Routine Follow-up Versus Self-assessment in Medical Abortion
|ClinicalTrials.gov Identifier: NCT01487213|
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Medical Abortion||Other: Home self assessment of complete medical abortion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||929 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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.
- Number of complete abortions [ Time Frame: Until 3 months post treatment ]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 ]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 ]Number of women reporting adverse events and side effects including infections, bleeding, pain
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487213
|Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital|
|Faculty of Medicine, University of Oslo and Dept. of Gynaecology,|
|Dept of Obstetrics and Gynecology, Karolinska University Hospital|
|Stockholm, Sweden, SE17176|
|Principal Investigator:||Kristina Gemzell-Danielsson, MD, PhD||Karolinska Institutet|