Short Cervix Research Articles

Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial]

ObjectiveCervical insufficiency accounts for 8 % of preterm births. Pessary and cerclage are considered preventive approaches for preterm birth. These interventions were compared in terms of reducing the prematurity rate in women with previous preterm birth, due to cervical insufficiency or due to having a short cervix in their current pregnancy. MethodsThis was a prospective, multicentric, open-label, randomised, pilot, controlled trial. Participants were women with singleton pregnancies who had previous preterm birth caused by cervical insufficiency or previous preterm birth and a short cervix [≤ 25 mm] in their current pregnancy. Women were randomised [1:1] to either cerclage or pessary. The primary outcome was to assess the feasibility of a trial on cervical pessary vs. cerclage to prevent preterm birth before 34 weeks in women with cervical insufficiency. As a secondary outcome, we studied the morbidity rate of the pessary versus the cerclage in women with cervical insufficiency and assessed the financial impact of using both devices in these women. The sample size was calculated based on the estimated population that we could potentially recruit: 60 women, 30 for each group, to ascertain whether the rate of preterm birth < 34 weeks of gestation may be reduced from 34 % to at least 27 % in the pessary group, as in the results obtained with the cerclage. ResultsNo significant differences in preterm birth < 34 weeks of gestation were observed in our study, although it was underpowered to detect these differences [the relative risk [RR] of PB < 34 weeks of gestation was 0.8 [95 % CI: 0.31–2.09, p = 0.888]. The rates of obstetric and perinatal complications were similar for both devices [15 cases in both groups, 50 % of cases [RR; 0.6–1.68; p = 1]. Cervical pessary had fewer secondary effects than the cerclage [less bleeding at insertion in the pessary group compared with cerclage, 1 case vs 14 cases, p < 0.001; less pain at removal in the pessary group compared with cerclage, 14 vs 22 cases. p = 0.042 and less bleeding, 2 cases vs. 10 cases, p = 0.027]. ConclusionsPessary does not seem less effective than cerclage, although these findings need to be confirmed in a larger randomised controlled trial. Pessary had fewer secondary effects than cerclage both at insertion and removal. SinopsisCervical pessary does not seem to be less effective than cerclage. Cervical pessary had fewer secondary effects than cerclage.

Rate of preterm delivery and latency period in asymptomatic patients undergoing cerclage for very short cervix ≤10.0 mm

AimTo estimate the rate of preterm delivery (PTD) and mean latency period to delivery in asymptomatic women with no history of preterm delivery and cervical length (CL) ≤10.0 mm undergoing or not cerclage and who were not treated with vaginal progesterone. MethodsRetrospective analysis of asymptomatic patients with singleton pregnancies and no history of preterm delivery, with an incidental finding of a CL ≤10.0 mm measured with transvaginal ultrasound during the mid-trimester scan, 56 of them (63.6%) underwent cerclage placement and 32 (36.4%) did not, none of them received vaginal progesterone. Those with evidence of advanced dilation, prolapsing, membranes, ruptured membranes, or positive signs of infection were not candidates for cerclage placement were excluded from the analysis. Differences in the prevalence of preterm birth, mean gestational age at delivery, and mean latency from very short cervix identification to delivery between the two groups were calculated. Associations between cerclage and preterm delivery adjusted for maternal characteristics and fetal weight, were estimated. ResultsMedian (range) gestational age at time of CL measurement in the cerclage group was (weeks/days) 20w6d (17w5d–23w3d) vs. 21w5d (17w6d–23w6d) in the no-cerclage group (p=0.02). No differences in CL were observed between those who had a cerclage (5.9 mm (SD 3.1 mm)) vs. those who did not (6.5 mm (SD 3.2 mm); p=0.4). The prevalence of preterm delivery (PTD) in women with cerclage vs. women without cerclage was: PTD <37 weeks 31/56 (55.3%) vs. 28/32 (87.5%); adjusted (a) OR 0.17 (95% CI; 0.05-0.62 p=0.008); PTD ≤34 weeks 27/56 (48.2%) vs. 24/32 (75.0%); aOR 0.16 (95% CI 0.05-0.55; p=0.02); PTD ≤28 weeks 19/56 (33.9%) vs. 22/32 (68.7%); aOR 0.15 (95% CI 0.05-0.51; p=0.002). The mean (range) gestational age at delivery was 32w6d (19w1d–40w1d) for the cerclage group, and 28w1d (20w1d–40w2d) for the no-cerclage group (p =0.001). The median (range) latency from the time of CL measurement to delivery in the cerclage group was 84 (8-144) vs. 43 (1-146) days in the no-cerclage group (p=0.003). ConclusionAmong low-risk asymptomatic women with a very short cervix (≤10.0 mm) in the midtrimester scan, those treated with cerclage have increased latency to delivery and lower prevalence of preterm birth as compared to expectant management.

