Dexamethasone for Preterm Labour

Phase 2

Completed

• Conditions: Prematurity
• Interventions: Drug: Dexamethasone 12; Drug: Dexamethasone 24 hours

• Registration Number: NCT01697098
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-23
• Study First Submitted QC: 2012-09-28
• Last Update Submitted: 2012-09-28
• Study First Posted: 2012-10-02
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12 hours Dexamethasone	Dexamethasone 12	Those patient will be given 12 hours dexamethasone after randomization
24 hours Dexamethasone	Dexamethasone 24 hours	Those patient will be give 24 hours dexamethasone after randomization

Primary Outcome Measures

Name	Time	Method
respiratory distress syndrome (RDS)	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

Name	Time	Method
Perinatal mortality	6 month	Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt