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

Transient Tachypnea of the Newborn Clinical Trial

Official title:

Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772381
• Other study ID #: noharabei
• Status: Completed
• Phase: N/A
• First received: December 31, 2012
• Last updated: January 18, 2013
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2013
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 44 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Transient Tachypnea of the Newborn

Intervention

Drug:
• Dexamethasone
Long acting corticosteroid

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Special care baby unit	Special care baby unit admission for babies with respiratory distress	24 hours	Yes
Secondary	Severity of respiratory distress	Severity of respiratory distress and the level of care in response	24 hours	Yes