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

Primary Purpose

Transient Tachypnea of the Newborn

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transient Tachypnea of the Newborn focused on measuring Dexamethasone, term, elective cesarean section

Eligibility Criteria

22 Years - 44 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexamethasone

Arm Description

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

Outcomes

Primary Outcome Measures

Special care baby unit
Special care baby unit admission for babies with respiratory distress

Secondary Outcome Measures

Severity of respiratory distress
Severity of respiratory distress and the level of care in response

Full Information

First Posted
December 31, 2012
Last Updated
January 18, 2013
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01772381
Brief Title
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
Official Title
Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of the Newborn
Keywords
Dexamethasone, term, elective cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone, im , 12 mg twice, 12 hrs apart, 48 hrs before elective cesarean section
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Long acting corticosteroid
Primary Outcome Measure Information:
Title
Special care baby unit
Description
Special care baby unit admission for babies with respiratory distress
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Severity of respiratory distress
Description
Severity of respiratory distress and the level of care in response
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha H Rabei, MD
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
34935127
Citation
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.
Results Reference
derived

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

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