Dexamethasone for Preterm Labour

Overview

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.

Full Title of Study: “Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2012

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.

Interventions

  • Drug: Dexamethasone 24 hours
  • Drug: Dexamethasone 12

Arms, Groups and Cohorts

  • Experimental: 12 hours Dexamethasone
    • Those patient will be given 12 hours dexamethasone after randomization
  • Experimental: 24 hours Dexamethasone
    • Those patient will be give 24 hours dexamethasone after randomization

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammed Khairy Ali, Women Health Hospital – Assiut University

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