Trial Outcomes & Findings for Patient Compliance With Long-Acting Reversible Contraception Administration (NCT NCT03305081)
NCT ID: NCT03305081
Last Updated: 2021-01-22
Results Overview
The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
6 months
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Immediate or Early Placement
Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
Interval Placement
Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
20
|
|
Overall Study
COMPLETED
|
15
|
5
|
|
Overall Study
NOT COMPLETED
|
10
|
15
|
Reasons for withdrawal
| Measure |
Immediate or Early Placement
Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
Interval Placement
Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Immediate or Early Placement
n=25 Participants
Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
Interval Placement
n=20 Participants
Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=25 Participants
|
19 Participants
n=20 Participants
|
42 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=25 Participants
|
20 Participants
n=20 Participants
|
45 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
20 participants
n=20 Participants
|
45 participants
n=45 Participants
|
|
Patients Presenting to the Office or Hospital
|
25 Participants
n=25 Participants
|
20 Participants
n=20 Participants
|
45 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.
Outcome measures
| Measure |
Immediate or Early Placement
n=25 Participants
Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
Interval Placement
n=20 Participants
Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
|---|---|---|
|
Number of Women With Placement of LARC
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 Weeks, 12 weeks postpartum, 6 months postpartumNumber of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, "Are you satisfied with this form of contraception?". Satisfaction determined if subject answers "Yes". A single value was calculated at the end of the study by summation at all three time points.
Outcome measures
| Measure |
Immediate or Early Placement
n=25 Participants
Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
Interval Placement
n=15 Participants
Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception
|
|---|---|---|
|
Patient Satisfaction With Method of LARC Using LARC Survey
|
10 Participants
|
2 Participants
|
Adverse Events
Immediate or Early Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interval Placement
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