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Effectiveness of ACS in Extreme Preemies

NCT02351310 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-03-14

No results posted yet for this study

Summary

This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs. placebo in singleton pregnancies who are threatening to deliver prematurely between 22 0/7 and 23 6/7 weeks on admission with the goal of improving composite neonatal mortality and morbidity.

Conditions

  • Preterm Labor
  • Premature Birth

Interventions

GENETIC

Placebo

Course of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart).

DRUG

Betamethasone

Course of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart)

Sponsors & Collaborators

  • Pediatrix

    lead OTHER

Principal Investigators

  • Thomas J Garite, MD · Pediatrix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02351310 on ClinicalTrials.gov