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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nifedipine | Active Comparator | 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. |
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| Oral Labetalol | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nifedipine | Drug | Administration of oral nifedipine to control postpartum hypertension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite maternal morbidity | Requiring antihypertensive medication in the postpartum period, readmission for high blood pressure | 0-6 weeks following delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashra Denise B Tugung, BSc | Contact | 9096515580 | atugung@llu.edu | |
| Nikia Gray-Hutto, RN, CCRP | Contact | 9095584000 | 44428 | nhutto@llu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Recruiting | Loma Linda | California | 92350 | United States |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D007741 | Labetalol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Oral Labetalol | Drug | Administration of oral labetalol to control postpartum hypertension. |
|
|
| 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 |
| D002318 | Cardiovascular Diseases |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |