Clinical trial NCT06340152: Multi-Omics for Maternal Health After Preeclampsia
Official title: Multi-Omics for Maternal Health After Preeclampsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-Eclampsia
Pregnancy Induced Hypertension
Keywords: hypertension
pregnancy
pre-eclampsia
postpartum
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
name: Vanderbilt University Medical Center
First posted: 2024-04-01
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Preeclampsia
timeFrame: 2nd trimester - 13 months postpartum
measure: Gestational hypertension
timeFrame: 2nd trimester - Delivery
measure: Postpartum hypertension
timeFrame: Delivery - 13 months postpartum
Secondary outcomes:
measure: Postpartum cardiovascular disease
timeFrame: Delivery - 13 months postpartum
Other outcomes:
measure: Other cardiovascular disease
timeFrame: 1st trimester - 13 months postpartum
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Louise Laurent, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Marni Jacobs, PhD
role: PRINCIPAL_INVESTIGATOR
References: