Routine Follow-up Versus Self-assessment in Medical Abortion
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial|
- Number of complete abortions [ Time Frame: Until 3 months post treatment ] [ Designated as safety issue: Yes ]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%.
- postabortion contraception [ Time Frame: until 12 months post treatment ] [ Designated as safety issue: No ]The use of contraception and rate of repeat abortion at follow-up questionnaire at one year.
- adverse events [ Time Frame: util 3 months post treatment ] [ Designated as safety issue: Yes ]Number of women reporting adverse events and side effects including infections, bleeding, pain
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
No Intervention: Controls
Routine follow-up at the clinic 2-3 weeks after the treatment
Home self test
Other: Home self assessment of complete medical abortion
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.
|Contact: Kristina Gemzell-Danielsson, MD, PhDfirstname.lastname@example.org|
|Contact: Kevin Sunde-Oppegaard, MD, PhDemail@example.com|
|Contact: Christian Fiala, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Christian Fiala, MD, PhD|
|Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital||Recruiting|
|Contact: Oskari Heikinheimo, MD, PhD email@example.com|
|Principal Investigator: Oskari Heikinheimo, MD, PhD|
|Faculty of Medicine, University of Oslo and Dept. of Gynaecology,||Recruiting|
|Contact: Erik Qvigstad, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Erik Qvigstad, MD, PhD|
|Dept of Obstetrics and Gynecology, Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, SE17176|
|Principal Investigator: Kristina Gemzell Danielsson, Prof.MD.PhD|
|Principal Investigator:||Kristina Gemzell-Danielsson, MD, PhD||Karolinska Institutet|