Contraception Clinical Trial
— NAPAOfficial title:
Immediate vs. Delayed Insertion of Nexplanon After Termination of Pregnancy Over 14-weeks Gestation (NAPA)
Verified date | February 2024 |
Source | Family Planning Associates Medical Group, LTD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Family Planning Associates Medical Grooup, LTD | Chicago | Illinois |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Family Planning Associates Medical Group, LTD | Merck Sharp & Dohme LLC, The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Implant Inserted | Whether participants had the implant inserted as part of the study | Within 4 weeks of abortion | |
Other | Completed 6-month Phone Call | Whether participants completed 6-month phone call follow-up. | 6 months | |
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. | 6 months | |
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. | 6 months | |
Secondary | Repeat Pregnancy | Occurrence of a pregnancy within 6 months after second-trimester abortion. | 6 months |
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