Pre-EclampsiaMOM-HealthNCT06340152
Multi-Omics for Maternal Health After Preeclampsia
An observational study of Pre-Eclampsia and Pregnancy Induced Hypertension, run by University of California, San Diego at 1 site in United States.
Trial summary
To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies. 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
- Pre-Eclampsia, Pregnancy Induced Hypertension
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to Dec 2028
- 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: The present research study focuses on hypertensive disorders of pregnancy, thus, it is necessary that pregnant participants be enrolled. Within this population, we aim to enroll at least 200 high-risk and 550 low-risk participants. Participation in the study will be limited to individuals who speak either English or Spanish, as study staff members are capable of communication with these individuals, and these languages represent the majority of patients seen at both study sites.
Who may be able to join
- Pregnant women 18 years of age to 50 years of age
- 10-24 weeks gestation at time of enrollment
- Singleton pregnancy
- Planning to deliver at a study site (UCSD or VUMC)
Who cannot join
- Inability to give informed consent
- Intrauterine fetal demise
- Fetal genetic or structural anomaly
- Institutionalization for psychiatric disorder, mental deficiency or incarcerated
- Active or history of malignancy requiring major surgery or systemic chemotherapy
- Multi-fetal gestation or a twin demise at any gestational age
- Known maternal or fetal chromosomal anomalies
- Patients who plan to keep their placenta after delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valentina Stanley contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92037
Maya Selvaraj, 858-776-8374, mlselvaraj@health.ucsd.edu
Louise Laurent, MD, PhD
About this study
To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.
Read the detailed description
The investigators will recruit and retain a diverse population of pregnant women who are high- and low-risk for hypertensive disorders of pregnancy/preeclampsia (HDP/PE) for longitudinal collection of phenotypic and environmental exposure measures and biosamples for integrative analysis of phenotypic, environmental, and multi-omic data to understand links between development of HDP/PE and associated fetal pathologies during pregnancy, as well as postpartum maternal health. Participation in the study will begin no later than the second trimester of pregnancy (enrollment by 24 weeks of gestation) and continue through the first year postpartum. Over the course of the study, biospecimens and relevant surveys and cardiovascular assessments will be collected at specified intervals/time-points, as outlined in the table below. In-person study visits should take no more than 30 minutes. Relevant medical information collected as part of routine clinical care will be obtained from the electronic medical record (EMR). The study will take place at UCSD and VUMC prenatal clinics and hospital labor and delivery units, or another private location of the participants choosing, such as their home or office.
- Conditions
- Pre-Eclampsia, Pregnancy Induced Hypertension
- Keywords
- hypertension, pregnancy, pre-eclampsia, postpartum
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low-risk pregnancy | Pregnant subjects with none of the following: chronic hypertension, pregestational diabetes, renal disease, autoimmune disease, history of preterm preeclampsia in a prior pregnancy | |
| High-risk pregnancy | Pregnant subjects with one or more of the following: chronic hypertension, pregestational diabetes, renal disease, autoimmune disease, history of preterm preeclampsia in a prior pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia
Measured: 2nd trimester - 13 months postpartum
Gestational hypertension
Measured: 2nd trimester - Delivery
Postpartum hypertension
Measured: Delivery - 13 months postpartum
Secondary outcomes (1)
Postpartum cardiovascular disease
Measured: Delivery - 13 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start20 Dec 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Louise Laurent, MD/PhD, University of California, San Diego
- Investigators
- Louise Laurent, MD, PhD, Principal investigator, UCSDMarni Jacobs, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340152
- Sponsor's protocol ID
- 808385
- Other IDs
- U01HG013189-01
- Acronym
- MOM-Health
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics for Maternal Health After Preeclampsia
- ClinicalTrials.gov ID
- NCT06340152
- Acronym / sponsor ID
- MOM-Health / 808385
- Conditions
- Pre-Eclampsia, Pregnancy Induced Hypertension
- Keywords
- hypertension, pregnancy, pre-eclampsia, postpartum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI), Vanderbilt University Medical Center
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Apr 2024 (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.
To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.
Detailed description
The investigators will recruit and retain a diverse population of pregnant women who are high- and low-risk for hypertensive disorders of pregnancy/preeclampsia (HDP/PE) for longitudinal collection of phenotypic and environmental exposure measures and biosamples for integrative analysis of phenotypic, environmental, and multi-omic data to understand links between development of HDP/PE and associated fetal pathologies during pregnancy, as well as postpartum maternal health. Participation in the study will begin no later than the second trimester of pregnancy (enrollment by 24 weeks of gestation) and continue through the first year postpartum. Over the course of the study, biospecimens and relevant surveys and cardiovascular assessments will be collected at specified intervals/time-points, as outlined in the table below. In-person study visits should take no more than 30 minutes. Relevant medical information collected as part of routine clinical care will be obtained from the electronic medical record (EMR). The study will take place at UCSD and VUMC prenatal clinics and hospital labor and delivery units, or another private location of the participants choosing, such as their home or office.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-risk pregnancy | – | –Pregnant subjects with none of the following: chronic hypertension, pregestational diabetes, renal disease, autoimmune disease, history of preterm preeclampsia in a prior pregnancy |
| High-risk pregnancy | – | –Pregnant subjects with one or more of the following: chronic hypertension, pregestational diabetes, renal disease, autoimmune disease, history of preterm preeclampsia in a prior pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The present research study focuses on hypertensive disorders of pregnancy, thus, it is necessary that pregnant participants be enrolled. Within this population, we aim to enroll at least 200 high-risk and 550 low-risk participants. Participation in the study will be limited to individuals who speak either English or Spanish, as study staff members are capable of communication with these individuals, and these languages represent the majority of patients seen at both study sites.
Key inclusion criteria (4 listed)
- Pregnant women 18 years of age to 50 years of age
- 10-24 weeks gestation at time of enrollment
- Singleton pregnancy
- Planning to deliver at a study site (UCSD or VUMC)
Key exclusion criteria (8 listed)
- Inability to give informed consent
- Intrauterine fetal demise
- Fetal genetic or structural anomaly
- Institutionalization for psychiatric disorder, mental deficiency or incarcerated
- Active or history of malignancy requiring major surgery or systemic chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preeclampsia
Time frame: 2nd trimester - 13 months postpartum
Gestational hypertension
Time frame: 2nd trimester - Delivery
Postpartum hypertension
Time frame: Delivery - 13 months postpartum
1 secondary outcome
Postpartum cardiovascular disease
Time frame: Delivery - 13 months postpartum
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 6 Apr 2025.
- Individual participant dataSharing planned: Yes
Related trials for Pre-Eclampsia
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Preeclampsia Intervention Netherlands
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Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
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Not yet recruitingPhase 4
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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.
Valentina Stanley contact
Louise Laurent, MD, PhD principal investigator
UCSD
Marni Jacobs, PhD principal investigator
UCSD
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 Pre-Eclampsia and Pregnancy Induced Hypertension, run by University of California, San Diego 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 4 inclusion and 8 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 6 Apr 2025. 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 Maya Selvaraj (858-249-5985, momhealthstudy@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia (time frame: 2nd trimester - 13 months postpartum). The study lists 3 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 6 Apr 2025.