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

NCT ID: NCT01772381

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Transient Tachypnea of the Newborn

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dexamethasone

Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

Long acting corticosteroid

Interventions

Dexamethasone

Long acting corticosteroid

Intervention Type: DRUG

Other Intervention Names

Decadron

Eligibility 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Noha Rabei

Assistant Professor, Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha H Rabei, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital

Locations

Ain Shams Maternity Hospital

Cairo, , Egypt

Countries

Egypt

References

Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.

Reference Type: DERIVED

PMID: 34935127 (View on PubMed)

Other Identifiers

noharabei

Identifier Type: -

Identifier Source: org_study_id