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Dexamethasone for Preterm Labour (PTL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697098
First Posted: October 2, 2012
Last Update Posted: October 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial

Resource links provided by NLM:


Further study details as provided by Mohammed Khairy Ali, Assiut University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Perinatal mortality [ Time Frame: 6 month ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697098


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

Responsible Party: Mohammed Khairy Ali, Women Health Hospital, Assiut University
ClinicalTrials.gov Identifier: NCT01697098     History of Changes
Other Study ID Numbers: Dexa WHH
First Submitted: September 23, 2012
First Posted: October 2, 2012
Last Update Posted: October 2, 2012
Last Verified: September 2012

Keywords provided by Mohammed Khairy Ali, Assiut University:
Dexamethasone
preterm labour
respiratory distress

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Glucocorticoids
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action