Prediction model for spontaneous preterm birth less than 32 weeks of gestation in low-risk women with mid-trimester short cervical length: a retrospective cohort study

BackgroundA short cervix in mid-trimester pregnancy is a risk factor for spontaneous preterm birth. However, there is currently a lack of predictive models and classification systems for predicting spontaneous preterm birth in these patients, especially those without additional risk factors for spontaneous preterm birth.MethodsA retrospective observational cohort study of low-risk singleton pregnant women with a short cervix (≤ 25 mm) measured by transvaginal ultrasonography between 22 and 24 weeks was conducted. A multivariate logistic regression model for spontaneous preterm birth < 32 weeks in low-risk pregnant women with a short cervix was constructed. Moreover, we developed a nomogram to visualize the prediction model and stratified patients into three risk groups (low-, intermediate-, and high-risk groups) based on the total score obtained from the nomogram model.ResultsBetween 2020 and 2022, 213 low-risk women with a short cervix in mid-trimester pregnancy were enrolled in the study. Univariate logistic analysis revealed that a high body mass index, a history of three or more miscarriages, multiparity, a short cervical length, leukocytosis, and an elevated C-reactive protein level were associated with spontaneous preterm birth < 32 weeks, but multivariate analysis revealed that multiparity (OR, 3.31; 95% CI, 1.13–9.68), leukocytosis (OR, 3.96; 95% CI, 1.24–12.61) and a short cervical length (OR, 0.88; 95% CI, 0.82–0.94) were independent predictors of sPTB < 32 weeks. The model incorporating these three predictors displayed good discrimination and calibration, and the area under the ROC curve of this model was as high as 0.815 (95% CI, 0.700-0.931). Patients were stratified into low- (195 patients), intermediate- (14 patients) and high-risk (4 patients) groups according to the model, corresponding to patients with scores ≤ 120, 121–146, and > 146, respectively. The predicted probabilities of spontaneous preterm birth < 32 weeks for these groups were 6.38, 40.62, and 71.88%, respectively.ConclusionsA noninvasive and efficient model to predict the occurrence of spontaneous preterm birth < 32 weeks in low-risk singleton pregnant women with a short cervix and a classification system were constructed in this study and can provide insight into the optimal management strategy for patients with different risk stratifications according to the score chart.

Cervical pessary versus vaginal progesterone in individuals with a singleton pregnancy and a short cervix: a randomized controlled trial

For asymptomatic individuals with a singleton pregnancy and a short cervix, vaginal progesterone significantly decreases the risk of PTB and improves perinatal outcomes. Cervical pessary is another option that has been evaluated with inconclusive results. There is; however, a lack of head-to-head comparisons between pessary and vaginal progesterone in this high risk population. This randomized controlled trial (RCT) aims to compare the effectiveness of pessary and vaginal progesterone for the prevention of PTB in individuals with a singleton pregnancy and a CL ≤25 mm. We conducted an open-label, multi-center, RCT (NCT04300322) at three hospitals in Vietnam. Asymptomatic individuals with a singleton pregnancy and a CL ≤25mm (at 16 to 22 weeks) were randomized (1:1 ratio) to receive either an Arabin® cervical pessary or 200-mg vaginal progesterone daily. Primary outcome was PTB <37 weeks of any cause. Secondary outcomes were maternal and neonatal complications. We planned to recruit 804 women to assess a 10% absolute risk reduction in PTB <37 weeks (alpha-error 0.05, power 80%, 5% lost to follow-up). In view of the potential harm of pessary on perinatal mortality and PTB <28 weeks reported recently in two recent trials, our study was halted on June 2023. Analysis was by intention-to-treat. Between May 2020 and May 2023, we randomized 301 participants to pessary (N=150) or vaginal progesterone (N=151). Seven participants withdrew consent and 13 were lost to follow-up, resulting in 281 participants available for analysis (pessary group N=139; vaginal progesterone group N=142). The primary outcome, any PTB <37 weeks rate, occurred in 15.1% in the pessary group versus 14.1% in the vaginal progesterone group (RR 1.07; 95% CI, 0.61 to 1.9). PTB <28 weeks and perinatal death rates were higher in the pessary group, although these differences did not reach statistical significance (7.9% versus 4.2%, RR 1.87; 95% CI, 0.71 to 4.9 and 4.3% versus 2.8%, RR 1.5; 95% CI, 0.34 to 9.2; respectively). Vaginal discharge was significantly more frequent in the pessary group. In this prematurely halted RCT involving individuals with a singleton pregnancy and a CL ≤25 mm, neither cervical pessary nor vaginal progesterone was found to be superior in the prevention of PTB <37 weeks. However, vaginal progesterone was associated with non-significantly lower rates of PTB <34, <28 weeks and perinatal death.

