Medical abortion up to 10 weeks of gestation performed by the woman at home

Home abortion up to 10 weeks of gestation - Home abortion

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004749-18-SE

Enrollment

320

Registered

2013-12-27

Start date

2014-03-05

Completion date

Unknown

Last updated

2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unwanted pregnancy and induced abortion

Interventions

Trade Name: Mifepristone Product Name: Mifegyn Pharmaceutical Form: Tablet Trade Name: Misoprostol Product Name: Misoprostol, Cytotec Product Code: A02BB01 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women with an unwanted pregnancy up to 10 weeks of gestation, opting for medical abortion at home. Women without a contraindication towards medical abortion. Over the age of 18 years Good general health Willing to participate in the study Intrauterine pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women with a pregnancy >10 weeks of gestation Contraindications for abortion outside the hospital Allergy towards abortion drugs Medical conditions suggesting contraindication for medical abortion

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if medical abortion at home up to 10 weeks of gestation is as safe and acceptable as was previously shown for abortions in earlier pregnancies (<9 weeks of gestation);Secondary Objective: To evaluate bleeding, pain and other possible side effects among women performing medical abortion at home in gestational week 10;Primary end point(s): Proportion of women in need for additional treatment due to incomplete abortion (surgical or medical methods).;Timepoint(s) of evaluation of this end point: Two-three weeks after treatment at follow-up	—

Measure

Time frame

Main Objective: To evaluate if medical abortion at home up to 10 weeks of gestation is as safe and acceptable as was previously shown for abortions in earlier pregnancies (<9 weeks of gestation);Secondary Objective: To evaluate bleeding, pain and other possible side effects among women performing medical abortion at home in gestational week 10;Primary end point(s): Proportion of women in need for additional treatment due to incomplete abortion (surgical or medical methods).;Timepoint(s) of evaluation of this end point: Two-three weeks after treatment at follow-up

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Two-three weeks after treatment at follow-up;Secondary end point(s): proportion of women with side effects such as bleeding and pain. Women´s acceptance of the treatment	—

Countries

Norway, Sweden, Ukraine

Contacts

Public ContactKI

Karolinska Institutet

lena.marions@ki.se46851776357

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026