DoMy
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.
Sponsor study identifier
interventional
320
1 country
8
Study Start
January 15, 2019
Actual (reported)Primary Completion
March 22, 2023
Actual (reported)Study Completion
April 4, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 4, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2018
Actual (reported)September 6, 2018
Actual (reported)January 15, 2019
Actual (reported)March 22, 2023
Actual (reported)April 4, 2023
Actual (reported)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
During 5 hour after Mifegyne® intake
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
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
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354, France
Chu Grenoble Alpes
Grenoble, 38043, France
Hospices Civils de Lyon
Lyon, 69002, France
Centre Hospitalier Du Belvedere
Mont-Saint-Aignan, France
Centre Clotilde Vautier de L'Union de Gestion de La Clinique Jules Verne de Nantes
Nantes, 44300, France
Assistance Publique Hôpitaux de Paris
Paris, 75184, France
Centre Hospitalier de Roubaix
Roubaix, 59056, France
EMILIE GARRIDO PRADALIE
APHM
320 participants (actual enrollment reported by the registry).
First Submitted
August 17, 2018
First Posted
September 6, 2018
Study Start
January 15, 2019
Actual (reported)Contact the study team to confirm eligibility.
Chu de Toulouse
Toulouse, France
Primary Completion
March 22, 2023
Actual (reported)Study Completion
April 4, 2023
Actual (reported)Last Updated
October 23, 2024
Record last verified: 2023-07
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Source: ClinicalTrials.gov.
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