Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
182 participants
OBSERVATIONAL
2017-01-05
2017-08-31
Brief Summary
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Detailed Description
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Current guidelines recommend two doses of ANCS administered 24 hours apart as a single "course." A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM.
One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately.
The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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antenatal corticosteroids
Women who received a rescue dose of steroids
Antenatal corticosteroids
Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods
No antenatal corticosteroids
Women who did not received a rescue dose of steroids
No interventions assigned to this group
Interventions
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Antenatal corticosteroids
Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
13 Years
55 Years
FEMALE
No
Sponsors
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St. Louis University
OTHER
Responsible Party
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Cara Buskmiller, MD
Principal Investigator
Principal Investigators
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Cara Buskmiller, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Locations
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St. Mary's Health Center
St Louis, Missouri, United States
Countries
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Other Identifiers
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27833
Identifier Type: -
Identifier Source: org_study_id