ClinicalTrials.gg
CompletedNCT01612923Updated Aug 27, 2013

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

A Phase 3 interventional study of Midwife in Medical Abortion, sponsored by Kristina Gemzell Danielsson. Completed at 1 site in Sweden. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-08-27.

Sponsored by Kristina Gemzell Danielsson · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,180
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Medical Abortion

Keywords

  • abortion
  • medical abortion
03

In context

Lead sponsor

Kristina Gemzell Danielsson is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • any medical condition which contraindicates medical abortion
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,180 participants (actual)

Study arms

  • Experimental
    midwife

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

    Other: Midwife

  • No intervention
    Physician

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

Interventions

  • OtherMidwife

    gynecological exam and ultrasound and contraceptive advice provided by midwife

06

What researchers measure

Primary outcomes

  1. feasibility

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

    Time frame: 3 weeks

Secondary outcomes

  1. efficacy

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

    Time frame: 3 weeks

  2. acceptability

    as assessed by questionnaire

    Time frame: 3 weeks

07

Study locations

1 site
  • Karolinska University Hospital
    Stockholm, 17177, Sweden
08

References and documents

Publications

  • Kopp Kallner H, Gomperts R, Salomonsson E, Johansson M, Marions L, Gemzell-Danielsson K. The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by doctors or by nurse-midwives: a randomised controlled equivalence trial. BJOG. 2015 Mar;122(4):510-7. doi: 10.1111/1471-0528.12982. Epub 2014 Jul 18. PubMed 25040643 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011, a primary completion of Jun 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2012
First posted
Jun 6, 2012
Start
Apr 2011
Primary completionActual
Jun 2012
CompletionActual
Jul 2012
Last update
Aug 27, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01612923
Lead sponsor
Kristina Gemzell Danielsson
Responsible party
Kristina Gemzell Danielsson (Professor, Karolinska Institutet) — Sponsor-investigator
First posted
Jun 6, 2012
Start date
Apr 2011
Primary completion
Jun 2012
Completion
Jul 2012
Last update
Aug 27, 2013

Study contacts

Kristina Gemzell Danielsson, professor
principal investigator · Karolinska Institutet
Helena Kopp Kallner, MD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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