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Completed

NCT Number: NCT01772381

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

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.

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Key information

Conditions

Transient Tachypnea of the Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea

Age range

22 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Long acting corticosteroid

Other names: Decadron

Primary outcomes

  1. Special care baby unit

    Time frame: 24 hours

    Special care baby unit admission for babies with respiratory distress

Secondary outcomes

  1. Severity of respiratory distress

    Time frame: 24 hours

    Severity of respiratory distress and the level of care in response

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2013
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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