Transabdominal-transvaginal ultrasound cervical length sequential screening to predict the risk of spontaneous preterm birth in singleton pregnancy women with low risk of preterm birth

Objective: To investigate the feasibility of predicting the risk of spontaneous preterm birth in singleton pregnancy women with low risk of preterm birth by transabdominal-transvaginal ultrasound cervical length sequential screening in the second trimester. Methods: This prospective longitudinal cohort study included singleton pregnant women at 11-13+6 gestational weeks who were admitted to Nanjing Drum Tower Hospital from January 2023 to September 2023. Transabdominal and transvaginal cervical lengths were measured during the mid-trimester fetal ultrasound scan at 18-24 weeks, and pregnancy outcomes were obtained after delivery. A short cervix was defined as a transvaginal cervical length of ≤25 mm, and the outcomes were defined as spontaneous preterm birth occurs between 20 and 36+6 weeks and extremely preterm birth before 32 weeks. The area under the receiver operating characteristic (ROC) curve was used to evaluate the effectiveness of predicting spontaneous preterm birth by transabdominal and transvaginal cervix length, as well as the effectiveness of predicting short cervix by transabdominal cervical length. The relationship between transabdominal and transvaginal cervical length was evaluated using a scatter plot. Results: A total of 562 cases were included in this study, comprising 33 cases of spontaneous preterm birth (7 cases occurring before 32 weeks) and 529 cases of term birth. (1) Compared to the term birth group, transabdominal cervical length (median: 37.6 vs 33.2 mm; Z=-3.838, P<0.001) and transvaginal cervical length (median: 34.0 vs 29.9 mm, Z=-3.030, P=0.002) in the spontaneous preterm birth group were significantly shorter. (2) The areas under the ROC curve for predicting spontaneous preterm birth by transabdominal and transvaginal cervical length were 0.699 (95%CI: 0.588-0.809) and 0.657 (95%CI: 0.540-0.774), respectively. The sensitivity, specificity and positive predictive value of transvaginal cervical length Conclusions: In singleton pregnancy women with low risk of preterm birth, transabdominal-transvaginal cervical length sequential screening can reduce unnecessary transvaginal ultrasounds by approximately 41% without missing the diagnosis of pregnant women with a short cervix. This method also enhances the effectiveness of transvaginal cervical length to spontaneous preterm birth.

Unravelling the genetic landscape of cervical insufficiency: Insights into connective tissue dysfunction and hormonal pathways

