Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus

Not Applicable

Completed

• Conditions: Transient Tachypnea of the Newborn
• Interventions: Drug: Dexamethasone

• Registration Number: NCT01772381
• Lead Sponsor: Ain Shams Maternity Hospital

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.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Study First Submitted: 2012-12-31
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-18
• Last Update Submitted: 2013-01-18
• Study First Posted: 2013-01-21
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Special care baby unit	24 hours	Special care baby unit admission for babies with respiratory distress

Secondary Outcome Measures

Name	Time	Method
Severity of respiratory distress	24 hours	Severity of respiratory distress and the level of care in response

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt