E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Health Care [N] - Health Services Administration [N04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal exclusion criteria |
Women who do not wish to participate or who are unable to communicate in Swedish or English. Women carrying a non-viable pregnancy (confirmed by ultrasonography). Women with a history or evidence of disorders that represent a contraindication to the use of Mifepristone or Misoprostol (adrenal pathology, steroid dependent cancer, porphyria, known allergy to the medication). Women with pre-existing health conditions in whom the execution of a medical abortion as judged by the investigator could compromise their condition will also be excluded. Examples of health conditions of concern are: severe anaemia, severe asthma, haemorrhagic disorders, treatment with anticoagulants or corticoids, severe cardiac disease or hypertension, severe liver disease, severe kidney disease or severe psychiatric disorders. Fetal malformation that may impact time–to-expulsion (such as hydrocephalus, hydrops/edema).
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of women who are treated as day care patients |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At discharge from the hospital |
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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Administration in the clinic |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |