Prevention of Preterm Birth With a Pessary in Twin Gestations (PoPPT)
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ClinicalTrials.gov Identifier: NCT02056639 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
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Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
University of Pennsylvania
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Conditions |
Premature Birth Short Cervix |
Intervention |
Device: Bioteque cup pessary |
Enrollment | 46 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Pessary | No Pessary |
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Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) Bioteque cup pessary |
No pessary will be used. Subjects will receive standard obstetrical management |
Period Title: Overall Study | ||
Started | 23 | 23 |
Completed | 23 | 23 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Pessary | No Pessary | Total | |
---|---|---|---|---|
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Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated) Bioteque cup pessary |
No pessary will be used. Subjects will receive standard obstetrical management | Total of all reporting groups | |
Overall Number of Baseline Participants | 23 | 23 | 46 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 23 participants | 46 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Between 18 and 65 years |
23 100.0%
|
23 100.0%
|
46 100.0%
|
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 23 participants | 46 participants | |
Female |
23 100.0%
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23 100.0%
|
46 100.0%
|
|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 23 participants | 23 participants | 46 participants |
23 100.0%
|
23 100.0%
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46 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
The main limitation of our study was the fact that it was stopped before planned enrollment was complete, which resulted in a small sample size.
More Information
Results Point of Contact
Name/Title: | Bridget Nolan |
Organization: | University of Pennsylvania |
Phone: | 2156623324 |
EMail: | bridget.nolan@uphs.upenn.edu |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02056639 |
Other Study ID Numbers: |
819122 |
First Submitted: | February 4, 2014 |
First Posted: | February 6, 2014 |
Results First Submitted: | October 24, 2017 |
Results First Posted: | May 29, 2018 |
Last Update Posted: | May 29, 2018 |