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Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: (BPCEN)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Surgical Abortion

Treatments

Drug: Mifépristone versus Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT03043014
2016-35

Details and patient eligibility

About

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 %.

Full 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

Enrollment

110 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Mifépristone group
Experimental group
Treatment:
Drug: Mifépristone versus Misoprostol
misoprostol group
Active Comparator group
Treatment:
Drug: Mifépristone versus Misoprostol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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