Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

Purpose

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.

Conditions

  • Postpartum Complication
  • Maternal Hypertension
  • High Blood Pressure

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Oral Nifedipine 		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.
  • Drug: Oral Nifedipine
    Administration of oral nifedipine to control postpartum hypertension.
    Other names:
    • Procardia, Procardia XL
Active Comparator
Oral Labetalol 		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.
  • Drug: Oral Labetalol
    Administration of oral labetalol to control postpartum hypertension.
    Other names:
    • Trandate

Recruiting Locations

Loma Linda University Health
Loma Linda 5367696, California 5332921 92350
Contact:
Ashra Tugung
atugung@llu.edu

More Details

Status
Recruiting
Sponsor
Loma Linda University

Study Contact

Ashra Denise B Tugung, BSc
9096515580
atugung@llu.edu

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.