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OpenTrials
Completed

NCT Number: NCT02037919

Nexplanon Application Post-Abortion (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.

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Key information

Conditions

Contraception Abortion, Therapeutic

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Family Planning Associates Medical Grooup, LTD, Chicago, Illinois, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Nexplanon Insertion

Other

Patient will have a Nexplanon inserted within 15 minutes of her abortion

Post-op Nexplanon Insertion

Other

Place Nexplanon at post operative visit rather than at surgery

Primary outcomes

  1. Intention-to-treat Analysis of Etonogestrel Implant Use

    Time frame: 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.

  2. Per-protocol Analysis of Etonogestrel Implant Use

    Time frame: 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 outcomes

  1. Repeat Pregnancy

    Time frame: 6 months

    Occurrence of a pregnancy within 6 months after second-trimester abortion.

Other outcomes

  1. Implant Inserted

    Time frame: Within 4 weeks of abortion

    Whether participants had the implant inserted as part of the study

  2. Completed 6-month Phone Call

    Time frame: 6 months

    Whether participants completed 6-month phone call follow-up.

Sponsors and collaborators

Lead sponsor

Family Planning Associates Medical Group, LTD

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • The Cleveland Clinic

Registry information

Official study title

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

Acronym: NAPA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 16, 2014
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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