Effectiveness and perinatal outcomes of history-indicated, ultrasound-indicated and physical examination-indicated cerclage: a retrospective study.

OBJECTIVE: To evaluate the effectiveness and perinatal outcomes of cerclage procedure according to indication. METHODS: The pregnancy and neonatal outcomes of the patients who underwent cerclage with the diagnosis of cervical insufficiency between January 2016 and December 2020 were retrospectively analyzed. Patients were categorized into three groups: a history-indicated group, an ultrasound-indicated group and a physical examination-indicated group. RESULTS: Seventy-three patients who underwent cerclage were included in the study. Of these, 41 (56.2%) had history-indicated, 17 (23.3%) had ultrasound-indicated and 15 (20.5%) had physical examination-indicated cerclages. Compared to history- and ultrasound-indicated cerclage group, duration from cerclage to delivery (18.6 ± 6.9 weeks vs 17.8±5.9 weeks vs 11 ± 5.3 weeks, p = 0.003) was significantly lower and delivery < 28 weeks (9.8% vs 5.9% vs 33.3%, p = 0.042) and delivery < 34 weeks of gestation (26.8% vs 11.8% vs 60%, p = 0.009) were significantly higher in physical examination-indicated cerclage group. In physical examination-indicated cerclage, compared with history- and ultrasound-indicated cerclage low birth weight, low APGAR score, neonatal intensive care unit admission and neonatal mortality were higher, although not statistically significant (p > 0.05). CONCLUSION: Pregnant women who underwent physical examination-indicated cerclage had higher risks for preterm delivery < 28 weeks and < 34 weeks than history- and ultrasound-indicated cerclage.

Pessary use in patients diagnosed with short cervix and cervical insufficiency.

OBJECTIVE: The aim was to evaluate the effectiveness of Arabin pessary use in patients with cervical insufficiency or short cervix before the 24th week of gestation and the impact of cervical examination findings prior to pessary application on the outcome in terms of the gestational week. MATERIALS AND METHODS: In our study, among the pregnancies between the 12th and 24th gestational weeks, 60 pregnant women with a preterm delivery history and/or cervical length less than 25 mm were included. Among these 60 patients, 43 of them had a short cervix, 17 of them had cervical insufficiency. Routine medical and obstetric history was obtained. In the vaginal examination, the cervix was evaluated in terms of patency, dilatation, and position. Cervical length, presence of debris, and funneling were evaluated by transvaginal ultrasound. After receiving patients' approval a cervical pessary was applied to patients. Pessaries of pregnant women with 37 weeks of gestation were removed. Before reaching the 37th gestation week, pessaries were withdrawn in patients who had ongoing vaginal bleeding, premature rupture of membranes, and preterm contractions unresponsive to tocolytic treatment. RESULTS: Thirty-one pregnant women (51.7%) out of 60 pregnant women who underwent pessary, delivered at 37 weeks and below. Delivery rates in the short cervical measurement group and cervical insufficiency group at ≤28 weeks, ≤34 weeks and ≤37 weeks were respectively (n = 21) 34.8% vs 36.3% (p = 0.976), (n = 29) 41.8% vs 64.7% (p = 0.111), (n = 31) 44.2% vs 70.6% (p = 0.888). The presence of cervical funneling before pessary application shows a statistically significant difference in terms of patient's giving birth before or after 28 weeks (p = 0.033). In patients with cervical funneling, there was a significant increase in a birth before 28 weeks. Depending on whether or not patients applying with pain need for tocolysis, it shows the statistically meaningful difference in terms of the patients giving birth before or after 34 weeks (p = 0.001) (OR 7, 61, 95% GA 2.4-24.6). In the group without the need for tocolysis, there is a meaningful increase in birth after 34 weeks. CONCLUSIONS: Our findings showed that, alongside the defined cervical risk factors, cervical funneling and the need for tocolysis are remarkable prognostic variables in pessary application.

