Surgical Abortion
Conditions
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
Interventions
DRUGMifépristone versus Misoprostol
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.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
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 . We 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
France
Outcome results
None listed