Oral Nifedipine Versus Oral Labetalol

NCT02168309 | Completed Results DMC

• 1 other identifier: Pro34034
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Postpartum Hypertension

Outcome Measures

Primary Outcomes (1)

• Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication

  Primary outcome

  24 hours

Secondary Outcomes (1)

• Total Length of Hospital Stay in Days

  0-10 days

Study Arms (2)

Labetalol

OTHER

Labetalol 200mg PO BID starting dose

Drug: Labetalol

Nifedipine

OTHER

Nifedpine XL starting at dose 30mg PO daily

Drug: Nifedipine

Interventions

Labetalol DRUG

Titrate up for blood pressure control

Also known as: Oral labetalol starting at dose 200mg PO BID

Labetalol

Nifedipine DRUG

Titrate up to achieve blood pressure control

Also known as: Oral nifedipine 30mg XL PO starting

Nifedipine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 27786578 DERIVED

MeSH Terms

Interventions

Labetalol; Nifedipine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kathryn Sharma
• Organization: Central Coast Perinatology

katy.jones@gmail.com

8058980258

Study Officials

• Sarah Kilpatrick

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 20, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: May 1, 2016
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-11

Locations

US (1)