The use of PAMG-1 testing in patients with preterm labor, intact membranes and a short sonographic cervix reduces the rate of unnecessary antenatal glucocorticoid administration.

OBJECTIVES: To assess the frequency of antenatal corticosteroid (ACS) administration in cases with shortened cervical length by addition of placental alpha-microglobulin-1 (PAMG-1) testing to sonographic examination. METHODS: Single centre retrospective cohort study. Rate of ACS administration was compared between cases with cervical length between 15 and 25 mm and cases with positive PAMG-1 testing and cervical length between 15 and 25 mm. We evaluated the following outcome parameters: Rate of ACS administration, gestational age at delivery, time to delivery, delivery within seven days, delivery <34 and <37 weeks' gestation, rate of admission to neonatal intensive care unit (NICU). RESULTS: In total, 130 cases were included. "PAMG-1 group" consisted of 68 women, 62 cases built the "historical control group". ACS administration was performed less frequently in the "PAMG-1 cohort" (18 (26%) vs. 46 (74%); p<0.001). The rate of delivery within seven days did not differ (2 (3%) vs. 4 (6.5%); p=0.4239). The rates of delivery <34 weeks' gestation (7 (10%) vs. 9 (15%); p=0.4643) and <37 weeks' gestation (19 (28%) vs. 26 (42%); p=0.0939) did not differ. Time to delivery interval was longer in the PAMG-1 group (61.5 vs. 43 days, p=0.0117). NICU admission occurred more often in the "historical control group" (22 (38%) vs. 28 (60%); p=0.0272). CONCLUSIONS: Addition of biomarker testing can help to avoid unnecessary ACS administrations in women with shortened cervical length.

Cervical cerclage application algorithm in continued cervical shortening cases despite vaginal progesterone.

OBJECTIVE: The aim of this study is evaluation of pregnancy outcomes of the asymptomatic cases with vaginal progesterone treatment for the 20-30 mm cervical length detected in the transvaginal ultrasonography for fetal abnormality screening and cervical cerclage after cervical length detected <20 mm in weekly cervical length measures; and present the treatment algorithm of progesterone treatment combined with cervical cerclage application. METHODS: Patients who have the inclusion criteria and cervical length more than 30 mm were categorized as group 1(n = 1948). Group 2 were included patients with cervical length shorter than 30 mm (n = 95). All patients of group 2 started to use vaginal natural progesterone 400 mg/day(n = 87). Pregnancies which progressed with cervical length above 20 mm were continued vaginal progesterone until 34. Gestational week and they were named as group 2A (n = 78). Cervical cerclage were applied to patients with cervical length below than 20 mm measured via transvaginal ultrasonography and they were categorized as group 2B (n = 9). RESULTS: Excluding 8 cases (8.42 %) which cervical cerclage were applied, 87 patients were administered vaginal progesterone and in 9 cases (10.34 %) cervical shortening were continued despite progesterone treatment. Four out of these nine cases (44.44 %) had cervical cerclage and their deliveries were delayed after 34 th gestational week. Vaginal progesterone treatment prevented cervical shortening in 89.66 % of patients who had cervical length between 20-30 mm and out of these patients. CONCLUSION: Cervical cerclage application algorithm in continued cervical shortening cases despite vaginal progesterone is beneficial to delay the delivery after 34 th gestational week and related to low complication rate.

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).

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 selected by cervical length (Non-Treated group, NTG), whereas those admitted from 2013 to 2018 (n = 25), were routinely submitted to cervical pessary plus progesterone after the diagnosis of short cervix from the 18th to the 27th weeks of gestation (Pessary-Progesterone group, PPG). The primary outcome analyzed was the rate of PBs before 34 weeks. RESULTS: There were no statistical differences between the NTG and the PPG regarding PB < 34 weeks (18.8% versus 40.0% respectively; p = 0.07) and the mean birthweight of the smallest twin (2,037 ± 425 g versus 2,195 ± 665 g; p = 0.327). The Kaplan-Meyer Survival analysis was performed, and there were no differences between the groups before 31.5 weeks. Logistic regression showed that a previous PB (< 37 weeks) presented an odds ratio (OR) of 15.951 (95% confidence interval [95%CI]: 1.294-196.557; p = 0.031*) for PB < 34 weeks in the PPG. CONCLUSION: In DC-DA twin pregnancies with a short cervix, (which means a higher risk of PB), the treatment with cervical pessary plus progesterone could be considered equivalent in several aspects related to PB in the NTG, despite the big difference between these groups.

