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SCARPH: Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

Sponsor
Loma Linda University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05551104
Collaborator
(none)
500
Enrollment
2
Arms
58.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Nifedipine
  • Drug: Oral Labetalol
 N/A

Detailed Description

High blood pressure (hypertension) is one of the most common medical disorders in pregnancy and affects 10% of all pregnancies in the United States, with possible short-term and long-term health complications including increased risk of stroke, and liver, kidney, and heart disease. Management of severe high blood pressure after delivery involves medications to lower blood pressure, strict discharge instructions and close follow- up after delivery. Both oral Nifedipine and oral Labetalol are considered safe agents for the treatment of postpartum high blood pressure, however few studies exist that directly compare the two. The investigators want to conduct this study because they want to compare the effects of oral Nifedipine or oral Labetalol on postpartum hypertension. In this study, subjects will get either oral Nifedipine or oral Labetalol. Subjects will not get both. No experimental drugs or devices will be used.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2027
Anticipated Study Completion Date :
Dec 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Oral Nifedipine

Participants will receive oral nifedipine for blood pressure control. Dosage may initially start at one 10mg capsule by mouth three times per 24 hours (total of 30mg a day), however dosage may be increased by 30mg increments (i.e. 20mg capsule three times a day for a total of 60mg a day). Maximum dosage for oral Nifedipine will be 120mg per day.

Drug: Oral Nifedipine
Administration of oral nifedipine to control postpartum hypertension.
Other Names:
  • Procardia, Procardia XL

    		•
    Active Comparator: Oral Labetalol

    Participants will receive oral labetalol for blood pressure control. Dosage may initially start at one 200mg tablet by mouth two times per 12 hours (total of 400mg every a day), however dosage may be increased by 100-200mg increments at a time. Maximum dosage for oral labetalol will be 2400mg per day.

    Drug: Oral Labetalol
    Administration of oral labetalol to control postpartum hypertension.
    Other Names:
  • Trandate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite maternal morbidity [0-6 weeks following delivery]

      Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure

    Secondary Outcome Measures

    1. Length of hospital stay of mothers [Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission.]

      The length of hospital stay for mothers will be measured in hours from the time of admission to labor and delivery unit to the time of discharge from the post-partum unit.

    2. Total number of participants who have need for second antihypertensive agent [0-6 weeks following delivery]

      The need to use a second (alternative) antihypertensive medication.

    Eligibility Criteria

    Criteria

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

    • Female

    • Women who develop postpartum hypertension* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control.

    • Postpartum hypertension requiring treatment are defined as systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg on at least 2 occasions at least 4 hours apart, or systolic blood pressure greater than or equal to 160mmHg or diastolic blood pressure greater than 110mmHg sustained for more than 15 minutes.

    Exclusion Criteria:

    • History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema

    • Contraindication to either Nifedipine or Labetalol

    • HR <60 or >110

    • Native language other than English or Spanish

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Loma Linda University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT05551104
    Other Study ID Numbers:
    • 5220259
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Dec 2, 2022
    Last Verified:
    Nov 1, 2022
    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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Loma Linda University
    Postpartum Hypertension
    Additional relevant MeSH terms:
    Hypertension
    Labetalol
    Nifedipine

    Study Results

    No Results Posted as of Dec 2, 2022