Characterization and Epigenetics of Post-Partum Preeclampsia

NCT ID: NCT02935556

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-03-09

Brief Summary

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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

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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.

Conditions

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Post Partum Pre-eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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post partum pre-eclampsia

women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery.

no intervention

Intervention Type OTHER

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.

no intervention

Intervention Type OTHER

database and epigenetic study

Interventions

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no intervention

database and epigenetic study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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New York University

OTHER

Sponsor Role collaborator

Society for Obstetric Anesthesia and Perinatology

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Louise Meng, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00104636

Identifier Type: -

Identifier Source: org_study_id

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