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

• 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: University of Pennsylvania
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Pessary	No Pessary
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

Baseline Characteristics

Arm/Group Title		Pessary	No Pessary	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Preterm Delivery
Description	[Not Specified]
Time Frame	Less than 34 weeks gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pessary	No Pessary
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pessary	No Pessary
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
Description	[Not Specified]
Time Frame	Less than 37 weeks gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pessary	No Pessary
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pessary	No Pessary
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
Description	Chorioamnionitis was recorded and analyzed for participants in each group.
Time Frame	Time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pessary	No Pessary
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%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Pessary		No Pessary
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%)
Serious Adverse Events
	Pessary		No Pessary
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0.00%)		0/23 (0.00%)
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

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

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
• 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