patient of 18 years or more, wishing an abortion with medication before 7 weeks of amenorrhea
Conditions
Interventions
Trade Name: MIFEPRISTONE 200MG
Product Name: MIFEGYNE
Product Code: MIFEPRISTONE
Pharmaceutical Form: Cachet
Pharmaceutical form of the placebo: Cachet
Route of administration of the placebo: Oral use
Sponsors
Assistance Publique Hôpitaux de Marseille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female aged 18 or over. Female with a single intrauterine pregnancy, the term of which is less than 7 weeks on the day of mifegyne intake, estimated by ultrasound with a cranio-caudal length measurement less than or equal to 10 millimeters. Woman seeking medical abortion in hospital. A woman who has signed a written informed consent and agrees to abide by the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Minor woman. Female with multiple pregnancy, uterine malformation (cloisonné uterus, bicorn, fibroma) or coagulation disorder defined by biological parameters (TP <70%, TCA patient / control ratio <1.20). Female 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; Female with contraindication to one of the analgesics used in the study (nefopam, paracetamol, opium, caffeine). Female not affiliated to the social security system. Wife with no informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this research is to compare the efficacy in reducing the pain of two doses of Mifegyne during medicinal abortion before 7 Weeks of amenorrhea (600 versus 200 mg).;Secondary Objective: The secondary objectives of this research are to compare the 2 dosages of Mifegyne (600 vs 200 mg) in terms of: • Pain within days of taking misoprostol • Pain between taking Mifegyne and misprostol • Failed method • Additional consultations and gestures following IVG4 consultation • Tolerance of drug-induced abortion • Abortion experience documented by the EVAN-LR self-questionnaire • Impact on the degree of anxiety of the subjects by the questionnaire STAI of anxiety • Patient satisfaction with an EVA scale and the SF12 questionnaire;Primary end point(s): The primary endpoint of efficacy is the hourly pain for 5 hours after taking misoprostol. The measurement is simple, reproducible, performed with an EN on the side of 0 to 10 (0 absence of pain, 10 maximum of pains felt). The ladder will be explained to the patient. The question asked will be: what is your pain now?;Timepoint(s) of evaluation of this end point: Patients will be assessed for consultation with the 2 abortion (IVG 2) prior to taking Mifegyne (J1), the next day (D2), IVG3 before taking misoprostol (J3) and the follow-up visit (IVG4) on a digital scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pains will be assessed at the consultation of voluntary termination of pregnancy 2 (IVG2) before taking Mifegyne (J1), the next day (D2), IVG3 prior to taking misoprostol (J3) and IVG4 on an EN. The questions will be as follows: At the consultation IVG1: "currently, what is your pain? " At the IVG2 consultation before taking misoprostol: "yesterday, what was the maximum pain felt? "And" currently, what is your pain? At IVG4: "The day after taking misoprostol and the day after, what was the maximum pain felt in the day? "And" currently, what is your pain? and "since the day after taking misoprostol and so far, what was the maximum pain and how many days have you had trouble" - The use of painkillers on the day of taking misoprostol and the following days, specifying the duration and quantity of ibuprofen and other analgesics taken. - Failed method Failure is defined by the ultrasound presence of a progressive pregnancy at the IVG4 or IVG5 consultation. The means used to enable the diagnosis of the failure will be those used by the investigating centers. - Additional consultations and gestures Additional consultations are planned over a one-month period after taking misoprostol (IVG5 and higher) if the physician deems it necessary to review the patient in relation to the medicinal abortion. It will be specified if it is a simple consultation or the realization of an uterine gesture for retention. The indication of consultation or additional gesture will be carried out according to the habits of the investigating centers. - Tolerance Tolerance will be assessed by the questioning before the end of hospitalization for misoprostol (IVG3). The following signs will be carefully collected: nausea, vomiting, fever, diarrhea, abdominal pain, other (to be specified by the patient). - Experience and Anxiety Assessment of anxiety will be assessed by passing the Anxiety Task Inventory (STAI). The STAI is a self-questionnaire developed by S | — |
Countries
France
Outcome results
None listed