Recruiting

Mitochondria & PTB

Sponsor:

Columbia University

Code:

NCT05229666

Conditions

Preterm Birth

Inflammation

Stress

Mental Health Issue

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cognitive Challenge

Study Details

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

Conditions

Preterm Birth

Inflammation

Stress

Mental Health Issue

Study ID

NCT05229666

Start date

Dec 9, 2021

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Cognitive Challenge

A cognitive challenge (Stroop Color-Word Test) administered at 36-38 weeks gestation to assess fetal heart rate reactivity in response to maternal acute stress.

Interventions

Cognitive Challenge

A cognitive challenge (Stroop Color-Word Test) administered at 36-38 weeks gestation to assess fetal heart rate reactivity in response to maternal acute stress.

Primary outcome measure

  • Higher percentage of Black and Hispanic women in high stress group [ Time Frame: At 12 - 38 weeks gestation ]

Central Contacts and Locations

Central contacts

Catherine Monk, PhD

646-774-8941cem31@cumc.columbia.edu

Elizabeth Werner, PhD

646-774-8835ew150@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Catherine Monk, PhD

917-543-6031cem31@columbia.edu

More Information

Sponsor

Columbia University

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-14.