“…Women using cervical pessary had more vaginal discharge and pain than those not using the device, but there were no severe side effects compromising the safety of the treatment. This is in accordance with other studies 10,12 and should be considered when selecting a treatment option.…”
Section: Discussionsupporting
confidence: 92%
“…15,32 A larger study by Nicolaides et al 11 also did not find a benefit of pessaries. In women with twin pregnancies, cervical pessaries are not effective in an unselected population 10,20,21 ; in women with short cervixes, cervical pessaries seem to reduce preterm birth in most studies, 20,21 but, again, not in the study of Nicolaides et al Given these mixed data, we consider questions about the role of cervical pessary to prevent preterm birth still open. Our data will be included in a planned individual participant meta-analysis that investigates the effectiveness of cervical pessary (PROSPERO 2018 CRD42018067740) in the prevention of preterm birth.
Authors' Data Sharing Statement
Will individual participant data be available (including data dictionaries)?…”
Section: Discussionmentioning
confidence: 93%
“…12,26–28 Few RCTs, however, included information of the use of progesterone in the pessary group, as was done in the earlier studies. 10,14,24…”
Section: Discussionmentioning
confidence: 99%
“…12,[26][27][28] Few RCTs, however, included information of the use of progesterone in the pessary group, as was done in the earlier studies. 10,14,24 Our RCT has several strengths. It has a large sample size and nearly complete follow-up.…”
Section: Discussionmentioning
confidence: 99%
“…Studies that evaluate cervical pessaries show conflicting results. [10][11][12][13][14][15] Some studies indicate a reduction in preterm birth, 13,[16][17][18][19] whereas other studies report no effect at all. 11,15,20,21 In view of this divergence, and hypothesizing that a mechanical (pessary) treatment would add to the reduction of preterm birth in combination with a biochemical (progesterone) treatment, we conducted a multicenter randomized controlled trial (RCT) that compared cervical pessary plus vaginal progesterone compared with vaginal progesterone only in women with short cervixes in midpregnancy.…”
To test the effectiveness of cervical pessary in addition to vaginal progesterone for the prevention of preterm birth in women with midpregnancy short cervixes.
METHODS:We performed a multicenter, open-label, randomized controlled trial in 17 perinatal centers. Asymptomatic women with singleton or twin pregnancies and cervical lengths of 30 mm or less, measured at 18 0/7-22 6/7 weeks of gestation, were randomized to cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesteroneonly group) (200 mg/day). Treatments were used from randomization to 36 weeks of gestation or delivery. The primary outcome was a composite of neonatal mortality and morbidity. Secondary outcomes were delivery before 37 weeks and before 34 weeks of gestation. Analysis was performed according to intention to treat.
“…Women using cervical pessary had more vaginal discharge and pain than those not using the device, but there were no severe side effects compromising the safety of the treatment. This is in accordance with other studies 10,12 and should be considered when selecting a treatment option.…”
Section: Discussionsupporting
confidence: 92%
“…15,32 A larger study by Nicolaides et al 11 also did not find a benefit of pessaries. In women with twin pregnancies, cervical pessaries are not effective in an unselected population 10,20,21 ; in women with short cervixes, cervical pessaries seem to reduce preterm birth in most studies, 20,21 but, again, not in the study of Nicolaides et al Given these mixed data, we consider questions about the role of cervical pessary to prevent preterm birth still open. Our data will be included in a planned individual participant meta-analysis that investigates the effectiveness of cervical pessary (PROSPERO 2018 CRD42018067740) in the prevention of preterm birth.
Authors' Data Sharing Statement
Will individual participant data be available (including data dictionaries)?…”
Section: Discussionmentioning
confidence: 93%
“…12,26–28 Few RCTs, however, included information of the use of progesterone in the pessary group, as was done in the earlier studies. 10,14,24…”
Section: Discussionmentioning
confidence: 99%
“…12,[26][27][28] Few RCTs, however, included information of the use of progesterone in the pessary group, as was done in the earlier studies. 10,14,24 Our RCT has several strengths. It has a large sample size and nearly complete follow-up.…”
Section: Discussionmentioning
confidence: 99%
“…Studies that evaluate cervical pessaries show conflicting results. [10][11][12][13][14][15] Some studies indicate a reduction in preterm birth, 13,[16][17][18][19] whereas other studies report no effect at all. 11,15,20,21 In view of this divergence, and hypothesizing that a mechanical (pessary) treatment would add to the reduction of preterm birth in combination with a biochemical (progesterone) treatment, we conducted a multicenter randomized controlled trial (RCT) that compared cervical pessary plus vaginal progesterone compared with vaginal progesterone only in women with short cervixes in midpregnancy.…”
To test the effectiveness of cervical pessary in addition to vaginal progesterone for the prevention of preterm birth in women with midpregnancy short cervixes.
METHODS:We performed a multicenter, open-label, randomized controlled trial in 17 perinatal centers. Asymptomatic women with singleton or twin pregnancies and cervical lengths of 30 mm or less, measured at 18 0/7-22 6/7 weeks of gestation, were randomized to cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesteroneonly group) (200 mg/day). Treatments were used from randomization to 36 weeks of gestation or delivery. The primary outcome was a composite of neonatal mortality and morbidity. Secondary outcomes were delivery before 37 weeks and before 34 weeks of gestation. Analysis was performed according to intention to treat.
We aimed to evaluate the effectiveness of cervical pessary for extending twin pregnancy in women with a short cervix. Methods Between January 2014 and March 2019, the use of a cervical pessary for twin pregnancy in women with a cervical length of ≤15 mm was investigated between 16 and 28 weeks of gestation. We included women with a shortened cervix after a cerclage procedure and visible fetal membranes and cervical dilatation. Thirteen patients underwent pessary insertion and were matched with a control group of 15 patients. Pregnancy and neonatal outcomes were compared between the groups. We excluded women with major fetal anomalies discovered before or after birth and known placenta previa. Results Women who underwent pessary insertion were diagnosed with a short cervix (0.65±0.47 vs. 0.66±0.51 cm in the pessary and control groups, respectively; P=0.957) at a gestational age similar to that of the controls (23.29 vs. 25.14 weeks, P=0.294). There was no significant difference in gestational age at delivery between them (33.29 vs. 27.29 weeks in the pessary and control groups, respectively, P=0.058). The pessary group had a longer interval between the diagnosis and delivery than the control group (60.7±28.3 vs. 22.6±24.5 days, P=0.001). The number of adverse neonatal outcomes was significantly lower in the pessary group (n=7; 28.0%) than in the control group (n=14; 58.3%; P=0.032). Conclusion The use of a cervical pessary may prolong gestation in twin pregnancies in women with an extremely short cervix until viable gestational age.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
