Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Stony Brook University
• Treatments: BB 1101; Betamethasone; Betamethasone acetate phosphate; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.