Actively Recruiting

Age: 18Years +
FEMALE
NCT06421493

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Humanitas University

Pieve Emanuele, Milan, Italy, 20072

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here