Background The intricate molecular pathways and genetic factors that underlie the pathophysiology of cervical insufficiency (CI) remain largely unknown and understudied. Methods We sequenced exomes from 114 patients in Latvia and Lithuania, diagnosed with a short cervix, CI, or a history of CI in previous pregnancies. To probe the well-known link between CI and connective tissue dysfunction, we introduced a connective tissue dysfunction assessment questionnaire, incorporating Beighton and Brighton scores. The phenotypic data obtained from the questionnaire was correlated with the number of rare damaging variants identified in genes associated with connective tissue disorders (in silico NGS panel). SKAT, SKAT-O, and burden tests were performed to identify genes associated with CI without a priori hypotheses. Pathway enrichment analysis was conducted using both targeted and genome-wide approaches. Results No patient could be assigned monogenic connective tissue disorder neither genetically, neither clinically upon clinical geneticist evaluation. Expanding our exploration to a genome-wide perspective, pathway enrichment analysis replicated the significance of extracellular matrix-related pathways as important contributors to CI’s development. A genome-wide burden analysis unveiled a statistically significant prevalence of rare damaging variants in genes and pathways associated with steroids (p-adj = 5.37E-06). Rare damaging variants, absent in controls (internal database, n = 588), in the progesterone receptor (PGR) (six patients) and glucocorticoid receptor (NR3C1) (two patients) genes were identified within key functional domains, potentially disrupting the receptors’ affinity for DNA or ligands. Conclusion Cervical insufficiency in non-syndromic patients is not attributed to a single connective tissue gene variant in a Mendelian fashion but rather to the cumulative effect of multiple inherited gene variants highlighting the significance of the connective tissue pathway in the multifactorial nature of CI. PGR or NR3C1 variants may contribute to the pathophysiology of CI and/or preterm birth through the impaired progesterone action pathways, opening new perspectives for targeted interventions and enhanced clinical management strategies of this condition.

A Review of the Literature: Amniotic Fluid "Sludge"-Clinical Significance and Perinatal Outcomes.

Introduction: This paper seeks to report and emphasize the most important aspects from the scientific literature about the diagnostic accuracy of the amniotic fluid "sludge" (AFS), its characterization, its treatment, and its association with premature birth. AFS is defined as a floating freely hyperechogenic material within the amniotic cavity in the proximity of the internal os. Materials and Methods: We conducted a search on Pubmed and Google Scholar for relevant articles on the subject of amniotic fluid "sludge" published until January 2024. Searches were focused on articles about diagnosis, treatment, maternal and neonatal outcomes, risk of preterm birth, and case reports. The full-text reading stage resulted in the inclusion of 51 studies. Results: AFS is independently associated with chorioamnionitis, preterm delivery, short cervix, increased risk of neonatal morbidity, and cervical insufficiency. This hyperechogenic free-floating material is linked with preterm birth before 32 weeks of gestation, especially when it is associated with short cervical length. Discussion: Present studies identify some controversial benefits of antibiotics in reducing the incidence of preterm birth in women with AFS. Nevertheless, in this review, we can conclude that the presence of AFS in pregnancy is a marker for the microbial invasion of the amniotic cavity, as it is associated with preterm birth. Further studies on a larger group of patients are necessary to clarify and exactly define the terms of managing these cases.

The impact of cut-off values on the prevalence of short cervical length in pregnancy

BackgroundA prior study suggested that implementing a cut-off value of ≤30 mm for a short cervical length (CL) could potentially introduce selection bias and alter the distribution of CL measurements. As such, the objective of this study is to evaluate how CL distribution and incidence of short CL are affected when using different cut-off values for a short CL. Study designThis is a secondary analysis of the Quadruple P (QP) Screening study; a prospective cohort study that included low-risk patients with singleton pregnancies undergoing fetal anomaly scan at 18–22 weeks of gestation, including a CL measurement. Patients with a short cervix, defined as ≤35 mm, were subsequently counseled for the QP trial; a randomized controlled trial (RCT) comparing progesterone to cervical pessary for the prevention of preterm birth. If participation to the RCT was refused, patients with a CL ≤25 mm were advised to use progestogen. The primary objective of this current study was to assess the normal distribution of CL across the entire cohort and to assess the incidence of short CL when using the cut-off values of ≤35 and ≤25 mm. Normal distributions for CL were simulated based on mean and standard deviation(SD) of the original data. The Kolmogorov-Smirnov test was used to evaluate the distribution of the CL measurements. Moreover, to evaluate the motives behind ultrasound measurements around the cut-off value, sonographers were asked to fill out a qualitative questionnaire. ResultsThe total cohort included 19.171 eligible participants who underwent CL measurement, with a mean CL of 43.9 mm (±8.1 SD). The distribution of all CL observed measurements deviated significantly from the normal distribution (p < 0.001). A total of 1.852 (9.7%) patients had short CL ≤35 mm, which was significantly lower than expected when compared to the simulated normal distribution (n = 2.661, 13.9%; p < 0.001). The incidence of short CL ≤25 mm in our cohort statistically differed from the simulated normal distribution (238, 1.2% vs 177, 0.9%; p=0.003). When comparing our data to the simulated normal distribution, the difference in distributions is most pronounced when examining the difference between 35 and 36 mm. Results of the questionnaire reveal sonographers claimed not to be influenced by a cut-off value for study participation or progesterone treatment. ConclusionThis study demonstrates that using any cut-off value for a short CL influences the incidence and distribution of CL. When using a cut-off value of ≤35 mm for study inclusion, the incidence of measurements of a short CL is lower than the anticipated incidence compared to a normal distribution. However, when using a cut-off value of ≤25 mm for progesterone treatment, the frequency of CL measurements is higher than expected below this threshold compared to a normal distribution. This study highlights the risk of introducing selection bias, most likely unintentionally, when cut-off values for short CL are used, regardless of the specific value chosen. Therefore healthcare providers should measure the CL with caution if essential decisions depend on a specific cut-off value.

