Lower and extended dosage of misoprostol for cervical ripening in 1st trimester miscarriage (MISO200): A randomized clinical trial. (February 2022)

• Record Type: Journal Article
• Authors: Strelow, Michele; Maissiat, Jackson; Savaris, Michele S.; da Silva, Daniel M.; Savaris, Ricardo F.
• Is Part Of: European journal of obstetrics, gynecology, and reproductive biology. Volume 269(2022)
• Page Start: 30
• Page End: 34
• Publication Date: 2022-02
• Subjects: MVA Manual Vaccum Aspiration -- FIGO International Federation in Obstetrics and Gynaecology -- GEU gynecologic emergency unit -- WHO World Health Organization -- HCPA Hospital de Clínicas de Porto Alegre -- FIPE Fundação Incentivo Pesquisa e Eventos; Cervical dilation -- First trimester -- Miscarriage -- Misoprostol -- Uterine aspiration; Obstetrics -- Periodicals; Gynecology -- Periodicals; Reproductive health -- Periodicals; Gynecology -- Periodicals; Obstetrics -- Periodicals; Reproduction -- Periodicals; Obstétrique -- Périodiques; Gynécologie -- Périodiques; Reproduction -- Périodiques; Verloskunde; Gynaecologie; Voortplanting (biologie); Gynecology; Obstetrics; Reproduction; Electronic journals; Periodicals; Electronic journals; 618.05
• DOI: 10.1016/j.ejogrb.2021.12.010
• Languages: English
• ISSNs: 0301-2115

Abstract

Highlights: The use of 200 µg of misoprostol may be used for priming uterine cervix before manual vacuum aspiration in first-trimester miscarriage. Cervical dilatation was ≥8mm in 52.3% (55 out of 105; 95%CI 42.9% to 61.6%) in the 200 and 71.7% (76 out of 106; 95%CI 62.4% to 79.4%) in the 200 µg and 400 µg groups, respectively. Abstract: Objective: To compare the efficacy of priming the uterine cervix before Manual Vaccum Aspiration (MVA) using 200 µg or 400 µg of vaginal misoprostol, inserted a mean time of 6 h before MVA in first trimester miscarriage. Study design: Randomized, triple-blind, non-inferiority clinical trial. Patients between 18 and 50 years old, with a diagnosis of miscarriage, were eligible for the study. Patients were allocated to receive either 200 μg or 400 µg of misoprostol before the MVA. The primary outcome was the need to dilate the uterine cervix with mechanical dilators (Hegar dilators). As a secondary outcome, cervical dilatation ≥8 mm before the procedure was considered successful. A difference of <25% was considered as non-inferior. Results: Between December 21, 2016 and October 6, 2019, 269 women were screened. After screening, 105 and 106 women received 200 µg and 400 µg of misoprostol, respectively. Mechanical cervical dilatation was not necessary in 84.8% (95%CI 77% to 90%) and 96.2% (95%CI 91% to 99%), in the 200 µg and 400 µg groups, respectively [difference = 11.5% (95%CI 3.7% to 19.2%). Cervical dilatation of ≥8 mm was 52.4% (95%CI 42.9% to 61.7%) in the 200 µg misoprostol group, while in the 400 µg group was 71.7% (95%CI 62.5% to 79.4%) [difference = 19.3% (95%CI 6.5 to 32.2). Conclusion: After a mean time of 6 h, 200 µg of vaginal misoprostol is not inferior to 400 µg of misoprostol for cervical priming before MVA, in first trimester miscarriage. This non-inferiority was not observed when the ≥8 mm criterion was considered.