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NCT00201643 · ClinicalTrials.gov registry record · Phase 4
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
A Phase 4 study of Preterm Delivery, sponsored by Obstetrix Medical Group.
- Completed
- Registry status
- Phase 4
- Development phase
- 437
- Enrollment target
- 20
- Study locations
NCT00201643: Completed Phase 4 study of Preterm Delivery, sponsored by Obstetrix Medical Group.
NCT00201643 is a Phase 4 study of Preterm Delivery that has completed, run by Obstetrix Medical Group. The registered enrollment target is 437 participants, below the 487-participant average among 4 other Preterm Delivery trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00201643, a Phase 4 study of Preterm Delivery, has completed, sponsored by Obstetrix Medical Group.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 437 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
This outcome measured the total number of neonates with Composite Neonatal morbidity who delivered at \< 34 weeks gestation. Composite Morbidity consisted of respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Betamethasone or Dexamethasone (2nd course of ACS)
Study Locations (20)
California
- Saddleback Memorial Medical Center - Laguna Hills
- Long Beach Memorial Medical Center - Long Beach
- University of Sourthern California-Irvine Medical Center - Orange
- Good Samaritan Hospital - San Jose
Colorado
- Swedish Medical Center - Denver
- Presbyterian/St Luke's Hospital - Denver
- Rose Medical Center - Denver
- Skyridge Medical Center - Lonetree
Arizona
- Desert Good Samaritan Hospital - Mesa
- Banner Good Sammaritan Hospital - Phoenix
- Tucson Medical Center - Tucson
Missouri
- Saint Luke's Hospital, Kansas City - Kansas City
- Saint John's Regional Health Center - Springfield
Nevada
- University Med. Ctr. of Southern Nevada - Las Vegas
- Sunrise Medical Center - Las Vegas
Tennessee
- Erlanger Medical Center - Chattanooga
- University of Tennessee Medical Center - Knoxville
Iowa
- Mercy Medical Center - Des Moines
Massachusetts
- Tufts-New England Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2003-11 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
What the finished NCT00201643 record still lists
NCT00201643 is an interventional study that assigns participants to a tested intervention. The registered 437 participants enrollment target is mid-sized for trials with a published cap, below the 487-participant average among 4 other Preterm Delivery trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Preterm Delivery appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00201643 names 20 study sites across 9 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT00201643 about?
NCT00201643 is a clinical study titled "A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome". 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.
What is the current status of trial NCT00201643?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 437 participants. The study started on 2003-11. Estimated completion is 2008-02.
What conditions does trial NCT00201643 study?
This clinical trial studies the following conditions: Preterm Delivery.
What interventions are being tested in trial NCT00201643?
The interventions under investigation include: Placebo (DRUG), Betamethasone or Dexamethasone (2nd course of ACS) (DRUG).
Who is sponsoring clinical trial NCT00201643?
This trial is sponsored by Obstetrix Medical Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00201643 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Iowa, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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