Clinical trial NCT05551104: Safest Choice of Antihypertensive Regimen for Postpartum Hypertension
Official title: Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postpartum Complication
Maternal Hypertension
High Blood Pressure
Keywords: Postpartum Hypertension
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite maternal morbidity
timeFrame: 0-6 weeks following delivery
Secondary outcomes:
measure: Length of hospital stay of mothers
timeFrame: Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission.
measure: Total number of participants who have need for second antihypertensive agent
timeFrame: 0-6 weeks following delivery
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
References: