Antenatal Corticosteroids Clinical Trial
Official title:
Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes
This study will review records of women who broke their water early who received a repeat course of antenatal steroids.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03668860 -
India Dexamethasone and Betamethasone
|
Phase 1 |