Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE)

Groussolles, Marion; Winer, Norbert; Sentilhes, Loïc; Biquart, Florence; Massoud, Mona; Vivanti, Alexandre J.; Bouchghoul, Hanane; Rozenberg, Patrick; Olivier, Pascale; Desbrière, Raoul; Chauleur, Céline; Perrotin, Franck; Coatleven, F.; Fuchs, Florent; Bretelle, Florence; Tsatsaris, Vassilis; Salomon, Laurent; Sananès, Nicolas; Kayem, Gilles; Houflin-Debarge, V.; Schmitz, Thomas; Benoist, G.; Arnaud, Catherine; Ehlinger, Virginie; Vayssière, Christophe

doi:10.1016/j.ajog.2022.01.038

Cited by 9 publications

(21 citation statements)

References 16 publications

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“… 29 The concurrent use of antibiotics and vaginal progesterone differed between trials, potentially affecting the biological effects. A learning curve of 30 patients, as already published by Franca et al, 8 had not been completed by investigators in many trials 17–24,26,27 …”

Section: Resultsmentioning

confidence: 99%

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Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta‐analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation

Kyvernitakis,

Baschat,

Malan

et al. 2023

Intl J Gynecology & Obste

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BackgroundFindings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.ObjectivesOur hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non‐adherence to these guidelines will probably contribute to its failure.Search Strategy and Selection CriteriaBased on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.Data Collection and AnalysisWe analyzed the implications of 14 criteria each accounting for 0–2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk–benefit ratio of medical devices.Main ResultsSeven RCTs in each singleton and twin pregnancies (5193 “cases”) were included, detecting a high heterogeneity within control groups (I2 = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre‐registration, but mainly non‐adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12–0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13–0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10–0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35–0.82) after a pessary as compared with controls.ConclusionNon‐audited RCTs and meta‐analyses mixing studies of different clinical quality as pre‐defined by a CEP and the MDR pose the risk for erroneous conclusions.

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Section: Resultsmentioning

confidence: 99%

“…Even the French PESSARONE trial 26 failed to reach the MDR‐based quality metrics, as 10.8% of the participants had missing values for the primary endpoint, 79% of parents refused neonatal data collection, and recruitment rates were extremely low.…”

Section: Discussionmentioning

confidence: 99%

Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta‐analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation

Kyvernitakis,

Baschat,

Malan

et al. 2023

Intl J Gynecology & Obste

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“…Eight studies had cervical pessary as the main intervention: six studies compared pessary vs control group 9,[42][43][44][45][46] , one study compared vaginal progesterone vs pessary 47 and one study compared the combined intervention pessary + vaginal progesterone vs progesterone 8 . Table 1 shows the descriptive characteristics of the included studies.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…25mm 41,43,44 , one study included CL< 30mm 36 , two studies included CL [?] 30mm 8,45 , studies included CL <35mm 9,40 , one study included CL[? ]35mm 46 , one studiy included CL<38mm 40 and eight studies included CL<40mm [31][32][33][34][35][37][38][39] .…”

Section: Study Characteristicsmentioning

confidence: 99%

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Interventions for preventing preterm birth in multiple gestations with short cervix -- a systematic review and network meta-analysis

Silva

Pacagnella

Pinheiro

et al. 2023

Preprint

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Background: Multiple gestation has a higher incidence of preterm birth(PTB), especially in the presence of a short cervix. Objectives: To perform a systematic review and network meta-analysis(NMA) evaluating the effect of progesterone, cerclage, cervical pessary and their combination as treatments for preventing PTB<34 weeks. Search strategy: PubMed, MEDLINE, Cochrane Library, EMBASE, Web of Science, BVS, Scopus, and grey literature were explored. Selection criteria: We included randomized controlled trials that compared an intervention with a control group or another intervention to prevent PTB in women with a twin pregnancy and a short cervix<40mm. Data collection and Analysis:Studies were checked for trustworthiness. We presented summary relative effect sizes(Odds Ratios) for each possible pair of interventions and we used the surface under the cumulative ranking curves(SUCRA) to rank all interventions. Main Results: A total of 20 studies participated in NMA. We found no evidence that the combined treatment of pessary and vaginal progesterone reduced the risk of spontaneous PTB <34 weeks when compared to no intervention(OR 0.68; 95%CI 0.16 to 2.9). Also, pessary(OR 0.78; 95%CI 0.49 to 1.3), vaginal progesterone(OR 0.79; CI95% 0.45 to 1.4) and injectable 17-OH progesterone alone(OR 0.85; CI95% 0.26 to 2.8) did not show a statistically significant reduction in spontaneous PTB. For overall PTB<34 weeks, findings were similar. Conclusions: We found no evidence that progesterone, cervical pessary, cerclage or their combination reduce PTB<34 weeks. There is an urgent need for randomized trials assessing these treatments in women with a multiple pregnancy and a short cervix.

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Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in twin gestations: a systematic review and meta-analysis

Conde-Agudelo

Romero

Rehal

et al. 2023

American Journal of Obstetrics and Gynecology

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Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE)

Cited by 9 publications

References 16 publications

Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta‐analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation

Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta‐analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation

Interventions for preventing preterm birth in multiple gestations with short cervix -- a systematic review and network meta-analysis

Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in twin gestations: a systematic review and meta-analysis

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