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Dexamethasone for Preterm Labour (PTL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University
ClinicalTrials.gov Identifier:
NCT01697098
First received: September 23, 2012
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prematurity
 Drug: Dexamethasone 24 hours
Drug: Dexamethasone 12
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • respiratory distress syndrome (RDS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.


Other Outcome Measures:
  • Neonatal intensive care [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.


Enrollment: 200
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 hours Dexamethasone
Those patient will be given 12 hours dexamethasone after randomization
 Drug: Dexamethasone 12
Other Name: glucocorticoids
Experimental: 24 hours Dexamethasone
Those patient will be give 24 hours dexamethasone after randomization
 Drug: Dexamethasone 24 hours
Other Name: glucocorticoids

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697098

Locations
Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
  More Information

No publications provided

Responsible Party: Mohammed Khairy Ali, Women Health Hospital, Assiut University
ClinicalTrials.gov Identifier: NCT01697098     History of Changes
Other Study ID Numbers: Dexa WHH
Study First Received: September 23, 2012
Last Updated: September 28, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Assiut University:
Dexamethasone
preterm labour
respiratory distress

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Glucocorticoids
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013