Postpartum Readmission

Sponsor
St. Louis University (Other)
Overall Status
Terminated
CT.gov ID
NCT03026686
Collaborator
(none)
335
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. There is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. Management before the onset of labor includes close monitoring of maternal and fetal status. Management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the ultimate treatment.

    Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness

    Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. During the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. This results in re-admission to the hospital for some women. The investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    335 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Postpartum Preeclampsia Readmission
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Sep 1, 2017
    Actual Study Completion Date :
    Sep 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. hypertension [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Hospital readmission for other complications.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • St. Louis University

    Investigators

    • Principal Investigator: Jennifer Goldkamp, MD, St. Louis University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer Goldkamp, MD, Principal investigator, St. Louis University
    ClinicalTrials.gov Identifier:
    NCT03026686
    Other Study ID Numbers:
    • 24998
    First Posted:
    Jan 20, 2017
    Last Update Posted:
    Oct 11, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2017