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

NCT02614781 | Completed

• 1 other identifier: RYMMA
• Study Type: observational
• Target: 892
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medical Termination of Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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

  at the follow up at 2-3 weeks after the inclusion

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

  at the follow up at 2-3 weeks after the inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women asking for medical abortion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordic Pharma SAS: lead

Study Sites (1)

Hôpital de la Conception

Marseille, 13385, France

Location

Study Officials

• Hélène HERMAN-DEMARS, MD

  NORDIC PHARMA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

FR (1)