Abortion-Related DisordersDoMyNCT03659045
Pain Assessment in MToP Up to 7 WA (during 5h After Misoprostol Intake)
A study testing scale of pain in people with Abortion-Related Disorders, run by Assistance Publique Hopitaux De Marseille at 8 sites in France.
Trial summary
In 2016, medical termination of pregnancy represent 64% of total abortions in France. Thus, it is a frequent act involving a large majority of women and a health-care public subject. The two medicines used in medical abortion are mifepristone and misoprostol. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Abortion-Related Disorders
- What is being tested?
- scale of pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Jan 2019to 4 Apr 2023
- Phase
- Interventional
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman aged 18 or over.
- A woman with a single intrauterine pregnancy, whose term is less than 7 weeks on the day of taking mifegyne, estimated by ultrasound with a measurement of the craniocaudal length less than or equal to 10 millimeters.
- Woman wishing a drug induced abortion in hospital.
- Woman having signed a written informed consent and pledging to respect the instructions of the protocol.
Who cannot join
- Minor woman.
- Women with multiple pregnancy, uterine malformation (septate uterus, cocked hat, fibroids) or a coagulation disorder defined by biological parameters (TP <70%, TCA patient / control ratio <1.20).
- Women with a contraindication to mifepristone: chronic adrenal insufficiency, severe asthma not controlled by treatment, hereditary porphyria, known allergy to the active substance or to any of the excipients.
- Women with a contraindication to misoprostol: hypersensitivity to the active substance, to any of the excipients or to other prostaglandins;
- Women presenting a contraindication to one of the analgesics used in the study (nefopam, paracetamol, opium, caffeine).
- Woman with suspected ectopic pregnancy
Show all 12Show fewer
- Woman with pregnancy not confirmed by ultrasound or biology
- Woman with a contraindication to the antiemetic potentially used (ondansetron)
- Women with a contraindication to lactose
- Patients undergoing treatment with one or more CYP3A4-moderate or potent drugs
- Female not affiliated to the social security scheme.
- Women having not signed informed consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Chu Grenoble Alpes
Grenoble, 38043
Hospices Civils de Lyon
Lyon, 69002
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
Centre Hospitalier Du Belvedere
Mont-Saint-Aignan
Centre Clotilde Vautier de L'Union de Gestion de La Clinique Jules Verne de Nantes
Nantes, 44300
Assistance Publique Hôpitaux de Paris
Paris, 75184
Centre Hospitalier de Roubaix
Roubaix, 59056
Chu de Toulouse
Toulouse
About this study
Official title: Double-blind, Randomized, Multicenter Study Evaluating 200 Mg Versus 600 Mg of Mifegyne® on Pain in Medical Termination of Pregnancy (MToP) Up to 7 Weeks of Amenorreha (WA). DoMy Study.
In 2016, medical termination of pregnancy represent 64% of total abortions in France. Thus, it is a frequent act involving a large majority of women and a health-care public subject. The two medicines used in medical abortion are mifepristone and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater than 90% up to 7 SA. Medical abortion may be performed in outpatient basis or in short-terme hospitalization. One of the limits of this technique development is the pain caused by the drugs intake mainly due to the uterine contractions induced by misoprostol intake. Thus it is recommended a systematic analgesics intake but despite these guidelines, pain level reported by the patients remains significant. There is very limited data on the misoprostol influence or mifepristone dose on pain. In a recent observational multicenter study, mifepristone 600 mg was reported to be associated with decreased pain compared with mifepristone 200 mg.
In this context, it is important to confirm by a higher level evidence of study that the protocol using mifepristone 600 mg decreases the pain level of medical abortion compared to a protocol using mifepristone 200 mg. In the absence of benefit, we will not be able to conclude to a benefit on the prevention of pain with a protocol associating 600 mg of mifepristone and 400 μg of misoprostol. If the benefit on pain is confirmed, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of quality of care or medical and economic impact.
Read more
The clinical study is interventional, prospective, comparative, randomized, double-blind, multi-center, conducted in 11 French hospitals carrying out voluntary medical termination of pregnancy.
The data will be collected by the physician during the 4 consultations (initial consultation of abortion request, inclusion consultation with Mifegyne® intake, consultation of misoprostol intake (short-terme hospitalization), follow-up consultation from the available data in the patient's medical file and from the questionning and clinical examination data made during these 4 consultations.