OBJETIVO: Este estudo tem como objetivo determinar se o uso de pessário cervical associado a progesterona em gestações de gêmeos dicoriônicos-diamnióticos (DC-DAs) com colo do útero curto (≤ 25 mm) apresenta taxa de parto prematuro (PP) equivalente à de gestações gemelares DC-DA sem nenhuma intervenção/não selecionadas. MéTODOS: Um estudo de coorte histórica foi realizado entre 2010 e 2018, incluindo um total de 57 mulheres grávidas com gestações gemelares DC-DA. As mulheres admitidas de 2010 a 2012 (n = 32) não receberam tratamento, e não foram selecionadas pelo comprimento cervical (grupo Não Tratado, GNT), enquanto as admitidas de 2013 a 2018 (n = 25) receberam pessário cervical rotineiramente associado a progesterona após o diagnóstico de colo curto entre a 18a e a 27ª semanas de gestação (grupo Pessário-Progesterona, GPP). O desfecho primário analisado foi a taxa de PP antes de 34 semanas. RESULTADOS: Não houve diferenças estatísticas entre o GNT e o GPP em relação ao PP < 34 semanas (respectivamente, 18,8% versus 40,0%; p = 0,07) e ao peso médio ao nascer do gêmeo menor (2.037 ± 425 g versus 2.195 ± 665 g; p = 0,327). A análise de Kaplan-Meyer foi realizada, e não houve diferenças entre os grupos antes de 31,5 semanas. A regressão logística demonstrou que o nascimento prematuro anterior (< 37 semanas) apresentou razão de probabilidades (odds ratio, OR) de 15,951 (intervalo de confiança de 95% [IC95%]: 1,294­196,557; p = 0,031*) para o nascimento prematuro < 34 semanas no GPP. CONCLUSãO: Em gêmeos DC-DA com colo uterino curto (o que significa maior risco de nascimento prematuro), o tratamento com pessário cervical associado a progesterona pode ser considerado equivalente em diversos aspectos relacionados à prematuridade no GNT, apesar da grande diferença entre os grupos.

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) / Pessário cervical associado a progesterona em gestações gemelares com colo curto comparado a gestações gemelares não selecionadas e não tratadas: estudo de coorte histórica de equivalência (Estudo de Pessário em Gêmeos EPM)

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 selected by cervical length (Non-Treated group, NTG), whereas those admitted from 2013 to 2018 (n = 25), were routinely submitted to cervical pessary plus progesterone after the diagnosis of short cervix from the 18th to the 27th weeks of gestation (Pessary-Progesterone group, PPG). The primary outcome analyzed was the rate of PBs before 34 weeks. Results There were no statistical differences between the NTG and the PPG regarding PB < 34 weeks (18.8%; versus 40.0%; respectively; p = 0.07) and the mean birthweight of the smallest twin (2,037 ± 425 g versus 2,195 ± 665 g; p = 0.327). The Kaplan-Meyer Survival analysis was performed, and there were no differences between the groups before 31.5 weeks. Logistic regression showed that a previous PB (< 37 weeks) presented an odds ratio (OR) of 15.951 (95%; confidence interval [95%;CI]: 1.294-196.557; p = 0.031*) for PB < 34 weeks in the PPG. Conclusion In DC-DA twin pregnancies with a short cervix, (which means a higher risk of PB), the treatment with cervical pessary plus progesterone could be considered equivalent in several aspects related to PB in the NTG, despite the big difference between these groups.

