Kypros H Nicolaides1, Argyro Syngelaki1, Liona C Poon1, Gemma Picciarelli1, Natasa Tul1, Aikaterini Zamprakou1, Evdoxia Skyfta1, Mauro Parra-Cordero1, Ricardo Palma-Dias1, Jesus Rodriguez Calvo1. 1. From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
Abstract
BACKGROUND: Preterm birth is the leading cause of neonatal and infant death and of disability among survivors. It is unclear whether a pessary inserted around the cervix reduces the risk of preterm singleton birth. METHODS: We conducted a multicenter, randomized, controlled trial comparing pessary placement with expectant management (control) in girls and women who were pregnant with singletons (singleton pregnancies) and who had a cervical length of 25 mm or less at 20 weeks 0 days to 24 weeks 6 days of gestation. Participants in either group who had a cervical length of 15 mm or less, at randomization or at subsequent visits, received treatment withvaginal progesterone. The primary outcome was spontaneous delivery before 34 weeks of gestation. RESULTS: In an intention-to-treat analysis, there was no significant difference between the pessary group (465 participants) and the control group (467 participants) in the rate of spontaneous delivery before 34 weeks (12.0% and 10.8%, respectively; odds ratio in the pessary group, 1.12; 95% confidence interval, 0.75 to 1.69; P=0.57). There were no significant differences in the rates of perinatal death (3.2% in the pessary group and 2.4% in the control group, P=0.42), adverse neonatal outcome (6.7% and 5.7%, respectively; P=0.55), or neonatal special care (11.6% and 12.9%, respectively; P=0.59). The incidence of new or increased vaginal discharge was significantly higher in the pessary group than in the control group. CONCLUSIONS: Among girls and women with singleton pregnancies who had a short cervix, a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management. (Funded by the Fetal Medicine Foundation; Current Controlled Trials number, ISRCTN01096902.).
RCT Entities:
BACKGROUND: Preterm birth is the leading cause of neonatal and infantdeath and of disability among survivors. It is unclear whether a pessary inserted around the cervix reduces the risk of preterm singleton birth. METHODS: We conducted a multicenter, randomized, controlled trial comparing pessary placement with expectant management (control) in girls and women who were pregnant with singletons (singleton pregnancies) and who had a cervical length of 25 mm or less at 20 weeks 0 days to 24 weeks 6 days of gestation. Participants in either group who had a cervical length of 15 mm or less, at randomization or at subsequent visits, received treatment with vaginal progesterone. The primary outcome was spontaneous delivery before 34 weeks of gestation. RESULTS: In an intention-to-treat analysis, there was no significant difference between the pessary group (465 participants) and the control group (467 participants) in the rate of spontaneous delivery before 34 weeks (12.0% and 10.8%, respectively; odds ratio in the pessary group, 1.12; 95% confidence interval, 0.75 to 1.69; P=0.57). There were no significant differences in the rates of perinatal death (3.2% in the pessary group and 2.4% in the control group, P=0.42), adverse neonatal outcome (6.7% and 5.7%, respectively; P=0.55), or neonatal special care (11.6% and 12.9%, respectively; P=0.59). The incidence of new or increased vaginal discharge was significantly higher in the pessary group than in the control group. CONCLUSIONS: Among girls and women with singleton pregnancies who had a short cervix, a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management. (Funded by the Fetal Medicine Foundation; Current Controlled Trials number, ISRCTN01096902.).
Authors: Andrea R Westervelt; Michael Fernandez; Michael House; Joy Vink; Chia-Ling Nhan-Chang; Ronald Wapner; Kristin M Myers Journal: J Biomech Eng Date: 2017-05-01 Impact factor: 2.097
Authors: Maged M Costantine; Lynda Ugwu; William A Grobman; Brian M Mercer; Alan T N Tita; Dwight J Rouse; Yoram Sorokin; Ronald J Wapner; Sean C Blackwell; Jorge E Tolosa; John M Thorp; Steve N Caritis Journal: Am J Obstet Gynecol Date: 2021-02-20 Impact factor: 10.693