self-administered at home abortion
Conditions
Interventions
Group 1: Phase 1: Overview of the clinical routine of medical abortion with outpatient setting in Germany, survey of experts
Group 2: Phase 2: Need for abortion and adjunctive medication, especially a
Sponsors
Zentrum für klinische Studien der Universität Witten/Herdecke
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase 1: - Doctors with practical experience in planning, performing, following up and documenting medical abortions with a clinic/practice within Germany - The experts have read the study information and consented to the study. Phase 2: - The participant collective includes all persons who terminated an unwanted, intrauterine pregnancy with medication during the survey period. The maximum gestational age is 63 days post menstruation (corresponding to the authorisation of medication abortion in Germany up to 9+0 weeks of pregnancy p.m.). - The minimum age is 18 years. - Sex female or diverse. - Patients must have sufficient knowledge of the German language. - Patients are able to give informed consent. - The study doctor is the doctor working in the abortion practice/clinic
Exclusion criteria
Exclusion criteria: Phase 1: - Doctors without practical experience in planning, performing, following up and documenting medication abortions - Doctors with practical experience in planning, performing, following up and documenting medication abortions with a clinic location/practice outside Germany - The experts have not read the study information and/or have not consented to the study. Phase 2: - Age is under 18 years. - There is no intrauterine pregnancy. - The gestational age is over 63 days post menstruation. - The patients do not have sufficient knowledge of the German language. - The patients are not capable of giving consent. - The patients have legal representation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: - Name, dosage, form of administration, dosage regimen, instructions for use and reason (indication) for the standard medication used for the medical termination of pregnancy - Deviating regimens - Professional experience - Number of doctors providing care, number of non-medical colleagues - Support services (sick leave, prescriptions, contact number for emergencies, tender loving care) Phase 2: Is there a significant difference between medication regimens with regard to the number of days with an NRS value < 3 (no pain)? | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: - Is there a significant difference between the medication regimens with regard to the pain score (NRS) - Number of pain days with an NRS = 3 - Rate of complete abortions - Length of the informative discussion - Gastrointestinal side effects (nausea, vomiting, diarrhoea) - Satisfaction with analgesia - Complications - Unscheduled contact with the practice - Overall satisfaction with care during the abortion (‘tender loving care’) - Satisfaction with chosen method | — |
Countries
Germany
Contacts
Public ContactLea Rikl
Zentrum für klinische Studien der Universität Witten/Herdecke
Outcome results
None listed