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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: 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 ]
    Special care baby unit admission for babies with respiratory distress

Secondary Outcome Measures:
  • Severity of respiratory distress [ Time Frame: 24 hours ]
    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   (Adult)
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.
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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

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

Additional relevant MeSH terms:
Transient Tachypnea of the Newborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Distress Syndrome, Newborn
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017