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OpenTrials
Completed

NCT Number: NCT02614781

Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.

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Key information

Conditions

Medical Termination of Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital de la Conception

Marseille, 13385, 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) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy
  • Patients for whom the physician decides to use a Mifegyne 600 mg and prostaglandin analogue combination for medical abortion
  • Patients agreeing to participate in the study after having 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 known hypersensitivity to mifepristone
  • Patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost).
  • Patients with severe and progressive disease
  • Patients with ectopic pregnancy

Treatment and study plan

Primary outcomes

  1. success rate of the protocol Mifegyne and prostaglandin analogue

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

    The success rate will be defined as complete abortion without surgical procedure

Secondary outcomes

  1. Success rate of the protocol Mifegyne and misoprostol per os.

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

    The success rate will be defined as complete abortion without surgical procedure

  2. rate of ongoing pregnancy by term.

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

  3. rate of patients requiring any additional procedures by term.

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

  4. Number of medical abortion using misoprostol

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

    The number of medical abortion using misoprostol will be described.

  5. Evaluation by patients of pain using a 5 level verbal rating scale

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

    Physician will ask patients to evaluate the pain by a 5 level verbal rating scale. the using of pain killers will be also described

Sponsors and collaborators

Lead sponsor

Nordic Pharma SAS

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2015
Registry last updated
Jul 11, 2016

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.

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