EUCTR2017‐004083‐35‐FR 2018.
| Study name | A double‐blind, randomized, multicenter study evaluating 200 mg versus 600 mg of Mifepristone on pain in voluntary abortion by drug prior to 7 SA. DoMy Study |
| Methods | |
| Participants | "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" |
| Interventions | Intervention: trade name: mifepristone 200 mg. Product name: Mifegyne. Product code: mifepristone. Pharmaceutical form: Cachet Pharmaceutical form of the placebo: Cachet. Route of administration of the placebo: oral use pharmaceutical form of the placebo: Cachet route of administration of the placebo: oral use Condition: patient of ≥ 18 years, wishing an abortion with medication before 7 weeks of amenorrhea. Therapeutic area: diseases [C] ‐ immune system diseases [C20] |
| Outcomes | "PRIMARY OUTCOME: 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). 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?" "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 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 OUTCOME: 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 Spielberger (Spielberger, 1983) and validated in French (Gauthier & Bouchard, 1993). It consists of 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence; anxiety. The experience of the abortion will be done by the EVAN‐LR self‐questionnaire. This assessment; at IVG2 and IVG consultation 4; Satisfaction; The satisfaction of the subjects will be assessed using an EVA, graduated from 0 to 10, completed by the patient at the IVG4 consultation as well as the questionnaire SF12 completed at the consultation IVG2 and IVG4. Timepoint(s) of evaluation of this end point: The average pain level on the initial time (primary endpoint) will be compared between the 2 groups (Student's t‐test or Mann Whitney's test as a function of the parameter distribution). The maximum pain value over the first 5 hours will be compared between the 2 groups, but in secondary analysis; For the secondary endpoints, qualitative variables will be compared between the 2 groups using the exact chi‐2 or Fisher test and the continuous variables will be compared is Student's t or Mann Whitney's test depending on the distribution of parameter. |
| Starting date | 2018 |
| Contact information | NA |
| Notes |