Clinical trial NCT01487213: Routine Follow-up Versus Self-assessment in Medical Abortion
Official title: Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion
Keywords: Medical abortion
Termination of pregnancy
Mifepristone
Misoprostol
Urine hCG
Follow Up
Termination of unwanted pregnancy. Self assessment (follow up) after medical abortion
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ullevaal University Hospital
name: University of Helsinki
name: Gynmed Clinic Vienna
First posted: 2011-12-07
Enrollment: 929
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Number of complete abortions
timeFrame: Until 3 months post treatment
Secondary outcomes:
measure: postabortion contraception
timeFrame: until 12 months post treatment
measure: adverse events
timeFrame: util 3 months post treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GynMed Clinic
city: Helsinki
country: Finland
facility: Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital
city: Oslo
country: Norway
facility: Faculty of Medicine, University of Oslo and Dept. of Gynaecology,
city: Stockholm
country: Sweden
facility: Dept of Obstetrics and Gynecology, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell-Danielsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.