NCT03043014

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

Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Surgical Abortion

Interventions

Type	Name	Description
DRUG	Mifépristone 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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-03-13
• Completion: 2022-11-15
• First posted: 2017-02-03
• Last updated: 2022-11-16

Locations

1 site across 1 country: France