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Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension

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ClinicalTrials.gov Identifier: NCT02426177
Recruitment Status : Unknown
Verified April 2015 by fariha javed, Dow University of Health Sciences.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
fariha javed, Dow University of Health Sciences

Tracking Information
First Submitted Date  ICMJE April 21, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
Blood Pressure less than 140/90 mm of hg [ Time Frame: 24 hours ]
less than 140/90 mm of hg
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension
Official Title  ICMJE Comparison of Oral Labetalol and Oral Nifedipine for Postpartum Hypertension Management
Brief Summary To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.
Detailed Description A comparison of oral labetalol and oral nifedipine for management of postpartum hypertension. Which drug is more effective in lowering blood pressures in patient with postpartum hypertension.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postnatal Hypertension
Intervention  ICMJE
  • Drug: Labetalol
    anti-hypertensive agents
  • Drug: Nifedipine
    calcium channel blocker ,for lowering blood pressure
Study Arms  ICMJE
  • Active Comparator: group A
    tab.labetalol is given to the patient with postpartum hypertension in dose of 100 mg 6 hourly increased to maximum 600 mg in 24 hours
    Intervention: Drug: Labetalol
  • Active Comparator: group B
    tab.nifedipine is given to the patient with postpartum hypertension in the dose of 10 mg twice a day to maximum dose of 60 mg per 24 hours
    Intervention: Drug: Nifedipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2015)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all women with postpartum hypertension as a continuation of pregnancy induced hypertension,eclampsia, pre-eclampsia or new onset de-novo postpartum hypertension,of any parity.
  • age group between 18-48.
  • after informed consent.

Exclusion Criteria:

  • all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded.
  • conditions in which drugs labetalol and nifedipine is contraindicated.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426177
Other Study ID Numbers  ICMJE DowUHS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party fariha javed, Dow University of Health Sciences
Study Sponsor  ICMJE Dow University of Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: fariha javed, mbbs Dow University of Health Sciences
PRS Account Dow University of Health Sciences
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP