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

Medical Termination of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614781
• Other study ID #: RYMMA
• Status: Completed
• Phase: N/A
• First received: November 20, 2015
• Last updated: July 6, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: French Data Protection AuthorityFrance: Conseil National de l'Ordre des Médecins
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 892
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amenorrhea
• Medical Termination of Pregnancy

Locations

Country	Name	City	State
France	Hôpital de la Conception	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Pharma SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	rate of ongoing pregnancy by term.		at the follow up at 2-3 weeks after the inclusion	No
Secondary	rate of patients requiring any additional procedures by term.		at the follow up at 2-3 weeks after the inclusion	No
Secondary	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	No
Secondary	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	No