Could a second dose of steroids help premature babies breathe easier?
NCT ID NCT02939742
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study investigates whether giving a repeat course of betamethasone, a steroid, to pregnant women with preterm premature rupture of membranes (PPROM) can improve health outcomes for their premature babies. The main goal is to see if it shortens the baby's stay in the neonatal intensive care unit (NICU) and reduces overall complications like respiratory distress. The trial compares a second course of betamethasone against a placebo in women who have already received one standard course.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Betamethasone (a corticosteroid)
- What this could lead to
- If effective, a repeat course of betamethasone could reduce the time premature babies spend in the NICU and lower their risk of breathing problems and other complications.
- What could go wrong
- This is a small, early-phase study, so results may not be conclusive. Corticosteroids carry risks for both mother and baby, and the benefits of a repeat course are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
33 people
The number who actually took part.
- Start date
-
Nov 2016
- Finished
-
Dec 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas Medical Branch in Galveston
Galveston, Texas, 77555, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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