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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00418353
Other study ID # 20024615
Secondary ID
Status Completed
Phase N/A
First received January 2, 2007
Last updated January 2, 2007
Start date August 2002
Est. completion date April 2005

Study information

Verified date January 2007
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.


Description:

We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University Hospital from August 1, 2002 through July 31, 2004. We excluded women with clinical chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical indications, quadruplets and higher order multiple gestation and those who declined enrollment. Consenting women were randomly allocated to one of two groups by the Pharmacy using computer generated random numbers. The statistical analysis was performed in accordance of the intention-to-treat principle. Student t test, Chi square and Fisher exact test were used for analysis. A P value of < .05 was considered statistically significant.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Women in preterm labor with intact membranes

- Women with preterm premature rupture of membranes

- Women been delivered for fetal and maternal indications

- Gestational age between 24 and 33 6/7 weeks’.

Exclusion Criteria:

- Clinical chorioamnionitis

- known major fetal structural anomalies,

- known fetal chromosomal abnormalities,

- prior antenatal steroid exposure,

- quadruplets and higher order multiple gestation

- Women who declined enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Betamethasone(Celestone soluspan) and Dexamethasone


Locations

Country Name City State
United States Stony Brook University Hospital Stony Brook New York

Sponsors (2)

Lead Sponsor Collaborator
University of Oklahoma Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory distress syndrome
Primary Intraventricular hemorrhage
Primary Neonatal mortality
Secondary Periventricular leukomalacia
Secondary Necrotizing enterocolitis
Secondary Neonatal sepsis
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