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Oral Nifedipine Versus Oral Labetalol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02168309
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Sarah Kilpatrick, Cedars-Sinai Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Postpartum Hypertension Drug: Labetalol Drug: Nifedipine Not Applicable

Detailed Description:

Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. While the true incidence of postpartum hypertension is unknown, blood pressure (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition.

The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared.

Our aim was to determine whether oral labetalol is associated with a shorter time to BP control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. Our primary outcome was time to sustained BP control defined as the absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Oral Nifedipine to Oral Labetolol for the Management of Severe Postpartum Hypertension
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Labetalol 200mg PO BID starting dose
Drug: Labetalol
Titrate up for blood pressure control
Other Name: Oral labetalol starting at dose 200mg PO BID

Nifedpine XL starting at dose 30mg PO daily
Drug: Nifedipine
Titrate up to achieve blood pressure control
Other Name: Oral nifedipine 30mg XL PO starting

Primary Outcome Measures :
  1. Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication [ Time Frame: 24 hours ]
    Primary outcome

Secondary Outcome Measures :
  1. Total Length of Hospital Stay in Days [ Time Frame: 0-10 days ]
    Secondary outcome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02168309

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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
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Principal Investigator: Sarah Kilpatrick Cedars-Sinai Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sarah Kilpatrick, Chair, Department of Obstetrics & Gynecology, Cedars-Sinai Medical Center Identifier: NCT02168309    
Other Study ID Numbers: Pro34034
First Posted: June 20, 2014    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists