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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02935556
Other study ID # PRO00104636
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date March 9, 2022

Study information

Verified date March 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.


Description:

Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date March 9, 2022
Est. primary completion date March 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Post partum pre-eclampsia Matching based on: - maternal age (years +/-3) - BMI (+/-5 points) - Ethnicity - Mode of delivery - Gestational age at delivery (+/7 days) - Smoking status Exclusion Criteria: - Intrapartum pre-eclampsia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
database and epigenetic study

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina
United States Columbia University Medical Center New York New York

Sponsors (3)

Lead Sponsor Collaborator
Duke University New York University, Society for Obstetric Anesthesia and Perinatology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary methylation signature on circulating monocytes 1 week post delivery