Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT05551104
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral Nifedipine — DRUG
    Administration of oral nifedipine to control postpartum hypertension.
  • Oral Labetalol — DRUG
    Administration of oral labetalol to control postpartum hypertension.

Study Details

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.

Key Dates

Start date
May 8, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Composite maternal morbidity [ Time Frame: 0-6 weeks following delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92350
Ashra Tugung

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