Maternal DistressNCT07296107
In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics
An observational study of Maternal Distress and Child Development, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Distress, Child Development
- What is being tested?
- Prenatal maternal psychosocial and biological assessment protocol
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 31 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This five-year study will recruit and enroll approximately 200 pregnant individuals, ages 18-50 years, using IVF (120 homologous, 60 donor oocyte/embryo) and their offspring to achieve a post-attrition sample size of n=180. While based in Washington Heights, the sample reflects individuals undergoing IVF, not the general neighborhood. Based on Columbia Fertility Center data and national IVF trends, the investigators expect participants to be mostly Non-Hispanic/Latinx. While the investigators aim for inclusivity and diversity, non-English speakers will not be enrolled due to study team language constraints.
Who may be able to join
- Individuals at 18-28 gestational weeks with donor and homologous IVF pregnancies, ages 18-50.
- 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.
- 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.
- Participants will include the offspring of patients receiving care and delivering at the above institutions.
- Enrollment Location(s): Columbia University Irving Medical Center's Department of OB/GYN, delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
Who cannot join
- Identified addiction disorder
- Severe psychiatric condition (defined as symptoms that significantly impair daily functioning and are untreated or not effectively managed)
- Multiple fetal pregnancy
- Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)
- Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis
- Not planning to deliver at a CUIMC-affiliated hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Khadija Jones, MPH, 917-817-1490, kj2660@cumc.columbia.edu
Catherine Monk, PhD
About this study
Official title: Leveraging IVF to Identify Prenatal Effects Independent of Shared Maternal-Child Genes
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.
Read more
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
Read the detailed description
To rigorously test the Developmental Origins of Health and Disease (DOHaD) research model, this project will leverage the spectacular scientific advancements of in vitro fertilization (IVF) and compare maternal prenatal distress effects between IVF donor oocyte/embryo and non-donor oocyte pregnancies. This will be the first study to use multidisciplinary (neurobehavioral, epigenetic, transcriptomic) methods with adoption-at-conception pregnant individuals to determine whether prenatal programming can be detected independent of shared maternal-child genes.
Decades of prospective DOHaD research with birthing individuals and their genetic children, including reports from our group, support the prenatal programming hypothesis that pregnant individuals' mental health affects the next generation's. Seminal, population-based studies using parent reports, such as the Avon Longitudinal Study of Parents and Children (ALSPAC), showed pregnant women in the top 15% for anxiety symptoms had children with nearly twice the risk of mental health disorders across ages 4-13 after controlling for confounders including postpartum depression. In our work and others' using objective assessments, maternal prenatal distress associated with higher 3rd trimester fetal heart rate (FHR) reactivity, from EEG in newborns lower high- frequency power and greater frontal asymmetry (itself associated with adult depression), and decrements in NIH ToolBox executive functioning and motor skills at 4-8 years old. However, for each of these findings, shared maternal-child genes cannot be ruled out. Animal models - in which the genetic background and stress exposure can be manipulated - show prenatal stress leads to anxious and depressed behavioral phenotypes independent of genetic inheritance, though limitations in the applicability to humans include: stressors' ecological validity, differences in gestational biology, and developmental timing. Genetically-informed studies, including those with donor IVF participants, show mixed evidence for prenatal distress effects. However, designs are frequently retrospective, including in IVF research, such that medical confounds also are not well controlled. Mechanistic approaches, such as our work and others' work focused on the placenta, a gestational organ at the maternal-fetal interface, show maternal distress associated with epigenetic regulation of placenta glucocorticoid and pro-inflammatory genes and child outcomes; to date, no study using IVF to circumvent genetic confounding has included mechanistic approaches. Finally, most DOHaD science concerns maternal distress effects; to advance prenatal programming research and enhance its relevance for clinical interventions, maternal social connection and other aspects of well-being also should be examined. Our study will address these design limitations and aim to identify maternal prenatal distress effects independent of shared maternal-child genes.
In a longitudinal study of 2nd trimester pregnant individuals (60 donor oocyte/embryo,120 non-donor oocyte), n=180 post attrition, protocol is: Zoom-based psychosocial questionnaires 24-28 weeks (Pregnancy Session 1); laboratory session for maternal EKG, blood pressure, blood draw (immune markers), psychosocial questionnaires, fetal neurobehavior 34-38 weeks (Pregnancy Session 2); collect placenta and cord blood (cortisol); newborn EEG in hospital; medical record data; and, methods: placenta targeted/genome-wide methylation, gene expression, distress, Allostatic Load (AL): Test three aims, identifying, independent of IVF group status.
