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

This study has been completed.
Information provided by (Responsible Party):
Noha Rabei, Ain Shams Maternity Hospital Identifier:
First received: December 31, 2012
Last updated: January 18, 2013
Last verified: January 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 Intervention
Transient Tachypnea of the Newborn
Drug: Dexamethasone

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Resource links provided by NLM:

Further study details as provided by Ain Shams Maternity Hospital:

Primary Outcome Measures:
  • Special care baby unit [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Special care baby unit admission for babies with respiratory distress

Secondary Outcome Measures:
  • Severity of respiratory distress [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Severity of respiratory distress and the level of care in response

Enrollment: 600
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone
Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section
Drug: Dexamethasone
Long acting corticosteroid
Other Name: Decadron

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.

Ages Eligible for Study:   22 Years to 44 Years
Genders 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.
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Please refer to this study by its identifier: NCT01772381

Ain Shams Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital
Principal Investigator: Noha H Rabei, MD Ain Shams Maternity Hospital
  More Information

Responsible Party: Noha Rabei, Assistant Professor, Obstetrics and Gynecology, Ain Shams Maternity Hospital Identifier: NCT01772381     History of Changes
Other Study ID Numbers: noharabei 
Study First Received: December 31, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ain Shams Maternity Hospital:
Dexamethasone, term, elective cesarean section

Additional relevant MeSH terms:
Transient Tachypnea of the Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors processed this record on May 02, 2016