Abortion, Therapeutic, Contraception
Conditions
Brief summary
Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.
Detailed description
Women will be contacted 6 months after their abortion to ask about contraception use and side effects.
Interventions
OTHERImmediate Nexplanon Insertion
Patient will have a Nexplanon inserted within 15 minutes of her abortion
OTHERPost-op Nexplanon Insertion
Place Nexplanon at post operative visit rather than at surgery
Sponsors
Merck Sharp & Dohme LLC
The Cleveland Clinic
Family Planning Associates Medical Group, LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older, * an intrauterine pregnancy \> 14 weeks and \<23 6/7 weeks gestation and desire termination of pregnancy * desire a Nexplanon for contraception * able to give informed consent in English * no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D&E
Exclusion criteria
* unable to give informed consent * have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon. * non-surgical management of pregnancy * prior participation in this study * breast cancer or a history of breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention-to-treat Analysis of Etonogestrel Implant Use | 6 months | Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations. |
| Per-protocol Analysis of Etonogestrel Implant Use | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeat Pregnancy | 6 months | Occurrence of a pregnancy within 6 months after second-trimester abortion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implant Inserted | Within 4 weeks of abortion | Whether participants had the implant inserted as part of the study |
| Completed 6-month Phone Call | 6 months | Whether participants completed 6-month phone call follow-up. |
Countries
United States
Participant flow
Recruitment details
A total of 148 participants were recruited and randomized into two study arms.
Pre-assignment details
Participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 73 |
| 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 | 75 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 30 | 45 |
Baseline characteristics
| Characteristic | Immediate Nexplanon Insertion | Post-op Nexplanon Insertion | Total |
|---|---|---|---|
| Age, Continuous | 25 years | 23 years | 24 years |
| Birth control methods used in the past Abstinence | 4 Participants | 1 Participants | 5 Participants |
| Birth control methods used in the past Barrier | 71 Participants | 71 Participants | 142 Participants |
| Birth control methods used in the past DMPA | 42 Participants | 45 Participants | 87 Participants |
| Birth control methods used in the past Implant | 3 Participants | 3 Participants | 6 Participants |
| Birth control methods used in the past LNG IUD | 5 Participants | 5 Participants | 10 Participants |
| Birth control methods used in the past None | 1 Participants | 3 Participants | 4 Participants |
| Birth control methods used in the past Pill, patch, or ring | 55 Participants | 52 Participants | 107 Participants |
| Birth control methods used in the past Withdrawal | 14 Participants | 21 Participants | 35 Participants |
| D&E indication Declined to answer | 2 Participants | 2 Participants | 4 Participants |
| D&E indication Fetal anomaly | 0 Participants | 2 Participants | 2 Participants |
| D&E indication Maternal health issue | 2 Participants | 4 Participants | 6 Participants |
| D&E indication Other | 15 Participants | 15 Participants | 30 Participants |
| D&E indication Social or economic | 59 Participants | 61 Participants | 120 Participants |
| Education Associate's degree | 5 Participants | 2 Participants | 7 Participants |
| Education Bachelor's degree | 3 Participants | 3 Participants | 6 Participants |
| Education High school equivalency certificate | 27 Participants | 25 Participants | 52 Participants |
| Education Less than high school | 10 Participants | 14 Participants | 24 Participants |
| Education Some college | 28 Participants | 31 Participants | 59 Participants |
| History of STI | 13 Participants | 14 Participants | 27 Participants |
| Insurance Type None | 20 Participants | 10 Participants | 30 Participants |
| Insurance Type Private | 3 Participants | 7 Participants | 10 Participants |
| Insurance Type Private and Public | 0 Participants | 1 Participants | 1 Participants |
| Insurance Type Public | 50 Participants | 57 Participants | 107 Participants |
| Latina | 22 Participants | 20 Participants | 42 Participants |
| Marital Status Married | 2 Participants | 2 Participants | 4 Participants |
| Marital Status Never married | 69 Participants | 70 Participants | 139 Participants |
