Routine Follow-up Versus Self-assessment in Medical Abortion

Not Applicable

Completed

• Conditions: Medical Abortion
• Interventions: Other: Home self assessment of complete medical abortion

• Registration Number: NCT01487213
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 929

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home self test	Home self assessment of complete medical abortion	Intervention

Primary Outcome Measures

Name	Time	Method
Number of complete abortions	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%.

Secondary Outcome Measures

Name	Time	Method
adverse events	util 3 months post treatment	Number of women reporting adverse events and side effects including infections, bleeding, pain
postabortion contraception	until 12 months post treatment	The use of contraception and rate of repeat abortion at follow-up questionnaire at one year.

Trial Locations

Locations (4)

Dept. Obstetrics and Gynaecology,Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

GynMed Clinic; 🇦🇹 Vienna, Austria

Faculty of Medicine, University of Oslo and Dept. of Gynaecology,; 🇳🇴 Oslo, Norway

Dept of Obstetrics and Gynecology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden