A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth

Nicolaides, Kypros H.; Syngelaki, Argyro; Poon, Liona C.; Picciarelli, Gemma; Tul, Nataša; Zamprakou, Aikaterini; Skyfta, Evdoxia; Parra-Cordero, Mauro; Palma-Dias, Ricardo; Calvo, J.

doi:10.1056/nejmoa1511014

Cited by 158 publications

(120 citation statements)

References 18 publications

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“…Six studies were assessed for eligibility. [3][4][5][6]12,13 Three trials including multiple pregnancies were excluded. [4][5][6] Three RCTs were therefore included in the meta-analysis.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…[4][5][6] Three RCTs were therefore included in the meta-analysis. 3,12,13 The overall risk of bias of the included trials was low ( Figure 2). All studies had a low risk of bias in "random sequence generation," "incomplete outcome data," and "selective reporting."…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

“…3 suppository daily containing natural progesterone up to 33 6 weeks' gestation. 13 None of the three trials used 17hydroxyprogesterone caproate as prophylactic treatment for women with prior SPTB.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

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Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta‐analysis

Saccone

Ciardulli

Xodo

et al. 2017

J of Ultrasound Medicine

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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 5 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 20 0 -24 6 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.

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“…Six studies were assessed for eligibility. [3][4][5][6]12,13 Three trials including multiple pregnancies were excluded. [4][5][6] Three RCTs were therefore included in the meta-analysis.…”

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

Section: Study Selection and Study Characteristicsmentioning

confidence: 99%

See 1 more Smart Citation

Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta‐analysis

Saccone

Ciardulli

Xodo

et al. 2017

J of Ultrasound Medicine

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“…[56][57][58] In addition, one study compared 17-OHPC with cerclage 59 and three studies compared natural progesterone with 17-OHPC [60][61][62] (Table 1, and see Supporting information, Figure S2). …”

Section: Study Characteristicsmentioning

confidence: 99%

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

Jarde

Lutsiv

Park

et al. 2017

BJOG

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Background Preterm birth (PTB) is the leading cause of infant death, but it is unclear which intervention is best to prevent it.Objectives To compare progesterone, cerclage and pessary, determine their relative effects and rank them.Search strategy We searched Medline, EMBASE, CINAHL, Cochrane CENTRAL and Web of Science (to April 2016), without restrictions, and screened references of previous reviews.Selection criteria We included randomised trials of progesterone, cerclage or pessary for preventing PTB in women with singleton pregnancies at risk as defined by each study.Data collection and analysis We extracted data by duplicate using a piloted form and performed Bayesian random-effects network meta-analyses and pairwise meta-analyses. We rated evidence quality using GRADE, ranked interventions using SUCRA and calculated numbers needed to treat (NNT).Main results We included 36 trials (9425 women; 25 low risk of bias trials). Progesterone ranked first or second for most outcomes, reducing PTB < 34 weeks [odds ratio (OR) 0.44; 95% credible interval (CrI) 0.22-0.79; NNT 9; low quality], <37 weeks (OR 0.58; 95% CrI 0.41-0.79; NNT 9; moderate quality), and neonatal death (OR 0.50; 95% CrI 0.28-0.85; NNT 35; high quality), compared with control, in women overall at risk. We found similar results in the subgroup with previous PTB, but only a reduction of PTB < 34 weeks in women with a short cervix. Pessary showed inconsistent benefit and cerclage did not reduce PTB < 37 or <34 weeks.Conclusions Progesterone was the best intervention for preventing PTB in singleton pregnancies at risk, reducing PTB < 34 weeks, <37 weeks, neonatal demise and other sequelae.Keywords Cervical cerclage, cervical pessary, network metaanalysis, preterm birth, progesterone, systematic review.Tweetable abstract Progesterone was better than cerclage and pessary to prevent preterm birth, neonatal death and more in network meta-analysis.Please cite this paper as: Jarde A, Lutsiv O, Park CK, Beyene J, Dodd JM, Barrett J, Shah PS, Cook JL, Saito S, Biringer AB, Sabatino L, Giglia L, Han Z, Staub K, Mundle W, Chamberlain J, McDonald SD. Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta-analysis.

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“…We will need more adaptive randomised trial Cervical cerclage remains the most popular first-line treatment choice, particularly in units without specialist preterm birth prevention services. This is likely to be the consequence of NICE guidance in combination with highprofile negative trials of vaginal progesterone 13 and the Arabin pessary 14 published in recent years.…”

Section: Discussionmentioning

confidence: 99%

The influence of the introduction of national guidelines on preterm birth prevention practice: UK experience

Care

Ingleby

Alfirević

et al. 2018

BJOG

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Objective To identify the current status of specialist preterm labour ( PTL ) clinics and identify changes in management trends over the last 5 years following release of the NICE preterm birth ( PTB ) guidance. Design Postal Survey of Clinical Practice. Setting UK . Population All consultant‐led obstetric units. Methods A questionnaire was sent by post to all 187 NHS consultant‐led obstetric units. Units with a specialist PTL clinic were asked to answer a further six questions defining their protocol for risk stratification and management. Main outcome measures Current practice in specialist PTL clinics. Changes in treatment trends over 5 years. Results Thirty‐three PTL prevention clinics were identified, with 73% running weekly. NHS staff (84%) have replaced university staff as the lead clinicians (from 69% in 2012 to 21% in 2017), suggesting this clinic has become increasingly integrated with standard care for women at the highest risk of PTB . There has been a large shift from nearly half of clinics offering cerclage as primary treatment for short cervix to offering more choice (30%) between at least two of cerclage, vaginal progesterone or pessary and combinations of primary treatments (18%), demonstrating more equipoise among clinicians regarding therapies for short cervix. Conclusions Over 5 years, there has been a 44% increase in the number of specialist PTL clinics in the UK . Although there is a better consensus over the target high‐risk population, there is increasing heterogeneity among first‐line treatments for short cervix. Tweetable abstract UK PTB prevention clinics have increased by 44% over 5 years, with increasing clinical equipoise to best Rx for short cervix.

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A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth

Cited by 158 publications

References 18 publications

Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta‐analysis

Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta‐analysis

Effectiveness of progesterone, cerclage and pessary for preventing preterm birth in singleton pregnancies: a systematic review and network meta‐analysis

The influence of the introduction of national guidelines on preterm birth prevention practice: UK experience

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