Multi-Omics for Maternal Health After Preeclampsia

Pre-Eclampsia Clinical Trial

— MOM-Health  

Official title:

Multi-Omics for Maternal Health After Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340152
• Other study ID #: 808385
• Secondary ID: U01HG013189-01
• Status: Recruiting
• Start date: December 20, 2023
• Est. completion date: December 2028

Study information

• Verified date: March 2024
• Source: University of California, San Diego
• Contact: Samantha La Belle
• Phone: 858-249-5985
• Email: slabelle[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

We 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pregnancy Induced Hypertension

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Human Genome Research Institute (NHGRI), Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other cardiovascular disease		1st trimester - 13 months postpartum
Primary	Preeclampsia		2nd trimester - 13 months postpartum
Primary	Gestational hypertension		2nd trimester - Delivery
Primary	Postpartum hypertension		Delivery - 13 months postpartum
Secondary	Postpartum cardiovascular disease		Delivery - 13 months postpartum