Legally Induced Abortion Without Mention of Complication, Pregnancy Complications
Conditions
Keywords
Medical abortion, Home abortion
Brief summary
Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.
Detailed description
The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention. Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility. The study will be performed in five abortion clinics in Sweden.
Interventions
PROCEDUREMedical abortion at home
Medical abortion using Mifepristone at the clinic followed by Cytotec at home
Sponsors
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy * Requesting and eligible for medical abortion * Confirmed intrauterine pregnancy * Gestational length no more than 70 days * Hemoglobin over 100g/l
Exclusion criteria
* Anemia * Contraindication to mifepristone (steroid-dependant cancer, porphyria) * Breast feeding * Advanced pregnancy (\>70 days) * Known liver disease * Bleeding disorder * Arterial hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of incomplete abortions | 4 weeks after treatment | Need for surgical or pharmaceutical intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of bleeding | 4 weeks after treatment | Measured by diary and questionnaires |
| Acceptance and satisfaction of treatment | 4 weeks after treatment | Questionnaires |
| Number of additional visits to the clinic | 4 weeks after treatment | — |
Countries
Sweden
Outcome results
None listed