Resumo Objetivo Este estudo tem como objetivo determinar se o uso de pessário cervical associado a progesterona em gestações de gêmeos dicoriônicos-diamnióticos (DC-DAs) com colo do útero curto (≤ 25 mm) apresenta taxa de parto prematuro (PP) equivalente à de gestações gemelares DC-DA sem nenhuma intervenção/não selecionadas. Métodos Um estudo de coorte histórica foi realizado entre 2010 e 2018, incluindo um total de 57 mulheres grávidas com gestações gemelares DC-DA. As mulheres admitidas de 2010 a 2012 (n = 32) não receberam tratamento, e não foram selecionadas pelo comprimento cervical (grupo Não Tratado, GNT), enquanto as admitidas de 2013 a 2018 (n = 25) receberam pessário cervical rotineiramente associado a progesterona após o diagnóstico de colo curto entre a 18a e a 27ª semanas de gestação (grupo Pessário-Progesterona, GPP). O desfecho primário analisado foi a taxa de PP antes de 34 semanas. Resultados Não houve diferenças estatísticas entre o GNT e o GPP em relação ao PP < 34 semanas (respectivamente, 18,8%; versus 40,0%;; p = 0,07) e ao peso médio ao nascer do gêmeo menor (2.037 ± 425 g versus 2.195 ± 665 g; p = 0,327). A análise de Kaplan-Meyer foi realizada, e não houve diferenças entre os grupos antes de 31,5 semanas. A regressão logística demonstrou que o nascimento prematuro anterior (< 37 semanas) apresentou razão de probabilidades (odds ratio, OR) de 15,951 (intervalo de confiança de 95%; [IC95%;]: 1,294-196,557; p = 0,031*) para o nascimento prematuro < 34 semanas no GPP. Conclusão Em gêmeos DC-DA com colo uterino curto (o que significa maior risco de nascimento prematuro), o tratamento com pessário cervical associado a progesterona pode ser considerado equivalente em diversos aspectos relacionados à prematuridade no GNT, apesar da grande diferença entre os grupos.

Cervical insufficiency: a noteworthy disease with controversies.

Cervical insufficiency (CI) is a mainly disease leading to recurrent abortions and preterm birth which may present in about 1% of obstetric populations. Recurrent pregnancy losses caused by CI incur serious economic burdens on society as well as huge psychological burdens to family members. However, many patients even clinicians in some areas of the world still remain confused about this disease. At the same time, the etiology of CI is still uncertain and it is still a controversial disease in diagnosis and treatment. This article summarizes the potential risk factors associated with CI, which could be worthy of attention and helpful for future research. It also reviews the methods for diagnosis and treatment of CI to better understand this noteworthy disease, as well as presents the related consensus and controversies according to the newly updated guidelines, which has practical significance for conducting more in-depth investigations in the future.

Very short cervix in low-risk asymptomatic singleton pregnancies: Outcome according to treatment and cervical length at diagnosis.

INTRODUCTION: The aim of this study was to explore the outcome of low-risk singleton pregnancies with very short cervical length (CL ≤15 mm) according to method of treatment and CL at diagnosis. MATERIAL AND METHODS: Retrospective study on singleton pregnancies devoid of risk factors for spontaneous preterm delivery identified in the course of universal screening programs by vaginal sonography at 20-24 weeks of gestation to have very short CL ≤ 15 mm. RESULTS: The study group consisted of 233 pregnancies with CL ≤ 15 mm of which 88 had cervical cerclage inserted and the remaining 145 were treated with vaginal progesterone. Mean CL at diagnosis was significantly shorter in the cerclage group (5 mm) compared with the progesterone group (12 mm). Regardless of treatment there was no difference in the rate of spontaneous preterm delivery at <32 weeks of gestation in women with CL ≥ 9 mm at screening (11% and 12% in the cerclage and progesterone groups, respectively). In contrast, in the subgroup with CL ≤ 8 mm cervical cerclage resulted in significantly lower rates of spontaneous preterm delivery at <32 weeks of gestation compared with progesterone treatment (20% and 45%, respectively, P = .009) and the median gestational age at birth was significantly greater (37 weeks vs 36 weeks, respectively, P = .013). CONCLUSIONS: The majority of asymptomatic singleton pregnancies with short CL will remain undelivered until 32 weeks of gestation whether treated with progesterone or cerclage. Women with extreme cervical shortening appear to benefit more from cervical cerclage.

