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CompletedNCT01772381Updated Jan 21, 2013

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

An interventional study of Dexamethasone in Transient Tachypnea of the Newborn, sponsored by Ain Shams Maternity Hospital. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-21.

Sponsored by Ain Shams Maternity Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
22 Years to 44 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Transient Tachypnea of the Newborn

Keywords

  • Dexamethasone, term, elective cesarean section
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In context

Tachypnea

39 studies on the registry are indexed under Tachypnea; 4 are open to participants now.

This study's enrollment of 600 is above the median of 100 across 30 interventional studies indexed under Tachypnea.

Browse Tachypnea studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 135 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Previous caesarean section
  • Complete 37 week calculated from the first day of the last menstrual period.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    Dexamethasone

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

    Drug: Dexamethasone

Interventions

  • DrugDexamethasone

    Long acting corticosteroid

    Also known as: Decadron

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What researchers measure

Primary outcomes

  1. Special care baby unit

    Special care baby unit admission for babies with respiratory distress

    Time frame: 24 hours

Secondary outcomes

  1. Severity of respiratory distress

    Severity of respiratory distress and the level of care in response

    Time frame: 24 hours

07

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
08

References and documents

Publications

  • 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. PubMed 34935127 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01772381
Lead sponsor
Ain Shams Maternity Hospital
Responsible party
Noha Rabei (Assistant Professor, Obstetrics and Gynecology, Ain Shams Maternity Hospital) — Principal investigator
First posted
Jan 21, 2013
Start date
Mar 2010
Primary completion
Mar 2011
Completion
Jun 2011
Last update
Jan 21, 2013

Study contacts

Noha H Rabei, MD
principal investigator · Ain Shams Maternity Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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