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Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion

NCT ID: NCT02304835

Last Updated: 2014-12-05

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

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Recruitment Status

COMPLETED

Total Enrollment

322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.

The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.

Detailed Description

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Conditions

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Abortion; Attempted, Medical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.
* Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.
* Informed patients accepting the computer processing of their medical data and their right of access and correction.

Exclusion Criteria

* Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.
* Patients with contraindications to medical abortion.
* Patients with severe and progressive disease.
* Patients unable to complete a questionnaire.
* Patients refusing to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nordic Pharma SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle HASSOUN, MD

Role: PRINCIPAL_INVESTIGATOR

Cabinet Médical

Locations

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Cabinet Médical

Paris, , France

Site Status

Countries

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France

Other Identifiers

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BETINA

Identifier Type: -

Identifier Source: org_study_id