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Quickstart of Nexplanon® at Medical Abortion

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ClinicalTrials.gov Identifier: NCT01920022
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE August 6, 2013
First Posted Date  ICMJE August 9, 2013
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Complete abortions without surgical intervention [ Time Frame: at 3 weeks follow up ]
Efficacy of the medical abortion treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quickstart of Nexplanon® at Medical Abortion
Official Title  ICMJE Early Versus Delayed Insertion of Nexplanon® at Medical Abortion - a Randomized Controlled Equivalence Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Early Pregnancy Termination
  • Medical Abortion
  • Postabortion Contraception
Intervention  ICMJE
  • Drug: Mifepristone
    Day one of medical abortion
  • Drug: etonorgestrel
    Other Name: Nexplanon, Contraceptive implant
Study Arms  ICMJE
  • Experimental: Etonorgestrel and mifepristone
    Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion
    Interventions:
    • Drug: Mifepristone
    • Drug: etonorgestrel
  • Active Comparator: mifepristone
    Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion
    Intervention: Drug: Mifepristone
Publications * Hognert H, Kopp Kallner H, Cameron S, Nyrelli C, Jawad I, Heller R, Aronsson A, Lindh I, Benson L, Gemzell-Danielsson K. Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial. Hum Reprod. 2016 Nov;31(11):2484-2490. Epub 2016 Sep 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2016)
551
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2013)
560
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920022
Other Study ID Numbers  ICMJE QW2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristina Gemzell Danielsson, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristina Gemzell-Danielsson, MD, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP