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Corticosteroid

Betamethasone for Pregnancy (ALPS Trial)

Phase 3
Waitlist Available
Led By Rebecca Clifton, PhD
Research Sponsored by The George Washington University Biostatistics Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery through hospital discharge
Awards & highlights

ALPS Trial Summary

This study is evaluating whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant.

Eligible Conditions
  • Pregnancy
  • Premature Birth
  • Respiratory Distress Syndrome
  • Pregnancy Outcomes

ALPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neonatal Composite Outcome
Secondary outcome measures
Birth Weight
Birth Weight Less Than 10th Percentile
Gestational Age at Delivery
+25 more

ALPS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: BetamethasoneActive Control1 Intervention
A course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart
Group II: PlaceboPlacebo Group1 Intervention
A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,811,275 Total Patients Enrolled
The George Washington University Biostatistics CenterLead Sponsor
23 Previous Clinical Trials
100,129 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,967 Previous Clinical Trials
2,670,066 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
New England Journal of MedicineJournal
Antenatal Betamethasone for Women at Risk for Late Preterm Delivery
Gyamfi-Bannerman, Cynthia, Elizabeth A. Thom, Sean C. Blackwell, Alan T.N. Tita, Uma M. Reddy, George R. Saade, Dwight J. Rouse, et al.. 2016. “Antenatal Betamethasone for Women at Risk for Late Preterm Delivery”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1516783.
clinicaltrials.govStudy
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
2010. "Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01222247.
~194 spots leftby May 2025
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