Multi-Omics for Maternal Health After Preeclampsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pre-Eclampsia, Pregnancy Induced Hypertension. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Preeclampsia [Time frame: 2nd trimester - 13 months postpartum]
- Gestational hypertension [Time frame: 2nd trimester - Delivery]
- Postpartum hypertension [Time frame: Delivery - 13 months postpartum]
Secondary outcome measures (1)
- Postpartum cardiovascular disease [Time frame: Delivery - 13 months postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, San Diego — San Diego
Identifiers
NCT: NCT06340152 · 808385 · U01HG013189-01