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

Kristina Gemzell Danielsson

Status and phase: Completed; Phase 3

Conditions: Medical Abortion

Treatments: Other: Midwife

Study type: Interventional

Funder types: Other

Identifiers

NCT01612923

W2010U

Details and patient eligibility

About

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.

Enrollment: 1,180 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• any medical condition which contraindicates medical abortion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,180 participants in 2 patient groups

midwife

Experimental group

Description:

Gynecological exam and ultrasound performed by midwife, medical abortion service provided by midwife,contraceptive advice provided by midwife. Follow-up visit provided by midwife

Treatment:

Other: Midwife

Physician

No Intervention group

Description:

Gynecological exam and ultrasound and contraceptive advice provided by physician. Medical abortion service and follow-up visit provided by midwife