NCT02935556

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

5.1 years

First QC Date

October 14, 2016

Last Update Submit

March 19, 2024

Conditions

Post Partum Pre-eclampsia

Keywords

Post Partum Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

  • methylation signature on circulating monocytes

    1 week post delivery

Study Arms (2)

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

no interventionOTHER

database and epigenetic study

controlspost partum pre-eclampsia

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Intrapartum pre-eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Medical Center

New York, New York, 10023, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be isolated from the whole blood.

Study Officials

  • Marie-Louise Meng, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 17, 2016

Study Start

February 1, 2017

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)