NCT03133104

Repeat Antenatal Corticosteroids

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 182 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 13 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antenatal Corticosteroids

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2017-01-05
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-04-28
• Last updated: 2017-11-29

Locations

1 site across 1 country: United States