Routine Follow-up Versus Self-assessment in Medical Abortion

Medical Abortion Clinical Trial

Official title:

Routine Follow-up Versus Self-assessment of Complete Abortion Following Medical Abortion, Effect on Its Success and Acceptability: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487213
• Other study ID #: WNI1000
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: August 6, 2013
• Start date: September 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 929
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medical Abortion

Intervention

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.

Locations

Country	Name	City	State
Austria	GynMed Clinic	Vienna
Finland	Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital	Helsinki
Norway	Faculty of Medicine, University of Oslo and Dept. of Gynaecology,	Oslo
Sweden	Dept of Obstetrics and Gynecology, Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Gynmed Clinic Vienna, Helsinki University, Ullevaal University Hospital

Countries where clinical trial is conducted

Austria,  Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	postabortion contraception	The use of contraception and rate of repeat abortion at follow-up questionnaire at one year.	until 12 months post treatment	No
Secondary	adverse events	Number of women reporting adverse events and side effects including infections, bleeding, pain	util 3 months post treatment	Yes