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Completed

NCT Number: NCT01697098

Dexamethasone for Preterm Labour

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.

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Key information

Conditions

Prematurity Dyspnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone 24 hours

Drug

Other names: glucocorticoids

Dexamethasone 12

Drug

Other names: glucocorticoids

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: PTL

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 2, 2012
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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