Nexplanon Application Post-Abortion (NAPA)

Not Applicable

Completed

• Conditions: Contraception; Abortion, Therapeutic
• Interventions: Other: Post-op Nexplanon Insertion; Other: Immediate Nexplanon Insertion

• 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

Arm && Interventions

Group	Intervention	Description
Post-op Nexplanon Insertion	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.
Immediate Nexplanon Insertion	Immediate Nexplanon Insertion	An etonogestrel rod will be placed within 15 minutes following the abortion procedure.

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