Mitochondrial and stress-related traits linked to preterm birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.