Dexamethasone for Preterm Labour

Prematurity Clinical Trial

— PTL  

Official title:

Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697098
• Other study ID #: Dexa WHH
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2012
• Last updated: September 28, 2012
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prematurity

Intervention

Drug:
• Dexamethasone 24 hours

• Dexamethasone 12

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal intensive care	Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.	6 month	No
Primary	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.	6 month	No
Secondary	Perinatal mortality	Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.	6 month	No