NCT02426177

Brief Summary

To compare effectiveness of oral labetalol and oral nifedipine for management of postpartum hypertension.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 21, 2015

Last Update Submit

April 23, 2015

Conditions

Postnatal Hypertension

Keywords

postpartum hypertensionlabetalol in postpartum hypertensionnifedipine in postpartum hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure less than 140/90 mm of hg

    less than 140/90 mm of hg

    24 hours

Study Arms (2)

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

LabetalolDRUG

anti-hypertensive agents

group A
NifedipineDRUG

calcium channel blocker ,for lowering blood pressure

group B

Eligibility Criteria

Age20 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • all women with chronic hypertension, uncontrolled and un treated medical disorders will be excluded.
  • conditions in which drugs labetalol and nifedipine is contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LabetalolNifedipine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • fariha javed, mbbs

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

fariha javed, mbbs

CONTACT

923009298708farihajaved207@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

April 24, 2015

Record last verified: 2015-04