Cervical Pessary Versus Vaginal Progesterone in Women With a Singleton Pregnancy, a Short Cervix, and No History of Spontaneous Preterm Birth at Less Than 34 Weeks’ Gestation: Open Label, Multicentre, Randomized, Controlled Trial

Cervical Pessary Versus Vaginal Progesterone in Women With a Singleton Pregnancy, a Short Cervix, and No History of Spontaneous Preterm Birth at Less Than 34 Weeks’ Gestation: Open Label, Multicentre, Randomized, Controlled Trial

Predictive value of short cervix in early third trimester for preterm birth in women with normal mid-trimester cervical length

BackgroundShort cervical length in the mid-trimester is a powerful predictor of preterm birth (PTB). However, clinical significance of cervical length in the third trimester for predicting PTB has not been established yet. ObjectiveTo examine the predictive role of a shortened cervix in the third trimester for PTB in women who had a normal cervical length in the second trimester Study designThis retrospective cohort study included women who underwent cervical length measured at least once in both the second trimester (16+0 weeks to 27+6weeks) and the early third trimester (28+0 weeks to 33+6 weeks). Women with short cervical length in the second trimester, those with multiple pregnancies, those who underwent cerclage operation, and those who had iatrogenic PTB were excluded. The study population was divided into two groups based on cervical length in the third trimester: a short cervix (≤25 mm) group and a control group (>25 mm). Rates of PTB (<37 weeks) were compared between two groups. Predictive performances of cervical length in the third trimester for PTB were assessed. ResultsWomen with a short cervical length at 28+0 to 33+6 weeks accounted for 12.6% (n=717) of the total study population (n=5682). PTB rate was 9.5% in the short cervix group, which was significantly higher than that (3.2%) in the control group (P<.001). The adjusted odds ratio for short cervical length on PTB was 2.73 (95% CI: 1.96–3.79). A short cervix in the third trimester had a sensitivity of 30.1%, a specificity of 88.1%, a positive predictive value of 9.5%, and a negative predictive value (NPV) of 96.8% in predicting PTB. The addition of third-trimester cervical length to the predictive model significantly increased the area under the curve from 0.64 (95% CI: 0.60–0.68) to 0.67 (95% CI: 0.63–0.71) (P=.002), demonstrating improved predictive performance. ConclusionApproximately 13% of women with normal cervical length in the mid-trimester had a short cervical length after 28 weeks, which increased the risk of PTB. The high specificity and NPV of third-trimester cervical length measurements underscore their critical utility in identifying women at low risk for preterm delivery.

Cervical sliding sign; does it have a contribution in cases of threatened preterm labor in singleton pregnancies with intact membranes?

