Cervical Pessary Plus Progesterone for Twin Pregnancy with Short Cervix Compared to Unselected and Non-Treated Twin Pregnancy: A Historical Equivalence Cohort Study (EPM Twin Pessary Study)
Abstract:Objective The present study aims to determine if the use of cervical pessary plus progesterone in short-cervix (≤ 25 mm) dichorionic-diamniotic (DC-DA) twin pregnancies is equivalent to the rate of preterm births (PBs) with no intervention in unselected DC-DA twin pregnancies.
Methods A historical cohort study was performed between 2010 and 2018, including a total of 57 pregnant women with DC-DA twin pregnancies. The women admitted from 2010 to 2012 (n = 32) received no treatment, and were not select… Show more
“…The remaining 28 studies were retrieved for full-text review, of which 12 papers did not meet the inclusion criteria for the following reasons: although cervical pessary combined with progesterone treatment was applied in partial patients, these patients were not individually analyzed in four studies; only cervical pessary or progesterone alone treatment, not combined treatment was used in five studies; two studies were protocols; singleton and multiple pregnancies were not individually analyzed in one study. Sixteen studies, with 1517 participants in the cervical pessary and vaginal progesterone combined therapy group and 1600 women in the control group were finally included [ 8 – 12 , 17 – 27 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…The cervical length of patients was less than 25 mm in most of studies (15/16, 93.9%). Of 16 studies, 12 studies [ 8 , 10 – 12 , 18 – 22 , 25 – 27 ] involved women with a singleton pregnancy and the other four [ 9 , 17 , 24 , 27 ] included women with multiple pregnancies. Five RCT [ 10 – 12 , 19 , 25 ] and four non-RCT [ 18 , 21 , 26 , 27 ] singleton studies included a control group receiving treatment with vaginal progesterone alone; two non-RCT singleton studies compared with a group receiving the combination of cervical cerclage and vaginal progesterone [ 18 , 20 ]; only one non-RCT singleton study used the group receiving vaginal progesterone + cervical cerclage + cervical pessary [ 18 ], tocolysis (ritodrine hydrochloride and magnesium sulfate) [ 22 ] or cervical pessary alone [ 8 ] as the control, respectively.…”
Section: Resultsmentioning
confidence: 99%
“…Furthermore, unlike cervical pessary and progesterone, cervical cerclage is a surgical procedure that is invasive, high-cost [ 15 ], and causes adverse complications (i.e., bleeding, infection) [ 16 ]. Thus, newly published studies about a combined therapy during 2018–2021 years mainly attempted to confirm the effects of cervical pessary plus progesterone on pregnancy and neonatal outcomes [ 17 – 27 ].…”
This study was to assess the effectiveness of cervical pessary combined with vaginal progesterone for the prevention of preterm birth (PTB). Ten studies about singleton [five randomized controlled trials (RCTs), vs vaginal progesterone; four cohorts, vs vaginal progesterone; two cohorts, vs cervical cerclage + vaginal progesterone] and two cohort studies about multiple pregnancies (vs vaginal progesterone) were included after searching electronic databases. For singleton pregnancies, the meta-analysis of three non-RCTs [relative risk (RR) = 0.41, p = 0.001] or total trials in non-Asian country (RR = 0.56, p = 0.03) revealed that compared with vaginal progesterone alone, cervical pessary + vaginal progesterone treatment had significant effectiveness on preventing PTB < 34 weeks, but not for five RCTs; meta-analysis of two trials showed that cervical pessary + vaginal progesterone had no significant prevention effects of PTB compared with cervical cerclage + vaginal progesterone. For multiple pregnancies, meta-analysis of two trials showed that compared with vaginal progesterone, cervical pessary + vaginal progesterone treatment increased neonatal birth weight (standardized mean difference = 0.50, p = 0.01). Trial sequential analysis implied additional studies were required. Four studies vs other controls (pessary, three-combined, tocolysis, conservative or no treatment; one study, each) were selected for systematic review. In conclusion, cervical pessary combined with vaginal progesterone may be safe and effective to prevent PTB in singleton pregnancies and increase neonatal birth weight in the multiple pregnancies compared with vaginal progesterone alone.
