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Quickstart of Nexplanon® at Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01920022
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : February 25, 2016
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Brief Summary:
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 or disease Intervention/treatment Phase
Early Pregnancy Termination Medical Abortion Postabortion Contraception Drug: Mifepristone Drug: etonorgestrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 551 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.
Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

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 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

Primary Outcome Measures :
  1. Complete abortions without surgical intervention [ Time Frame: at 3 weeks follow up ]
    Efficacy of the medical abortion treatment

Secondary Outcome Measures :
  1. Unplanned pregnancy [ Time Frame: during one year FU ]
    Numbers of pregnancies within the first year following the index abortion

  2. Number of women with complications [ Time Frame: evaluated at the 3weeks FU ]
    reports and rates of AE/SAE

  3. Rate of implant insertion [ Time Frame: up to 1year FU ]
    Compliance, contraceptive usage

  4. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01920022

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Sahlgrenska Universitetssjukhuset/Östra
Göteborg, Sweden
Linköping, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden, 17176
Danderyds Hospital
Stockholm, Sweden
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
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Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet Identifier: NCT01920022    
Other Study ID Numbers: QW2013
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
medical abortion
postabortion contraception
subdermal contraceptive implant
Additional relevant MeSH terms:
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Contraceptive Agents
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
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents