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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Conditions
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Transient Tachypnea of the Newborn

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section | Drug: Dexamethasone<br>* Long acting corticosteroid<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Special care baby unit | Special care baby unit admission for babies with respiratory distress | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of respiratory distress | Severity of respiratory distress and the level of care in response | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, term, elective cesarean section