Dexamethasone for Preterm Labour (PTL)

September 28, 2012 updated by: Mohammed Khairy Ali, Assiut University

Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial

The investigators sought to determine whether the incidence of neonatal respiratory distress syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of dexamethasone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The administration of glucocorticoids to accelerate fetal lung maturity in patients with preterm delivery plays an important role for obstetrics and neonatal care. Many studies have shown that maternal administration of glucocorticoids has a significant beneficial effect in decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34 weeks of gestation.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patient with threatened or established preterm labor between 28 - 34 weeks attended to our emergency unit

Exclusion Criteria:

  • emergent obstetric conditions like:

    • Antepartum hemorrhage in severe attack
    • Antepartum eclampsia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 hours Dexamethasone
Those patient will be given 12 hours dexamethasone after randomization
Drug: Dexamethasone 12
Other Names:
  • glucocorticoids
Experimental: 24 hours Dexamethasone
Those patient will be give 24 hours dexamethasone after randomization
Drug: Dexamethasone 24 hours
Other Names:
  • glucocorticoids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory distress syndrome (RDS)
Time Frame: 6 month
determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of dexamethasone.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal mortality
Time Frame: 6 month
Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.
6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal intensive care
Time Frame: 6 month
Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 23, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexa WHH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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