A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks' gestation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Obstetrix Medical Group
• Treatments: BB 1101; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 25 to 32 6/7 weeks gestation

• Singleton or twin gestation

• Received 1st course of betamethasone prior to 30 weeks' gestation

• Began 1st course of betamethasone at least 14 days prior to randomization

• Risk of delivery in next 7 days due to either maternal or fetal complication (e.g. preterm labor, severe preeclampsia, IUGR, etc.)

• Intact membranes

Exclusion Criteria:

• Known major fetal anomalies (eg: anencephaly, renal agenesis etc…)

• High order multiple gestation (triplets or higher)

• Cervical dilation > 5 cm

• Clinical chorioamnionitis prior to initiation of second course (two or more of the following; antepartum temperature > 38ºC (100.4ºF), uterine tenderness, foul smelling vaginal discharge or amniotic fluid, maternal tachycardia (>100beats/min), fetal tachycardia (>160 beats/min), or white blood cell count >20x109/L.define)

• Ruptured membranes prior to initiation of second course of betamethasone

• Already receiving corticosteroids for other conditions (e.g. Lupus, asthma)

• Maternal condition contraindicating the use of steroids (e.g. HIV, active Tuberculosis)

• Participation in conflicting study