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Prevention of Preterm Birth With a Pessary in Singleton Gestations (PoPPS)

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ClinicalTrials.gov Identifier: NCT02056652
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : May 28, 2018
Last Update Posted : May 28, 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 Preterm Birth
Short Cervix
Intervention Device: Bioteque cup pessary
Enrollment 122
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 23 6/7 weeks gestation, and will be removed during the 37th 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 61 61
Completed 60 58
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             0             3
Arm/Group Title Pessary No Pessary Total
Hide Arm/Group Description

Use of the Bioteque cup pessary. Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th 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 61 61 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Maternal Age Number Analyzed 61 participants 61 participants 122 participants
27.7
(23.0 to 32.3)
29.5
(23.0 to 34.8)
28.6
(23.0 to 34.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Female
61
 100.0%
61
 100.0%
122
 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 61 participants 61 participants 122 participants
61
 100.0%
61
 100.0%
122
 100.0%
1.Primary Outcome
Title Number of Subjects Experiencing Preterm Birth
Hide Description Birth before 37 weeks gestation was captured.
Time Frame Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)
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 23 6/7 weeks gestation, and will be removed during the 37th 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 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
26
  43.3%
23
  39.7%
2.Secondary Outcome
Title Average Birth Weight of Babies Born on Trial
Hide Description The birth weights of babies born in the pessary group was compared to those born in the no pessary 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 23 6/7 weeks gestation, and will be removed during the 37th 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 60 58
Mean (Full Range)
Unit of Measure: grams
2788
(1285 to 3188)
2843
(1035 to 3329)
3.Secondary Outcome
Title Number of Participants That Experienced Spontaneous Preterm Births on Trial
Hide Description The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.
Time Frame Before 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 23 6/7 weeks gestation, and will be removed during the 37th 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 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
23
  38.3%
19
  32.8%
4.Secondary Outcome
Title Number of Participants Experiencing Spontaneous Rupture of Membranes
Hide Description Rupture of membranes before 34 weeks gestation was captured in each group.
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 23 6/7 weeks gestation, and will be removed during the 37th 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 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
18
  30.0%
10
  17.2%
5.Secondary Outcome
Title Number of Subjects Experiencing Neonatal Death
Hide Description Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.
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 23 6/7 weeks gestation, and will be removed during the 37th 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 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.0%
6
  10.3%
6.Secondary Outcome
Title Number of Subjects Experiencing Chorioamnionitis
Hide Description The AE of Chorioamnionitis was captured for 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 23 6/7 weeks gestation, and will be removed during the 37th 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 60 58
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.7%
4
   6.9%
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 23 6/7 weeks gestation, and will be removed during the 37th 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   0/61 (0.00%)      0/61 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pessary No Pessary
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/61 (0.00%)    
Show Other (Not Including Serious) Adverse Events 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   3/61 (4.92%)      6/61 (9.84%)    
Pregnancy, puerperium and perinatal conditions     
Bacterial Vaginosis * [1]  3/61 (4.92%)  3 6/61 (9.84%)  6
*
Indicates events were collected by non-systematic assessment
[1]
BV was accessed in both groups
Our main limitation was the small sample size due to the fact that the study was stopped before planned enrollment was completed. In order to reach significance, we would need for the next 60 subjects randomized to the pessary group.
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
Name/Title: Bridget Nolan
Organization: University of Pennsylvania
Phone: 2156623324
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02056652     History of Changes
Other Study ID Numbers: 817797
First Submitted: February 4, 2014
First Posted: February 6, 2014
Results First Submitted: October 24, 2017
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018