High Blood Pressure, Maternal Hypertension, Postpartum Complication
Conditions
Keywords
Postpartum Hypertension
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.
Interventions
DRUGOral Nifedipine
Administration of oral nifedipine to control postpartum hypertension.
DRUGOral Labetalol
Administration of oral labetalol to control postpartum hypertension.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite maternal morbidity | 0-6 weeks following delivery | Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay of mothers | Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission. | 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 | 0-6 weeks following delivery | The need to use a second (alternative) antihypertensive medication. |
Countries
United States
Contacts
CONTACTAshra Denise B Tugung, BSc
CONTACTNikia Gray-Hutto, RN, CCRP
Outcome results
None listed