Stress Phenotypes and Preterm Birth

NCT05229666 | Recruiting

• 3 other identifiers: AAAU9052R01MD0162788144
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Inflammation; Preterm Birth; Stress; Mental Health Issue

Outcome Measures

Primary Outcomes (1)

• Higher percentage of Black and Hispanic women in high stress group

  The high stress group is calculated using various measures including multiple psychosocial, life course, biological variables, and acute stress reactivity to a cognitive challenge (Stroop test).

  Prenatal

Secondary Outcomes (1)

• Relatively earlier gestational age at birth in high stress group

  At birth

Study Arms (1)

Cognitive Challenge

OTHER

Other: Cognitive Challenge

Interventions

Cognitive Challenge OTHER

Cognitive challenge delivered via computer.

Cognitive Challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Inflammation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Monk, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Monk, PhD

CONTACT

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

Elizabeth Werner, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diana Vagelos Professor of Women's Mental Health (in Obstetrics and Gynecology and Psychiatry)

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 8, 2022
• Study Start: December 9, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)