Stress Phenotypes and Preterm Birth
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT05229666
- Status
- Recruiting
Conditions
- Inflammation
- Mental Health Issue
- Preterm Birth
- Stress
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Cognitive Challenge — OTHERA cognitive challenge (Stroop Color-Word Test) administered at 36-38 weeks gestation to assess fetal heart rate reactivity in response to maternal acute stress.
Study Details
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
Key Dates
- Start date
- Dec 9, 2021
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Other: Cognitive ChallengeA 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
- Catherine Monk, PhD646-774-8941
- Elizabeth Werner, PhD646-774-8835
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 |
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