Article A new approach in the induction of labor with misoprostol vaginal insert in high-risk pregnancy obese women Valentin Nicolae, Varlas 1,2 *; Georgiana, Bostan 3 ; Bogdana Adriana, Năsui 4 *; Nicolae, Bacalbașa 2 and Anca Lucia, Pop 5 1 Department of Obstetrics and Gynaecology, Filantropia Clinical Hospital, Bucharest, Romania; varlas.valentin@umfcd.ro; 2 Senior Lecturer, Department of Obstetrics and Gynaecology, "Carol Davila" University of Medicine and Pharmacy, 37 Dionisie Lupu St., 020021 Bucharest, Romania; varlas.valentin@umfcd.ro (V.N.V.) bacalbasa.nicolae@umfcd.ro; (N.B.) 3 County Emergency Hospital "St. John the New", Suceava, Romania; bostangeorgiana@yahoo.com; (G.B.) 4 Department of Community Health, "Iuliu Hațieganu" University of Medicine and Pharmacy, 6 Louis Pasteur Street, Cluj-Napoca 400349, Romania; nasuibogdana@yahoo.ro or adriana.nasui@umfcluj.ro (B.A.N) 5 Department of Clinical Laboratory, Food Safety, "Carol Davila" University of Medicine and Pharmacy, 6 Traian Vuia Street, Bucharest 020945, Romania; ancapop@hotmail.com, anca.pop@umfcd.ro (A.L.P.); *Correspondence authors: adriana.nasui@umfcluj.ro (BAN), varlas.valentin@umfcd.ro. (VNV) Phone: +40- 727-144912; +40-722-384409. Abstract: Background and objectives: Induction of labor (IOL) is an event that occurs in up to one- quarter of pregnancies; less is known about the outcomes and safety of IOL in obese pregnant woman; no data is available on misoprostol vaginal insert (MVI) IOL in high-risk pregnancy obese women. Objectives: (1) to evaluate the rate of successful IOL with 200 μg MVI in obese (Body Mass Index - BMI over 30 kg/m 2 ) high-risk pregnant women: late-term pregnancy, hypertension or diabetes, compared to obese non-high-risk ones; (2) to evaluate the safety profile of MVI in high-risk pregnancy obese patients. Study design: We conducted a cross-sectional study in "Filantropia" Clinical Hospital, Bucharest, Romania, from June 2017 to September 2019 (28 months). From a total of 11,096 registered live births, IOL was performed in 206 obese patients; 74 obese high-risk pregnant patients matched the inclusion criteria; of these, 33.8% pregnancies (n=25) were late-term (41 – 41+6 weeks), 43.2% (n=32) had associated pathologies (hypertension and diabetes); labor induction was guided using a standardized protocol. We evaluated the maternal and gestational age, parity, fetal tachysystole, hyper-stimulation, initial cervical status, time from induction to delivery, drug side effects, mode of delivery, and neonatal outcomes. Results: (a) The overall successful labor induction rate, evaluated by the vaginal delivery rate, was 71.6% (n=53), spontaneously or instrumentally assisted; 28.4% (n=21) births were unsuccessful MVI IOL, converted into caesareans. (b) No significant differences were found regarding the maternal outcomes; in terms of perinatal outcomes of safety, four cases of high-risk pregnancies vaginally delivered were associated with neonatal intensive care unit (NICU) admissions and a one-minute Apgar score under seven (5.4%). Most cases with adverse effects of misoprostol have been managed by vaginal delivery, except three cases of emergency C- section. Conclusions: Misoprostol vaginal insert is a safe choice in IOL in obese high-risk pregnancies with good maternal and perinatal outcomes. Keywords: misoprostol; induction of labor; high-risk pregnancy; obesity; perinatal outcome. 1. Introduction Induction of labor (IOL – artificially initiated labor) is an event that occurs in up to 25% of pregnancies [1]. Cervical status is a good predictor of vaginal delivery, evaluated using the Bishop's scoring system [2]. Any induction method is effective in a woman with a favorable cervix (Bishop's Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 25 November 2020 doi:10.20944/preprints202011.0653.v1 © 2020 by the author(s). Distributed under a Creative Commons CC BY license.