Multi-Omics for Maternal Health After Preeclampsia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorUniversity of California, San Diego
About this trial
To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Inability to give informed consent
Intrauterine fetal demise
Fetal genetic or structural anomaly
Institutionalization for psychiatric disorder, mental deficiency or incarcerated
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,100 Participants
are grouped into 2 trial groupsGroup A: Low-risk pregnancy
Group B: High-risk pregnancy
Trial outcomes
Primary outcomes
1
Preeclampsia
Time frame
2nd trimester - 13 months postpartum2
Gestational hypertension
Time frame
2nd trimester - Delivery3
Postpartum hypertension
Time frame
Delivery - 13 months postpartumSecondary outcomes
1
Postpartum cardiovascular disease
Time frame
Delivery - 13 months postpartumOther outcomes
1
Other cardiovascular disease
Time frame
1st trimester - 13 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
National Human Genome Research Institute (NHGRI)
Collaborator
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov