Medical Termination of Pregnancy
Conditions
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.
Interventions
None listed
Sponsors
Nordic Pharma SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | 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 |
Countries
France
Outcome results
None listed