Trials
Search / Trial NCT06421493

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

Launched by ISTITUTO CLINICO HUMANITAS · May 14, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

Microbiome Immune System Metabolome

ClinConnect Summary

This clinical trial is studying how the bacteria in a pregnant woman's gut may affect her immune system and metabolism, particularly in relation to preeclampsia (PE), a serious condition that can cause high blood pressure and protein issues during pregnancy. The researchers want to understand the differences in gut bacteria between two types of preeclampsia, one related to problems with the placenta and the other linked to metabolic issues like obesity. By learning more about this connection, they hope to find better ways to identify and prevent preeclampsia.

Women who are over 18 years old and are pregnant with one baby may be eligible to participate, especially if they have been diagnosed with high blood pressure or fetal growth issues. The study is currently looking for participants, and those who join will undergo assessments to help researchers understand their gut health during pregnancy. It's important to note that women with certain health conditions or those expecting multiple babies cannot participate. This study aims to gather valuable information that could lead to improved care for pregnant women at risk of preeclampsia.

Gender

FEMALE

Eligibility 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

About Istituto Clinico Humanitas

Istituto Clinico Humanitas is a leading clinical research organization based in Italy, dedicated to advancing medical science through innovative clinical trials and research initiatives. With a strong emphasis on patient-centered care and cutting-edge methodologies, the institute collaborates with various stakeholders in the healthcare sector to develop and evaluate new therapies and treatment protocols. Its multidisciplinary team of experts is committed to ensuring the highest standards of ethical practice and scientific rigor, contributing to significant advancements in medical knowledge and improved patient outcomes.

Locations

Pieve Emanuele, Milan, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0