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Safety and Efficacy of Medical Abortion Provided by Midlevel Providers or Physicians

Phase 3
Completed
Conditions
Medical Abortion
Interventions
Other: Midwife
Registration Number
NCT01612923
Lead Sponsor
Kristina Gemzell Danielsson
Brief Summary

The physical examination before an abortion is usually performed by a physician. However, in many countries access to physicians is limited. To increase access to safe abortion this study wishes to examine if midlevel providers such as specially trained midwives can provide safe abortion services. Midwives in study were specially trained to perform early pregnancy ultrasound and if needed to consult a physician. The midwife then provided the abortion service as well as the contraceptive advice. Women were randomized to receive the service from a midwife or a physician.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
1180
Inclusion Criteria
  • healthy women aged 18-45 with no contraindication to medical abortion
Exclusion Criteria
  • any medical condition which contraindicates medical abortion

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
midwifeMidwifeGynecological exam and ultrasound performed by midwife, medical abortion service provided by midwife,contraceptive advice provided by midwife. Follow-up visit provided by midwife
Primary Outcome Measures
NameTimeMethod
feasibility3 weeks

Successful completion of abortion without need for unscheduled visits or calls.

Secondary Outcome Measures
NameTimeMethod
efficacy3 weeks

complete uterine evacuation without the need for further medical or surgical intervention

acceptability3 weeks

as assessed by questionnaire

Trial Locations

Locations (1)

Karolinska University Hospital

πŸ‡ΈπŸ‡ͺ

Stockholm, Sweden

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