- Conditions
- Maternal Distress, Child Development
- Being tested
- Prenatal maternal psychosocial and biological assessment protocol
- Keywords
- Developmental Origins of Health and Disease (DOHaD), Maternal Health, Child development, IVF
- Medical subject headings
- Developmental Origins of Health and Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal maternal psychosocial and biological assessment protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Prenatal maternal psychosocial and biological assessment protocol | |
| 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) Receives: Other: Prenatal maternal psychosocial and biological assessment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fetal heart rate (FHR)
This is to measure 3rd trimester fetal heart rate (FHR) reactivity. Change in FHR in response to maternal response to the Stroop task, indicating greater fetal autonomic response associated with maternal distress. Units: Beats per minute (bpm). Greater FHR indicates higher stress.
Measured: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)
Standard deviation of fetal heart rate
This is to measure fetal heart rate (FHR) variability, reflecting less vagal modulation of the heart associated with maternal distress. Units: Standard deviation of beats per minute. Lesser standard deviation (SD) indicates lower stress.
Measured: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)
Cross correlation of fetal movement and heart rate change
This is to measure fetal heart rate (FHR)-movement coupling, reflecting central nervous system regulation. Units: Cross correlation value. Lower value indicates lower coupling.
Measured: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)
Average percent DNA methylation of the FKBP5 gene in placental tissue
This is to measure FKBP5 DNA Methylation. Units: proportion of methylated vs unmethylated. Greater percent indicates higher methylation.
Measured: At delivery (approximately 37-40 weeks)
Average percent DNA methylation of the HSD11B2 gene in placental tissue
This is to measure HSD11B2 DNA Methylation. Units: proportion of methylated vs unmethylated. Greater percent indicates higher methylation.
Measured: At delivery (approximately 37-40 weeks)
Relative expression of key pro-inflammatory markers in placental tissue
This is to measure expression of Pro-Inflammatory Placental Genes. Units: Gene expression. Greater value indicates greater expression.
Measured: At delivery (approximately 37-40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 May 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DistressStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Catherine Monk, Columbia University
- Investigators
- Catherine Monk, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296107
- Sponsor's protocol ID
- AAAV4123
- Other IDs
- 1R01HD118949-01
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging IVF to Identify Prenatal Effects Independent of Shared Maternal-Child Genes
- ClinicalTrials.gov ID
- NCT07296107
- Acronym / sponsor ID
- AAAV4123
- Conditions
- Maternal Distress, Child Development
- Keywords
- Developmental Origins of Health and Disease (DOHaD), Maternal Health, Child development, IVF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
To rigorously test the Developmental Origins of Health and Disease (DOHaD) research model, this project will leverage the spectacular scientific advancements of in vitro fertilization (IVF) and compare maternal prenatal distress effects between IVF donor oocyte/embryo and non-donor oocyte pregnancies. This will be the first study to use multidisciplinary (neurobehavioral, epigenetic, transcriptomic) methods with adoption-at-conception pregnant individuals to determine whether prenatal programming can be detected independent of shared maternal-child genes.
Decades of prospective DOHaD research with birthing individuals and their genetic children, including reports from our group, support the prenatal programming hypothesis that pregnant individuals' mental health affects the next generation's. Seminal, population-based studies using parent reports, such as the Avon Longitudinal Study of Parents and Children (ALSPAC), showed pregnant women in the top 15% for anxiety symptoms had children with nearly twice the risk of mental health disorders across ages 4-13 after controlling for confounders including postpartum depression. In our work and others' using objective assessments, maternal prenatal distress associated with higher 3rd trimester fetal heart rate (FHR) reactivity, from EEG in newborns lower high- frequency power and greater frontal asymmetry (itself associated with adult depression), and decrements in NIH ToolBox executive functioning and motor skills at 4-8 years old. However, for each of these findings, shared maternal-child genes cannot be ruled out. Animal models - in which the genetic background and stress exposure can be manipulated - show prenatal stress leads to anxious and depressed behavioral phenotypes independent of genetic inheritance, though limitations in the applicability to humans include: stressors' ecological validity, differences in gestational biology, and developmental timing. Genetically-informed studies, including those with donor IVF participants, show mixed evidence for prenatal distress effects. However, designs are frequently retrospective, including in IVF research, such that medical confounds also are not well controlled. Mechanistic approaches, such as our work and others' work focused on the placenta, a gestational organ at the maternal-fetal interface, show maternal distress associated with epigenetic regulation of placenta glucocorticoid and pro-inflammatory genes and child outcomes; to date, no study using IVF to circumvent genetic confounding has included mechanistic approaches. Finally, most DOHaD science concerns maternal distress effects; to advance prenatal programming research and enhance its relevance for clinical interventions, maternal social connection and other aspects of well-being also should be examined. Our study will address these design limitations and aim to identify maternal prenatal distress effects independent of shared maternal-child genes.
