MedDataX Logo

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

NCT ID: NCT01612923

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medical Abortion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

abortion medical abortion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Midwife

Intervention Type OTHER

gynecological exam and ultrasound and contraceptive advice provided by midwife

Physician

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midwife

gynecological exam and ultrasound and contraceptive advice provided by midwife

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* any medical condition which contraindicates medical abortion
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kristina Gemzell Danielsson

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristina Gemzell Danielsson

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristina Gemzell Danielsson, professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Helena Kopp Kallner, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25040643 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

W2010U

Identifier Type: -

Identifier Source: org_study_id