NCT01920022

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
551

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2013

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

August 6, 2013

Last Update Submit

February 24, 2016

Conditions

Early Pregnancy TerminationMedical AbortionPostabortion Contraception

Keywords

medical abortionpostabortion contraceptionLARCNexplanonsubdermal contraceptive implant

Outcome Measures

Primary Outcomes (1)

  • Complete abortions without surgical intervention

    Efficacy of the medical abortion treatment

    at 3 weeks follow up

Secondary Outcomes (4)

  • Unplanned pregnancy

    during one year FU

  • Number of women with complications

    evaluated at the 3weeks FU

  • Rate of implant insertion

    up to 1year FU

  • Bleeding

    Evaluated at 1 year FU

Study Arms (2)

Etonorgestrel and mifepristone

EXPERIMENTAL

Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion

Drug: MifepristoneDrug: etonorgestrel

mifepristone

ACTIVE COMPARATOR

Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion

Drug: Mifepristone

Interventions

MifepristoneDRUG

Day one of medical abortion

Etonorgestrel and mifepristonemifepristone
etonorgestrelDRUG
Also known as: Nexplanon, Contraceptive implant
Etonorgestrel and mifepristone

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sahlgrenska Universitetssjukhuset/Östra

Gothenburg, Sweden

Location

Universitetssjukhuset

Linköping, Sweden

Location

Universitetssjukhuset i Örebro

Örebro, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, 17176, Sweden

Location

Danderyds Hospital

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Chalmers Sexual and Reproductive Health Service

Edinburgh, EH3 9ES, United Kingdom

Location

Related Publications (1)

  • 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. doi: 10.1093/humrep/dew238. Epub 2016 Sep 22.

    PMID: 27664217DERIVED

MeSH Terms

Interventions

MifepristoneetonogestrelContraceptive Agents

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Kristina Gemzell-Danielsson, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 9, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

GB(1)SE(6)