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

• Sponsor: Ain Shams Maternity Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01772381
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 40

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transient Tachypnea of the Newborn	Drug: Dexamethasone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section	Drug: Dexamethasone; Long acting corticosteroid; Other Names: Decadron

Outcome Measures

Primary Outcome Measures

1. Special care baby unit [24 hours]

   Special care baby unit admission for babies with respiratory distress

Secondary Outcome Measures

1. Severity of respiratory distress [24 hours]

   Severity of respiratory distress and the level of care in response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams Maternity Hospital

Investigators

• Principal Investigator: Noha H Rabei, MD, Ain Shams Maternity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noha Rabei, Assistant Professor, Obstetrics and Gynecology, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT01772381
• Other Study ID Numbers: noharabei
• First Posted: Jan 21, 2013
• Last Update Posted: Jan 21, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Noha Rabei, Assistant Professor, Obstetrics and Gynecology, Ain Shams Maternity Hospital: Dexamethasone, term, elective cesarean section
• Additional relevant MeSH terms: Tachypnea; Transient Tachypnea of the Newborn; Dexamethasone

Study Results

No Results Posted as of Jan 21, 2013