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:10.1097/01.ogx.0000488680.91547.3a

Cited by 39 publications

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“…Six studies were assessed for eligibility . Three trials including multiple pregnancies were excluded .…”

Section: Resultsmentioning

confidence: 99%

“…Three trials including multiple pregnancies were excluded . Three RCTs were therefore included in the meta‐analysis . The overall risk of bias of the included trials was low (Figure ).…”

Section: Resultsmentioning

confidence: 99%

“…Regarding the use of progesterone, 2 trials did not use it . In Nicolaides et al, 359 women (38.5%), from both the pessary and control groups, with CL ≤15 mm at randomization or subsequent visit, received 200 mg vaginal suppository daily containing natural progesterone up to 33 weeks' gestation . None of the three trials used 17‐hydroxyprogesterone caproate as prophylactic treatment for women with prior SPTB.…”

Section: Resultsmentioning

confidence: 99%

“…All 3 trials included both low‐risk (without prior SPTB) and high‐risk (with prior SPTB) women. The higher rate of preterm birth in the control group in 1 of the trials (26.8%) is not concordant with those of the control groups of the other 2 trials . The small number of studies did not permit meaningful stratified meta‐analyses to explore the test performance in sensitivity analyses according to the study's risk of bias.…”

Section: Commentmentioning

confidence: 86%

“…None of the included studies was double‐blind. More than half of the women included in the analysis (932 out of the 1420) came from 1 large trial, which therefore drives the summary statistics . All 3 trials included both low‐risk (without prior SPTB) and high‐risk (with prior SPTB) women.…”

Section: Commentmentioning

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 . Three trials including multiple pregnancies were excluded .…”

Section: Resultsmentioning

confidence: 99%

“…Three trials including multiple pregnancies were excluded . Three RCTs were therefore included in the meta‐analysis . The overall risk of bias of the included trials was low (Figure ).…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Commentmentioning

confidence: 86%

Section: Commentmentioning

confidence: 99%

See 3 more Smart Citations

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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Cervical pessary plus vaginal progesterone versus long‐term tocolysis for the prevention of preterm birth: An observational retrospective study

Tajima

Yanazume

Orita

et al. 2020

Intl J Gynecology & Obste

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Objective To compare cervical pessaries plus vaginal progesterone versus long‐term tocolysis for preventing preterm birth for women with a short cervix. Methods Retrospective evaluation of women with singleton pregnancy who received cervical pessaries plus vaginal progesterone (combined group) or ritodrine hydrochloride (tocolysis group) for short cervix (≤25 mm at 20–24 weeks, or ≤20 mm at 25–34 weeks) at a general hospital in Kagoshima, Japan, 2015–2019. The primary outcome was rate of preterm birth (<36 weeks); secondary outcomes were maternal hospital admittance and treatment complications. Results Data were evaluated from 95 women (combined group, n=43; tocolysis group, n=52). There was no significant difference in cervical length or gestational age at intervention between the groups. Overall, 3/43 (7.0%) women delivered before 36 weeks in the combined group versus 16/52 (30.8%) in the tocolysis group (relative risk, 0.56; 95% confidence interval, 0.41–0.76; P=0.004). Median maternal admittance was shorter in the combined group (6.6 vs 41.0 days, P<0.001). Although 36/43 (83.7%) women in the combined group reported increased vaginal discharge, no major complications occurred. Conclusion A combination of pessaries and vaginal progesterone reduced the rate of preterm birth (<36 weeks) for women with short cervix as compared with long‐term tocolysis.

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FIGO good practice recommendations on the use of pessary for reducing the frequency and improving outcomes of preterm birth

Grobman

Norman

Jacobsson

et al. 2021

Intl J Gynecology & Obste

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A pessary is a device made of synthetic material that is placed in the vagina. One potential application of the pessary has been preventing preterm birth in high-risk groups, such as women with a singleton pregnancy with a shortened cervix in the mid-gestation, or those with a twin gestation. One hypothesis is that the pessary alters the cervico-uterine angle to a more posterior position, which reduces cervical compression and other changes. Nevertheless, the exact physiologic mechanism by which a more posterior cervix would lead to a lower preterm birth rate has not been demonstrated.There have been several randomized trials within the last decade (and many more ongoing) that have evaluated whether pessary is a beneficial strategy for preterm birth prevention in a variety of

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

Cited by 39 publications

References 0 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

Cervical pessary plus vaginal progesterone versus long‐term tocolysis for the prevention of preterm birth: An observational retrospective study

FIGO good practice recommendations on the use of pessary for reducing the frequency and improving outcomes of preterm birth

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