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Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies with Short Cervical Length a Systematic Reviewand Meta-Analysis

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Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies with Short Cervical Length a Systematic Reviewand Meta-Analysis ORIGINAL RESEARCH Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length A Systematic Reviewand Meta-analysis Gabriele Saccone, MD, Andrea Ciardulli, Serena Xodo, MD, Lorraine Dugoff, MD, Jack Ludmir, MD, Giorgio Pagani, MD, Silvia Visentin, MD, Salvatore Gizzo, MD, Nicola Volpe, MD, Giuseppe Maria Maruotti, MD, Giuseppe Rizzo, MD, Pasquale Martinelli, MD, Vincenzo Berghella, MD Supplemental material online at Objectives—To evaluate the effectiveness of cervical pessary for preventing sponta- wileyonlinelibrary.com/journal/jum neous preterm birth (SPTB) in singleton gestations with a second trimester short Received August 24, 2016, from the Department cervix. of Neuroscience, Reproductive Sciences and Den- Methods—Electronic databases were searched from their inception until February tistry, School of Medicine, University of Naples Federico II, Naples, Italy (P.M., G.M.M., G.S.); 2016. We included randomized clinical trials (RCTs) comparing the use of the cer- Italian Society of Ultrasound in Obstetrics and Gyne- vical pessary with expectant management in singletons pregnancies with transvaginal cology (SIEOG), Rome, Italy (S.G., P.M., G.M.M., ultrasound cervical length (TVU CL) 25 mm. The primary outcome was inci- G.P., G.R., G.S., S.V., N.V.); Department of Obstet- rics and Gynecology, Catholic University of Sacred dence of SPTB <34 weeks. The summary measures were reported as relative risk Heart, Rome, Italy (A.C.); Department of Gynaecol- (RR) with 95% confidence interval (CI). ogy and Obstetrics, School of Medicine, University of Udine, Udine, Italy (S.X.); Department of Obstetrics Results—Three RCTs (n 5 1,420) were included. The mean gestational age (GA) and Gynecology, Division of Maternal-Fetal Medicine at randomization was approximately 22 weeks. The Arabin pessary was used as and Reproductive Genetics, Perelman School of Med- icine, University of Pennsylvania, Philadelphia, Penn- intervention in all three trials, and was removed by vaginal examination at approxi- sylvania USA (L.D.); Department of Obstetrics and mately 37 weeks. Cervical pessary was not associated with prevention of SPTB <37 Gynecology, Division of Maternal-Fetal Medicine, Per- (20.2% vs 50.2%; RR 0.50, 95% CI 0.23 to 1.09), <34, <32, and <28 weeks, com- elman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania USA (J.L.); Department pared to no pessary. No differences were found in the mean of GA at, interval from of Maternal and Fetal Health, Fondazione Poliambu- randomization to delivery, incidence of preterm premature rupture of membranes lanza, Brescia, Italy (G.P.); Department of Woman’s and of cesarean delivery, and in neonatal outcomes. The Arabin pessary was associ- and Child’s Health, University of Padua, Padua, Italy (S.G., S.V.); Feto-Maternal Medicine Unit, Parma ated with a significantly higher risk of vaginal discharge. University Hospital, Parma, Italy (N.V.); Depart- 0 6 ment of Obstetrics and Gynecology, UniversitaRoma Conclusions—In singleton pregnancies with a TVU CL 25mm at 20 –24 weeks, Tor Vergata, Rome, Italy (G.R.); and Department of the Arabin pessary does not reduce the rate of spontaneous preterm delivery or Obstetrics and Gynecology, Division of Maternal- improve perinatal outcome. Individual patient data meta-analysis may clarify Fetal Medicine, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsyl- whether cervical pessary may be beneficial in subgroups, such as only singleton ges- vania USA (V.B.). Manuscript accepted for tations without prior SPTB or by different CL cutoffs. publication October 12, 2016. Key Words—cerclage; cervix; meta-analysis; obstetrics; preterm birth; review; Address correspondence to Vincenzo Berghella, MD, Department of Obstetrics and Gynecology, Division transvaginal ultrasound cervix of Maternal-Fetal Medicine, Thomas Jefferson University, 833 Chestnut St, Philadelphia, PA 19107 USA. E-mail: [email protected] CI, confidence interval; CL, cervical length; GA, gestational age; MD, mean difference; RCT, pontaneous preterm birth (SPTB) remains the number one randomized clinical trial; RR, relative risk; SPTB, cause of perinatal mortality in many countries, including the spontaneous preterm birth; TVU, transvaginal United States.1 In singleton gestations, a short cervical length ultrasound S (CL) on transvaginal ultrasound (TVU) has been shown to be a doi:10.7863/ultra.16.08054 better predictor of SPTB than digital examination and fetal fibronectin.2 VC 2017 by the American Institute of Ultrasound in Medicine | J Ultrasound Med 2017; 36:1535–1543 | 0278-4297 | www.aium.org