Cervical pessary vs vaginal progesterone for prevention of preterm birth in women with twin pregnancy and short cervix: economic analysis following randomized controlled trial.

OBJECTIVE: To compare the cost-effectiveness of cervical pessary vs vaginal progesterone to prevent preterm birth and neonatal morbidity in women with twin pregnancy and a short cervix. METHODS: Between 4 March 2016 and 3 June 2017, we performed this economic analysis following a randomized controlled trial (RCT), performed at My Duc Hospital, Ho Chi Minh City, Vietnam, that compared cervical pessary to vaginal progesterone in women with twin pregnancy and cervical length < 38 mm between 16 and 22 weeks of gestation. We used morbidity-free neonatal survival as a measure of effectiveness. Data on pregnancy outcome, maternal morbidity and neonatal complications were collected prospectively from medical files; additional information was obtained via telephone interviews with the patients. The incremental cost-effectiveness ratio was calculated as the incremental cost required to achieve one extra surviving morbidity-free neonate in the pessary group compared with in the progesterone group. Probabilistic and one-way sensitivity analyses were also performed. RESULTS: During the study period, we screened 1113 women with twin pregnancy, of whom 300 fulfilled the inclusion criteria of the RCT and gave informed consent to participate. These women were assigned randomly to receive cervical pessary (n = 150) or vaginal progesterone (n = 150), with two women and one woman, respectively, being lost to follow-up. The rate of morbidity-free neonatal survival was significantly higher in the pessary group compared with the progesterone group (n = 241/296 (81.4%) vs 219/298 (73.5%); relative risk, 1.11 (95% CI, 1.02-1.21), P = 0.02). The mean total cost per woman was 3146 € in the pessary group vs 3570 € in the progesterone group (absolute difference, -424 € (95% CI, -842 to -3 €), P = 0.048). The cost per morbidity-free neonate was significantly lower in the pessary group compared with that in the progesterone group (2492 vs 2639 €; absolute difference, -147 € (95% CI, -284 to 10 €), P = 0.035). CONCLUSION: In women with twin pregnancy and a short cervix, cervical pessary improves significantly the rate of morbidity-free neonatal survival while reducing costs, as compared with vaginal progesterone. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Changes in fetal membrane histology with cervical insufficiency and transabdominal cerclage.

OBJECTIVE: To determine whether term fetal membranes from transabdominal cerclage (TAC) patients have favorable characteristics compared with membranes from patients without TAC. METHODS: A prospective study of consecutive pregnant women who had undergone TAC and were delivered by elective cesarean after 37 weeks before the onset of labor at Cliniques universitaires Saint-Luc, Brussels, between January 2015 and June 2016. Membranes were collected from two areas: overlying the cervix and located far from the cervix. Membrane thickness, 15-hydroxyprostaglandin dehydrogenase (PGDH), toll-like receptor-2 (TLR2) expression, and senescence were measured and compared between the TAC group and a control group without TAC enrolled using the same study criteria. RESULTS: In the cervical area of the TAC group, the chorion was significantly thicker (P=0.003). PGDH and TLR2 expression were also significantly increased in the cervical area of the TAC group (P=0.021 and P=0.043, respectively). Senescence was significantly decreased in the TAC group (P=0.001). CONCLUSION: A significant relationship between chorion thickening and increase in PGDH and TLR2 expression and decrease in senescence was reported in the cervical area of membranes in the TAC group. These membrane changes could prevent triggering of parturition and may account for favorable outcomes and clinical success in pregnancies with TAC.

