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OpenTrials
Completed

NCT Number: NCT02304835

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.

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Key information

Conditions

Abortion; Attempted, Medical

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cabinet Médical

Paris, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.

    Time frame: At the follow-up at 2-3 weeks after inclusion

    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.

Secondary outcomes

  1. Acceptability of the urinary semi-quantitative test by the patient

    Time frame: at the follow up at 2-3 weeks after the inclusion

    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?)

Sponsors and collaborators

Lead sponsor

Nordic Pharma SAS

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2014
Registry last updated
Dec 5, 2014

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.