Nexplanon Application Post-Abortion (NAPA)

Contraception Clinical Trial

— NAPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037919
• Other study ID #: IIS#50302: Women's Health MISP
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: May 2017

Study information

• Verified date: February 2024
• Source: Family Planning Associates Medical Group, LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Abortion, Therapeutic
• Contraception

Intervention

Other:
• Immediate Nexplanon Insertion
Patient will have a Nexplanon inserted within 15 minutes of her abortion
• Post-op Nexplanon Insertion
Place Nexplanon at post operative visit rather than at surgery

Locations

Country	Name	City	State
United States	Family Planning Associates Medical Grooup, LTD	Chicago	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Family Planning Associates Medical Group, LTD	Merck Sharp & Dohme LLC, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

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