Multi-Omics for Maternal Health After Preeclampsia

NCT06340152 | Recruiting

• 2 other identifiers: 808385U01HG013189-01
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pre-Eclampsia; Pregnancy Induced Hypertension

Keywords

hypertension; pregnancy; pre-eclampsia; postpartum

Outcome Measures

Primary Outcomes (3)

• Preeclampsia

  2nd trimester - 13 months postpartum

• Gestational hypertension

  2nd trimester - Delivery

• Postpartum hypertension

  Delivery - 13 months postpartum

Secondary Outcomes (1)

• Postpartum cardiovascular disease

  Delivery - 13 months postpartum

Other Outcomes (1)

• Other cardiovascular disease

  1st trimester - 13 months postpartum

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant women 18 years of age to 50 years of age
• weeks gestation at time of enrollment
• Singleton pregnancy
• Planning to deliver at a study site (UCSD or VUMC)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Human Genome Research Institute (NHGRI): collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Louise Laurent, MD, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

• Marni Jacobs, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Selvaraj

CONTACT

858-249-5985; momhealthstudy@health.ucsd.edu

Valentina Stanley

CONTACT

858-249-5985

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)