Characterization and Epigenetics of Post-Partum Preeclampsia

Terminated

• Conditions: Post Partum Pre-eclampsia
• Interventions: Other: no intervention

• Registration Number: NCT02935556
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Study Start: 2017-02-01
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post partum pre-eclampsia	no intervention	women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery.
controls	no intervention	women with normal deliveries and normal post part courses who match the post partum pre-eclampsia women in age, BMI, smoking status, gestational age and race/ethnicity.

Primary Outcome Measures

Name	Time	Method
methylation signature on circulating monocytes	1 week post delivery

Trial Locations

Locations (2)

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States