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P-PAT: Preeclampsia Postpartum Antihypertensive Treatment

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT04298034
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
35.4
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to compare whether antihypertensive treatment in the postpartum period decreases postpartum hypertension and its associated maternal morbidity, including risk of readmission and healthcare utilization in comparison with no treatment. Women with preeclampsia diagnosed during the antepartum, intrapartum or postpartum period will be randomized to either initiate antihypertensive treatment or standard of care. We hypothesize that postpartum antihypertensive treatment of patients with preeclampsia will decrease risk of hospital readmission, healthcare utilization and the number of severe range blood pressures at postpartum follow-up visits.

Condition or Disease Intervention/Treatment Phase
  • Drug: Labetalol, Nifedipine
 Phase 3

Detailed Description

This will be a randomized, controlled trial of 300 women with a diagnosis of preeclampsia at any point in their current pregnancy or immediately postpartum. Immediately postpartum is defined as preeclampsia diagnosed after delivery but prior to discharge from the hospital. The diagnosis of preeclampsia will be made using standardized definitions by the American College of Obstetrics and Gynecology. Preeclampsia is diagnosed with new-onset hypertension of blood pressure of greater than or equal to 140 systolic blood pressure or greater than or equal to 90 diastolic blood pressure recorded twice at least four hours apart AND proteinuria, defined as 300mg of protein in a 24hour urine collection or a protein/creatinine ratio of 0.3. If the above blood pressure criteria are met and there is not proteinuria, preeclampsia can still be diagnosed if there is thrombocytopenia with platelet count of less than 100,000, renal insufficiency with creatinine of greater than 1.1 or twice the patient's individual baseline, impaired liver function with AST or ALT twice normal or epigastric/right upper quadrant pain, pulmonary edema, new-onset headache unresponsive to medication, or visual disturbance. All of these findings should not be explained by an alternative diagnosis.

Women will be consented and randomized at the time of their diagnosis, within 96 hours of their delivery. The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol, nifedipine or hydralazine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects. All subject's blood pressures will be monitored per standard postpartum protocols. As per standard practice, all patients with preeclampsia will be asked to return at 7-10 days for a blood pressure check and then again at 6 weeks for a complete postpartum assessment.

Consent of patients, review of blood pressures, data collection and storage, and statistical analysis will be performed at the Medical College of Wisconsin (MCW) through the Maternal Fetal medicine department. Women will be allowed to continue routine antenatal, intrapartum and postpartum care with their primary obstetrician. The research team will follow enrolled patients through the 6-week postpartum follow up.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Statistician will be masked to which group the patient was randomized to.
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial for Postpartum Antihypertensive Treatment of Women With Preeclampsia
Actual Study Start Date :
Jul 17, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

The patients randomized to the treatment group will have an antihypertensive medication prescribed to them. The specific medication will be either labetalol or nifedipine based on allergies and clinically appropriateness of the medication. The patient will be instructed on the dosing, timing, and possible adverse effects.

Drug: Labetalol, Nifedipine
Antihypertensive treatment that is safe and well studied in peripartum women.
Other Names:
  • Procardia
  • Trandate, Normodyne

    		•
    No Intervention: No-treatment

    Outcome Measures

    Primary Outcome Measures

    1. Hospital Readmission [Within 6 weeks from delivery]

    Secondary Outcome Measures

    1. Rate of Healthcare Utilization [Within 6 weeks from delivery]

      hospital readmissions, increased number of postpartum visits or phone calls, emergency room or urgent care visits, consultation with primary care (internal medicine, family medicine), cardiology, or maternal-fetal-medicine specialists

    2. percentage of severe range blood pressures at the 7-10 days postpartum visit [7-10 days postpartum]

    3. percentage of severe range blood pressures at the 6 week postpartum visit [Approximately 6 weeks postpartum]

    4. compare mean systolic and mean diastolic blood pressure values at 7-10 days postpartum and at 6weeks postpartum [6 weeks pospartum]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >= 18 years old

    • Immediately postpartum (delivered in previous 96 hours)

    • Diagnosed with preeclampsia during pregnancy, labor or immediately postpartum

    • 30% of blood pressures in the postpartum period were elevated (systolic 140 or higher OR diastolic 90 or higher)

    Exclusion Criteria:

    • Chronic hypertension with superimposed preeclampsia

    • Diagnosis of preeclampsia after discharge from delivery hospitalization

    • Persistent severe range blood pressures after delivery requiring initiation of antihypertensive regimen by the care team

    • 50% of blood pressures in the postpartum period were normal (systolic less than 140 AND diastolic less than 90)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical College of Wisconsin-Froedtert Hospital Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Anna Palatnik, MD, Assistant Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT04298034
    Other Study ID Numbers:
    • PRO36760
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Hypertension, Pregnancy-Induced
    Labetalol
    Nifedipine

    Study Results

    No Results Posted as of Dec 8, 2021