← Back to Search

Corticosteroid

Betamethasone - ACTIVE for Premature Birth (ACSinPROM Trial)

Phase 2 & 3
Waitlist Available
Led By Richard Porreco, MD
Research Sponsored by Mednax Center for Research, Education, Quality and Safety
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants age 18 years or older
24w0d to 32w6d weeks gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Awards & highlights

ACSinPROM Trial Summary

This trial will compare the effects of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.

Eligible Conditions
  • Premature Birth

ACSinPROM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ACSinPROM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and anytime during the pregnancy prior to birth (~ 9 months of pregnancy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite Neonatal Morbidity
Secondary outcome measures
Baby's Head Circumference
Baby's birth weight
Gestational age of baby
+8 more

ACSinPROM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Betamethasone - ACTIVEExperimental Treatment1 Intervention
Booster Course of Antenatal Steroids consists of Betamethasone [12 mg intramuscular injection, 24 hours apart X 2 doses] or if unavailable may give Dexamethasone [6 mg intramuscularly 12 hours apart x 4 doses]
Group II: normal saline - PLACEBOPlacebo Group1 Intervention
Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Betamethasone - ACTIVE
2016
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

Mednax Center for Research, Education, Quality and SafetyLead Sponsor
36 Previous Clinical Trials
18,266 Total Patients Enrolled
10 Trials studying Premature Birth
1,895 Patients Enrolled for Premature Birth
PediatrixLead Sponsor
36 Previous Clinical Trials
18,266 Total Patients Enrolled
10 Trials studying Premature Birth
1,895 Patients Enrolled for Premature Birth
Richard Porreco, MDPrincipal InvestigatorPediatrix
3 Previous Clinical Trials
5,390 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~22 spots leftby Mar 2025