Nexplanon Application Post-Abortion (NAPA) (NAPA)

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Abortion, Therapeutic
• Intervention / Treatment: Other: Immediate Nexplanon Insertion; Other: Post-op Nexplanon Insertion

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60661
      • Family Planning Associates Medical Grooup, LTD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeat Pregnancy	Occurrence of a pregnancy within 6 months after second-trimester abortion.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Inserted	Whether participants had the implant inserted as part of the study	Within 4 weeks of abortion
Completed 6-month Phone Call	Whether participants completed 6-month phone call follow-up.	6 months

Collaborators and Investigators

• Sponsor: Family Planning Associates Medical Group, LTD
• Collaborators: Merck Sharp & Dohme LLC; The Cleveland Clinic
• Investigators: Principal Investigator: Miriam Cremer, MD, MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimated): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Desogestrel; Etonogestrel
• Other Study ID Numbers: IIS#50302: Women's Health MISP