Pain Assessment in MToP up to 7 WA (During 5h After Misoprostol Intake)
Condition: Abortion-Related Disorders
Study type: Interventional

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. 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.
    

Intervention name(s): scale of pain
Intervention type(s): Other
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment