Multi-Omics for Maternal Health After Preeclampsia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-Eclampsia
- Sponsor
- University of California, San Diego
- Enrollment
- 1100
- Locations
- 1
- Primary Endpoint
- Gestational hypertension
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Louise Laurent, MD/PhD
Professor
University of California, San Diego
Eligibility Criteria
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
Outcomes
Primary Outcomes
Gestational hypertension
Time Frame: 2nd trimester - Delivery
Postpartum hypertension
Time Frame: Delivery - 13 months postpartum
Preeclampsia
Time Frame: 2nd trimester - 13 months postpartum
Secondary Outcomes
- Postpartum cardiovascular disease(Delivery - 13 months postpartum)