Medical Termination of PregnancyNCT02614781
Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
An observational study of Medical Termination of Pregnancy, run by Nordic Pharma SAS at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical Termination of Pregnancy
- How many people
- 892 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women asking for medical abortion
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Medical Termination of Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of the protocol Mifegyne and prostaglandin analogue
The success rate will be defined as complete abortion without surgical procedure
Measured: At the follow-up at 2-3 weeks after inclusion
Secondary outcomes (5)
Success rate of the protocol Mifegyne and misoprostol per os.
The success rate will be defined as complete abortion without surgical procedure
Measured: at the follow up at 2-3 weeks after the inclusion
rate of ongoing pregnancy by term.
Measured: at the follow up at 2-3 weeks after the inclusion
rate of patients requiring any additional procedures by term.
Measured: at the follow up at 2-3 weeks after the inclusion
Number of medical abortion using misoprostol
The number of medical abortion using misoprostol will be described.
Measured: at the follow up at 2-3 weeks after the inclusion
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
Measured: at the follow up at 2-3 weeks after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Termination of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hélène HERMAN-DEMARS, MD, Study director, NORDIC PHARMA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614781
- Sponsor's protocol ID
- RYMMA
- Status last verified
- Jul 2016
- First submitted
- 20 Nov 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea
- ClinicalTrials.gov ID
- NCT02614781
- Acronym / sponsor ID
- RYMMA
- Conditions
- Medical Termination of Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Nordic Pharma SASIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women asking for medical abortion
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
success rate of the protocol Mifegyne and prostaglandin analogue
Time frame: At the follow-up at 2-3 weeks after inclusion
The success rate will be defined as complete abortion without surgical procedure
5 secondary outcomes
Success rate of the protocol Mifegyne and misoprostol per os.
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
rate of patients requiring any additional procedures by term.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène HERMAN-DEMARS, MD study director
NORDIC PHARMA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Termination of Pregnancy, run by Nordic Pharma SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of the protocol Mifegyne and prostaglandin analogue (time frame: At the follow-up at 2-3 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.