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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772381
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):
Noha Rabei, Ain Shams Maternity Hospital

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
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 : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

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 Name: Decadron

Primary Outcome Measures :
  1. Special care baby unit [ Time Frame: 24 hours ]
    Special care baby unit admission for babies with respiratory distress

Secondary Outcome Measures :
  1. Severity of respiratory distress [ Time Frame: 24 hours ]
    Severity of respiratory distress and the level of care in response

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772381

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

Responsible Party: Noha Rabei, Assistant Professor, Obstetrics and Gynecology, Ain Shams Maternity Hospital Identifier: NCT01772381     History of Changes
Other Study ID Numbers: noharabei
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Noha Rabei, 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
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