Oral Nifedipine Versus Oral Labetalol
Information source: Cedars-Sinai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Postpartum Hypertension
Intervention: Labetalol (Drug); Nifedipine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Cedars-Sinai Medical Center Overall contact:
Kathryn Sharma, MD, Phone: (310)423-0895, Email: kathryn.sharma@cshs.org
Summary
This study's aim is to determine whether oral extended release nifedipine is superior to
oral labetolol for the management of postpartum severe hypertension, specifically time to
achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral
extended release nifedipine is superior to oral labetolol for achieving goal blood pressure
in the postpartum period.
Clinical Details
Official title: Comparison of Oral Nifedipine to Oral Labetolol for the Management of Severe Postpartum Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time (hours) to attain sustained blood pressure goal after treatment initiated with antihypertensive medication
Secondary outcome: Total length of hospital stay in hours
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Age ≥ 18 years with the abililty to give informed consent
- Intrauterine pregnancy ≥ 32 weeks
- Postpartum
- Persistent postpartum blood pressures ≥ 160/105 on two or more occasions
- Primary obstetrician amenable to starting either study medication in the postpartum
period
Exclusion Criteria:
- Use of other oral antihypertensives concomitantly
- Known AV heart block
- HR <60 or >120
- Absolute contraindication to nifedipine or labetolol such as allergy
- Significant renal disease (Cr >1. 5 mg/dL)
- Heart failure
- Moderate persistent or severe asthma
- Preexisting diagnosis of chronic hypertension with medical treatment before delivery
- Chronic hypertension
Locations and Contacts
Kathryn Sharma, MD, Phone: (310)423-0895, Email: kathryn.sharma@cshs.org
Cedars Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Kathryn Sharma, MD, Phone: 310-423-0895, Email: kathryn.sharma@cshs.org
Additional Information
Starting date: June 2014
Last updated: February 2, 2015
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