Read the detailed description
Background and purpose of the study: In 2015, the voluntary interruption of medication pregnancy represented 57% of the total number of abortions in metropolitan France, ie 116,000 annual acts. Thus, it is a frequent act involving a very large majority of women and a subject of public health. The two molecules used in drug-induced abortion are mifepristone and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater than 90% before 7 SA. One of the limits of the diffusion of this technique is the pain caused by the drug intake mainly at the time of the uterine contractions induced by the taking of misoprostol. Thus it is recommended a systematic taking of analgesics but despite these recommendations the level of pain reported by the patients remains high. There is very little data on the influence of the dose of misoprotol or mifepristone on pain. In a recent multicenter observational study, mifepristone 600 mg was reported to be associated with a decrease in pain compared with 200 mg while the misoprostol dose had no influence.
In this context, it is important to confirm by a higher level of evidence study whether the protocol using 600 mg mifepristone decreases the pain level of drug-induced abortion compared to a protocol using 200 mg, at the same dose of misoprostol .
MATERIAL AND METHODS: A prospective, randomized, double-blind, multi-center clinical study, conducted in metropolitan France, in 11 hospital centers performing drug-induced abortion involving 320 patients. The inclusion criteria will be patients requesting a drug-induced abortion, agreeing to participate in the study and not having a contraindication to both study drugs. The main criterion will be the pain felt within 5 hours after taking misoprostol. The secondary criteria will be the pain felt and painkillers consumed during the various stages of drug induced abortion, the failure rate, the number of intermediate consultations, tolerance and quality of life.
Expected results and consequences: In the absence of benefit, the investigators will not be able to conclude to a benefit on the prevention of the pain with a protocol associating 600 mg of mifepristone and 400 μg of misoprostol. In the event of confirmation of benefit on pain, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of the quality of care or the medical and economic impact.
- Conditions
- Abortion-Related Disorders
- Being tested
- scale of pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scale of painOther
The measurement is simple, reproducible, performed using a scale of pain rated from 0 to 10 (0 absence of pain, 10 maximum of pain felt)
| Study group | Role | What they receive |
|---|---|---|
| Mifegyne® 600MG | Experimental | Patients assigned to this group will receive three 200 mg tablets of Mifegyne® taken during the consultation Patients will answer to a scale of pain Receives: Other: scale of pain |
| Mifegyne® 200MG | Placebo comparator | Patients assigned to this group will receive one 200 mg Mifegyne® tablet and two placebo tablets that will be taken during the consultation.
Patients will answer to a scale of pain Receives: Other: scale of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment in MToP up to 7 WA after Mifegyne® intake
Pain measurement is simple, reproducible, performed by numeric scale rated from 0 to 100 (0 no pain, 100 maximum pain felt). The scale will be explained to the patient
Measured: During 5 hour after Mifegyne® intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start15 Jan 2019
- Primary completion22 Mar 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion-Related DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659045
- Sponsor's protocol ID
- 2017-53
- Acronym
- DoMy
- Status last verified
- Jul 2023
- First submitted
- 17 Aug 2018
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Multicenter Study Evaluating 200 Mg Versus 600 Mg of Mifegyne® on Pain in Medical Termination of Pregnancy (MToP) Up to 7 Weeks of Amenorreha (WA). DoMy Study.
- ClinicalTrials.gov ID
- NCT03659045
- Acronym / sponsor ID
- DoMy / 2017-53
- Conditions
- Abortion-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
In 2016, medical termination of pregnancy represent 64% of total abortions in France. Thus, it is a frequent act involving a large majority of women and a health-care public subject. The two medicines used in medical abortion are mifepristone and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater than 90% up to 7 SA. Medical abortion may be performed in outpatient basis or in short-terme hospitalization. One of the limits of this technique development is the pain caused by the drugs intake mainly due to the uterine contractions induced by misoprostol intake. Thus it is recommended a systematic analgesics intake but despite these guidelines, pain level reported by the patients remains significant. There is very limited data on the misoprostol influence or mifepristone dose on pain. In a recent observational multicenter study, mifepristone 600 mg was reported to be associated with decreased pain compared with mifepristone 200 mg.
In this context, it is important to confirm by a higher level evidence of study that the protocol using mifepristone 600 mg decreases the pain level of medical abortion compared to a protocol using mifepristone 200 mg. In the absence of benefit, we will not be able to conclude to a benefit on the prevention of pain with a protocol associating 600 mg of mifepristone and 400 μg of misoprostol. If the benefit on pain is confirmed, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of quality of care or medical and economic impact.
The clinical study is interventional, prospective, comparative, randomized, double-blind, multi-center, conducted in 11 French hospitals carrying out voluntary medical termination of pregnancy.
