Cervical Preparation of Abortions Under Paracervical Block in the First Trimester:
- Conditions
- Surgical Abortion
- Interventions
- Registration Number
- NCT03043014
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- Brief Summary
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.
90% of the abortions are performed during the first trimester of pregnancy before 13 weeks. Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %.
- Detailed Description
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.
Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %. In France, about 75 % of the surgical abortions are performed under general anesthesia (GA). Nevertheless, the risk of complications is higher under GA. The risk of death is more important (0,58 for 100 000) with GA. GA increases by a factor 1,7 the risk of bleeding, 2,2 the risk of uterine perforation, 8,2 the risk of intra-abdominal bleeding, 2,9 the risk of cervical tearing, and 5 the risk of transfusion. The difficulty of pain control under local anesthetia (LA) explains this method is less choosen by the women. Indeed, a lot of women consider the surgical abortion under LA extremely uncomfortable. The paracervical block for the abortion under LA in the first trimester demonstrated its efficiency in the reduction of the per-operating pain whatever the term of the pregnancy compared with the absence of anesthesia. The cervical preparation demonstrated benefits in term of cervical dilation, per-operating bleeding, and complications incidence. The misoprostol and the mifepristone are 2 molecules recommended for the cervical preparation on the first trimester
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
aged 18 or over with a single intra uterine pregnancy whose term is between 6 and 14 weeks the day of the abortion estimated by ultrasound by a measurement of the cranio-caudal length between 5 and 84 millimeters surgical abortion under local anesthesia informed written consent
minor multiple pregnancy Uterine malformation coagulation disorder defined by biological parameters (TP<70%, TCA patient / control ratio < 1.20) Allergy or hypersensitivity to any of the active substance or to any of the excipients Contraindication to mifepristone chronic renal insufficiency severe asthma uncontrolled by treatment hereditary porphyria allergy to the active substance or to any of the excipients; not affiliated to the social security system; no informed consent. Suspicion of ectopic pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mifépristone group Mifépristone versus Misoprostol - misoprostol group Mifépristone versus Misoprostol -
- Primary Outcome Measures
Name Time Method Anxiety 48 hours STAI anxiety questionnaire;it 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 of anxiety.
per operative pain 20 minutes It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital de la conception Assistance Publique Hôpitaux de Marseille
🇫🇷Marseille, France