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

Pediatrix

Status and phase: Completed; Phase 3; Phase 2

Conditions: Premature Birth

Treatments: Other: Normal Saline - PLACEBO; Drug: Betamethasone - ACTIVE

Study type: Interventional

Funder types: Other

Identifiers

NCT02469519

OBX0034

Details and patient eligibility

About

This trial hopes to prospectively evaluate the impact 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.

Full description

This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.

Enrollment: 194 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants age 18 years or older
• 24w0d to 32w6d weeks gestation
• Singleton pregnancy
• Received first course of ACS at or prior to 31w6d gestation
• Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization
• Expectant management planned
• Premature Ruptured membranes (PROM) before onset of labor

Exclusion criteria

• Known major fetal anomalies
• Multiple gestation
• Not a candidate for expectant management
• Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9
• Already receiving corticosteroids for another condition
• Any contraindications to the maternal use of corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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194 participants in 2 patient groups, including a placebo group

Betamethasone - ACTIVE

Experimental group

Description:

Booster Course of Antenatal Steroids consists of Betamethasone \[12 mg intramuscular injection, 24 hours apart X 2 doses\] or if unavailable may give Dexamethasone \[6 mg intramuscularly 12 hours apart x 4 doses\]

Treatment:

Drug: Betamethasone - ACTIVE

normal saline - PLACEBO

Placebo Comparator group

Description:

Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.

Treatment:

Other: Normal Saline - PLACEBO