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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2014
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 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 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
Epistemonikos ID: b09e9a952a15b4de1974c6ad34bff1a9d852f818
First added on: Jul 27, 2021