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

NCT06421493 | Recruiting DMC

• 1 other identifier: 0004622
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preeclampsia

Keywords

microbiome; immune system; metabolome

Outcome Measures

Primary Outcomes (3)

• Study of the Characteristics of Maternal Gut Microbiota in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction.

  Study of the characteristics of the microbiota in fecal samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction.

  through study completion, an average of 1 year

• Study of the Characteristics of Metabolome, in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction.

  Study of the characteristics of the metabolites in fecal and blood samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction.

  through study completion, an average of 1 year

• Study of the Characteristics of NK and B Cells in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction.

  Study of the characteristics of NK and B cells in blood samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Study of the Characteristics of Microbiota in Women with Pregnancies

  through study completion, an average of 1 year

• Study of the Evolution of Metabolome in Women with Pregnancies

  through study completion, an average of 1 year

• Study of the Evolution of NK and B Cells in Women with Pregnancies

  through study completion, an average of 1 year

• Evaluation of a Possible Correlation Between Dietary Habits and Maternal Gut Microbiota

  through study completion, an average of 1 year

Study Arms (2)

Case group

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

Controls

Age \> 18 years Singleton pregnancy Feto vivo a 11-13 settimane di gravidanza Low-risk pregnancies in first-trimester screening for preeclampsia and fetal growth restriction, with physiological follow-up visits until delivery (homogeneous control sample)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with pregnancies complicated by hypertensive disorders associated with or without fetal growth restriction in the second and third trimesters, and women identified as high-risk for the development of preeclampsia from the first trimester of pregnancy, will be offered the opportunity to participate in the study. To obtain a control sample, equal participation (1:1 ratio) of pregnant women identified as low-risk in first-trimester screening for preeclampsia and fetal growth restriction, who will undergo physiological follow-up visits until delivery, will also be requested. Recruitment of controls will follow an alternating principle: high risk-low risk-high risk-low risk. Patients will be followed up at defined intervals, varying depending on the underlying condition. High-risk patients and controls will be seen once per trimester if the pregnancy remains uncomplicated.

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Humanitas University

Pieve Emanuele, Milan, 20072, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The protocol involves analyzing the maternal microbiota and metabolome from fecal samples and blood samples collected from women who have consented to the study. The blood will be centrifuged to separate the plasma from the cellular fraction. The isolated plasma will be frozen at -80°C for subsequent metabolomic and microbiota analyses, while the cells will be resuspended in phosphate-buffered saline (PBS) in equal volume to the isolated plasma. focal material will be stored at -80°C.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 20, 2024
• Study Start: June 6, 2020
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

IT (1)