Recruiting
Phase 3

Antihypertensive Regimen

Sponsor:

Loma Linda University

Code:

NCT05551104

Conditions

Postpartum Complication

Maternal Hypertension

High Blood Pressure

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Nifedipine

Oral Labetalol

Study Details

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.

Conditions

Postpartum Complication

Maternal Hypertension

High Blood Pressure

Study ID

NCT05551104

Start date

May 8, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Oral Nifedipine

Administration of oral nifedipine to control postpartum hypertension.

Oral Labetalol

Administration of oral labetalol to control postpartum hypertension.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ashra Denise B Tugung, BSc

9096515580atugung@llu.edu

Nikia Gray-Hutto, RN, CCRP

9095584000nhutto@llu.edu

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92350

Contacts

Ashra Tugung

atugung@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Postpartum Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-02-04.