ObjectiveTo investigate the contribution of the cervical sliding sign to conventional cervical length measurement in patients at risk of preterm labor. MethodsThe study, performed as a prospective cohort study, included patients admitted to a tertiary research hospital with a diagnosis of threatened preterm labor. The participants were divided into two groups: those who gave birth before and after 37 weeks of gestation. The clinical and demographic characteristics, cervical length, presence of a short cervix (SC), and cervical sliding sign (CSS) were compared between the groups. Furthermore, correlation and regression analyses were conducted to investigate the relationship between the presence of a SC, the presence of CSS, and the coexistence of these two findings with preterm delivery, as well as the interval between the symptoms and delivery being less than four weeks. ResultsThe study included 77 patients who delivered prematurely and 65 patients who delivered at term. The following variables were significantly lower in the preterm delivery group: cervical length, gestational age at delivery, neonatal weight, and time between the first examination and delivery (p = 0.003, <0.001, <0.001 and < 0.001, respectively). A higher percentage of women in the preterm delivery group exhibited a diagnosis of a SC, the presence of CSS, and the coexistence of both conditions (p = 0.002, 0.012 and 0.018, respectively). The results of the logistic regression analysis indicated that the odds ratios for preterm delivery were 3.3 in the presence of a SC alone, 2.67 in the presence of CSS alone, and 2.85 in the association of both findings (p = 0.003, 0.013 and 0.021 respectively). The odds ratios for delivery in less than four weeks were 3.08 in the presence of a SC alone, 3.4 in the presence of CSS alone, and 3.54 in the association of both findings (p = 0.004, 0.002 and 0.005 respectively). ConclusionIn singleton pregnant women presenting with threatened preterm labor, the presence of CSS is associated with an increased risk of preterm delivery and a decreased presentation-to-delivery interval. However, its contribution to conventional cervical length measurement appears to be relatively limited.

Introduction of universal transvaginal cervical length measurement does not decrease spontaneous preterm delivery rate compared to universal transabdominal screening with reflex cut‐off: A pre‐post study

AbstractObjectivesThe objective of our study is to examine cervical length measurements, identification of short cervix, vaginal progesterone use, and rate of spontaneous preterm delivery before and after departmental transition to a universal transvaginal ultrasound screening protocol from a universal transabdominal screening protocol.MethodsThis is a retrospective observational pre–post study examining the year prior to and year following a transition to a universal transvaginal ultrasound screening protocol to assess cervical length at the time of the anatomy survey. Prior to this transition, universal transabdominal cervical length screening was performed, with reflex transvaginal ultrasound measurement if transabdominal measurement was &lt;35 mm or was unable to be obtained.ResultsA total of 1760 charts were reviewed; 962 charts were from the pre‐transition/transabdominal year and 798 charts were from the post‐transition/transvaginal year. In the post‐transition/transvaginal year, cervical length less than 20 mm was identified in 1.5% of cases, compared to 0.7% of cases in the pre‐transition/transabdominal year (p = 0.114). There was no difference in the rate of spontaneous preterm delivery between the two groups (5.1% in the pre‐transition/transabdominal year vs. 6.9% in the post‐transition/transvaginal year; p = 0.111).ConclusionsIn this pre‐post study, introduction of a universal transvaginal cervical length screening did not decrease spontaneous preterm delivery rates or detection of short cervix &lt;20 mm, compared to a protocol of universal transabdominal cervical length screening with reflex to transvaginal for measurement &lt;35 mm.

Comparing cervical cerclage, pessary and vaginal progesterone for prevention of preterm birth in women with a short cervix (SuPPoRT): A multicentre randomised controlled trial.

