Trial Outcomes & Findings for Nexplanon Application Post-Abortion (NAPA) (NCT NCT02037919)
NCT ID: NCT02037919
Last Updated: 2024-02-12
Results Overview
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
6 months
Results posted on
2024-02-12
Participant Flow
A total of 148 participants were recruited and randomized into two study arms.
Participants were randomized.
Participant milestones
| Measure |
Immediate Nexplanon Insertion
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
75
|
|
Overall Study
Had Implant Inserted
|
73
|
32
|
|
Overall Study
Contacted at Six Months and Using Implant
|
40
|
19
|
|
Overall Study
Contacted at 6 Months and Not Using Implant
|
3
|
11
|
|
Overall Study
COMPLETED
|
43
|
30
|
|
Overall Study
NOT COMPLETED
|
30
|
45
|
Reasons for withdrawal
| Measure |
Immediate Nexplanon Insertion
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
30
|
45
|
Baseline Characteristics
Nexplanon Application Post-Abortion (NAPA)
Baseline characteristics by cohort
| Measure |
Immediate Nexplanon Insertion
n=73 Participants
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=75 Participants
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=93 Participants
|
23 years
n=4 Participants
|
24 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
28 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
45 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Native American or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
73 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Education
Less than high school
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Education
High school equivalency certificate
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Education
Some college
|
28 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Education
Associate's degree
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Education
Bachelor's degree
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Marital Status
Never married
|
69 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Marital Status
Married
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Marital Status
Separated or divorced
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Positive Smoking Status
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Insurance Type
None
|
20 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Insurance Type
Public
|
50 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Insurance Type
Private
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Insurance Type
Private and Public
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Using insurance for D&E
Yes
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Using insurance for D&E
No
|
20 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Using insurance for D&E
Not Covered
|
52 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Latina
|
22 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Total no. of pregnancies
Total
|
4 Number of pregnancies
n=93 Participants
|
4 Number of pregnancies
n=4 Participants
|
4 Number of pregnancies
n=27 Participants
|
|
Total no. of pregnancies
Term
|
1 Number of pregnancies
n=93 Participants
|
1 Number of pregnancies
n=4 Participants
|
1 Number of pregnancies
n=27 Participants
|
|
Total no. of pregnancies
Preterm
|
0 Number of pregnancies
n=93 Participants
|
0 Number of pregnancies
n=4 Participants
|
0 Number of pregnancies
n=27 Participants
|
|
Total no. of pregnancies
Abortion
|
1 Number of pregnancies
n=93 Participants
|
1 Number of pregnancies
n=4 Participants
|
1 Number of pregnancies
n=27 Participants
|
|
No. of children alive
|
2 Number of children alive
n=93 Participants
|
1 Number of children alive
n=4 Participants
|
1.5 Number of children alive
n=27 Participants
|
|
Prior D&E
|
36 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
D&E indication
Social or economic
|
59 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
D&E indication
Fetal anomaly
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
D&E indication
Maternal health issue
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
D&E indication
Other
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
D&E indication
Declined to answer
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Birth control methods used in the past
Implant
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Birth control methods used in the past
LNG IUD
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Birth control methods used in the past
Pill, patch, or ring
|
55 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Birth control methods used in the past
DMPA
|
42 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Birth control methods used in the past
Barrier
|
71 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
142 Participants
n=27 Participants
|
|
Birth control methods used in the past
Abstinence
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Birth control methods used in the past
Withdrawal
|
14 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Birth control methods used in the past
None
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
History of STI
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsCurrent use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations.
Outcome measures
| Measure |
Immediate Nexplanon Insertion
n=73 Participants
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=75 Participants
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Intention-to-treat Analysis of Etonogestrel Implant Use
Using implant at 6 months
|
40 Participants
|
19 Participants
|
|
Intention-to-treat Analysis of Etonogestrel Implant Use
Implant removed before 6 months
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Calculated using only participants who completed the 6-month follow-up.
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations.
Outcome measures
| Measure |
Immediate Nexplanon Insertion
n=43 Participants
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=30 Participants
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Per-protocol Analysis of Etonogestrel Implant Use
Using implant at 6 months
|
40 Participants
|
19 Participants
|
|
Per-protocol Analysis of Etonogestrel Implant Use
Implant removed before 6 months
|
3 Participants
|
3 Participants
|
|
Per-protocol Analysis of Etonogestrel Implant Use
Implant never placed
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOccurrence of a pregnancy within 6 months after second-trimester abortion.
Outcome measures
| Measure |
Immediate Nexplanon Insertion
n=43 Participants
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=30 Participants
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Repeat Pregnancy
Repeat pregnancy within 6 months
|
1 Participants
|
1 Participants
|
|
Repeat Pregnancy
No repeat pregnancy in 6 months
|
42 Participants
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 4 weeks of abortionWhether participants had the implant inserted as part of the study
Outcome measures
| Measure |
Immediate Nexplanon Insertion
n=73 Participants
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=75 Participants
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Implant Inserted
|
73 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsWhether participants completed 6-month phone call follow-up.
Outcome measures
| Measure |
Immediate Nexplanon Insertion
n=73 Participants
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=75 Participants
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Completed 6-month Phone Call
|
43 Participants
|
30 Participants
|
Adverse Events
Immediate Nexplanon Insertion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Post-op Nexplanon Insertion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immediate Nexplanon Insertion
n=73 participants at risk
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion: Patient will have a Nexplanon inserted within 15 minutes of her abortion
|
Post-op Nexplanon Insertion
n=75 participants at risk
Participants in the "delayed" placement group will be asked to return to Family Planning Associates for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion: Place Nexplanon at post operative visit rather than at surgery
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
0.00%
0/73 • 2 years
|
1.3%
1/75 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
Rapid weight loss
|
0.00%
0/73 • 2 years
|
1.3%
1/75 • Number of events 3 • 2 years
|
|
Reproductive system and breast disorders
Post abortal endometritis
|
1.4%
1/73 • Number of events 1 • 2 years
|
0.00%
0/75 • 2 years
|
|
Reproductive system and breast disorders
Pregnancy
|
1.4%
1/73 • Number of events 1 • 2 years
|
0.00%
0/75 • 2 years
|
Additional Information
Allison A. Cowett, MD MPH
Family Planning Associates Medical Group , Ltd.
Phone: 312-707-8988
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place