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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2016
• Main ID: NCT02614781
• Date of registration: 20/11/2015
• Prospective Registration: No
• Primary sponsor: Nordic Pharma SAS
• Public title: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
• Scientific title: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
• Date of first enrolment: November 2015
• Target sample size: 892
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02614781
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Hélène HERMAN-DEMARS, MD
• Affiliation: NORDIC PHARMA

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Medical Termination of Pregnancy

Primary Outcome(s)

success rate of the protocol Mifegyne and prostaglandin analogue [Time Frame: At the follow-up at 2-3 weeks after inclusion]

Secondary Outcome(s)

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

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

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]

Success rate of the protocol Mifegyne and misoprostol per os. [Time Frame: at the follow up at 2-3 weeks after the inclusion]

Number of medical abortion using misoprostol [Time Frame: at the follow up at 2-3 weeks after the inclusion]

Secondary ID(s)

RYMMA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors