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

Completed

• Conditions: Medical Termination of Pregnancy

• Registration Number: NCT02614781
• Lead Sponsor: Nordic Pharma SAS

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 892

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital de la Conception; 🇫🇷 Marseille, France