Gabriele Saccone1,2, Andrea Ciardulli3, Serena Xodo4, Lorraine Dugoff5, Jack Ludmir6, Giorgio Pagani2,7, Silvia Visentin2,8, Salvatore Gizzo2,8, Nicola Volpe2,9, Giuseppe Maria Maruotti1,2, Giuseppe Rizzo2,10, Pasquale Martinelli1,2, Vincenzo Berghella11. 1. Department of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy. 2. Italian Society of Ultrasound in Obstetrics and Gynecology (SIEOG), Rome, Italy. 3. Department of Obstetrics and Gynecology, Catholic University of Sacred Heart, Rome, Italy. 4. Department of Gynaecology and Obstetrics, School of Medicine, University of Udine, Udine, Italy. 5. Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine and Reproductive Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 6. Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 7. Department of Maternal and Fetal Health, Fondazione Poliambulanza, Brescia, Italy. 8. Department of Woman's and Child's Health, University of Padua, Padua, Italy. 9. Feto-Maternal Medicine Unit, Parma University Hospital, Parma, Italy. 10. Department of Obstetrics and Gynecology, Università Roma Tor Vergata, Rome, Italy. 11. Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Abstract
OBJECTIVES: To evaluate the effectiveness of cervical pessary for preventing spontaneous preterm birth (SPTB) in singleton gestations with a second trimester short cervix. METHODS: Electronic databases were searched from their inception until February 2016. We included randomized clinical trials (RCTs) comparing the use of the cervical pessary with expectant management in singletons pregnancies with transvaginal ultrasound cervical length (TVU CL) ≤25 mm. The primary outcome was incidence of SPTB <34 weeks. The summary measures were reported as relative risk (RR) with 95% confidence interval (CI). RESULTS: Three RCTs (n = 1,420) were included. The mean gestational age (GA) at randomization was approximately 22 weeks. The Arabin pessary was used as intervention in all three trials, and was removed by vaginal examination at approximately 37 weeks. Cervical pessary was not associated with prevention of SPTB <37 (20.2% vs 50.2%; RR 0.50, 95% CI 0.23 to 1.09), <34, <32, and <28 weeks, compared to no pessary. No differences were found in the mean of GA at, interval from randomization to delivery, incidence of preterm premature rupture of membranes and of cesarean delivery, and in neonatal outcomes. The Arabin pessary was associated with a significantly higher risk of vaginal discharge. CONCLUSIONS: In singleton pregnancies with a TVU CL ≤25mm at 200 -246 weeks, the Arabin pessary does not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. Individual patient data meta-analysis may clarify whether cervical pessary may be beneficial in subgroups, such as only singleton gestations without prior SPTB or by different CL cutoffs.
OBJECTIVES: To evaluate the effectiveness of cervical pessary for preventing spontaneous preterm birth (SPTB) in singleton gestations with a second trimester short cervix. METHODS: Electronic databases were searched from their inception until February 2016. We included randomized clinical trials (RCTs) comparing the use of the cervical pessary with expectant management in singletons pregnancies with transvaginal ultrasound cervical length (TVU CL) ≤25 mm. The primary outcome was incidence of SPTB <34 weeks. The summary measures were reported as relative risk (RR) with 95% confidence interval (CI). RESULTS: Three RCTs (n = 1,420) were included. The mean gestational age (GA) at randomization was approximately 22 weeks. The Arabin pessary was used as intervention in all three trials, and was removed by vaginal examination at approximately 37 weeks. Cervical pessary was not associated with prevention of SPTB <37 (20.2% vs 50.2%; RR 0.50, 95% CI 0.23 to 1.09), <34, <32, and <28 weeks, compared to no pessary. No differences were found in the mean of GA at, interval from randomization to delivery, incidence of preterm premature rupture of membranes and of cesarean delivery, and in neonatal outcomes. The Arabin pessary was associated with a significantly higher risk of vaginal discharge. CONCLUSIONS: In singleton pregnancies with a TVU CL ≤25mm at 200 -246 weeks, the Arabin pessary does not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. Individual patient data meta-analysis may clarify whether cervical pessary may be beneficial in subgroups, such as only singleton gestations without prior SPTB or by different CL cutoffs.
Authors: Diana Herrera-Perez; Alyson Haslam; Tyler Crain; Jennifer Gill; Catherine Livingston; Victoria Kaestner; Michael Hayes; Dan Morgan; Adam S Cifu; Vinay Prasad Journal: Elife Date: 2019-06-11 Impact factor: 8.140
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