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Safest Choice of Antihypertensive Regimen for Postpartum Hypertension (SCARPH)

Primary Purpose

Postpartum Complication, Maternal Hypertension, High Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Nifedipine
Oral Labetalol
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Complication focused on measuring Postpartum Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral Nifedipine

Oral Labetalol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Total number of participants who have need for second antihypertensive agent
The need to use a second (alternative) antihypertensive medication.

Full Information

First Posted
September 19, 2022
Last Updated
July 18, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT05551104
Brief Title
Safest Choice of Antihypertensive Regimen for Postpartum Hypertension
Acronym
SCARPH
Official Title
Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 30, 2027 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Complication, Maternal Hypertension, High Blood Pressure
Keywords
Postpartum Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Nifedipine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oral Labetalol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Nifedipine
Other Intervention Name(s)
Procardia, Procardia XL
Intervention Description
Administration of oral nifedipine to control postpartum hypertension.
Intervention Type
Drug
Intervention Name(s)
Oral Labetalol
Other Intervention Name(s)
Trandate
Intervention Description
Administration of oral labetalol to control postpartum hypertension.
Primary Outcome Measure Information:
Title
Composite maternal morbidity
Description
Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure
Time Frame
0-6 weeks following delivery
Secondary Outcome Measure Information:
Title
Length of hospital stay of mothers
Description
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.
Time Frame
Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission.
Title
Total number of participants who have need for second antihypertensive agent
Description
The need to use a second (alternative) antihypertensive medication.
Time Frame
0-6 weeks following delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashra Denise B Tugung, BSc
Phone
9096515580
Email
atugung@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nikia Gray-Hutto, RN, CCRP
Phone
9095584000
Ext
44428
Email
nhutto@llu.edu
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashra Tugung
Email
atugung@llu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

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