Multi-Omics for Maternal Health After Preeclampsia

Recruiting

• Conditions: Pre-Eclampsia; Pregnancy Induced Hypertension

• Registration Number: NCT06340152
• Lead Sponsor: University of California, San Diego

Brief Summary

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 Timeline

• Study Start: 2023-12-20
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-04-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational hypertension	2nd trimester - Delivery
Postpartum hypertension	Delivery - 13 months postpartum
Preeclampsia	2nd trimester - 13 months postpartum

Secondary Outcome Measures

Name	Time	Method
Postpartum cardiovascular disease	Delivery - 13 months postpartum

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States