Quickstart of Nexplanon® at Medical Abortion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01920022
First received: August 6, 2013
Last updated: February 24, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Early Pregnancy Termination
Medical Abortion
Postabortion Contraception
Drug: Mifepristone
Drug: etonorgestrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Complete abortions without surgical intervention [ Time Frame: at 3 weeks follow up ] [ Designated as safety issue: No ]
    Efficacy of the medical abortion treatment


Secondary Outcome Measures:
  • Unplanned pregnancy [ Time Frame: during one year FU ] [ Designated as safety issue: No ]
    Numbers of pregnancies within the first year following the index abortion

  • Number of women with complications [ Time Frame: evaluated at the 3weeks FU ] [ Designated as safety issue: Yes ]
    reports and rates of AE/SAE

  • Rate of implant insertion [ Time Frame: up to 1year FU ] [ Designated as safety issue: No ]
    Compliance, contraceptive usage

  • Bleeding [ Time Frame: Evaluated at 1 year FU ] [ Designated as safety issue: Yes ]
    Bleeding will be evaluated with regard to both bleeding during the medical abortion and bleeding patterns during the one year FU


Enrollment: 551
Study Start Date: October 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920022

Locations
Sweden
Sahlgrenska Universitetssjukhuset/Östra
Göteborg, Sweden
Universitetssjukhuset
Linköping, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden, 17176
Danderyds Hospital
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
Universitetssjukhuset i Örebro
Örebro, Sweden
United Kingdom
Chalmers Sexual and Reproductive Health Service
Edinburgh, United Kingdom, EH3 9ES
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
  More Information

Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01920022     History of Changes
Other Study ID Numbers: QW2013 
Study First Received: August 6, 2013
Last Updated: February 24, 2016
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
medical abortion
postabortion contraception
LARC
Nexplanon
subdermal contraceptive implant

Additional relevant MeSH terms:
Contraceptive Agents
Mifepristone
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Steroidal
Abortifacient Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Progestins
Hormones

ClinicalTrials.gov processed this record on July 28, 2016