Patients with acute cervical insufficiency without intra-amniotic infection/inflammation treated with cerclage have a good prognosis.

Background The frequency of intra-amniotic infection/inflammation (IAI/I) in patients with midtrimester cervical insufficiency is up to 50%. Our purpose was to determine the perinatal outcomes of cervical cerclage in patients with acute cervical insufficiency with bulging membranes, and to compare the admission-to-delivery interval and pregnancy outcomes according to the results of amniotic fluid (AF) analysis and cerclage placement. Methods This was a retrospective cohort study including singleton pregnancies with cervical insufficiency between 15 and 26.9 weeks in two tertiary health centers. IAI/I was defined when at least one of the following criteria was present in AF: (a) a white blood cell (WBC) count >50 cells/mm3; (b) glucose concentration <14 mg/dL; and/or (c) a Gram stain positive for bacteria. Three different groups were compared: (1) absence of IAI/I with placement of a cerclage; (2) amniocentesis not performed with placement of a cerclage; and (3) IAI/I with or without a cerclage. Results Seventy patients underwent an amniocentesis to rule out IAI/I. The prevalence of IAI/I was 19%. Forty-seven patients underwent a cerclage. Patients with a cerclage had a longer median admission-to-delivery interval (33 vs. 2 days; P < 0.001) and delivered at a higher median gestational age (27.4 vs. 22.6 weeks; P = 0.001) than those without a cerclage. The neonatal survival rate in the cerclage group was 62% vs. 23% in those without a cerclage (P = 0.01). Patients without IAI/I who underwent a cerclage had a longer median admission-to-delivery interval (43 vs. 1 day; P < 0.001), delivered at a higher median gestational age (28 vs. 22.1 weeks; P = 0.001) and had a higher neonatal survival rate (67% vs. 8%; P < 0.001) than those with IAI/I. Conclusion The pregnancy outcomes of patients with midtrimester cervical insufficiency and bulging membranes are poor as they have a high prevalence of IAI/I. Therefore, a pre-operative amniocentesis is key to identify the best candidates for the subsequent placement of a cerclage.

[Induction of labor in women with previous caesarean delivery with balloon catheter: Is it worth it?] / Déclenchement par ballonnet en cas d'utérus cicatriciel et col défavorable : la tentative en vaut-elle la chandelle ?

OBJECTIF: Balloon catheters for labor induction at term after previous cesarean section is an alternative option to iterative cesarean section. The aim of this study was to analyze the maternal and neonatal outcomes of the trial of labor after cesarean (TOLAC) in women with unfavorable cervix and balloon catheter induction, 2 years after introduction of this process. METHODS: Unicentric observational study of women with term cephalic singleton, unfavorable cervix (simplified Bishop score<5) after TOLAC using double-balloon catheter. Were analyzed the mode of delivery and severe maternal (uterine rupture, post-partum hemorrhage, severe perineal tears) and neonatal (neonatal unit admission, APGAR<7 at 5minutes, pH<7.1) outcomes. Predictive factors for failed TOLAC were analyzed by using multivariate logistic regression. RESULTS: Between 2016-2017, 455 (75.4%) women had TOLAC, whose 59 (13%) women with balloon catheter. The overall vaginal delivery (VD) was 73.9%. After Balloon catheter, the VD rate was 50.8%, versus 79.1% after spontaneous labor, and 68.2% after alone oxytocin/artificial membrane rupture induction (P<0.05). Previous VD (aOR 0.176 CI-95% [0.048-0.651]) and prior sweeping membrane (aOR 0.161 CI-95% [0.034-0.761]) was protective for cesarean section after TOLAC. Severe maternal and neonatal morbidities were observed in 10 (17%) and 8 (13.6%) cases, respectively. CONCLUSION: Double-Balloon catheter is an option for unfavorable cervix and term induction after previous cesarean section. However, the TOLAC in women whose unfavorable cervix is not without maternal and neonatal risk, especially due to its failure.