The data will be collected by the physician during the 4 consultations (initial consultation of abortion request, inclusion consultation with Mifegyne® intake, consultation of misoprostol intake (short-terme hospitalization), follow-up consultation from the available data in the patient's medical file and from the questionning and clinical examination data made during these 4 consultations.
Detailed description
Background and purpose of the study: In 2015, the voluntary interruption of medication pregnancy represented 57% of the total number of abortions in metropolitan France, ie 116,000 annual acts. Thus, it is a frequent act involving a very large majority of women and a subject of public health. The two molecules used in drug-induced abortion are mifepristone and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater than 90% before 7 SA. One of the limits of the diffusion of this technique is the pain caused by the drug intake mainly at the time of the uterine contractions induced by the taking of misoprostol. Thus it is recommended a systematic taking of analgesics but despite these recommendations the level of pain reported by the patients remains high. There is very little data on the influence of the dose of misoprotol or mifepristone on pain. In a recent multicenter observational study, mifepristone 600 mg was reported to be associated with a decrease in pain compared with 200 mg while the misoprostol dose had no influence.
In this context, it is important to confirm by a higher level of evidence study whether the protocol using 600 mg mifepristone decreases the pain level of drug-induced abortion compared to a protocol using 200 mg, at the same dose of misoprostol .
MATERIAL AND METHODS: A prospective, randomized, double-blind, multi-center clinical study, conducted in metropolitan France, in 11 hospital centers performing drug-induced abortion involving 320 patients. The inclusion criteria will be patients requesting a drug-induced abortion, agreeing to participate in the study and not having a contraindication to both study drugs. The main criterion will be the pain felt within 5 hours after taking misoprostol. The secondary criteria will be the pain felt and painkillers consumed during the various stages of drug induced abortion, the failure rate, the number of intermediate consultations, tolerance and quality of life.
Expected results and consequences: In the absence of benefit, the investigators will not be able to conclude to a benefit on the prevention of the pain with a protocol associating 600 mg of mifepristone and 400 μg of misoprostol. In the event of confirmation of benefit on pain, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of the quality of care or the medical and economic impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifegyne® 600MG | Experimental | Other: scale of painPatients assigned to this group will receive three 200 mg tablets of Mifegyne® taken during the consultation Patients will answer to a scale of pain |
| Mifegyne® 200MG | Placebo comparator | Other: scale of painPatients assigned to this group will receive one 200 mg Mifegyne® tablet and two placebo tablets that will be taken during the consultation. Patients will answer to a scale of pain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Woman aged 18 or over.
- A woman with a single intrauterine pregnancy, whose term is less than 7 weeks on the day of taking mifegyne, estimated by ultrasound with a measurement of the craniocaudal length less than or equal to 10 millimeters.
- Woman wishing a drug induced abortion in hospital.
- Woman having signed a written informed consent and pledging to respect the instructions of the protocol.
Key exclusion criteria (12 listed)
- Minor woman.
- Women with multiple pregnancy, uterine malformation (septate uterus, cocked hat, fibroids) or a coagulation disorder defined by biological parameters (TP <70%, TCA patient / control ratio <1.20).
- Women with a contraindication to mifepristone: chronic adrenal insufficiency, severe asthma not controlled by treatment, hereditary porphyria, known allergy to the active substance or to any of the excipients.
- Women with a contraindication to misoprostol: hypersensitivity to the active substance, to any of the excipients or to other prostaglandins;
- Women presenting a contraindication to one of the analgesics used in the study (nefopam, paracetamol, opium, caffeine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scale of painThe measurement is simple, reproducible, performed using a scale of pain rated from 0 to 10 (0 absence of pain, 10 maximum of pain felt) | Other | Mifegyne® 200MG, Mifegyne® 600MG |
Primary outcome
Pain assessment in MToP up to 7 WA after Mifegyne® intake
Time frame: During 5 hour after Mifegyne® intake
Pain measurement is simple, reproducible, performed by numeric scale rated from 0 to 100 (0 no pain, 100 maximum pain felt). The scale will be explained to the patient
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 23 Oct 2024.
- Individual participant dataSharing planned: No
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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.
EMILIE GARRIDO PRADALIE study director
APHM
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scale of pain in people with Abortion-Related Disorders, run by Assistance Publique Hopitaux De Marseille at 8 sites 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 12 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
Pain assessment in MToP up to 7 WA after Mifegyne® intake (time frame: During 5 hour after Mifegyne® intake). 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 23 Oct 2024.