TerminatedPhase 2/3

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

Stopped: Low study recruitment

United States33 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Length of stay in the neonatal intensive care unit (NICU)

Timeframe: daily from birth of infant up to one year

Trial details

NCT IDNCT02939742

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-20

View on ClinicalTrials.gov More PPROM trials