EUCTR2014‐002974‐35‐SE.
Methods | Randomised trial |
Participants | "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" |
Interventions | "INTERVENTION: Trade Name: Mifegyne Pharmaceutical Form: Tablet Trade Name: Cytotec Pharmaceutical Form: Tablet Trade Name: Naproxen Pharmaceutical Form: Tablet Trade Name: Alvedon Pharmaceutical Form: Tablet" CONDITION: Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] Young women with unwanted pregnancies seeking abortion care |
Outcomes | "PRIMARY OUTCOME: Main Objective: To study if home abortion is more acceptable for young women than induced medical abortion at the clinic Primary end point(s): Acceptability measured on questionnaires 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 Timepoint(s) of evaluation of this end point: The day after the abortion and after 3 weeks" "SECONDARY OUTCOME: 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" |
Notes |