Saccone et al—Pessary in Singletons With Short Cervix The cervical pessary is a silicone device that has of a pseudo-random sequence; eg, odd/even hospital been used to prevent SPTB. The leading hypotheses for number or date of birth, alternation) were also excluded. itsmechanismsaretwo:thatthepessaryhelpstokeep the cervix closed, and that the pessary changes the incli- Data Extraction and Risk of Bias Assessment nation of the cervical canal so that the pregnancy weight The risk of bias in each included study was assessed by is not directly above the internal os. The efficacy of cervi- using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions.10 Seven do- cal pessary has been assessed in several populations, mains related to risk of bias were assessed in each including singleton gestations with short CL,3 unselected included trial since there is evidence that these issues are twins,4,5 twins with a short CL,6 and triplet pregnancies.7 associated with biased estimates of treatment effect: 1) Several randomized clinical trials (RCTs) have been random sequence generation; 2) allocation conceal- published3–6 and several are ongoing.7–9 However, no ment; 3) blinding of participants and personnel; 4) consensus on the use of cervical pessary in pregnancy or blinding of outcome assessment; 5) incomplete out- guidelines for management have been assessed. come data; 6) selective reporting; and 7) other bias. The aim of this systematic review with meta- Review authors’ judgments were categorized as “low analysis was to evaluate the effectiveness of cervical risk,” “high risk,” or “unclear risk” of bias.10 pessary for preventing SPTB in singleton gestations Two authors (G.S., A.C.) independently assessed with a short cervix in the second trimester. inclusion criteria, risk of bias, and data extraction. Dis- agreements were resolved by consensus through dis- Materials and Methods cussion. Data from each eligible study were extracted without modification of original data onto custom- Search Strategy made data-collection forms. Differences were reviewed The review protocol was established by two investiga- and further resolved by common review of the entire tors (G.S., V.B.) prior to commencement and was reg- process. istered with the PROSPERO International Prospective Primary and secondary outcomes were defined be- Register of Systematic Reviews (registration No. CRD fore data extraction. The primary outcome was incidence 42016035938). of SPTB <34 weeks. The secondary outcomes were Two authors (G.S., A.C.) identified trials by search- SPTB <37, < 32, and <28 weeks; PTB (either sponta- ing independently the electronic databases MEDLINE, neous or indicated) < 34 weeks; mean gestational age Scopus, ClinicalTrials.gov, the PROSPERO Interna- (GA) at delivery (in weeks); mean latency (ie, interval tional Prospective Register of Systematic Reviews, from randomization to delivery) (in days); incidence of EMBASE, and the Cochrane Central Register of Con- preterm premature rupture of membranes; incidence of trolled Trials with the use of a combination of the fol- cesarean delivery (CD); maternal side effects (ie, vaginal lowing text words: “pessary,” “cervical,” “cervix,” discharge, bacterial vaginosis); and neonatal outcomes “cervical length,” “preterm birth,” “randomized trial,” including mean birth weight (in grams), incidence of “preterm delivery,” “prematurity” “clinical,” and “insuf- low birth weight (ie, birth weight < 2500 grams), ficiency” from inception of each database until February necrotizing enterocolitis, respiratory distress syndrome, 2016. Agreement regarding potential relevance was intraventricular hemorrhage (grade 3 or 4), admission to reached by discussion with a third reviewer (V.B.). neonatal intensive care unit, fetal mortality (ie, fetal death after 20 weeks), neonatal mortality (ie, death of a live-born baby within the first 28 days of life), and peri- Study Selection natal death (ie, either fetal mortality or neonatal All RCTs comparing the use of cervical pessary (ie, mortality). intervention group) with expectant management (ie, control group) for prevention of SPTB in singleton Data Analysis pregnancies with short CL, defined as TVU CL The data analysis was completed independently by two 25 mm, were included in the meta-analysis. Trials on authors (G.S., S.X.) using Review Manager 5.3 (The multiple pregnancies were excluded. Quasi-randomized Nordic Cochrane Centre, Cochrane Collaboration, trials (ie, trials in which allocation was done on the basis Copenhagen).10 The completed analyses were then 1536 J Ultrasound Med 2017; 36:1535–1543 Saccone et al—Pessary in Singletons With Short Cervix compared, and any difference was resolved with review abnormalities, painful regular uterine contractions, active of the entire data and independent analysis. Between- vaginal bleeding, ruptured
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