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Recruiting

NCT Number: NCT06340152

Multi-Omics for Maternal Health After Preeclampsia

To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Louise Laurent, MD, PhD

PRINCIPAL_INVESTIGATOR

Marni Jacobs, PhD

PRINCIPAL_INVESTIGATOR

Maya Selvaraj

CONTACT

[email protected]

858-776-8374

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Preeclampsia

    Time frame: 2nd trimester - 13 months postpartum

  2. Gestational hypertension

    Time frame: 2nd trimester - Delivery

  3. Postpartum hypertension

    Time frame: Delivery - 13 months postpartum

Secondary outcomes

  1. Postpartum cardiovascular disease

    Time frame: Delivery - 13 months postpartum

Other outcomes

  1. Other cardiovascular disease

    Time frame: 1st trimester - 13 months postpartum

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Selvaraj

CONTACT

[email protected]

858-249-5985

Valentina Stanley

CONTACT

858-249-5985

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)
  • Vanderbilt University Medical Center

Registry information

Acronym: MOM-Health

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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