Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

NCT ID: NCT05551104

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Postpartum Complication; Maternal Hypertension; High Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oral Nifedipine

Intervention Type: DRUG

Administration of oral nifedipine to control postpartum hypertension.

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.

Group Type: ACTIVE_COMPARATOR

Oral Labetalol

Intervention Type: DRUG

Administration of oral labetalol to control postpartum hypertension.

Interventions

Oral Nifedipine

Administration of oral nifedipine to control postpartum hypertension.

Intervention Type: DRUG

Oral Labetalol

Administration of oral labetalol to control postpartum hypertension.

Intervention Type: DRUG

Other Intervention Names

Procardia, Procardia XL; Trandate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loma Linda University Health

Loma Linda, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashra Denise B Tugung, BSc

Role: CONTACT

atugung@llu.edu

9096515580

Nikia Gray-Hutto, RN, CCRP

Role: CONTACT

nhutto@llu.edu

9095584000 ext. 44428

Facility Contacts

Ashra Tugung

Role: primary

atugung@llu.edu

Other Identifiers

5220259

Identifier Type: -

Identifier Source: org_study_id