NCT03026686

Brief Summary

This is a retrospective chart review of women who labored and delivered in a single health care center. From that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. The study will also look at "Controls," a group of women with similar risk factors but did not require readmission.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

January 18, 2017

Last Update Submit

October 10, 2017

Conditions

Postpartum Hypertension

Outcome Measures

Primary Outcomes (1)

  • hypertension

    compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.

    1 year

Study Arms (2)

readmit

women who were re-admitted in the post partum period for a hypertensive disorder

Controls

women with similar risk factors but did not require readmission

Eligibility Criteria

Age14 Years - 55 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women postpartum who are re-admitted for hypertension disorders

You may qualify if:

  • Women who labored and delivered at a single hospital Readmitted (within 6 weeks post partum (PP) or less)to the hospital for hypertension disorder, with or without hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia (PreE), severe pre eclampsia (sPreE), HELLP ("HELLP" is an abbreviation of the three main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet count.).
  • Controls Group with PreE, not readmitted or No PreE

You may not qualify if:

  • Hospital readmission for other complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jennifer Goldkamp, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 20, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share