Recruiting

Maternal Stress

Sponsor:

Columbia University

Code:

NCT07296107

Conditions

Maternal Distress

Child Development

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Prenatal maternal psychosocial and biological assessment protocol

Study Details

Brief summary:

This study examines how maternal stress during pregnancy affects infant brain and behavioral development, focusing on whether these effects are due to the prenatal environment or shared genes. By comparing IVF pregnancies using donor eggs/embryos (no shared genetics) with non-donor IVF pregnancies, the investigators aim to understand how stress influences the baby's development independent of genetic factors.

Participants will complete questionnaires, provide blood samples, and take part in placenta and cord blood collection, fetal monitoring, and newborn brain activity assessments.

Aim 1: The influence of maternal distress on perinatal neurobehavioral development.

Hypotheses: Independent of IVF group status, higher maternal AL will be associated with higher 3rd trimester FHR reactivity, lower FHR variability, AND lower FHR-movement coupling

Aim 2: Maternal distress affecting placenta gene methylation.

Hypotheses: Independent of IVF group status, maternal AL will be associated with placenta differential DNA methylation in glucocorticoid-regulating genes (FKBP5 and HSD11B2),

Aim 3: Maternal experiences associated with unique placenta transcriptomic profiles.

Hypotheses: Independent of IVF group status, maternal AL and well-being each will be associated with unique placenta gene expression in pro-inflammatory genes

Conditions

Maternal Distress

Child Development

Study ID

NCT07296107

Start date

May 8, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Individuals at 18-28 gestational weeks with donor and homologous IVF pregnancies, ages 18-50.
2. Participants must be patients receiving their perinatal health care through Columbia University Irving Medical Center's Department of OB/GYN and delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
3. Participants must be patients delivering at Columbia University Irving Medical Center's Department of OB/GYN and delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
4. Participants will include the offspring of patients receiving care and delivering at the above institutions.
5. Enrollment Location(s): Columbia University Irving Medical Center's Department of OB/GYN, delivering at New York-Presbyterian Morgan Stanley Children's Hospital.

Exclusion Criteria:

1. Identified addiction disorder
2. Severe psychiatric condition (defined as symptoms that significantly impair daily functioning and are untreated or not effectively managed)
3. Multiple fetal pregnancy
4. Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)
5. Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis
6. Not planning to deliver at a CUIMC-affiliated hospital

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

Donor Oocyte/Embryo IVF Pregnancies

This cohort includes pregnant individuals who conceived through in vitro fertilization (IVF) using donor oocytes or embryos, and are therefore not genetically related to the fetus. Participants follow the same study protocol as the non donor oocyte cohort, with enrollment in the second trimester and data collection through delivery and early postpartum. The purpose of including this cohort is to evaluate the effects of maternal prenatal distress and well-being on perinatal development independent of shared maternal-child genetics. Data collection includes psychosocial questionnaires, maternal physiological monitoring, blood draws for immune and transcriptomic analyses, placental and cord blood collection at delivery, newborn physiological monitoring during the postpartum hospital stay, and birth outcomes obtained from the electronic health record (EHR).

Non-Donor Oocyte IVF Pregnancies

This cohort includes pregnant individuals who conceived through IVF using their own oocytes, and are therefore genetically related to the fetus. Participants follow the same study protocol as the donor oocyte cohort, with enrollment in the second trimester and data collection through delivery and early postpartum. This group serves as a comparison to assess whether observed associations between maternal prenatal distress, biological markers, and infant neurodevelopment are attributable to intrauterine (environmental) influences or shared genetic factors. Data collection includes psychosocial questionnaires, maternal physiological monitoring, blood draws for immune and transcriptomic analyses, placental and cord blood collection at delivery, newborn physiological monitoring during the postpartum hospital stay, and birth outcomes obtained from the electronic health record (EHR)

Interventions

Prenatal maternal psychosocial and biological assessment protocol

This is not a therapeutic or experimental intervention. The data-collection protocol includes structured psychosocial questionnaires, physiological monitoring, maternal blood draws, placental and cord blood collection, and newborn physiological monitoring. These procedures are used to observe associations between maternal prenatal distress and infant outcomes. All participants undergo the same assessments; no clinical treatment or behavioral manipulation is delivered.

Primary outcome measure

  • Change in fetal heart rate (FHR) [ Time Frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy) ]
  • Standard deviation of fetal heart rate [ Time Frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy) ]
  • Cross correlation of fetal movement and heart rate change [ Time Frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy) ]
  • Average percent DNA methylation of the FKBP5 gene in placental tissue [ Time Frame: At delivery (approximately 37-40 weeks) ]
  • Average percent DNA methylation of the HSD11B2 gene in placental tissue [ Time Frame: At delivery (approximately 37-40 weeks) ]
  • Relative expression of key pro-inflammatory markers in placental tissue [ Time Frame: At delivery (approximately 37-40 weeks) ]

Central Contacts and Locations

Central contacts

Catherine Monk, PhD

917-543-6031cem31@cumc.columbia.edu

Khadija Jones, MPH

917-817-1490kj2660@cumc.columbia.edu

Locations

Columbia University Irving Medical Center/New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Khadija Jones, MPH

917-817-1490kj2660@cumc.columbia.edu

Principal Investigator:

Catherine Monk, PhD

More Information

Sponsor

Columbia University

Last update posted

Jul 7, 2026

Last verified

Jun, 2026

Keywords

  • Developmental Origins of Health and Disease (DOHaD)
  • Maternal Health
  • Child development
  • IVF

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 2026-07-07.