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

• Sponsor: Nordic Pharma SAS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02614781
• Collaborator: (none)
• Enrollment: 892
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 149.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical Termination of Pregnancy

Study Design

• Study Type: Observational
• Actual Enrollment: 892 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. rate of ongoing pregnancy by term. [at the follow up at 2-3 weeks after the inclusion]

3. rate of patients requiring any additional procedures by term. [at the follow up at 2-3 weeks after the inclusion]

4. 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.

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital de la Conception	Marseille		France	13385

Sponsors and Collaborators

• Nordic Pharma SAS

Investigators

• Study Director: Hélène HERMAN-DEMARS, MD, NORDIC PHARMA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nordic Pharma SAS
• ClinicalTrials.gov Identifier: NCT02614781
• Other Study ID Numbers: RYMMA
• First Posted: Nov 25, 2015
• Last Update Posted: Jul 11, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Amenorrhea

Study Results

No Results Posted as of Jul 11, 2016