Sergey V Barinov1, Irina V Shamina1, Oksana V Lazareva1, Yuliya I Tirskaya1, Vyacheslav V Ralko2, Lyudmila L Shkabarnya2, Galina B Dikke3, Dmitry M Kochev4, Lyudmila L Klementyeva5. 1. a Russian Ministry of Healthcare, State Budget Educational Institution of Higher Professional Education "Omsk State Medical Academy" , Omsk , Russia. 2. b Perinatal Centre, Budget Healthcare Omsk Region Institution "Regional Clinical Hospital" , Omsk , Russia. 3. c Federal State Autonomous Educational Institution "Peoples' Friendship University of Russia" , Moscow , Russia. 4. d ZAO "Pentkroft Pharma" , Moscow , Russia , and. 5. e OOO "Alpha-EmBio" , Omsk , Russia.
Abstract
OBJECTIVE: This study aimed to compare the efficacy of combined use of Arabin pessary, cervical cerclage and progesterone with progesterone-only management of pregnant women at high risk of preterm birth. MATERIALS AND METHODS: The study included 203 pregnant women at high risk of preterm birth who were randomised to receive Arabin pessary (Group 1, n = 82) and progesterone, circular cervical cerclage and progesterone (Group 2, n = 121) or progesterone treatment only (Group3, controls, n = 50). Patients in the pessary and cerclage group also received progesterone. RESULTS: The use of Arabin pessary combined with progesterone resulted in a 2.5-fold decrease in the rate of vaginal dysbiosis in pregnancy (p = 0.015) and almost three-fold reduction in in the postpartum period (p = 0.037), combined with circular cervical cerclage and progesterone. Suture eruption was observed in 4.3% of women. In patients with abnormal placental location, placental migration was observed in 62.1% of patients in Group I, 52.1% in Group II and a significantly lower proportion of patients (14.0%) in Group III (p = 0.001). Bleeding during pregnancy was observed significantly more often in both comparison groups (p = 0.005). Incidence of intrapartum bleeding was 17.4% (p = 0.011) in Group II and 24.5% in Group III (p = 0.002). Intrapartum chorioamnionitis was observed in 4.3% of patients in Group II and 2.04% of patients in Group III. CONCLUSIONS: The use of Arabin pessary compbined with progesterone reduces the rate of infectious complications and bleeding during pregnancy and the postpartum period.
RCT Entities:
OBJECTIVE: This study aimed to compare the efficacy of combined use of Arabin pessary, cervical cerclage and progesterone with progesterone-only management of pregnant women at high risk of preterm birth. MATERIALS AND METHODS: The study included 203 pregnant women at high risk of preterm birth who were randomised to receive Arabin pessary (Group 1, n = 82) and progesterone, circular cervical cerclage and progesterone (Group 2, n = 121) or progesterone treatment only (Group3, controls, n = 50). Patients in the pessary and cerclage group also received progesterone. RESULTS: The use of Arabin pessary combined with progesterone resulted in a 2.5-fold decrease in the rate of vaginal dysbiosis in pregnancy (p = 0.015) and almost three-fold reduction in in the postpartum period (p = 0.037), combined with circular cervical cerclage and progesterone. Suture eruption was observed in 4.3% of women. In patients with abnormal placental location, placental migration was observed in 62.1% of patients in Group I, 52.1% in Group II and a significantly lower proportion of patients (14.0%) in Group III (p = 0.001). Bleeding during pregnancy was observed significantly more often in both comparison groups (p = 0.005). Incidence of intrapartum bleeding was 17.4% (p = 0.011) in Group II and 24.5% in Group III (p = 0.002). Intrapartum chorioamnionitis was observed in 4.3% of patients in Group II and 2.04% of patients in Group III. CONCLUSIONS: The use of Arabin pessary compbined with progesterone reduces the rate of infectious complications and bleeding during pregnancy and the postpartum period.
Authors: Panagiotis Tsikouras; George Anastasopoulos; Vasileios Maroulis; Anastasia Bothou; Anna Chalkidou; Dorelia Deuteraiou; Xanthoula Anthoulaki; Georgios Tsatsaris; Arzou Halil Bourazan; George Iatrakis; Stefanos Zervoudis; Georgios Galazios; Lola-Katerina Inagamova; Roland Csorba; Alexander-Tobias Teichmann Journal: Int J Environ Res Public Health Date: 2018-04-18 Impact factor: 3.390
Authors: George U Eleje; Ahizechukwu C Eke; Joseph I Ikechebelu; Ifeanyichukwu U Ezebialu; Princeston C Okam; Chito P Ilika Journal: Cochrane Database Syst Rev Date: 2020-09-24