The women are 18 years old or more, wishing an abortion under local anesthesia, between 6 and 14 weeks the day of the abortion.
Conditions
Interventions
Trade Name: MIFEPRISTONE 200 MG
Product Name: MIFEGYNE
Product Code: MIFEPRISTONE
Pharmaceutical Form: Cachet
Trade Name: GYMISO 200MIC
Sponsors
Assistance Publique Hôpitaux de Marseille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women aged 18 or over; Woman with a single intrauterine pregnancy, the term is between 6SA and strictly less than 14 weeks on the day of the abortion, estimated by ultrasound measurement of the cranio-caudal length of between 5 and 84 millimeters; Female looking for abortions under local anesthesia; Women who have signed a written informed consent and agreeing to abide by the instructions of 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 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Woman wishing to interrupt her participation in the study before the end; Woman for whom surgery was not performed (no show the patient the day of surgery, miscarriage before the operation). Women who have not followed the protocol (not taken for a product).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the level of per-operating pain during the surgical abortion under paracervical block in the first trimester after cervical preparation with mifepristone or misoprostol.; Secondary Objective: compare two treatment strategies in terms of: • Pain during the suction phase after the mechanical dilation, immediate post-operative pain • Occurrence of perioperative complications: cervical tear, uterine perforation, hemorrhage • Response Time • Quantity of intraoperative bleeding • Lived perioperative documented by EVAN-LR self-administered questionnaire • Impact on the level of anxiety of the subjects by the STAI Anxiety Questionnaire • Tolerance (side effects, adverse events) • Satisfaction of patient, physician satisfaction ;Primary end point(s): The primary endpoint of efficacy is represented by pain during expansion gathered immediately at the end of the mechanical dilation. The measurement is simple, reproducible, performed with an EN listed from 0 to 10 (0 no pain, 10 maximum pain experienced).;Timepoint(s) of evaluation of this end point: The evaluation of intraoperative pain occurs during the operation immediately after the mechanical dilation of the cervix. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The duration of the intervention: this is the time between the passage of the first dilator and the end of the endo-uterine aspiration; it will be expressed in minutes; - Pre pain and post-operative will be assessed using EN at the entrance to the operating room and immediately at the end of the intervention, respectively; - Pain during the suction phase will be assessed using EN immediately at the end of the aspiration; - Intraoperative complications Intraoperative complications will be carefully documented, distinguishing between minor and major complications, including: - Cervical tear: injury to the neck after requiring the surgeon to suture hemostasis or reconstruction of the cervical anatomy; - Uterine perforation: diagnosis by the operator of uterine perforation intraoperative ultrasound or instrumental evaluation; - Bleeding of average gravity occurred between stopping the suction and duration considered significant bleeding requiring hospitalization cover of aspiration or injection of oxytocin; - Severe severity of hemorrhage occurred between stopping the suction and duration considered significant bleeding hospitalization requiring blood transfusion or uterine artery embolization or surgical hemostat (hysterectomy, arterial ligation). - Lived perioperative The experienced perioperative be evaluated postoperatively using a self-administered questionnaire (Auquier 1999 Pernoud 1999 Maurice 2011). This is a standardized questionnaire and validated, whose purpose is to understand the experience of perioperative anesthesia multidimensional way. There is a version for the regional anesthesia, called EVAN-LR (Mauritius-Szamburski, 2012). - Tolerance Tolerance will be assessed by examination prior to the start of the intervention. The following si | — |
Countries
France
Contacts
Public ContactCatherine GEINDRE
Assistance Publique Hôpitaux de Marseille
Outcome results
None listed