Nexplanon Application Post-Abortion (NAPA)

Not Applicable

Completed

• Conditions: Contraception; Abortion, Therapeutic

• Registration Number: NCT02037919
• Lead Sponsor: Family Planning Associates Medical Group, LTD

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.

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Study Start: 2014-06
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2018-09-10
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-02-12
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Repeat Pregnancy	6 months	Occurrence of a pregnancy within 6 months after second-trimester abortion.

Trial Locations

Locations (2)

Family Planning Associates Medical Grooup, LTD; 🇺🇸 Chicago, Illinois, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States