Nexplanon Application Post-Abortion

Study Overview
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Brief Summary
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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
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Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Official Title
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Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)

Conditions
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Contraception, Abortion, Therapeutic

Intervention / Treatment
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* Other: Immediate Nexplanon Insertion
* Other: Post-op Nexplanon Insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Nexplanon Insertion<br>An etonogestrel rod will be placed within 15 minutes following the abortion procedure. | Other: Immediate Nexplanon Insertion<br>* Patient will have a Nexplanon inserted within 15 minutes of her abortion<br>|
| Active Comparator: Post-op Nexplanon Insertion<br>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. | Other: Post-op Nexplanon Insertion<br>* Place Nexplanon at post operative visit rather than at surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nexplanon use | Current use of Nexplanon, confirmed via phone by participant palpation, at 6 months post-insertion. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeat pregnancy | Occurrence of a pregnancy within 6 months after second-trimester abortion. | 6 months | 
| Side-effects of Nexplanon use | Qualitative and quantitative self-reports of common side-effects of Nexplanon use. | 6 mo. | 
| Contraceptive method satisfaction | Satisfaction with contraceptive method, as assessed by a Satisfaction Questionnaire, at 6 months post-abortion. | 6 months |