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 range

18 Years – 50 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Number of Days in the Neonatal Intensive Care Unit (NICU)

Timeframe: daily from birth of infant up to one year or discharge from the NICU, whichever occurred first

Trial details

NCT IDNCT02939742

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-20

Results submitted2025-03-25

View on ClinicalTrials.gov More PPROM trials