CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 437 enrolled
Drug / intervention
Betamethasone or Dexamethasone (2nd course of ACS) +1 moredrug
Likely dose
Betamethasone or Dexamethasone second course (specific dose not detailed in trial record)AI-extracted
Key inclusion· 6
  • ✓Gestational age 25 to 32+6 weeks
  • ✓Singleton or twin pregnancy
  • ✓Received first course of betamethasone prior to 30 weeks gestation
  • ✓At least 14 days have passed since starting first betamethasone course
Key exclusion· 7
  • ✕Known major fetal anomalies (anencephaly, renal agenesis, etc.)
  • ✕High-order multiple gestation (triplets or higher)
  • ✕Cervical dilation >5 cm
  • ✕Clinical chorioamnionitis prior to second course (defined by ≥2 of: temperature >38°C, uterine tenderness, foul-smelling discharge, maternal heart rate >100 bpm, fetal heart rate >160 bpm, WBC >20×10⁹/L)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00201643
NCT00201643Phase 4Completed
CompareCT.gov

A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome

Obstetrix Medical Group·interventional·Posted Sep 20, 2005·Updated Jan 7, 2015

In Brief

A Phase 4 clinical trial evaluating Betamethasone or Dexamethasone (2nd course of ACS) and Placebo for Preterm Delivery. Completed, enrolled 437 participants across 22 sites.

Detailed Summary

The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks' gestation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Delivery
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartNov 1, 2003
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Betamethasone or Dexamethasone (2nd course of ACS)drug

Course of Betamethasone or Dexamethasone

Placebodrug

Course of Placebo (NS)