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Cervical Pessary for Preventing Preterm Birth in Twin Pregnancies with Short Cervical Length: a Systematic Review and Meta-Analysis

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Cervical Pessary for Preventing Preterm Birth in Twin Pregnancies with Short Cervical Length: a Systematic Review and Meta-Analysis View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Archivio della ricerca - Università degli studi di Napoli Federico II The Journal of Maternal-Fetal & Neonatal Medicine ISSN: 1476-7058 (Print) 1476-4954 (Online) Journal homepage: http://www.tandfonline.com/loi/ijmf20 Cervical pessary for preventing preterm birth in twin pregnancies with short cervical length: a systematic review and meta-analysis Gabriele Saccone, Andrea Ciardulli, Serena Xodo, Lorraine Dugoff, Jack Ludmir, Francesco D’Antonio, Simona Boito, Elena Olearo, Carmela Votino, Giuseppe Maria Maruotti, Giuseppe Rizzo, Pasquale Martinelli & Vincenzo Berghella To cite this article: Gabriele Saccone, Andrea Ciardulli, Serena Xodo, Lorraine Dugoff, Jack Ludmir, Francesco D’Antonio, Simona Boito, Elena Olearo, Carmela Votino, Giuseppe Maria Maruotti, Giuseppe Rizzo, Pasquale Martinelli & Vincenzo Berghella (2017) Cervical pessary for preventing preterm birth in twin pregnancies with short cervical length: a systematic review and meta-analysis, The Journal of Maternal-Fetal & Neonatal Medicine, 30:24, 2918-2925, DOI: 10.1080/14767058.2016.1268595 To link to this article: http://dx.doi.org/10.1080/14767058.2016.1268595 Accepted author version posted online: 05 Submit your article to this journal Dec 2016. Published online: 12 Jan 2017. Article views: 319 View related articles View Crossmark data Citing articles: 6 View citing articles Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijmf20 Download by: [Thomas Jefferson University] Date: 30 September 2017, At: 17:36 THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE, 2017 VOL. 30, NO. 24, 2918–2925 http://dx.doi.org/10.1080/14767058.2016.1268595 REVIEW ARTICLE Cervical pessary for preventing preterm birth in twin pregnancies with short cervical length: a systematic review and meta-analysis Gabriele Sacconea,b , Andrea Ciardullic, Serena Xodod, Lorraine Dugoffe, Jack Ludmirf, Francesco D’Antoniob,g, Simona Boitob,h, Elena Olearob,i, Carmela Votinob,j, Giuseppe Maria Maruottia,b, Giuseppe Rizzob,k , Pasquale Martinellia,b and Vincenzo Berghellal aDepartment of Neuroscience, Reproductive Sciences and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy; bItalian Society of Ultrasound in Obstetrics and Gynecology (SIEOG); cDepartment of Obstetrics and Gynecology, Catholic University of Sacred Heart, Rome, Italy; dDepartment of Gynaecology and Obstetrics, School of Medicine, University of Udine, Udine, Italy; eDepartment of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine and Reproductive Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA USA; fDepartment of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; gFetal Medicine and Cardiology Unit, Department of Obstetrics and Gynecology, University Hospital of Northern Norway. Perinatology Research group, Department of Clinical Medicine, University of Tromso, Norway; hDepartment of Obstetrics and Gynecology, L. Mangiagalli Fondazione IRCCS Ca’Granada, Ospedale Maggiore Policlinico, Milan, Italy; iDepartment of Surgical Sciences, University of Turin, Turin, Italy; jDepartment of Experimental and Clinical Medicine, Division of Obstetrics and Gynaecology, Magna Graecia University of Catanzaro, Catanzaro, Italy; kDepartment of Obstetrics and Gynecology, Universita Roma Tor Vergata, Rome, Italy; lDepartment of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA, USA ABSTRACT ARTICLE HISTORY Objective: To evaluate the effectiveness of cervical pessary for preventing spontaneous preterm Received 24 October 2016 birth (SPTB) in twin pregnancies with an asymptomatic transvaginal ultrasound cervical length Accepted 1 December 2016 (TVU CL) in the second trimester. Methods: We performed a meta-analysis including all randomized clinical trials (RCTs) comparing KEYWORDS the use of cervical pessary (i.e. intervention group) with expectant management (i.e. control < Meta-analysis; review; group). The primary outcome was incidence of SPTB 34 weeks. cervix; cerclage; Results: Three trials, including 481 twin pregnancies with short cervix, were analyzed. Two RCTs transvaginal ultrasound defined short cervix as TVU CL 25 mm and one as TVU CL 38 mm. Pessary was not associated with prevention of SPTB, and the mean gestational age at delivery and the mean latency were similar in the pessary group compared to the control group. Moreover, no benefits were noticed in neonatal outcomes. Conclusions: Use of the Arabin