Actively Recruiting
Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
Led by Istituto Clinico Humanitas · Updated on 2024-05-20
300
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
I
Istituto Clinico Humanitas
Lead Sponsor
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsor
AI-Summary
What this Trial Is About
Preeclampsia (PE) is a significant cause of maternal and fetal morbidity and mortality, characterized by high blood pressure and proteinuria during pregnancy. It has two main phenotypes: one linked to placental damage and the other to metabolic factors like obesity. Early identification of high-risk groups is crucial, though there's ongoing disagreement over its classification. Research suggests a potential connection between maternal gut bacteria and PE, offering avenues for improved prevention strategies. This study aims to investigate the differences in maternal gut microbiota between these two PE phenotypes.
CONDITIONS
Official Title
Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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 or severe psychiatric disorders
- Age <18 years
- Women who have not provided informed consent for the study
- Women with HIV, HBV, or HCV infection
- Women with a history of leukemia or lymphoma
- Women with immunodeficiency
- Women who have used corticosteroids or other immunosuppressants in the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Humanitas University
Pieve Emanuele, Milan, Italy, 20072
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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