Cervical Cerclage versus Vaginal Progesterone for Management of Short Cervix in Low-Risk Women.

OBJECTIVE: To evaluate the risk of preterm birth in low-risk women with cervical length (CL) ≤25 mm on transvaginal ultrasound (TVUS) managed with vaginal progesterone (VagP) therapy versus cerclage. STUDY DESIGN: This is a retrospective cohort of women with no prior history of preterm birth or cervical insufficiency and CL ≤ 25 mm on TVUS, managed with either VagP therapy alone or cerclage (with or without VagP). The primary outcome was rate of preterm delivery < 37 weeks gestational age (GA). Secondary outcomes included delivery at ≤ 32 or ≤ 28 weeks GA, premature preterm rupture of membranes, pregnancy latency, GA at delivery, and composite neonatal outcome. RESULTS: Women undergoing cerclage placement (n = 31) were older and had an earlier GA at the time of diagnosis of short cervix compared with women receiving VagP (n = 62). Delivery at < 37 weeks occurred in 21/62 (33.9%) in the VagP group and 14/31 (45.2%) in the cerclage group (adjusted odds ratio: 1.72, 95% confidence interval: 0.52, 5.66). There were no differences in secondary outcomes. CONCLUSION: Cerclage compared with VagP therapy did not decrease risk of preterm birth in women with CL ≤ 25 mm. Further research is needed to determine optimal management in such women given a residual 40% risk of preterm birth despite optimal therapy.

[Clinical outcome of therapeutic cervical cerclage in short cervix syndrome].

Objective: To investigate the clinical effect of therapeutic cervical cerclage on short cervix syndrome for anti-premature birth in the second trimester. Methods: Totally 44 singleton pregnant patients were diagnosed as short cervix syndrome, which was cervical length ≤2.5 cm without cervical dilatation, and received treatment from January 2008 and July 2015 in Peking University Third Hospital were collected. Among them, 30 patients who received therapeutic cervical cerclage were defined as cerclage group and another 14 cases who received conservative treatment were defined as un-cerclage group. The days of conservative treatment, delivery rate of different gestational weeks, birth weight of newborns, neonatal survival rate within 7 days of birth were analyzed between the two groups. Results: There were no significant differences between the two groups in days of pregnancy conservative treatment [103 (84-141) vs 105 (85-114) days], delivery weeks [38.0 (35.5-39.4) vs 38.5 (37.3-39.5) weeks], birth weight of newborns [3 120 (2 750-3 400) vs 3 130 (2 760-3 545) g], and survival rate of newborns [100% (30/30) vs 13/14]. The fetuses of both groups were all delivered after 28 weeks. There was no significant difference in accumulated delivery rate between the two groups after 32 weeks, 34 weeks, and 37 weeks, respectively (all P>0.05) . Conclusions: The treatment of cervical cerclage is not superior to conservative means in single pregnancy of cervical length ≤2.5 cm without cervical dilatation. For such patients with short cervix syndrome, the treatment of cervical cerclage may not be necessary, but dynamic monitoring and search for the causing factors and prompt treatment are more important.

The role of predictive vaginal biomarkers in women with cervical cerclage.

Cervical cerclage is currently one of the primary methods of treatment for cervical insufficiency (CI). Identifying methods in order to selectively apply cerclage may allow us to further limit unnecessary procedures. In this regard, a limited number of inflammatory and extracellular matrix biomarkers measurable non-invasively at the level of the cervix have been examined. In this review we summarize the current research on the use of cervical biomarkers in predicting cerclage failure and propose potential objectives for future research.

Adjuvant administration of 17-α-hydroxy-progesterone caproate in women with three or more second trimester pregnancy losses undergoing cervical cerclage is no more effective than cerclage alone.

