RecruitingNCT06421493

Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders


Sponsor

Istituto Clinico Humanitas

Enrollment

300 participants

Start Date

Jun 6, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria9

  • 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

Locations(1)

Humanitas University

Pieve Emanuele, Milan, Italy

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NCT06421493


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