Medical termination of pregnancy from day 85 to day 153 of gestation: A randomized comparison between administration of the initial dose of misoprostol at home or in the clinic

INTERVENTION: Trade Name: Cytotec Product Name: Cytotec Pharmaceutical Form: Tablet INN or Proposed INN: misoprostol Current Sponsor code: 11033 Other descriptive name: MISOPROSTOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.8‐ CONDITION: Therapeutic area: Health Care [N] ‐ Health Services Administration [N04] Unwanted pregnancy PRIMARY OUTCOME: Main Objective: To compare the number of patients who are treated as day care patients in medical abortion from day 85 to day 153 of gestation when administrated the first dose of misoprostol at home or in the clinic Primary end point(s): Proportion of women who are treated as day care patients Secondary Objective: Time spent in hospital (h), ; the induction‐to‐abortion interval (defined as the time (min) from the first dose of Misoprostol until the expulsion of the foetus) (mean/median), ; the success rate of the termination of pregnancy at 24 hours (success will be defined as the expulsion of the foetus), and doses of Misoprostol used (mean/median). ; rate of complications ; surgical interventions for incomplete or retained placenta (evacuation rates) side effects w; pain during the abortion ; Acceptability Timepoint(s) of evaluation of this end point: At discharge from the hospital SECONDARY OUTCOME: Secondary end point(s): At discharge from the clinic;; ‐ Time spent in hospital (h),; ‐ the induction‐to‐abortion interval (defined as the time (min) from the first dose of Misoprostol until the expulsion of the foetus) (mean/median), ; ; At 24 h following initiation of misoprostol; ‐ the success rate of the termination of pregnancy at 24 hours (success will be defined as the expulsion of the foetus), and doses of Misoprostol used (mean/median). ; ; At Follow‐up;; ‐ rate of complications ; ‐ surgical interventions for incomplete or retained placenta (evacuation ‐ ‐ ‐ ‐‐ ‐ rates) side effects ; ‐ pain during the abortion ; ‐ Acceptability Timepoint(s) of evaluation of this end point: At discharge from the clinic;; ‐ Time spent in hospital (h),; ‐ the induction‐to‐abortion interval (defined as the time (min) from the first dose of Misoprostol until the expulsion of the foetus) (mean/median), ; ; At 24 h following initiation of misoprostol; ‐ the success rate of the termination of pregnancy at 24 hours (success will be defined as the expulsion of the foetus), and doses of Misoprostol used (mean/median). ; ; At Follow‐up;; ‐ rate of complications ; ‐ surgical interventions for incomplete or retained placenta (evacuation ‐ ‐ ‐ ‐‐ ‐ rates) side effects ; ‐ pain during the abortion ; ‐ Acceptability INCLUSION CRITERIA: Women aged >/= 18 years requesting a termination of pregnancy, the gestational age being determined to 85 – 153 days (with ultrasonography), willing and able to understand and participate after the study has been explained, with good understanding of Swedish or English language, in general good health, with a single intrauterine pregnancy, who have given their informed consent 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 896 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range