Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins)

2016 ◽  
Vol 214 (2) ◽  
pp. 145-152 ◽  
Author(s):  
Maria Goya ◽  
Maria de la Calle ◽  
Laia Pratcorona ◽  
Carme Merced ◽  
Carlota Rodó ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Cervical Pessary ◽  
Multicenter Randomized Controlled Trial

scholarly journals Cervical Pessary versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women with Placenta Previa: A Randomized Controlled Trial

2019 ◽  
Vol 09 (02) ◽  
pp. e160-e166
Author(s):  
Irene Stafford ◽  
Thomas Garite ◽  
Kimberly Maurel ◽  
C. Combs ◽  
Kent Heyborne ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Placenta Previa ◽  
Controlled Trial ◽  
Expectant Management ◽  
Randomized Controlled ◽  
Cervical Pessary ◽  
Multicenter Randomized Controlled Trial ◽  
To Receive ◽  
Type Of Delivery

Objective This multicenter randomized controlled trial compared cervical pessary (CP) versus expectant management (EM) in women with placenta previa between 22.0 and 32.0 in prolonging gestation until ≥ 36.0 weeks' gestation. Study Design This study took place from November 2016 to June 2018. Women were randomized to receive either the Bioteque CP or EM. The pessary was removed at ≥ 36.0 weeks unless indicated. The primary outcome was gestational age (GA) at delivery, with secondary outcomes including need for transfusion, number and duration of antepartum admissions, type of delivery, and neonatal outcomes. A total of 140 patients were needed to show a 3-week prolongation of pregnancy in the pessary group; however, the trial was stopped early due to budgetary issues. Results Of the 33 eligible women, 17 were enrolled. Although not statistically significant, the mean GA at delivery in the CP group was greater than women in the EM group (36.5 ± 1.23 vs. 36.0 ± 2.0; p = 0.1673). The number and duration of antepartum admissions was greater in the EM group (2.7 ± 0.58 vs. 16.0 ± 22.76 days; p = 0.1264) as well. Conclusion Although the study was underpowered to determine the primary outcome, safety and feasibility of CP in pregnancies complicated with previa were demonstrated.

scholarly journals LB 1: Randomized controlled trial: Arabin pessary to prevent preterm birth in twin pregnancies with short cervix

2020 ◽  
Vol 222 (1) ◽  
pp. S756 ◽  
Author(s):  
Jane E. Norman ◽  
John Norrie ◽  
Graeme MacLennan ◽  
David Cooper ◽  
Sonia Whyte ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Twin Pregnancies

scholarly journals A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rodolfo C. Pacagnella ◽  
◽  
Ben W. Mol ◽  
Anderson Borovac-Pinheiro ◽  
Renato Passini ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Birth ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Cervical Length ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Short Cervix ◽  
Randomized Controlled ◽  
Vaginal Progesterone

Abstract Background Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. Methods This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. Discussion In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. Trial registration Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111–1164-2636, 2014/11/18.

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