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

A

Ain Shams Maternity Hospital

Status

Completed

Conditions

Transient Tachypnea of the Newborn

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT01772381
noharabei

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 patients

Sex

Female

Ages

22 to 44 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

Dexamethasone
Experimental group
Description:
Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section
Treatment:
Drug: Dexamethasone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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