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 %.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
Hôpital de la conception Assistance Publique Hôpitaux de Marseille
Marseille, France
per operative pain
It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).
Time frame: 20 minutes
Anxiety
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.
Time frame: 48 hours
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