Effectiveness of ACS in Extreme Preemies

• Status: Withdrawn
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and morbidity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mednax Center for Research, Education and Quality; Mednax Center for Research, Education, Quality and Safety
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion Criteria:

• 18 years of age at time of study entry

• Gestational age between 22 0/7 to 23 6/7 weeks, inclusive at time of randomization regardless of whether the provider and patient decide to consider the fetus viable and provide obstetric interventions and cesarean section if needed.

• Singleton pregnancy

• Threatening to deliver by the best estimate of the clinician within the ensuing week

• Thought by the clinician to be able to delay delivery at least 3 hours from the time of randomization.

• Desired Pregnancy

• All clinical complications related to or leading to delivery except those listed as exclusion criteria are eligible. All of the following clinical complications are eligible including but not limited to:

• premature labor,

• incompetent cervix with or without prolapsing membranes,

• Preterm Premature Rupture of the membranes (PPROM),

• chorioamnionitis,

• all hypertensive disorders of pregnancy,

• vaginal bleeding due to placenta previa, abruption or unknown etiology,

• being delivered for medical complication of pregnancy, and others.

Exclusion Criteria:

• Maternal history of insulin dependent diabetes

• Known congenital fetal anomaly

• Known Hydrops fetalis with this current pregnancy

• Severe intrauterine growth restriction < 10% percentile

• Patient receiving corticosteroids for other maternal indications other than for fetal lung maturity

• Patient with h/o HIV or active Tuberculosis.

• Any other known contraindication to corticosteroids