Stress Phenotypes and Preterm Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorColumbia University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Challenge
Other interventionA cognitive challenge (Stroop Color-Word Test) administered at 36-38 weeks gestation to assess fetal heart rate reactivity in response to maternal acute stress.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Cognitive ChallengeOther 1 intervention
Trial outcomes
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).
Time frame
At 12 - 38 weeks gestationSecondary outcomes
1
Relatively earlier gestational age at birth in high stress group
The high stress phenotype is calculated using various measures including, multiple psychosocial, life course, biological variables, and acute stress reactivity to a cognitive challenge (Stroop test).
Time frame
At birth, approximately 32 - 42 weeks gestationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov