Trial Outcomes & Findings for Insertion of an Intrauterine Device (IUD) After Medical Abortion (NCT NCT00621543)
NCT ID: NCT00621543
Last Updated: 2011-07-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Three months
Results posted on
2011-07-14
Participant Flow
Participant milestones
| Measure |
Observation- All Subjects
Women choosing intra-uterine contraception after medical abortion.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Observation- All Subjects
Women choosing intra-uterine contraception after medical abortion.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
Baseline Characteristics
Insertion of an Intrauterine Device (IUD) After Medical Abortion
Baseline characteristics by cohort
| Measure |
Observation- All Subjects
n=120 Participants
Women choosing intra-uterine contraception after medical abortion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
28 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three monthsOutcome measures
| Measure |
Single Arm Study
n=97 Participants
|
|---|---|
|
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
|
4 percentage of participants
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Single Arm Study
n=97 Participants
|
|---|---|
|
Percentage of Women Continuing IUD Use at 3 Months
|
80. percentage of participants
Interval 74.0 to 86.0
|
Adverse Events
Observation- All Subjects
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