Unwanted pregnancy
Conditions
Interventions
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(
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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;Primary end point(s): Proportion of women who are treated as day care patients;Timepoint(s) of evaluation of this end point: At discharge from the hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sweden
Contacts
Public ContactKristina Gemzell Danielsson
Karolinska Institutet
Outcome results
None listed