Trial Outcomes & Findings for Prevention of Preterm Birth With a Pessary in Twin Gestations (NCT NCT02056639)

NCT ID: NCT02056639

Last Updated: 2018-05-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Less than 34 weeks gestation
• Results posted on: 2018-05-29

Participant Flow

Participant milestones

Measure	Pessary 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 No pessary will be used. Subjects will receive standard obstetrical management
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Preterm Birth With a Pessary in Twin Gestations

Baseline characteristics by cohort

Measure	Pessary n=23 Participants 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 n=23 Participants No pessary will be used. Subjects will receive standard obstetrical management	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: Less than 34 weeks gestation

Outcome measures

Measure	Pessary n=23 Participants 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 n=23 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Participants With Preterm Delivery	9 Participants	8 Participants

SECONDARY outcome

Timeframe: Time of delivery

The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.

Outcome measures

Measure	Pessary n=23 Participants 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 n=23 Participants No pessary will be used. Subjects will receive standard obstetrical management
Average Birth Weight of Babies in Each Group	2190 grams Interval 1115.0 to 2540.0	2220 grams Interval 1864.0 to 2583.0

SECONDARY outcome

Timeframe: Less than 37 weeks gestation

Outcome measures

Measure	Pessary n=23 Participants 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 n=23 Participants No pessary will be used. Subjects will receive standard obstetrical management
Spontaneous Preterm Birth Rates	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.

Outcome measures

Measure	Pessary n=23 Participants 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 n=23 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Participants That Experienced Neonatal Death	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Time of delivery

Chorioamnionitis was recorded and analyzed for participants in each group.

Outcome measures

Measure	Pessary n=23 Participants 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 n=23 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Subjects Experiencing Chorioamnionitis	3 Participants	0 Participants

Adverse Events

Pessary

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

No Pessary

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pessary n=23 participants at risk 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 n=23 participants at risk No pessary will be used. Subjects will receive standard obstetrical management
Pregnancy, puerperium and perinatal conditions UTI	13.0% 3/23 • Number of events 3	4.3% 1/23 • Number of events 1

Additional Information

Bridget Nolan

University of Pennsylvania

Phone: 2156623324

Email: bridget.nolan@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place