Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

High Blood Pressure Clinical Trial

— SCARPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05551104
• Other study ID #: 5220259
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Loma Linda University
• Contact: Ashra Denise B Tugung, BSc
• Phone: 9096515580
• Email: atugung[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension
• Maternal Hypertension

Intervention

Drug:
• Oral Nifedipine
Administration of oral nifedipine to control postpartum hypertension.
• Oral Labetalol
Administration of oral labetalol to control postpartum hypertension.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite maternal morbidity	Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure	0-6 weeks following delivery
Secondary	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.
Secondary	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