Trial Outcomes & Findings for Postplacental Mirena IUD Insertion and Estimating Expulsion Rates. (NCT NCT01230242)
NCT ID: NCT01230242
Last Updated: 2021-12-17
Results Overview
Number of participants who expelled IUDs by12 weeks postpartum across all participants
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
up to 12 weeks postpartum
Results posted on
2021-12-17
Participant Flow
Only 4 subjects were consented out of the 20. Of those 4 only 3 had the IUD inserted.
Participant milestones
| Measure |
Mirena IUD Placement Immediately Post-delivery
Subjects to have Mirena IUD Placement Immediately Post-delivery
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Mirena IUD Placement Immediately Post-delivery
Subjects to have Mirena IUD Placement Immediately Post-delivery
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.
Baseline characteristics by cohort
| Measure |
Mirena IUD Placement Immediately Post-delivery
n=4 Participants
Subjects to have Mirena IUD Placement Immediately Post-delivery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks postpartumNumber of participants who expelled IUDs by12 weeks postpartum across all participants
Outcome measures
| Measure |
Mirena IUD Placement Immediately Post-delivery
n=4 Participants
Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.
Levonorgestrel Intrauterine Device: levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
|
|---|---|
|
Number of Participants Who Expelled IUDs by12 Weeks Postpartum
|
1 Participants
|
Adverse Events
Mirena IUD Placement Immediately Post-delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place