Multiple versus single courses of antenatal corticosteroids for preterm birth: a pilot study

Area of Science:

• Obstetrics and Gynecology
• Neonatal Medicine
• Clinical Trial Design

Background:

• Antenatal corticosteroids (ACS) are crucial for fetal lung maturation in preterm birth risk.
• The optimal regimen for ACS, particularly multiple courses, remains under investigation.
• Concerns exist regarding potential adverse effects of repeated ACS exposure.

Purpose of the Study:

• To assess the feasibility of a multicenter trial on multiple ACS courses versus a single course.
• To evaluate the impact of multiple ACS courses on perinatal/neonatal outcomes and hormonal levels.
• To determine the risk of complications necessitating ACS discontinuation.

Main Methods:

• A randomized, double-masked, placebo-controlled trial design was proposed.
• Women at 24-30 weeks gestation at risk for preterm birth received weekly betamethasone or placebo.
• Recruitment occurred between 24-30 weeks gestation, continuing until 33 weeks or delivery.

Main Results:

• Low recruitment (15%) due to physician concerns about potential adverse effects of multiple ACS courses.
• No complications requiring ACS discontinuation were observed.
• No significant differences in cord blood or maternal plasma cortisol and ACTH levels between groups.

Conclusions:

• Physician and patient support is critical for the feasibility of multicenter trials on multiple ACS courses.
• A definitive multicenter randomized controlled trial is necessary to establish the benefits and risks.
• Current data suggest no significant hormonal alterations with multiple ACS courses in this pilot study.