National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

A Randomized Placebo-Controlled Trial of
Antenatal Corticosteroid Regimens

Related Publications & Presentations

Objective

To test the hypothesis that in women < 32 weeks gestation who are atrisk for spontaneous preterm delivery and who remain pregnant more than withseven days after initial corticosteroid therapy, weekly re-administration of corticosteroids will decrease neonatal morbidity compared with a single course of corticosteroids.

Conclusion

Repeated exposure to antenatal corticosteroids significantly reduced specific neonatal morbidities but did not improve composite neonatal outcome. This was accompanied by a reduction in birth weight and an increase in small for gestational age infants.

Clinical Centers

Magee Womens, Tennessee, Alabama, Wayne State, Cincinnati, Wake Forest, Chicago, Ohio State, U of Miami, UTSW, Utah, MCP Hahnemann

Major Eligibility Criteria

• 24-31⁶ weeks gestation
• At risk for PTD with intact membranes
• Corticosteroid use in previous 7 days
• Informed consent

Groups

• Experimental:
• weekly 2 ml IM injection containing 12 mg betamethasone, q24 hours x 2 doses
• Placebo:
• Matching doses of placebo for betamethasone

Sample Size

• Goal = 2400 (1200/group)

Scheduled Evaluations/ Data Collection

• History
• Re-admissions, study visits for drug administration, labor and delivery, 6 weeks post-partum, NICU admission
• Maternal blood at randomization, after 3 courses, at delivery, cord blood and heelstick (100 neonates < 34 weeks at delivery)
• Neonatal anthropometrics
• ACTH Stimulation test (60 patients)
• Auditory Evoked Response test (130 patients)
• Neonatal cranial ultrasound
• Neurological examination at 24 months
• Neurological examination at 3 years (500 patients)

Management Protocols

• Coded medications:
• Betamethasone / placebo course weekly

Outcome Measures

• Primary:
• Composite outcome including neonatal mortality/stillbirth, severe RDS, chronic lung disease, grade III/IV IVH, PVL
• Secondary:
• Neonatal morbidity
• Maternal morbidity
• Neonatal growth parameters
• Infant neurological parameters

Timetable

• Randomization: 03/2000-03/2004
• Data Collection: 03/2000-05/2006
• Closeout/Final Analysis: 05/2006-11/2006