Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

NCT05551104 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 5220259
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

Postpartum Hypertension

Outcome Measures

Primary Outcomes (1)

• Composite maternal morbidity

  Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure

  0-6 weeks following delivery

Secondary Outcomes (2)

• Length of hospital stay of mothers

  Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission.

• Total number of participants who have need for second antihypertensive agent

  0-6 weeks following delivery

Study Arms (2)

Oral Nifedipine

ACTIVE COMPARATOR

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.

Drug: Oral Nifedipine

Oral Labetalol

ACTIVE COMPARATOR

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.

Drug: Oral Labetalol

Interventions

Oral Nifedipine DRUG

Administration of oral nifedipine to control postpartum hypertension.

Also known as: Procardia, Procardia XL

Oral Nifedipine

Oral Labetalol DRUG

Administration of oral labetalol to control postpartum hypertension.

Also known as: Trandate

Oral Labetalol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Interventions

Nifedipine; Labetalol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Central Study Contacts

Ashra Denise B Tugung, BSc

CONTACT

9096515580; atugung@llu.edu

Nikia Gray-Hutto, RN, CCRP

CONTACT

9095584000; nhutto@llu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: May 8, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)