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NCT02056639 · ClinicalTrials.gov registry record · NA
Prevention of Preterm Birth With a Pessary in Twin Gestations
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT02056639: Completed NA study, sponsored by University of Pennsylvania.
NCT02056639 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02056639, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United States are twins, as are one in six infants who die in the first month of life. Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. There is currently no effective treatment to decrease the incidence of PTB in women with twin gestations, but there is some evidence that the use of a cervical pessary in women with a short cervix has promise. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.
Interventions
- DEVICE Bioteque cup pessary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-10 |
| Phase | NA |
What the finished NCT02056639 record still lists
NCT02056639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Bioteque cup pessary is the first listed.
NCT02056639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02056639 about?
NCT02056639 is a clinical study titled "Prevention of Preterm Birth With a Pessary in Twin Gestations". Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the Unit...
What is the current status of trial NCT02056639?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2014-02. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02056639?
The interventions under investigation include: Bioteque cup pessary (DEVICE).
Who is sponsoring clinical trial NCT02056639?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02056639's enrollment target sits among peer trials
46 1402nd of 2000 higher than 590 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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