Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Nebraska Methodist Health System
Study ID
NCT05309460
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hypertension in Pregnancy
  • Postpartum Preeclampsia

Eligibility Criteria

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

Interventions

  • Labetalol Oral Tablet — DRUG
    See Labetalol arm.
  • NIFEdipine ER — DRUG
    See Nifedipine arm.

Study Details

Randomized trial comparing risk of hospital readmission and hypertensive complications between patients managed on Labetalol compared to Nifedipine.

Key Dates

Start date
Jun 20, 2022
Status verified
Apr 2024
Primary completion
May 1, 2024
Completion
Dec 1, 2024

Study Design

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

Arms

  • Active Comparator: Nifedipine
    Patients randomized to Nifedipine will be started on Nifedipine XR 30mg BID. Escalation in therapy to be determined by primary provider. Maximum dose of Nifedipine is 120mg daily. All patients will be monitored for signs and symptoms of hypotension or medication side effect- severe HA, orthostasis, syncope.
  • Active Comparator: Labetalol
    Patients randomized to Labetalol will be started on 200mg TID. Escalation in therapy to be determined by primary provider. Maximum dose is 2400mg in a day. All patients will be monitored for signs and symptoms of hypotension or medication side effect- orthostasis, syncope, bradycardia.

Primary Outcome Measure

Readmission [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nebraska Methodist Women's HospitalOmahaNebraska68022
Todd Lovgren
[email protected]
402-815-1970
Josh Dahlke
[email protected]
4028151970

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By research site
Nebraska Methodist Women's Hospital· Omaha, NE

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