Quickstart of Nexplanon® at Medical Abortion

Overview

Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC – i.e., inserting it during the surgical procedure – is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.

Full Title of Study: “Early Versus Delayed Insertion of Nexplanon® at Medical Abortion – a Randomized Controlled Equivalence Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2015

Interventions

  • Drug: Mifepristone
    • Day one of medical abortion
  • Drug: etonorgestrel

Arms, Groups and Cohorts

  • Experimental: Etonorgestrel and mifepristone
    • Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion
  • Active Comparator: mifepristone
    • Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion

Clinical Trial Outcome Measures

Primary Measures

  • Complete abortions without surgical intervention
    • Time Frame: at 3 weeks follow up
    • Efficacy of the medical abortion treatment

Secondary Measures

  • Unplanned pregnancy
    • Time Frame: during one year FU
    • Numbers of pregnancies within the first year following the index abortion
  • Number of women with complications
    • Time Frame: evaluated at the 3weeks FU
    • reports and rates of AE/SAE
  • Rate of implant insertion
    • Time Frame: up to 1year FU
    • Compliance, contraceptive usage
  • Bleeding
    • Time Frame: Evaluated at 1 year FU
    • Bleeding will be evaluated with regard to both bleeding during the medical abortion and bleeding patterns during the one year FU

Participating in This Clinical Trial

Inclusion Criteria

  • women opting for medical abortion and post abortion Nexplanon – no contraindicated to medical abortion or Nexplanon (according to the SMPc) gestational length up to and including 63 days (determined with ultrasonography) – able and willing to provide informed consent Exclusion Criteria:

  • unwilling to participate, – unable to communicate in Swedish and English and – minors (i.e. women < 18 years of age), – contraindications to Nexplanon® – women with pathological pregnancies

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kristina Gemzell Danielsson, Professor – Karolinska Institutet
  • Overall Official(s)
    • Kristina Gemzell-Danielsson, MD, PhD, Principal Investigator, Karolinska Institutet

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