Is home abortion mora acceptable for teenagers than abortion at the clinic? A randomized trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002974-35-SE

Enrollment

160

Registered

2014-07-09

Start date

2014-10-07

Completion date

Unknown

Last updated

2024-07-29

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

Conditions

Young women with unwanted pregnancies seeking abortion care

Interventions

Trade Name: Mifegyne Pharmaceutical Form: Tablet Trade Name: Cytotec Pharmaceutical Form: Tablet Trade Name: Naproxen Pharmaceutical Form: Tablet Trade Name: Alvedon Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy women aged 13-17, seeking medical abortion Normal pregnancy at the most 9 gestational weeks Able to have a guardian present at home Informed consent from guardians Are the trial subjects under 18? yes Number of subjects for this age range: 160 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Severe psychiatric or somatic disease or drug abuse Allergy to mifepristone, misoprostol, naproxen or paracetamol Contraindications to mifepristone, misoprostol, naproxen or paracetamol Not Swedish speaking Home abortion not acceptable No consent from guardians

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if home abortion is more acceptable for young women than induced medical abortion at the clinic;Secondary Objective: To compare the home abortion group with the clinic abortion group regarding: - Pain and use of analgetics - Number of unsceduled visits to the clinic -Acceptability for the guardian -Contraceptive use after six months;Primary end point(s): Acceptability measured on questionnaires;Timepoint(s) of evaluation of this end point: The day after the abortion and after 3 weeks	—

Measure

Time frame

Main Objective: To study if home abortion is more acceptable for young women than induced medical abortion at the clinic;Secondary Objective: To compare the home abortion group with the clinic abortion group regarding: - Pain and use of analgetics - Number of unsceduled visits to the clinic -Acceptability for the guardian -Contraceptive use after six months;Primary end point(s): Acceptability measured on questionnaires;Timepoint(s) of evaluation of this end point: The day after the abortion and after 3 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Pain, bleedings and other complications detected with diaries and from medical records at the clinic Guardians acceptability measured with questionnaires Contraceptive use checked after 6 months;Timepoint(s) of evaluation of this end point: Diaries filled in from the abortion and another 3 weeks Questionnaires filled in before the abortion, the day after and after 3 weeks Contraceptive use after 6 months	—

Measure

Time frame

Secondary end point(s): Pain, bleedings and other complications detected with diaries and from medical records at the clinic Guardians acceptability measured with questionnaires Contraceptive use checked after 6 months;Timepoint(s) of evaluation of this end point: Diaries filled in from the abortion and another 3 weeks Questionnaires filled in before the abortion, the day after and after 3 weeks Contraceptive use after 6 months

—

Countries

Sweden

Contacts

Public ContactUmeå University

Umeå University

marie.bixo@obgyn.umu.se

Outcome results

None listed

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