Characterization and Epigenetics of Post-Partum Preeclampsia

March 19, 2024 updated by: Duke University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10023
        • Columbia University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who present to the hospital with postpartum pre-eclampsia are matched with women who never have PP-PEC (post-partum preeclampsia).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
post partum pre-eclampsia
women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery.
Other: no intervention
database and epigenetic study
controls
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.
Other: no intervention
database and epigenetic study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
methylation signature on circulating monocytes
Time Frame: 1 week post delivery
1 week post delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

New York University
Society for Obstetric Anesthesia and Perinatology

Investigators

  • Principal Investigator: Marie-Louise Meng, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimated)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00104636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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