In a longitudinal study of 2nd trimester pregnant individuals (60 donor oocyte/embryo,120 non-donor oocyte), n=180 post attrition, protocol is: Zoom-based psychosocial questionnaires 24-28 weeks (Pregnancy Session 1); laboratory session for maternal EKG, blood pressure, blood draw (immune markers), psychosocial questionnaires, fetal neurobehavior 34-38 weeks (Pregnancy Session 2); collect placenta and cord blood (cortisol); newborn EEG in hospital; medical record data; and, methods: placenta targeted/genome-wide methylation, gene expression, distress, Allostatic Load (AL): Test three aims, identifying, independent of IVF group status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor Oocyte/Embryo IVF Pregnancies | – | Other: Prenatal maternal psychosocial and biological assessment protocolThis 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 | – | Other: Prenatal maternal psychosocial and biological assessment protocolThis 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This five-year study will recruit and enroll approximately 200 pregnant individuals, ages 18-50 years, using IVF (120 homologous, 60 donor oocyte/embryo) and their offspring to achieve a post-attrition sample size of n=180. While based in Washington Heights, the sample reflects individuals undergoing IVF, not the general neighborhood. Based on Columbia Fertility Center data and national IVF trends, the investigators expect participants to be mostly Non-Hispanic/Latinx. While the investigators aim for inclusivity and diversity, non-English speakers will not be enrolled due to study team language constraints.
Key inclusion criteria (5 listed)
- Individuals at 18-28 gestational weeks with donor and homologous IVF pregnancies, ages 18-50.
- 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.
- 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.
- Participants will include the offspring of patients receiving care and delivering at the above institutions.
- Enrollment Location(s): Columbia University Irving Medical Center's Department of OB/GYN, delivering at New York-Presbyterian Morgan Stanley Children's Hospital.
Key exclusion criteria (6 listed)
- Identified addiction disorder
- Severe psychiatric condition (defined as symptoms that significantly impair daily functioning and are untreated or not effectively managed)
- Multiple fetal pregnancy
- Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)
- Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal maternal psychosocial and biological assessment protocolThis 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. | Other | Donor Oocyte/Embryo IVF Pregnancies, Non-Donor Oocyte IVF Pregnancies |
Primary outcome
Change in fetal heart rate (FHR)
Time frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)
This is to measure 3rd trimester fetal heart rate (FHR) reactivity. Change in FHR in response to maternal response to the Stroop task, indicating greater fetal autonomic response associated with maternal distress. Units: Beats per minute (bpm). Greater FHR indicates higher stress.
Standard deviation of fetal heart rate
Time frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)
This is to measure fetal heart rate (FHR) variability, reflecting less vagal modulation of the heart associated with maternal distress. Units: Standard deviation of beats per minute. Lesser standard deviation (SD) indicates lower stress.
Cross correlation of fetal movement and heart rate change
Time frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)
This is to measure fetal heart rate (FHR)-movement coupling, reflecting central nervous system regulation. Units: Cross correlation value. Lower value indicates lower coupling.
Average percent DNA methylation of the FKBP5 gene in placental tissue
Time frame: At delivery (approximately 37-40 weeks)
This is to measure FKBP5 DNA Methylation. Units: proportion of methylated vs unmethylated. Greater percent indicates higher methylation.
Average percent DNA methylation of the HSD11B2 gene in placental tissue
Time frame: At delivery (approximately 37-40 weeks)
This is to measure HSD11B2 DNA Methylation. Units: proportion of methylated vs unmethylated. Greater percent indicates higher methylation.
Relative expression of key pro-inflammatory markers in placental tissue
Time frame: At delivery (approximately 37-40 weeks)
This is to measure expression of Pro-Inflammatory Placental Genes. Units: Gene expression. Greater value indicates greater expression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Monk, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Distress and Child Development, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Monk, PhD (917-543-6031, cem31@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fetal heart rate (FHR) (time frame: At Pregnancy Session 2 (approximately 34-36 weeks of pregnancy)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.