“…The remaining 28 studies were retrieved for full-text review, of which 12 papers did not meet the inclusion criteria for the following reasons: although cervical pessary combined with progesterone treatment was applied in partial patients, these patients were not individually analyzed in four studies; only cervical pessary or progesterone alone treatment, not combined treatment was used in five studies; two studies were protocols; singleton and multiple pregnancies were not individually analyzed in one study. Sixteen studies, with 1517 participants in the cervical pessary and vaginal progesterone combined therapy group and 1600 women in the control group were finally included [ 8 – 12 , 17 – 27 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…The cervical length of patients was less than 25 mm in most of studies (15/16, 93.9%). Of 16 studies, 12 studies [ 8 , 10 – 12 , 18 – 22 , 25 – 27 ] involved women with a singleton pregnancy and the other four [ 9 , 17 , 24 , 27 ] included women with multiple pregnancies. Five RCT [ 10 – 12 , 19 , 25 ] and four non-RCT [ 18 , 21 , 26 , 27 ] singleton studies included a control group receiving treatment with vaginal progesterone alone; two non-RCT singleton studies compared with a group receiving the combination of cervical cerclage and vaginal progesterone [ 18 , 20 ]; only one non-RCT singleton study used the group receiving vaginal progesterone + cervical cerclage + cervical pessary [ 18 ], tocolysis (ritodrine hydrochloride and magnesium sulfate) [ 22 ] or cervical pessary alone [ 8 ] as the control, respectively.…”
Section: Resultsmentioning
confidence: 99%
“…Furthermore, unlike cervical pessary and progesterone, cervical cerclage is a surgical procedure that is invasive, high-cost [ 15 ], and causes adverse complications (i.e., bleeding, infection) [ 16 ]. Thus, newly published studies about a combined therapy during 2018–2021 years mainly attempted to confirm the effects of cervical pessary plus progesterone on pregnancy and neonatal outcomes [ 17 – 27 ].…”
This study was to assess the effectiveness of cervical pessary combined with vaginal progesterone for the prevention of preterm birth (PTB). Ten studies about singleton [five randomized controlled trials (RCTs), vs vaginal progesterone; four cohorts, vs vaginal progesterone; two cohorts, vs cervical cerclage + vaginal progesterone] and two cohort studies about multiple pregnancies (vs vaginal progesterone) were included after searching electronic databases. For singleton pregnancies, the meta-analysis of three non-RCTs [relative risk (RR) = 0.41, p = 0.001] or total trials in non-Asian country (RR = 0.56, p = 0.03) revealed that compared with vaginal progesterone alone, cervical pessary + vaginal progesterone treatment had significant effectiveness on preventing PTB < 34 weeks, but not for five RCTs; meta-analysis of two trials showed that cervical pessary + vaginal progesterone had no significant prevention effects of PTB compared with cervical cerclage + vaginal progesterone. For multiple pregnancies, meta-analysis of two trials showed that compared with vaginal progesterone, cervical pessary + vaginal progesterone treatment increased neonatal birth weight (standardized mean difference = 0.50, p = 0.01). Trial sequential analysis implied additional studies were required. Four studies vs other controls (pessary, three-combined, tocolysis, conservative or no treatment; one study, each) were selected for systematic review. In conclusion, cervical pessary combined with vaginal progesterone may be safe and effective to prevent PTB in singleton pregnancies and increase neonatal birth weight in the multiple pregnancies compared with vaginal progesterone alone.
“…One retrospective cohort study of twin pregnancies draws a conclusion that cervical pessary combined with vaginal progesterone could prolonged pregnancy and reduce risk of adverse neonatal outcomes [24]. In 2020, a retrospective study of 57 patients with (dichorionic diamniotic twin (DCDA) showed that a cervical pessary combined with vaginal progesterone reduced the rate of preterm birth in patients [25]. There is one study showed that cervical pessary combined with vaginal progesterone could prolonged pregnancy, reduce prematurity rate and a low rate of perinatal complications [26].…”
Conclusion The cervical pessary can extend the gestational week of
short-cervix twin pregnancy without clinical symptoms, reduce the
premature birth rate before 34 weeks of gestation, improve pregnancy
outcome, reduce neonatal mortality, reduce necrotizing enterocolitis
incidence, neonatal sepsis incidence, and improve neonatal outcome. For
patients with a cervical length less than 38mm, a cervical pessary can
be performed to extend the gestational week. For patients with a
cervical length less than 25mm, a cervical pessary can effectively
prolong the gestational age and improve the maternal and fetal outcomes.
The cervical pessary is safe for patients with twin pregnancies. Suggest
that twin-preganct-patients with CL<38mm should consider take
cervical pessary in advance. In terms of long-term efficacy, there is no
evidence of cervical support placement on the long-term maternal
prognosis. In terms of economic benefits, cervical support is better
than vaginal progesterone, but this conclusion still needs more research
to prov
Cervical pessary is a new treatment for preterm birth and have obtained a lot of space in clinical practice because its real efficacy, which unconsidered the bias produced by some research. There is a lack of evidence about cervical pessary in many aspects and only those who handle this device every day can note and call for attention. Experience is the central point about cervical pessary in this article, and important centers with training and expertise must be taken the front of this issue, because low experience probably is one of the causes of contradictory results in literature. In fact, we have a lot of aspects that need attention and never were treated because always the efficacy is questioned and do not open space for other important aspects. We have a lot of o issues to discuss during this article such as the indication of a cervical pessary, the needs of guidelines about pessary, including a learning curve of pessary treatment, the relevant aspects about insertion of the device, its association with other medications, needs for hospitalization, which is the best management for the vaginal discharge pessary related, how to handle the pelvic pain after insertion, the urinary symptoms, the obstipation, and the inhibition of preterm labor during pessary treatment, and finally, what are the relevant aspects about the withdrawal of cervical pessary?
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