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.

Study Overview

• Status: Completed
• Conditions: Medical Termination of Pregnancy

• Study Type: Observational
• Enrollment (Actual): 892

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13385
    • Hopital de la Conception

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) 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of the protocol Mifegyne and prostaglandin analogue	The success rate will be defined as complete abortion without surgical procedure	At the follow-up at 2-3 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of the protocol Mifegyne and misoprostol per os.	The success rate will be defined as complete abortion without surgical procedure	at the follow up at 2-3 weeks after the inclusion
rate of ongoing pregnancy by term.		at the follow up at 2-3 weeks after the inclusion
rate of patients requiring any additional procedures by term.		at the follow up at 2-3 weeks after the inclusion
Number of medical abortion using misoprostol	The number of medical abortion using misoprostol will be described.	at the follow up at 2-3 weeks after the inclusion
Evaluation by patients of pain using a 5 level verbal rating scale	Physician will ask patients to evaluate the pain by a 5 level verbal rating scale. the using of pain killers will be also described	at the follow up at 2-3 weeks after the inclusion

Collaborators and Investigators

• Sponsor: Nordic Pharma SAS
• Investigators: Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Amenorrhea
• Other Study ID Numbers: RYMMA