| Marital Status Separated or divorced | 2 Participants | 3 Participants | 5 Participants |
| No. of children alive | 2 Number of children alive | 1 Number of children alive | 1.5 Number of children alive |
| Positive Smoking Status | 17 Participants | 15 Participants | 32 Participants |
| Prior D&E | 36 Participants | 41 Participants | 77 Participants |
| Race/Ethnicity, Customized Race African American | 45 Participants | 52 Participants | 97 Participants |
| Race/Ethnicity, Customized Race Native American or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 28 Participants | 22 Participants | 50 Participants |
| Region of Enrollment United States | 73 Participants | 75 Participants | 148 Participants |
| Sex: Female, Male Female | 73 Participants | 75 Participants | 148 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total no. of pregnancies Abortion | 1 Number of pregnancies | 1 Number of pregnancies | 1 Number of pregnancies |
| Total no. of pregnancies Preterm | 0 Number of pregnancies | 0 Number of pregnancies | 0 Number of pregnancies |
| Total no. of pregnancies Term | 1 Number of pregnancies | 1 Number of pregnancies | 1 Number of pregnancies |
| Total no. of pregnancies Total | 4 Number of pregnancies | 4 Number of pregnancies | 4 Number of pregnancies |
| Using insurance for D&E No | 20 Participants | 11 Participants | 31 Participants |
| Using insurance for D&E Not Covered | 52 Participants | 61 Participants | 113 Participants |
| Using insurance for D&E Yes | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 75 |
| other Total, other adverse events | 2 / 73 | 1 / 75 |
| serious Total, serious adverse events | 0 / 73 | 0 / 75 |
Outcome results
Primary
Intention-to-treat Analysis of Etonogestrel Implant Use
Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Nexplanon Insertion | Intention-to-treat Analysis of Etonogestrel Implant Use | Using implant at 6 months | 40 Participants |
| Immediate Nexplanon Insertion | Intention-to-treat Analysis of Etonogestrel Implant Use | Implant removed before 6 months | 3 Participants |
| Post-op Nexplanon Insertion | Intention-to-treat Analysis of Etonogestrel Implant Use | Using implant at 6 months | 19 Participants |
| Post-op Nexplanon Insertion | Intention-to-treat Analysis of Etonogestrel Implant Use | Implant removed before 6 months | 3 Participants |
Primary
Per-protocol Analysis of Etonogestrel Implant Use
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.
Time frame: 6 months
Population: Calculated using only participants who completed the 6-month follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Nexplanon Insertion | Per-protocol Analysis of Etonogestrel Implant Use | Implant removed before 6 months | 3 Participants |
| Immediate Nexplanon Insertion | Per-protocol Analysis of Etonogestrel Implant Use | Using implant at 6 months | 40 Participants |
| Immediate Nexplanon Insertion | Per-protocol Analysis of Etonogestrel Implant Use | Implant never placed | 0 Participants |
| Post-op Nexplanon Insertion | Per-protocol Analysis of Etonogestrel Implant Use | Using implant at 6 months | 19 Participants |
| Post-op Nexplanon Insertion | Per-protocol Analysis of Etonogestrel Implant Use | Implant removed before 6 months | 3 Participants |
| Post-op Nexplanon Insertion | Per-protocol Analysis of Etonogestrel Implant Use | Implant never placed | 8 Participants |
Secondary
Repeat Pregnancy
Occurrence of a pregnancy within 6 months after second-trimester abortion.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Nexplanon Insertion | Repeat Pregnancy | Repeat pregnancy within 6 months | 1 Participants |
| Immediate Nexplanon Insertion | Repeat Pregnancy | No repeat pregnancy in 6 months | 42 Participants |
| Post-op Nexplanon Insertion | Repeat Pregnancy | Repeat pregnancy within 6 months | 1 Participants |
| Post-op Nexplanon Insertion | Repeat Pregnancy | No repeat pregnancy in 6 months | 29 Participants |
Other Pre-specified
Completed 6-month Phone Call
Whether participants completed 6-month phone call follow-up.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Nexplanon Insertion | Completed 6-month Phone Call | 43 Participants |
| Post-op Nexplanon Insertion | Completed 6-month Phone Call | 30 Participants |
Other Pre-specified
Implant Inserted
Whether participants had the implant inserted as part of the study
Time frame: Within 4 weeks of abortion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Nexplanon Insertion | Implant Inserted | 73 Participants |
| Post-op Nexplanon Insertion | Implant Inserted | 32 Participants |