Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean|
- Special care baby unit [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Special care baby unit admission for babies with respiratory distress
- Severity of respiratory distress [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Severity of respiratory distress and the level of care in response
|Study Start Date:||March 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section
Long acting corticosteroid
Other Name: Decadron
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772381
|Ain Shams Maternity Hospital|
|Principal Investigator:||Noha H Rabei, MD||Ain Shams Maternity Hospital|