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Prevention of Preterm Birth With a Pessary in Twin Gestations (PoPPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056639
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description

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
Arm/Group Title Pessary No Pessary Total
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
23
 100.0%
46
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
23
 100.0%
23
 100.0%
46
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 23 participants 46 participants
23
 100.0%
23
 100.0%
46
 100.0%
1.Primary Outcome
Title Number of Participants With Preterm Delivery
Hide Description [Not Specified]
Time Frame Less than 34 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
9
  39.1%
8
  34.8%
2.Secondary Outcome
Title Average Birth Weight of Babies in Each Group
Hide Description The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.
Time Frame Time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description:
A biotec. pessary will be placed in subjects.
No pressary will be inserted and subjects will follow standard of care.
Overall Number of Participants Analyzed 23 23
Mean (Full Range)
Unit of Measure: grams
2190
(1115 to 2540)
2220
(1864 to 2583)
3.Secondary Outcome
Title Spontaneous Preterm Birth Rates
Hide Description [Not Specified]
Time Frame Less than 37 weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
12
  52.2%
12
  52.2%
4.Secondary Outcome
Title Number of Participants That Experienced Neonatal Death
Hide Description Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.
Time Frame Between birth and 28 days of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
4
  17.4%
3
  13.0%
5.Secondary Outcome
Title Number of Subjects Experiencing Chorioamnionitis
Hide Description Chorioamnionitis was recorded and analyzed for participants in each group.
Time Frame Time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
3
  13.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pessary No Pessary
Hide Arm/Group Description

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
All-Cause Mortality
Pessary No Pessary
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/23 (0.00%)    
Hide Serious Adverse Events
Pessary No Pessary
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/23 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pessary No Pessary
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/23 (13.04%)      1/23 (4.35%)    
Pregnancy, puerperium and perinatal conditions     
UTI *  3/23 (13.04%)  3 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bridget Nolan
Organization: University of Pennsylvania
Phone: 2156623324
EMail: bridget.nolan@uphs.upenn.edu
Layout table for additonal information
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