Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

NCT00418353 | Completed

• 1 other identifier: 20024615
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Distress Syndrome; Intraventricular Hemorrhage; Neonatal Mortality

Keywords

Antenatal corticosteroids; Betamethasone; Dexamethasone; Premature

Outcome Measures

Primary Outcomes (3)

• Respiratory distress syndrome

• Intraventricular hemorrhage

• Neonatal mortality

Secondary Outcomes (3)

• Periventricular leukomalacia

• Necrotizing enterocolitis

• Neonatal sepsis

Interventions

Betamethasone(Celestone soluspan) and Dexamethasone DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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'.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Stony Brook University: collaborator

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 117913, United States

Location

Related Publications (1)

• Elimian A, Garry D, Figueroa R, Spitzer A, Wiencek V, Quirk JG. Antenatal betamethasone compared with dexamethasone (betacode trial): a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):26-30. doi: 10.1097/01.AOG.0000268281.36788.81.

  PMID: 17601892 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Andrew A Elimian, M.D

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: August 1, 2002
• Study Completion: April 1, 2005
• Last Updated: January 4, 2007

Record last verified: 2007-01

Locations

US (1)