Microbial Metabolites and Outcomes of Pregnancy Study

NCT06362356 | Active Not Recruiting

• 1 other identifier: 24-106
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction. Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants. Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes.

Conditions

Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (3)

• TMAO level

  TMAO level in maternal blood and urine

  10-14 weeks gestation

• TMAO level

  TMAO level in maternal blood and urine

  24-28 weeks gestation

• TMAO level

  TMAO level in maternal blood and urine

  Delivery

Study Arms (1)

Pregnant persons

This prospective longitudinal cohort will enroll pregnant patients in their first trimester of pregnancy (10-14 weeks gestation).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female pregnant persons
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant persons ages 18-45 years, who receive prenatal care and plan to deliver at Cleveland Clinic (Ohio locations). Patients must be able to speak and read English, have a single viable intrauterine pregnancy with no known fetal abnormalities at the time of enrollment. Patients with fetuses diagnosed with multiple gestation, chromosomal anomalies, major birth defects, or congenital infections will be excluded.

You may qualify if:

• Able to speak and read English
• Single, viable intrauterine pregnancy
• No known fetal abnormalities

You may not qualify if:

• Multiple gestation
• Chromosomal abnormalities
• Major birth defects
• Congenital infections

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, cord blood and placenta

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Cara Dolin, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)