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NCT Number: NCT05551104

Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University Health

Loma Linda, California, 92350, United States

Location status: Recruiting

Location contact

Ashra Tugung

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Nifedipine

Drug

Administration of oral nifedipine to control postpartum hypertension.

Other names: Procardia, Procardia XL

Oral Labetalol

Drug

Administration of oral labetalol to control postpartum hypertension.

Other names: Trandate

Primary outcomes

  1. Composite maternal morbidity

    Time frame: 0-6 weeks following delivery

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

Secondary outcomes

  1. Length of hospital stay of mothers

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

    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.

  2. Total number of participants who have need for second antihypertensive agent

    Time frame: 0-6 weeks following delivery

    The need to use a second (alternative) antihypertensive medication.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashra Denise B Tugung, BSc

CONTACT

[email protected]

9096515580

Nikia Gray-Hutto, RN, CCRP

CONTACT

[email protected]

9095584000 ext. 44428

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Acronym: SCARPH

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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