Quickstart of Nexplanon® at Medical Abortion

February 24, 2016 updated by: Kristina Gemzell Danielsson, Karolinska Institutet

Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

551

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska Universitetssjukhuset/Östra
      • Linköping, Sweden
        • Universitetssjukhuset
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden
        • Danderyds Hospital
      • Stockholm, Sweden, 17176
        • Karolinska Universitetssjukhuset
      • Örebro, Sweden
        • Universitetssjukhuset I Orebro
  • United Kingdom
      • Edinburgh, United Kingdom, EH3 9ES
        • Chalmers Sexual and Reproductive Health Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etonorgestrel and mifepristone
Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion
Drug: Mifepristone
Day one of medical abortion
Drug: etonorgestrel
Other Names:
  • Nexplanon, Contraceptive implant
Active Comparator: mifepristone
Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion
Drug: Mifepristone
Day one of medical abortion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unplanned pregnancy
Time Frame: during one year FU
Numbers of pregnancies within the first year following the index abortion
during one year FU
Number of women with complications
Time Frame: evaluated at the 3weeks FU
reports and rates of AE/SAE
evaluated at the 3weeks FU
Rate of implant insertion
Time Frame: up to 1year FU
Compliance, contraceptive usage
up to 1year FU
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
Evaluated at 1 year FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QW2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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