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

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.

Study Overview

• Status: Completed
• Conditions: Abortion; Attempted, Medical

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Cabinet Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women asking for medical abortion

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.	There was concordance if : The result of urinary test is < 1000 IU/L and the value of β-hCG blood measurement was < 1000 IU/L, Or if; The result of urinary test is ≥ 1000 iu/L and the value of β-hCG blood measurement was ≥ 1000 IU/L. There was discrepancy if: The result of urinary test is ≥ 1000 IU/L and the value of β-hCG blood measurement was < 1000 IU/L, Or if; The result of urinary test is < 1000 IU/L and the value of β-hCG blood measurement was ≥ 1000 IU/L.	At the follow-up at 2-3 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the urinary semi-quantitative test by the patient	The analysis of the acceptability is descriptive: The rate of patients who performed the urinary test.; Assessment of the urinary test by physicIan : very easy/easy/difficult/Impossible; The assessment by the patient: questionnaire (Have you found the explanations given sufficient for performing the test?, How did you find the carrying out of this test? What are your feelings about checking the results of the medical abortion yourself?)	at the follow up at 2-3 weeks after the inclusion

Collaborators and Investigators

• Sponsor: Nordic Pharma SAS
• Investigators: Principal Investigator: Danielle HASSOUN, MD, Cabinet Medical

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: BETINA