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Clinical Trials/NCT01772381
NCT01772381
Completed
Not Applicable

Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Ain Shams Maternity Hospital1 site in 1 country600 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Dexamethasone
Conditions
Transient Tachypnea of the Newborn
Sponsor
Ain Shams Maternity Hospital
Enrollment
600
Locations
1
Primary Endpoint
Special care baby unit
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care.

Aim of the Work: To assess the effect of prophylactic dexamethasone administration before elective cesarean section at term in reducing neonatal respiratory complications.

Patients and methods: 600 women were included in the study and were planned to have elective caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before delivery. 300 patients were the control group.

The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS) and the need for mechanical ventilation.

Detailed Description

Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
June 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha Rabei

Assistant Professor, Obstetrics and Gynecology

Ain Shams Maternity Hospital

Eligibility Criteria

Inclusion Criteria

  • Previous caesarean section
  • Complete 37 week calculated from the first day of the last menstrual period.

Exclusion Criteria

  • Obstetric complications such as pre-eclampsia, antepartum hemorrhage or known fetal anomaly.
  • Hypertensive patients.
  • Chronic disease e.g. diabetes mellitus.
  • Known renal disease.
  • Pre-operative infection.

Arms & Interventions

Dexamethasone

Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section

Intervention: Dexamethasone

Outcomes

Primary Outcomes

Special care baby unit

Time Frame: 24 hours

Special care baby unit admission for babies with respiratory distress

Secondary Outcomes

  • Severity of respiratory distress(24 hours)

Study Sites (1)

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