Effect of Antenatal Corticosteroids in Late Preterm
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
To test the effect on premature infants of a one-time course of betamethasone administered in weeks 34-36 of gestation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 19, 2012
October 1, 2012
2 years
October 17, 2012
October 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neonate respiratory distress syndrome
1 year
Secondary Outcomes (1)
1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications
1 week
Study Arms (2)
betamethasoneb, 34-36 weeks, preterm labor
EXPERIMENTALbetamethasone 12 mg 2 injections will be given 24-hours apart.
preterm labor, 34-37 weeks
NO INTERVENTIONbetamethasone 12 mg 2 injections will be given 24-hours apart.
Interventions
Eligibility Criteria
You may qualify if:
- \. Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to enhance fetal lung maturity during pregnancy 2. Clinical, sonographic or laboratory suspicion of premature labor 3. Singleton or twin pregnancy
You may not qualify if:
- Premature rupture of membranes
- Fetus with known defects
- Suspicion of fetal distress
- Betamethasone administered during pregnancy for any reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2012
First Posted
October 19, 2012
Study Start
November 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2015
Last Updated
October 19, 2012
Record last verified: 2012-10