Characterization and Epigenetics of Post-Partum Preeclampsia | NCT02935556

Studies
Characterization and Epigenetics of Post-Partum Preeclampsia

NCT02935556

Sponsor

Duke University

Status

Terminated

Last Update Posted

Mar 20, 2024Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Post Partum Pre-eclampsia

Interventions

no intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low Accrual

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Mar 9, 2022Actual

Completion Date

Mar 9, 2022Actual

First Submitted Date

Oct 14, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 20, 2024Actual

Name	Class
New York University	OTHER
Society for Obstetric Anesthesia and Perinatology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
post partum pre-eclampsia		women with normal deliveries followed by post partum pre-eclampsia within 1 month of delivery.	Other: no intervention
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	database and epigenetic study	controls post partum pre-eclampsia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie-Louise Meng, MD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center		New York	New York	10023	United States
Duke University Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided