Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 31, 2012
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedJanuary 21, 2013
January 1, 2013
1 year
December 31, 2012
January 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Special care baby unit
Special care baby unit admission for babies with respiratory distress
24 hours
Secondary Outcomes (1)
Severity of respiratory distress
24 hours
Study Arms (1)
Dexamethasone
EXPERIMENTALDexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section
Interventions
Eligibility Criteria
You may qualify if:
- Previous caesarean section
- Complete 37 week calculated from the first day of the last menstrual period.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams Maternity Hospital
Cairo, Egypt
Related Publications (1)
Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.
PMID: 34935127DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noha H Rabei, MD
Ain Shams Maternity Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Obstetrics and Gynecology
Study Record Dates
First Submitted
December 31, 2012
First Posted
January 21, 2013
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
January 21, 2013
Record last verified: 2013-01