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

Information source: Ain Shams Maternity Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transient Tachypnea of the Newborn

Intervention: Dexamethasone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ain Shams Maternity Hospital

Official(s) and/or principal investigator(s):
Noha H Rabei, MD, Principal Investigator, Affiliation: Ain Shams Maternity Hospital

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.

Clinical Details

Official title: Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Special care baby unit

Secondary outcome: Severity of respiratory distress

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

Minimum age: 22 Years. Maximum age: 44 Years. Gender(s): Female.

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.

Locations and Contacts

Ain Shams Maternity Hospital, Cairo, Egypt
Additional Information

Starting date: March 2010
Last updated: January 18, 2013

Page last updated: August 23, 2015

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