Mitochondrial and stress-related traits linked to preterm birth
Stress Phenotypes and Preterm Birth: Immune and Energetic Cellular Dysregulation and the Preventive Effect of Social Support
This project will test whether mitochondrial DNA and stress-response changes during early pregnancy are linked to the risk of having a preterm birth in pregnant women under 28 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05229666 on ClinicalTrials.gov |
What this trial studies
Pregnant women in their first or second trimester will undergo a brief cognitive challenge while researchers collect blood and other biological samples to measure mitochondrial DNA, inflammatory markers, and stress-response signals. Participants' psychosocial histories, including childhood trauma, will be recorded and compared with biological measures and pregnancy outcomes to see who delivers preterm. The study focuses on maternal inheritance of mitochondria as a possible mechanism for intergenerational transmission of preterm birth risk and for racial disparities in rates. Enrollment and in-person procedures take place at Columbia University Irving Medical Center, and participants are followed to delivery at CUIMC/NYP.
Who should consider this trial
Good fit: Pregnant women aged 18 or older in their first or second trimester (before 28 weeks), not currently smoking, drinking alcohol, or using illegal drugs, planning to deliver at CUIMC/NYP, and not taking regular medications that affect cardiovascular or inflammatory systems are the intended participants.
Not a fit: Women with multi-fetal pregnancies, inflammatory autoimmune conditions, regular use of excluded cardiovascular or anti-inflammatory medications, or those beyond 28 weeks gestation are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, this work could reveal biological markers and pathways linking stress to preterm birth that help identify high-risk pregnancies earlier and guide targeted prevention strategies.
How similar studies have performed: Traditional biomarker efforts to predict preterm birth have largely been unsuccessful, and using mitochondrial DNA together with acute stress-challenge responses is a relatively novel approach with limited direct precedent but growing evidence linking stress, inflammation, and mitochondrial dysfunction to adverse pregnancy outcomes.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Monk, PhD — Columbia University
- Study coordinator: Catherine Monk, PhD
- Email: cem31@cumc.columbia.edu
- Phone: 646-774-8941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.