| NCT ID | NCT05229666 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-12-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-12-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pregnancy ends in preterm birth (PTB) for approximately 1 in 10 women, though more often for Non-Hispanic Black women, 14.12% PTB rate, compared to 9.09% for Non-Hispanic White women. Psychosocial stress and childhood trauma each are associated with risk for PTB and PTB has an intergenerational impact: mothers born preterm are more likely to give birth preterm, especially amongst Black women. In this project, we will study mitochondria, which contain their own genome, the mitochondria DNA, and are inherited from the mother, as they represent a potential intersection point between psychosocial experiences and their biological embedding in underlying disease outcomes such as PTB
Eligibility Criteria
Inclusion Criteria * Pregnant women 18 years of age or older (based on self-report) * Not currently smoking, drinking alcohol, or taking drugs (based on self-report) * Planning to deliver at CUIMC/NYP (based on self-report) * In the first or second trimester of pregnancy (prior to 28 weeks gestation) (based on self-report of estimated date of delivery) Exclusion Criteria * Multi-fetal pregnancy (based on self-report) * Taking medications regularly that affect the cardiovascular and inflammatory systems, including NSAIDS and other anti-inflammatories, α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2- adrenoceptor agonists) (based on self-report) * This does NOT include baby aspirin or low-dose aspirin, as baby aspirin / low-dose aspirin is not normally considered to be an NSAID. * Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis (based on self-report)
Contact & Investigator
Catherine Monk, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05229666 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05229666 currently recruiting?
Yes, NCT05229666 is actively recruiting participants. Contact the research team at cem31@cumc.columbia.edu for enrollment information.
Where is the NCT05229666 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05229666 clinical trial?
NCT05229666 is sponsored by Columbia University. The principal investigator is Catherine Monk, PhD at Columbia University. The trial plans to enroll 200 participants.