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NCT06362356 · ClinicalTrials.gov registry record
Microbial Metabolites and Outcomes of Pregnancy Study
A clinical trial of Hypertensive Disorder of Pregnancy, sponsored by The Cleveland Clinic.
- Active
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT06362356: Active study of Hypertensive Disorder of Pregnancy, sponsored by The Cleveland Clinic.
NCT06362356 is a study of Hypertensive Disorder of Pregnancy that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 200 participants, below the 2,675-participant average among 8 other Hypertensive Disorder of Pregnancy trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06362356, a study of Hypertensive Disorder of Pregnancy, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
TMAO level in maternal blood and urine
Conditions Studied
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT06362356 still lists
NCT06362356 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,675-participant average among 8 other Hypertensive Disorder of Pregnancy trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Hypertensive Disorder of Pregnancy appearing as the primary indexed condition, and to 0 interventions.
NCT06362356 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06362356 about?
NCT06362356 is a clinical study titled "Microbial Metabolites and Outcomes of Pregnancy Study". 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 w...
What is the current status of trial NCT06362356?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2024-03-05. Estimated completion is 2026-12-31.
What conditions does trial NCT06362356 study?
This clinical trial studies the following conditions: Hypertensive Disorder of Pregnancy.
Who is sponsoring clinical trial NCT06362356?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06362356 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertensive Disorder of Pregnancy
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Where NCT06362356's enrollment target sits among peer trials
200 5th of 8 higher than 4 of 8 other Hypertensive Disorder of Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertensive Disorder of Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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