OBJECTIVE: To investigate the role of adjuvant 17-α-hydroxy-progesterone caproate (17OHP-C) in reducing the risk of preterm delivery <34 weeks and adverse perinatal outcomes in women with ≥3 second trimester pregnancy losses attributed to cervical insufficiency undergoing prophylactic cerclage. MATERIAL AND METHODS: Retrospective cohort study of women with prophylactic cerclage placed between 2006 and 2014 divided into a cohort of (i) those receiving adjuvant 17OHP-C (n=43), and (ii) controls with cerclage alone (n=59). RESULTS: Demographic characteristics were comparable in both groups. There was no significant difference in gestational age at delivery between the cerclage-17OHP-C group (33.4±5.6 weeks) and the cerclage-alone group (34.4±4.6 weeks); P=0.33. We noted a non-significant increase for deliveries <34 weeks in the cerclage-17OHP-C group (44.2%) compared to controls (28.8%) which remained non-significant after adjusting for confounders; P=0.46. There was no statistically significant difference in the rate of delivery <37, 32, 28 and 24 weeks. Adverse neonatal outcomes were comparable in both groups (cerclage-17OHP-C 48.8% vs. cerclage-alone 39%); P=0.43. CONCLUSION: Intramuscular 17OHP-C in combination with prophylactic cerclage in women with cervical insufficiency and ≥3 second trimester pregnancy losses had no synergistic effect in reducing the rate of recurrent preterm birth or improving perinatal outcomes.

Outcomes following rescue cerclage in twin pregnancies.

OBJECTIVE: Our aim was to compare perinatal outcomes in twin pregnancies complicated by premature asymptomatic cervical dilatation treated with rescue cerclage and expectant management. METHODS: A retrospective cohort study was conducted at a single tertiary referral center between 2003 and 2014 and included all women with twins found to have a dilated cervix with intact membranes before 25-week gestation. Pregnancy outcomes were compared between women with rescue cerclage and those managed expectantly. A total of 36 women were eligible for the study, 27 (75.0%) of whom had a rescue cerclage compared to 9 (25.0%) women managed expectantly. Student's t-test was used to compare continuous variables between the groups and the chi-square and Fisher's exact tests were used for categorical variables as appropriate. Statistical analysis was performed with the SPSS v21.0 software (IBM Corp; Armonk, NY). Differences were considered significant when the p value was less than .05. RESULTS: Among the 27 women with a rescue cerclage, the mean gestational age at time of cerclage insertion was 21.5 ± 2.6 weeks. The intervention and control groups were similar with respect to the degree of cervical dilatation at presentation (2.6 ± 1.3 versus 3.0 ± 1.5 cm, p = .5). Women in the cerclage group gave birth at a more advanced gestation (28.9 ± 6.1 versus 24.2 ± 2.6 weeks, respectively, p = .03) and were less likely to give birth at <34 and <28 weeks (66.7 versus 100.0%, p = .046, and 59.3 versus 100.0%, p = .02, respectively). The mean latency from the placement of cerclage to delivery was 7.3 ± 5.5 weeks. Similar findings were observed when analysis was limited to women with cervical dilatation of ≤3 cm at presentation. CONCLUSIONS: In asymptomatic women with twin pregnancies and cervical dilatation before 25 weeks of gestation, rescue cerclage can prolong pregnancy and improve perinatal outcomes when compared to expectant management.

Prevention of preterm birth: Novel interventions for the cervix.

Preterm birth is the leading cause of neonatal mortality and morbidity worldwide. Spontaneous preterm birth is a complex, multifactorial condition in which cervical dysfunction plays an important role in some women. Current treatment options for cervical dysfunction include cerclage and supplemental progesterone. In addition, cervical pessary is being studied in research protocols. However, cerclage, supplemental progesterone and cervical pessary have well known limitations and there is a strong need for alternate treatment options. In this review, we discuss two novel interventions to treat cervical dysfunction: (1) injectable, silk protein-based biomaterials for cervical tissue augmentation (injectable cerclage) and (2) a patient-specific pessary. Three-dimensional computer simulation of the cervix is performed to provide a biomechanical rationale for the interventions. Further development of these novel interventions could lead to new treatment options for women with cervical dysfunction.