Repeat Antenatal Corticosteroids

Completed

• Conditions: Antenatal Corticosteroids
• Interventions: Other: Antenatal corticosteroids

• Registration Number: NCT03133104
• Lead Sponsor: St. Louis University

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.

Study Timeline

• Study Start: 2017-01-05
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

• pregnant women with preterm premature rupture of membranes

Exclusion Criteria

• Women who did not have preterm premature rupture of membranes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antenatal corticosteroids	Antenatal corticosteroids	Women who received a rescue dose of steroids

Primary Outcome Measures

Name	Time	Method
Infant outcomes	1 year	infant birth weight

Trial Locations

Locations (1)

St. Mary's Health Center; 🇺🇸 Saint Louis, Missouri, United States