[Conflicting recommendations between the French national authority for health (HAS) and clinical practice guidelines (CNGOF); focus on 200 late medical abortions, conducted outside marketing authorizations]

Abstract

Objectives: There are conflicting recommandations about late medical abortion: the French National College of Gynaecologists and Obstetricians (CNGOF) and the French Superior Health Authority are opposed. The aim was to assess misoprostol's efficiency in medical abortions at 9 to 14 weeks gestational age (GA) METHODS: This is an epidemiologic retrospective study led from March 2017 till January 2019, in Evreux's hospital, France, including all patients undergoing a medical abortion from 9 to 14 weeks GA. We followed the CNGOF's recommandations published in 2016. The main efficacy parameter was the failure rate of medical abortion at 9 to 14 weeks GA. The secondary efficacy parameters were the number of patients absent at the post-medical abortion examination, the consumption of misoprostol, the consumption of symptomatic treatment, the type of complication and the length of hospital stay.

Results: 200 patients were included: 19 patients had vacuum aspiration, so we report a 10.2 % failure rate (95% CI: 6.4%; 15.7%). 7 (3.5%) had vacuum aspiration for haemorrhage (2 (1%) receveived a blood transfusion) 9 (4.5%) had a vacuum aspiration for failure and 3 (1.5%) for retention. 71 (35.5%) patients were absent at the post-medical abortion examination. The mean consumption of misoprostol was 1234μg (441). The mean length of hospital stay was 12.2hours (8.28).

Conclusions: The abortion failure rate is 10.2%. Our study didn't report any elements of bad tolerance of misoprostol in this indication.

Keywords: Efficacité; Efficiency; Hors AMM; IVG médicamenteuse tardive; Late medical abortion; Outside marketing authorizations.