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OpenTrials
Completed

NCT Number: NCT01920022

Quickstart of Nexplanon® at Medical Abortion

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.

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Key information

Conditions

Early Pregnancy Termination Medical Abortion Postabortion Contraception

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sahlgrenska Universitetssjukhuset/Östra, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Day one of medical abortion

etonorgestrel

Drug

Other names: Nexplanon, Contraceptive implant

Primary outcomes

  1. Complete abortions without surgical intervention

    Time frame: at 3 weeks follow up

    Efficacy of the medical abortion treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2013
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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