NCT01487213

Brief Summary

The main objective of the study is to optimize the routines for follow-up after medical abortion in order to give women more autonomy by reducing the number of consultations involved and to reduce the frequency of postabortal curettage. This will be achieved by providing means for women for postabortal self-assessment with the use of a quantitative urinary hCG test.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
929

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
4 countries

4 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

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

December 2, 2011

Last Update Submit

August 6, 2013

Conditions

Medical Abortion

Keywords

Medical abortionTermination of pregnancyMifepristoneMisoprostolUrine hCGFollow UpTermination of unwanted pregnancy. Self assessment (follow up) after medical abortion

Outcome Measures

Primary Outcomes (1)

  • Number of complete abortions

    The primary objective is thus to demonstrate the non-inferiority of self-assessment of complete abortion following medical abortion compared to routine follow-up in terms of the percentage of women requiring surgical abortion, within a margin of non-inferiority of 5%.

    Until 3 months post treatment

Secondary Outcomes (2)

  • postabortion contraception

    until 12 months post treatment

  • adverse events

    util 3 months post treatment

Study Arms (2)

Controls

NO INTERVENTION

Routine follow-up at the clinic 2-3 weeks after the treatment

Home self test

OTHER

Intervention

Other: Home self assessment of complete medical abortion

Interventions

Home self assessment of complete medical abortionOTHER

Self assessment of complete abortion using a home semiquantitative U-hCG test. Follow-up out patient review two-three weeks later by qualified practitioner to evaluate success of procedure using the clinic's standard routine. The patient charts will be reviewed after three months in order to control for possible extra visits related to abortion-related complications.

Home self test

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women requesting termination of pregnancy by means of mifepristone followed by home administration of misoprostol at \< /=63 days of gestation, with no contraindication to medical abortion and self administration of misoprostol at home, and who have given their informed consent will be eligible for study recruitment.

You may not qualify if:

  • women who do not wish to participate
  • women who do not want home administration of misoprostol
  • women who are unable to communicate in Swedish, Norwegian, English, Finnish or German and women with symptoms and signs of ectopic pregnancy
  • minors (i.e. women \< 18 years of age) will not be enrolled for the study.
  • women seeking termination of pregnancy with no sign of a visible intrauterine pregnancy (i.e. visible intrauterine yolk sac).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GynMed Clinic

Vienna, Austria

Location

Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital

Helsinki, Finland

Location

Faculty of Medicine, University of Oslo and Dept. of Gynaecology,

Oslo, Norway

Location

Dept of Obstetrics and Gynecology, Karolinska University Hospital

Stockholm, SE17176, Sweden

Location

Related Publications (1)

  • Oppegaard KS, Qvigstad E, Fiala C, Heikinheimo O, Benson L, Gemzell-Danielsson K. Clinical follow-up compared with self-assessment of outcome after medical abortion: a multicentre, non-inferiority, randomised, controlled trial. Lancet. 2015 Feb 21;385(9969):698-704. doi: 10.1016/S0140-6736(14)61054-0. Epub 2014 Oct 30.

    PMID: 25468164DERIVED

Study Officials

  • Kristina Gemzell-Danielsson, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, MD, PhD

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 7, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

SE(1)FI(1)AU(1)NO(1)