Comparison of Tab.Labetalol and Tab.Nifedipine for Manage... | NCT02426177

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

NCT02426177

Sponsor

Dow University of Health Sciences

Status

Unknown status

Last Update Posted

Apr 24, 2015Estimated

Enrollment

98Estimated

Phase

Phase 3

Conditions

Postnatal Hypertension

Interventions

Labetalol
Nifedipine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Apr 21, 2015

First Submission Date that Met QC Criteria

Apr 23, 2015

First Posted Date

Apr 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2015

Last Update Posted Date

Apr 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

fariha javed, resident, Dow University of Health SciencesPrincipal Investigator

Lead Sponsor

Dow University of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Active Comparator	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	Drug: Labetalol
group B	Active Comparator	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	Drug: Nifedipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Labetalol	Drug	anti-hypertensive agents	group A
Nifedipine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Pressure less than 140/90 mm of hg	less than 140/90 mm of hg	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
fariha javed, mbbs	Contact	923009298708		farihajaved207@yahoo.com

Overall Officials

Name	Affiliation	Role
fariha javed, mbbs	Dow University of Health Sciences	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007741	Labetalol
D009543	Nifedipine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided