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Completed

NCT Number: NCT03133104

Repeat Antenatal Corticosteroids

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

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Key information

Age range

13 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Mary's Health Center

St Louis, Missouri, 63117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women with preterm premature rupture of membranes

Exclusion criteria

  • Women who did not have preterm premature rupture of membranes

Treatment and study plan

Antenatal corticosteroids

Other

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

Primary outcomes

  1. Infant outcomes

    Time frame: 1 year

    infant birth weight

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2017
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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