Repeat Antenatal Corticosteroids

S

Saint Louis University (SLU)

Status

Completed

Conditions

Antenatal Corticosteroids

Treatments

Other: Antenatal corticosteroids

Study type

Observational

Funder types

Other

Identifiers

NCT03133104
27833

Details and patient eligibility

About

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

Full 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.

Enrollment

182 patients

Sex

Female

Ages

13 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

pregnant women with preterm premature rupture of membranes

Exclusion criteria

Women who did not have preterm premature rupture of membranes

Trial design

182 participants in 2 patient groups

antenatal corticosteroids
Description:
Women who received a rescue dose of steroids
Treatment:
Other: Antenatal corticosteroids
No antenatal corticosteroids
Description:
Women who did not received a rescue dose of steroids

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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