Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.

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

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate

Criteria

Inclusion Criteria:

• Maternal age ≥ 18 years

• Preterm premature rupture of membranes, demonstrated clinically by speculum exam

• Cervical dilation visually ≤ 5cm on sterile speculum exam

• Planned delivery at John Sealy Hospital (JSH)

• Gestational age of membrane rupture and initiation of first course of antenatal corticosteroids between 23 5/7 - 32 5/7 weeks

• Planned pregnancy continuation with no indication for delivery for at least 7 days

Exclusion Criteria:

• Maternal age > 50 years

• Gestational age < 23 5/7 weeks or > 32 5/7 weeks

• Known major congenital abnormalities, aneuploidy, or genetic syndrome

• Intrauterine fetal demise

• Any indication for expedited delivery

• Maternal chorioamnionitis

• Known allergy or adverse reaction to corticosteroids