Recruiting

Labetalol & Nifedipine

Sponsor:

Nebraska Methodist Health System

Code:

NCT05309460

Conditions

Postpartum Preeclampsia

Hypertension in Pregnancy

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Labetalol Oral Tablet

NIFEdipine ER

Study Details

Brief summary:

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

Conditions

Postpartum Preeclampsia

Hypertension in Pregnancy

Study ID

NCT05309460

Start date

Jun 20, 2022

Status verified date

Apr, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Any patient admitted for delivery by cesarean or vaginal delivery at 24 weeks gestation or greater with hypertension(HTN). Hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN. Following enrollment, treatment will be escalated at discretion of primary provider with the goal of normotension.

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Labetalol Oral Tablet

See Labetalol arm.

NIFEdipine ER

See Nifedipine arm.

Primary outcome measure

  • Readmission [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Todd Lovgren, MD

4028151970todd.lovgren@nmhs.org

Joshua Dahlke, MD

4028151970joshua.dahlke@nmhs.org

Locations

Nebraska Methodist Women's Hospital

Recruiting

Omaha, Nebraska, United States, 68022

Contacts

Todd Lovgren

402-815-1970todd.lovgren@nmhs.org

Josh Dahlke

4028151970joshua.dahlke@nmhs.org

More Information

Sponsor

Nebraska Methodist Health System

Last update posted

Apr 12, 2024

Last verified

Apr, 2024

Keywords

  • Nifedipine
  • Labetalol
  • Postpartum
  • Hypertension
  • Preeclampsia
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nebraska Methodist Health System on 2024-04-12.