NCT01697098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
Last Updated

October 2, 2012

Status Verified

September 1, 2012

Enrollment Period

6 months

First QC Date

September 23, 2012

Last Update Submit

September 28, 2012

Conditions

Prematurity

Keywords

Dexamethasonepreterm labourrespiratory distress

Outcome Measures

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.

    6 month

Secondary Outcomes (1)

  • Perinatal mortality

    6 month

Other Outcomes (1)

  • Neonatal intensive care

    6 month

Study Arms (2)

12 hours Dexamethasone

EXPERIMENTAL

Those patient will be given 12 hours dexamethasone after randomization

Drug: Dexamethasone 12

24 hours Dexamethasone

EXPERIMENTAL

Those patient will be give 24 hours dexamethasone after randomization

Drug: Dexamethasone 24 hours

Interventions

Dexamethasone 24 hoursDRUG
Also known as: glucocorticoids
24 hours Dexamethasone
Dexamethasone 12DRUG
Also known as: glucocorticoids
12 hours Dexamethasone

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • emergent obstetric conditions like:
  • Antepartum hemorrhage in severe attack
  • Antepartum eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Premature BirthObstetric Labor, PrematureDyspnea

Interventions

DexamethasoneGlucocorticoids

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Women Health Hospital

Study Record Dates

First Submitted

September 23, 2012

First Posted

October 2, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-09

Locations

EG(1)