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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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

Page last updated: August 23, 2015

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