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NCT00163020 · ClinicalTrials.gov registry record · Phase 2
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
A Phase 2 study, sponsored by Obstetrix Medical Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 321
- Enrollment target
NCT00163020: Completed Phase 2 study, sponsored by Obstetrix Medical Group.
NCT00163020 is a Phase 2 study that has completed, run by Obstetrix Medical Group. The registered enrollment target is 321 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00163020, a Phase 2 study, has completed, sponsored by Obstetrix Medical Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 321 participants
- Enrollment target
Study Summary
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: 1. Twin pregnancy 2. Triplet pregnancy
Primary Outcome
Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measu
Interventions
- DRUG Placebo
- DRUG 17-alpha-hydroxyprogesterone caproate injectable
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2004-11 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00163020 record still lists
NCT00163020 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00163020 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00163020 about?
NCT00163020 is a clinical study titled "17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies". Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. This study involves two concurrent double-blinded randomized c...
What is the current status of trial NCT00163020?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2004-11. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00163020?
The interventions under investigation include: Placebo (DRUG), 17-alpha-hydroxyprogesterone caproate injectable (DRUG).
Who is sponsoring clinical trial NCT00163020?
This trial is sponsored by Obstetrix Medical Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00163020's enrollment target sits among peer trials
321 151st of 2000 higher than 1,849 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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