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OpenTrials
Completed

NCT Number: NCT01612923

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

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.

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Key information

Conditions

Medical Abortion

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Karolinska University Hospital

Stockholm, 17177, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • any medical condition which contraindicates medical abortion

Treatment and study plan

Midwife

Other

gynecological exam and ultrasound and contraceptive advice provided by midwife

Primary outcomes

  1. feasibility

    Time frame: 3 weeks

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

Secondary outcomes

  1. efficacy

    Time frame: 3 weeks

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

  2. acceptability

    Time frame: 3 weeks

    as assessed by questionnaire

Sponsors and collaborators

Lead sponsor

Kristina Gemzell Danielsson

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 6, 2012
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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