Safest Choice of Antihypertensive Regimen for Postpartum Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Nifedipine, Oral Labetalol.
- Who it may be relevant to
- Registry conditions: Postpartum Complication, Maternal Hypertension, High Blood Pressure. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)
Overview
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.
Interventions
- Drug Oral Nifedipine
Administration of oral nifedipine to control postpartum hypertension. - Drug Oral Labetalol
Administration of oral labetalol to control postpartum hypertension.
Primary outcome measures
- Composite maternal morbidity [Time frame: 0-6 weeks following delivery]
Secondary outcome measures (2)
- 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.]
- Total number of participants who have need for second antihypertensive agent [Time frame: 0-6 weeks following delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Loma Linda University Health — Loma Linda
Identifiers
NCT: NCT05551104 · 5220259