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Repeat Antenatal Corticosteroids

Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03133104
Enrollment
182
Registered
2017-04-28
Start date
2017-01-05
Completion date
2017-08-31
Last updated
2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal Corticosteroids

Brief summary

This study will review records of women who broke their water early who received a repeat course of antenatal steroids.

Detailed description

Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight. 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.

Interventions

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

Sponsors

St. Louis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* pregnant women with preterm premature rupture of membranes

Exclusion criteria

* Women who did not have preterm premature rupture of membranes

Design outcomes

Primary

MeasureTime frameDescription
Infant outcomes1 yearinfant birth weight

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026