Niloofar Karbasian1, Mahdi Sheikh2, Reihaneh Pirjani3, Shahla Hazrati2, Fatemeh Tara1, Sedigheh Hantoushzadeh2. 1. Breastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran. 2. Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. 3. Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Abstract
AIM: We compared the effectiveness of a combined treatment involving cervical pessary plus vaginal progesterone to vaginal progesterone alone in decreasing the rate of preterm birth in women with short cervix in the second gestational trimester. METHODS: This prospective, open-label, randomized clinical trial was conducted on 144 pregnant women with singleton pregnancy who had a cervical length ≤ 25 mm, at 18-22 gestational weeks (GW). Seventy-three patients were assigned to receive 400 mg of daily vaginal progesterone (group A), and 73 to receive cervical pessary plus 400 mg of daily vaginal progesterone (group B), until the 37th GW. The patients were then followed until delivery. RESULTS: The rates of preterm birth were 16.4% in group A and 19.7% in group B, which were not statistically different (P = 0.6). There were no statistically significant differences in the rates of preterm birth at <37, <34, <32, and ≤26 GW between participants randomized to each group (P = 0.55). The rates of low-birthweight delivery were 17.8% in group A, and 23.9% in group B, which were not statistically different (P = 0.36). The rates of premature rupture of membranes, chorioamnionitis, the requirement for neonatal intensive care unit admission, andfetal and neonatal deaths were similar between the two groups. CONCLUSION: In pregnancies with short cervix at mid-pregnancy, combination therapy of cervical pessary plus daily vaginal progesterone does not have any additional benefit over daily vaginal progesterone alone in reducing the rate of preterm birth and adverse pregnancy outcomes.
RCT Entities:
AIM: We compared the effectiveness of a combined treatment involving cervical pessary plus vaginal progesterone to vaginal progesterone alone in decreasing the rate of preterm birth in women with short cervix in the second gestational trimester. METHODS: This prospective, open-label, randomized clinical trial was conducted on 144 pregnant women with singleton pregnancy who had a cervical length ≤ 25 mm, at 18-22 gestational weeks (GW). Seventy-three patients were assigned to receive 400 mg of daily vaginal progesterone (group A), and 73 to receive cervical pessary plus 400 mg of daily vaginal progesterone (group B), until the 37th GW. The patients were then followed until delivery. RESULTS: The rates of preterm birth were 16.4% in group A and 19.7% in group B, which were not statistically different (P = 0.6). There were no statistically significant differences in the rates of preterm birth at <37, <34, <32, and ≤26 GW between participants randomized to each group (P = 0.55). The rates of low-birthweight delivery were 17.8% in group A, and 23.9% in group B, which were not statistically different (P = 0.36). The rates of premature rupture of membranes, chorioamnionitis, the requirement for neonatal intensive care unit admission, and fetal and neonatal deaths were similar between the two groups. CONCLUSION: In pregnancies with short cervix at mid-pregnancy, combination therapy of cervical pessary plus daily vaginal progesterone does not have any additional benefit over daily vaginal progesterone alone in reducing the rate of preterm birth and adverse pregnancy outcomes.
Authors: Rodolfo C Pacagnella; Ben W Mol; Anderson Borovac-Pinheiro; Renato Passini; Marcelo L Nomura; Kleber Cursino Andrade; Nathalia Ellovitch; Karayna Gil Fernandes; Thaísa Guedes Bortoletto; Cynara Maria Pereira; Maria Julia Miele; Marcelo Santucci França; Jose G Cecatti Journal: BMC Pregnancy Childbirth Date: 2019-11-27 Impact factor: 3.007