Safest Choice of Antihypertensive Regimen for Postpartum Hypertension (SCARPH)

Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)

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.

Study Overview

• Status: Recruiting
• Conditions: High Blood Pressure; Postpartum Complication; Maternal Hypertension
• Intervention / Treatment: Drug: Oral Nifedipine; Drug: Oral Labetalol

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ashra Denise B Tugung, BSc; Phone Number: 9096515580; Email: atugung@llu.edu
• Study Contact Backup: Name: Nikia Gray-Hutto, RN, CCRP; Phone Number: 44428 9095584000; Email: nhutto@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Recruiting
      • Loma Linda University Health
      • Contact: Ashra Tugung; Email: atugung@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Oral Nifedipine; Administration of oral nifedipine to control postpartum hypertension.; Other Names: Procardia, Procardia XL
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.	Drug: Oral Labetalol; Administration of oral labetalol to control postpartum hypertension.; Other Names: Trandate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite maternal morbidity	Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure	0-6 weeks following delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay of mothers	The length of hospital stay for mothers will be measured in hours from the time of admission to labor and delivery unit to the time of discharge from the post-partum unit.	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	The need to use a second (alternative) antihypertensive medication.	0-6 weeks following delivery

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum Hypertension
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Hypertension; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amides; Amines; Alcohols; Amino Alcohols; Ethanolamines; Dihydropyridines; Salicylamides; Nifedipine; Labetalol
• Other Study ID Numbers: 5220259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes