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

Primary Purpose

Postnatal Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Labetalol
Nifedipine
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postnatal Hypertension focused on measuring postpartum hypertension, labetalol in postpartum hypertension, nifedipine in postpartum hypertension

Eligibility Criteria

20 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group A

    group B

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Blood Pressure less than 140/90 mm of hg
    less than 140/90 mm of hg

    Secondary Outcome Measures

    Full Information

    First Posted
    April 21, 2015
    Last Updated
    April 23, 2015
    Sponsor
    Dow University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02426177
    Brief Title
    Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension
    Official Title
    Comparison of Oral Labetalol and Oral Nifedipine for Postpartum Hypertension Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dow University of Health Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postnatal Hypertension
    Keywords
    postpartum hypertension, labetalol in postpartum hypertension, nifedipine in postpartum hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    Labetalol
    Intervention Description
    anti-hypertensive agents
    Intervention Type
    Drug
    Intervention Name(s)
    Nifedipine
    Intervention Description
    calcium channel blocker ,for lowering blood pressure
    Primary Outcome Measure Information:
    Title
    Blood Pressure less than 140/90 mm of hg
    Description
    less than 140/90 mm of hg
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    48 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    fariha javed, mbbs
    Phone
    923009298708
    Email
    farihajaved207@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    fariha javed, mbbs
    Organizational Affiliation
    Dow University of Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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