Oral Nifedipine Versus Oral Labetalol

NCT ID: NCT02168309

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-05-31

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.

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.

Conditions

Severe Postpartum Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Labetalol

Labetalol 200mg PO BID starting dose

Group Type: OTHER

Labetalol

Intervention Type: DRUG

Titrate up for blood pressure control

Nifedipine

Nifedpine XL starting at dose 30mg PO daily

Group Type: OTHER

Nifedipine

Intervention Type: DRUG

Titrate up to achieve blood pressure control

Interventions

Labetalol

Titrate up for blood pressure control

Intervention Type: DRUG

Nifedipine

Titrate up to achieve blood pressure control

Intervention Type: DRUG

Other Intervention Names

Oral labetalol starting at dose 200mg PO BID; Oral nifedipine 30mg XL PO starting

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Kilpatrick

Chair, Department of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Kilpatrick

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27786578 (View on PubMed)

Other Identifiers

Pro34034

Identifier Type: -

Identifier Source: org_study_id