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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Noha Rabei, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT01772381
First received: December 31, 2012
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   22 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772381

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

No publications provided

Responsible Party: Noha Rabei, Assistant Professor, Obstetrics and Gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov 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:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013