Trial Outcomes & Findings for Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents (NCT NCT03585504)
NCT ID: NCT03585504
Last Updated: 2018-10-04
Results Overview
We compare the number of participants continuing the implant at six months in each group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
81 participants
Primary outcome timeframe
6 months
Results posted on
2018-10-04
Participant Flow
Participant milestones
| Measure |
Intervention Group
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Control Group
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
26
|
29
|
Reasons for withdrawal
| Measure |
Intervention Group
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Control Group
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
26
|
29
|
Baseline Characteristics
Age was not recorded in the baseline questionnaire.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=41 Participants
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Control Group
n=40 Participants
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.93 years
STANDARD_DEVIATION 1.64 • n=15 Participants • Age was not recorded in the baseline questionnaire.
|
19.64 years
STANDARD_DEVIATION 1.03 • n=11 Participants • Age was not recorded in the baseline questionnaire.
|
19.24 years
STANDARD_DEVIATION 1.42 • n=26 Participants • Age was not recorded in the baseline questionnaire.
|
|
Sex: Female, Male
Female
|
41 Participants
n=41 Participants
|
40 Participants
n=40 Participants
|
81 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=41 Participants
|
31 Participants
n=40 Participants
|
61 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=41 Participants
|
7 Participants
n=40 Participants
|
15 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=81 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=41 Participants
|
40 participants
n=40 Participants
|
81 participants
n=81 Participants
|
PRIMARY outcome
Timeframe: 6 monthsWe compare the number of participants continuing the implant at six months in each group.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Control Group
n=11 Participants
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
|---|---|---|
|
Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum
|
15 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsCompare the number of participants who reported that they were somewhat or very satisfied with their subjective bleeding experience at six months postpartum in each group. Each participant was asked, "Please indicate your overall level of satisfaction with your bleeding." The response options were "very satisfied", "somewhat satisfied", "somewhat dissatisfied", and "very dissatisfied". The outcome measure was treated as a categorical variable.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Control Group
n=11 Participants
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
|---|---|---|
|
Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsComparison of the number of participants in each group who report that they were somewhat or very satisfied with their contraceptive method choice at six months postpartum in each group. Participants were asked, " How would you rate your overall satisfaction with implanon?" The response options were "very satisfied", "somewhat satisfied", "somewhat dissatisfied", and "very dissatisfied". The outcome measure was treated as a categorical variable.
Outcome measures
| Measure |
Intervention Group
n=15 Participants
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
Control Group
n=11 Participants
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Etonogestrel contraceptive implant: Etonogestrel contraceptive implant
|
|---|---|---|
|
Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.
|
14 Participants
|
6 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Dr. Angela Dempsey
Medical University of South Carolina
Phone: 843-762-4500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place