used corticosteroids or other immunosuppressants in the last 3 months
Where this trial is running
Pieve Emanuele, Milan
- Humanitas University — Pieve Emanuele, Milan, Italy (Recruiting)
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.