Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
|ClinicalTrials.gov Identifier: NCT01772381|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Transient Tachypnea of the Newborn||Drug: Dexamethasone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section
Long acting corticosteroid
Other Name: Decadron
- Special care baby unit [ Time Frame: 24 hours ]Special care baby unit admission for babies with respiratory distress
- Severity of respiratory distress [ Time Frame: 24 hours ]Severity of respiratory distress and the level of care in response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772381
|Ain Shams Maternity Hospital|
|Principal Investigator:||Noha H Rabei, MD||Ain Shams Maternity Hospital|