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Dexamethasone for Preterm Labour (PTL)

Primary Purpose

Prematurity

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone 24 hours
Dexamethasone 12
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prematurity focused on measuring Dexamethasone, preterm labour, respiratory distress

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Women Health Hospital - Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

12 hours Dexamethasone

24 hours Dexamethasone

Arm Description

Those patient will be given 12 hours dexamethasone after randomization

Those patient will be give 24 hours dexamethasone after randomization

Outcomes

Primary Outcome Measures

respiratory distress syndrome (RDS)
determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of dexamethasone.

Secondary Outcome Measures

Perinatal mortality
Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.

Full Information

First Posted
September 23, 2012
Last Updated
September 28, 2012
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT01697098
Brief Title
Dexamethasone for Preterm Labour
Acronym
PTL
Official Title
Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Dexamethasone, preterm labour, respiratory distress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 hours Dexamethasone
Arm Type
Experimental
Arm Description
Those patient will be given 12 hours dexamethasone after randomization
Arm Title
24 hours Dexamethasone
Arm Type
Experimental
Arm Description
Those patient will be give 24 hours dexamethasone after randomization
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 24 hours
Other Intervention Name(s)
glucocorticoids
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 12
Other Intervention Name(s)
glucocorticoids
Primary Outcome Measure Information:
Title
respiratory distress syndrome (RDS)
Description
determine whether the incidence of neonatal respiratory distress syndrome (RDS) is similar with 12- vs 24-hour dosing interval of dexamethasone.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Perinatal mortality
Description
Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.
Time Frame
6 month
Other Pre-specified Outcome Measures:
Title
Neonatal intensive care
Description
Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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Dexamethasone for Preterm Labour

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