Repeat Antenatal Corticosteroids

Antenatal Corticosteroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133104
• Other study ID #: 27833
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: November 27, 2017
• Start date: January 5, 2017
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

Inclusion Criteria:

• pregnant women with preterm premature rupture of membranes

Exclusion Criteria:

• Women who did not have preterm premature rupture of membranes

Related Conditions & MeSH terms

• Antenatal Corticosteroids

Intervention

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

Locations

Country	Name	City	State
United States	St. Mary's Health Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant outcomes	infant birth weight	1 year