Trial Outcomes & Findings for A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A (NCT NCT01973777)

Results Overview

The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

at 6-8 weeks

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	IUB Inserted There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device
Overall Study STARTED	51
Overall Study One Year Follow-up	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IUB Inserted n=51 Participants There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device
Age, Continuous	27 years n=99 Participants
Sex: Female, Male Female	51 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: at 6-8 weeks

The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus

Outcome measures

Outcome measures
Measure	IUB Inserted n=49 Participants There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device
Expulsion Rate	9 participants

SECONDARY outcome

Timeframe: 12 months

infection, perforation, pregnancy

Outcome measures

Outcome measures
Measure	IUB Inserted n=44 Participants There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device
Complication	1 participants

SECONDARY outcome

Timeframe: 12 months

patient-reported acceptability

Outcome measures

Outcome measures
Measure	IUB Inserted n=44 Participants There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device
Acceptability	15 participants

Adverse Events

IUB Inserted

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IUB Inserted n=51 participants at risk There is one arm of women who will have IUBs inserted IUB: intrauterine contraceptive device
Reproductive system and breast disorders expulsions	29.4% 15/51 • Number of events 15

Additional Information

Dr Ellen Wiebe

University of British Columbia

Phone: 6047095611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place