Oral Nifedipine Versus Oral Labetalol

Comparison of Oral Nifedipine to Oral Labetolol for the Management of Severe Postpartum Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Severe Postpartum Hypertension
• Intervention / Treatment: Drug: Labetalol; Drug: Nifedipine

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Labetalol; Labetalol 200mg PO BID starting dose	Drug: Labetalol; Titrate up for blood pressure control; Other Names: Oral labetalol starting at dose 200mg PO BID
Other: Nifedipine; Nifedpine XL starting at dose 30mg PO daily	Drug: Nifedipine; Titrate up to achieve blood pressure control; Other Names: Oral nifedipine 30mg XL PO starting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication	Primary outcome	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Length of Hospital Stay in Days	Secondary outcome	0-10 days

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Sarah Kilpatrick, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Sharma KJ, Greene N, Kilpatrick SJ. Oral labetalol compared to oral nifedipine for postpartum hypertension: A randomized controlled trial. Hypertens Pregnancy. 2017 Feb;36(1):44-47. doi: 10.1080/10641955.2016.1231317. Epub 2016 Oct 27.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Nifedipine; Labetalol
• Other Study ID Numbers: Pro34034