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

University of California San Diego

Status: Enrolling

Conditions: Pregnancy Induced Hypertension; Pre-Eclampsia

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06340152

808385

U01HG013189-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,100 participants in 2 patient groups

Low-risk pregnancy

Description:

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

Description:

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