pessary in twin pregnancies with short TVU CL at 16–24 weeks does not prevent SPTB or improve perinatal outcome. Introduction including singletons with short CL [3], unselected twins Downloaded by [Thomas Jefferson University] at 17:36 30 September 2017 Spontaneous preterm birth (SPTB) remains the number [4,5], twins with short CL [6], and triplet pregnancies one cause of perinatal mortality in many countries, [7]. Several randomized clinical trials (RCTs) have been – – including the United States [1]. Multiple gestations are published [3 6], and several are ongoing [7 9]. at increased risk of SPTB [1]. A short cervical length However, no consensus on use of the cervical pessary (CL) on transvaginal ultrasound (TVU) has been shown in pregnancy or guidelines for management has been to be a good predictor of SPTB, in both singletons and assessed. twins [2]. The aim of this systematic review was to assess the The cervical pessary is a silicone device that has effectiveness of the cervical pessary in preventing SPTB been used to prevent SPTB. The efficacy of the cervical in women with twin gestations with an asymptomatic pessary has been assessed in several populations short CL in the second trimester. CONTACT Vincenzo Berghella [email protected] Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Thomas Jefferson University, 833 Chestnut, Philadelphia, PA 19107, USA All authors contributed equally to this work ß 2017 Informa UK Limited, trading as Taylor & Francis Group THE JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE 2919 Methods were extracted without modification of original data onto custom-made data collection forms. Differences Eligibility criteria were reviewed, and further resolved by common The review protocol was established by two investiga- review of the entire process. tors (G. S. and V. B.) prior to commencement and was registered with the PROSPERO International Data extraction Prospective Register of Systematic Reviews (registra- tion No. CRD42016035936). Primary and secondary outcomes were defined before Two authors (G. S. and A. C.) identified trials by data extraction. The primary outcome was incidence of independently searching the electronic databases SPTB <34 weeks. The secondary outcomes were MEDLINE, Scopus, ClinicalTrials.gov, the PROSPERO SPTB <37, <32, and <28 weeks, PTB <37, <34, <32, International Prospective Register of Systematic and <28 weeks,mean gestational age (GA) at delivery Reviews, EMBASE, and the Cochrane Central Register (in weeks), mean latency (i.e. time from randomization of Controlled Trials with the use of a combination of to delivery) (in days), and neonatal outcomes, includ- the following text words: “pessary,”“cervical,”“cervix,” ing incidence of low birth weight (LBW) (i.e. BW <2500 “cervical length,”“preterm birth,”“twins,”“randomized grams), incidence of very LBW (VLBW) (i.e. BW <1500 trial,”“preterm delivery,”“prematurity”“clinical,” and grams), necrotizing enterocolitis (NEC), sepsis, respira- “insufficiency” from inception of each database until tory distress syndrome (RDS), intraventricular hemor- February 2016. Agreement regarding potential rele- rhage (IVH) (grade 3 or 4), admission to neonatal vance was reached by discussion with a third reviewer intensive care unit (NICU), fetal mortality (i.e. fetal (S. X.). death after 20 weeks), neonatal mortality (i.e. death of a live-born baby within the first 28 days of life), and perinatal death (i.e. either fetal mortality or neonatal Study selection mortality). We included all RCTs comparing the use of cervical We planned to assess the primary outcome (i.e. inci- pessary (i.e. intervention group) with expectant man- dence of SPTB <34 weeks) in subgroup analyses classi- agement (i.e. control group) for prevention of SPTB in fying whole trials by interaction test as described by twin pregnancies with short CL. Trials on singleton Cochrane Handbook for Systematic Review of gestations and higher-order multiples other than twin Interventions.10 The subgroup analyses entailed: twins gestations were excluded. Quasi-randomized trials (i.e. with prior SPTB; twins without prior SPTB; TVU CL trials in which allocation was done on the basis of a 25 mm; and TVU CL 20 mm. pseudo-random sequence, e.g. odd/even hospital number or date of birth, alternation) were also Data analysis excluded. The data analysis was completed independently by two authors (G. S. and S. X.) using Review Manager 5.3 Risk of bias (Copenhagen: The Nordic Cochrane Centre, Cochrane The risk of bias in each included study was assessed Collaboration, 2014) [10]. The completed analyses Downloaded by [Thomas Jefferson University] at 17:36 30 September 2017 using the criteria outlined in the Cochrane Handbook were then compared,
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