Trial Outcomes & Findings for Prevention of Preterm Birth With a Pessary in Singleton Gestations (NCT NCT02056652)

NCT ID: NCT02056652

Last Updated: 2018-05-29

Results Overview

Birth before 37 weeks gestation was captured.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)
• 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 23 6/7 weeks gestation, and will be removed during the 37th 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	61	61
Overall Study COMPLETED	60	58
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Pessary 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 No pessary will be used. Subjects will receive standard obstetrical management
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Prevention of Preterm Birth With a Pessary in Singleton Gestations

Baseline characteristics by cohort

Measure	Pessary n=61 Participants 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 n=61 Participants No pessary will be used. Subjects will receive standard obstetrical management	Total n=122 Participants Total of all reporting groups
Age, Customized Maternal Age	27.7 years n=5 Participants	29.5 years n=7 Participants	28.6 years n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	61 Participants n=7 Participants	122 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	61 Participants n=5 Participants	61 Participants n=7 Participants	122 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)

Birth before 37 weeks gestation was captured.

Outcome measures

Measure	Pessary n=60 Participants 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 n=58 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Subjects Experiencing Preterm Birth	26 Participants	23 Participants

SECONDARY outcome

Timeframe: Time of delivery

The birth weights of babies born in the pessary group was compared to those born in the no pessary group

Outcome measures

Measure	Pessary n=60 Participants 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 n=58 Participants No pessary will be used. Subjects will receive standard obstetrical management
Average Birth Weight of Babies Born on Trial	2788 grams Interval 1285.0 to 3188.0	2843 grams Interval 1035.0 to 3329.0

SECONDARY outcome

Timeframe: Before 37 weeks gestation

The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.

Outcome measures

Measure	Pessary n=60 Participants 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 n=58 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Participants That Experienced Spontaneous Preterm Births on Trial	23 Participants	19 Participants

SECONDARY outcome

Timeframe: Less than 34 weeks gestation

Rupture of membranes before 34 weeks gestation was captured in each group.

Outcome measures

Measure	Pessary n=60 Participants 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 n=58 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Participants Experiencing Spontaneous Rupture of Membranes	18 Participants	10 Participants

SECONDARY outcome

Timeframe: Between birth and 28 days of age

Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.

Outcome measures

Measure	Pessary n=60 Participants 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 n=58 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Subjects Experiencing Neonatal Death	3 Participants	6 Participants

SECONDARY outcome

Timeframe: Time of delivery

The AE of Chorioamnionitis was captured for each group.

Outcome measures

Measure	Pessary n=60 Participants 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 n=58 Participants No pessary will be used. Subjects will receive standard obstetrical management
Number of Subjects Experiencing Chorioamnionitis	7 Participants	4 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: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pessary n=61 participants at risk 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 n=61 participants at risk No pessary will be used. Subjects will receive standard obstetrical management
Pregnancy, puerperium and perinatal conditions Bacterial Vaginosis	4.9% 3/61 • Number of events 3	9.8% 6/61 • Number of events 6

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