High Blood Pressure Clinical Trial
— SCARPHOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Health | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
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 |
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