Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes (ACSinPROM Trial)

Phase 2 & 3

Waitlist Available

Led By Richard Porreco, MD

Research Sponsored by Pediatrix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up anytime during the pregnancy prior to birth (~ 9 months of pregnancy)

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

Preterm Birth
Premature Birth

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ anytime during the pregnancy prior to birth (~ 9 months of pregnancy)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Neonatal Morbidity

Secondary study objectives

Baby's Head Circumference

Baby's birth weight

Gestational age of baby

+8 more

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

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