Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?

15-0280

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.

2016-11-01

2023-12-20

2023-12-20

Terminated

Early phase I

33

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}

2024-01-26