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CompletedNCT01697098PTLUpdated Oct 2, 2012

Dexamethasone for Preterm Labour

A Phase 2 interventional study of Dexamethasone 24 hours and Dexamethasone 12 in Prematurity, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-10-02.

Sponsored by Assiut University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Prematurity

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Keywords

  • Dexamethasone
  • preterm labour
  • respiratory distress
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 200 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • All patient with threatened or established preterm labor between 28 - 34 weeks attended to our emergency unit

Exclusion criteria

Exclusion Criteria:

  • emergent obstetric conditions like:

    • Antepartum hemorrhage in severe attack
    • Antepartum eclampsia
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    12 hours Dexamethasone

    Those patient will be given 12 hours dexamethasone after randomization

    Drug: Dexamethasone 12

  • Experimental
    24 hours Dexamethasone

    Those patient will be give 24 hours dexamethasone after randomization

    Drug: Dexamethasone 24 hours

Interventions

  • DrugDexamethasone 24 hours

    Also known as: glucocorticoids

  • DrugDexamethasone 12

    Also known as: glucocorticoids

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 month

Secondary outcomes

  1. Perinatal mortality

    Determine whether the incidence of perinatal mortality is similar with 12- vs 24-hour dosing interval of dexamethasone.

    Time frame: 6 month

Other outcomes

  1. Neonatal intensive care

    Determine whether the incidence of admission to Neonatal intensive care is similar with 12- vs 24-hour dosing interval of dexamethasone.

    Time frame: 6 month

07

Study locations

1 site
  • Women Health Hospital - Assiut university
    Assiut, 71111, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01697098
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Women Health Hospital, Assiut University) — Principal investigator
First posted
Oct 2, 2012
Start date
Jan 2012
Primary completion
Jul 2012
Completion
Aug 2012
Last update
Oct 2, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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