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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mednax Center for Research, Education and Quality; Mednax Center for Research, Education, Quality and Safety
• Treatments: BB 1101; Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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