Multi-Omics for Maternal Health After Preeclampsia (MOM-Health)

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

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; Pregnancy Induced Hypertension

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 Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Maya Selvaraj; Phone Number: 858-249-5985; Email: momhealthstudy@health.ucsd.edu
• Study Contact Backup: Name: Valentina Stanley; Phone Number: 858-249-5985

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • University of California, San Diego
      • Contact: Maya Selvaraj; Phone Number: 858-776-8374; Email: mlselvaraj@health.ucsd.edu
      • Contact: Louise Laurent, MD, PhD
      • Contact: Marni Jacobs, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preeclampsia	2nd trimester - 13 months postpartum
Gestational hypertension	2nd trimester - Delivery
Postpartum hypertension	Delivery - 13 months postpartum

Secondary Outcome Measures

Outcome Measure	Time Frame
Postpartum cardiovascular disease	Delivery - 13 months postpartum

Other Outcome Measures

Outcome Measure	Time Frame
Other cardiovascular disease	1st trimester - 13 months postpartum

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Vanderbilt University Medical Center; National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Louise Laurent, MD, PhD, UCSD; Principal Investigator: Marni Jacobs, PhD, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; pregnancy; postpartum; pre-eclampsia
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
• Other Study ID Numbers: 808385; U01HG013189-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No