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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01612923
Enrollment
1180
Registered
2012-06-06
Start date
2011-04-30
Completion date
2012-07-31
Last updated
2013-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Abortion

Keywords

abortion, medical abortion

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.

Interventions

OTHERMidwife

gynecological exam and ultrasound and contraceptive advice provided by midwife

Sponsors

Kristina Gemzell Danielsson
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* healthy women aged 18-45 with no contraindication to medical abortion

Exclusion criteria

* any medical condition which contraindicates medical abortion

Design outcomes

Primary

MeasureTime frameDescription
feasibility3 weeksSuccessful completion of abortion without need for unscheduled visits or calls.

Secondary

MeasureTime frameDescription
efficacy3 weekscomplete uterine evacuation without the need for further medical or surgical intervention
acceptability3 weeksas assessed by questionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026