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Clinical Trials/NCT02935556
NCT02935556TerminatedNot Applicable

Characterization and Epigenetics of Post-Partum Preeclampsia

Duke University2 sites in 1 country12 target enrollmentStarted: February 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
12
Locations
2
Primary Endpoint
methylation signature on circulating monocytes

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

methylation signature on circulating monocytes

Time Frame: 1 week post delivery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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