Cervical cerclage, cervical pessary, and vaginal progesterone have each been shown to reduce preterm birth (PTB) in high-risk women, but to our knowledge, there has been no randomised comparison of the 3 interventions. The SuPPoRT "Stitch, Pessary, or Progesterone Randomised Trial" was designed to compare the rate of PTB <37 weeks between each intervention in women who develop a short cervix in pregnancy. SuPPoRT was a multicentre, open label 3-arm randomised controlled trial designed to demonstrate equivalence (equivalence margin 20%) conducted from 1 July 2015 to 1 July 2021 in 19 obstetric units in the United Kingdom. Asymptomatic women with singleton pregnancies with transvaginal ultrasound cervical lengths measuring <25 mm between 14+0 and 23+6 weeks' gestation were eligible for randomisation (1:1:1) to receive either vaginal cervical cerclage (n = 128), cervical pessary (n = 126), or vaginal progesterone (n = 132). Minimisation variables were gestation at recruitment, body mass index (BMI), and risk factor for PTB. The primary outcome was PTB <37 weeks' gestation. Secondary outcomes included PTB <34 weeks', <30 weeks', and adverse perinatal outcome. Analysis was by intention to treat. A total of 386 pregnant women between 14+0 and 23+6 weeks' gestation with a cervical length <25 mm were randomised to one of the 3 interventions. Of these women, 67% were of white ethnicity, 18% black ethnicity, and 7.5% Asian ethnicity. Mean BMI was 25.6. Over 85% of women had prior risk factors for PTB; 39.1% had experienced a spontaneous PTB or midtrimester loss (>14 weeks gestation); and 45.8% had prior cervical surgery. Data from 381 women were available for outcome analysis. Using binary regression, randomised therapies (cerclage versus pessary versus vaginal progesterone) were found to have similar effects on the primary outcome PTB <37 weeks (39/127 versus 38/122 versus 32/132, p = 0.4, cerclage versus pessary risk difference (RD) -0.7% [-12.1 to 10.7], cerclage versus progesterone RD 6.2% [-5.0 to 17.0], and progesterone versus pessary RD -6.9% [-17.9 to 4.1]). Similarly, no difference was seen for PTB <34 and 30 weeks, nor adverse perinatal outcome. There were some differences in the mild side effect profile between interventions (vaginal discharge and bleeding) and women randomised to progesterone reported more severe abdominal pain. A small proportion of women did not receive the intervention as per protocol; however, per-protocol and as-treated analyses showed similar results. The main study limitation was that the trial was underpowered for neonatal outcomes and was stopped early due to the COVID-19 pandemic. In this study, we found that for women who develop a short cervix, cerclage, pessary, and vaginal progesterone were equally efficacious at preventing PTB, as judged with a 20% equivalence margin. Commencing with any of the therapies would be reasonable clinical management. These results can be used as a counselling tool for clinicians when managing women with a short cervix. EU Clinical Trials register. EudraCT Number: 2015-000456-15, clinicaltrialsregister.eu., ISRCTN Registry: ISRCTN13364447, isrctn.com.

Comparison of Short Cervical Lengths in Singleton and Twin Pregnancies

Introduction: Multifetal gestations are six times more likely to give birth preterm and 13 times more likely to give birth before 32 weeks gestation than women with singleton gestation (Martin et al, 2014-2018). Abnormal cervical shortening measured with transvaginal ultrasonography has been associated with an increased risk of preterm birth (Iams et al, 1996). In singleton pregnancies, midtrimester cervical length of less than 2.5 cm measured between 16-24 weeks has been associated with an increased risk of preterm birth in a variety of screened populations (Crane, JM., Hutchens, D., 2008). In twin pregnancies, a shortened cervix in the second trimester is more common than in singleton pregnancies and can be a predictor of early preterm birth (Yang et al, 2000). Current guidelines from ACOG, state that the data is insufficient to recommend for or against routine endovaginal ultrasound screening of cervical length in twin pregnancy. Our aim was to determine if twin gestations have shorter cervical lengths than singletons at the time of midtrimester anatomy scan, and to investigate the correlation of cervical length with the likelihood of spontaneous preterm birth. Methods: Retrospective chart review between January 2016-January 2022 identified patients with cervical shortening (&lt;2.5 cm) at the time of mid-trimester anatomical ultrasound exam. Exams were performed at the Maternal Fetal Medicine Department at Promedica Toledo Hospital between 16 and 24 weeks’ gestation. Cervical lengths and delivery data were collected and analyzed. Results: 122 patients met inclusion criteria, with 95(78%) singleton pregnancies, and 27(22%) twin gestations. Singleton gestations had an average short cervical length of 1.8 ± 0.6cm, whereas twin gestations had an average short cervical length of 1.29 ± 0.55cm (p&lt;0.0001). Twin gestations were more likely than singleton gestations to have a very short cervical length &lt;1.5cm (OR=6.75, 95% CI 2.59-17.58, p =0.0001). Average gestational age of delivery for singleton gestations identified with a short cervix was 35w6d ± 4w4d, whereas the average age at delivery for twin gestations was 31w6d ± 5w6d (p=0.0002). Discussion: Our results are consistent with previous reports that cervical shortening is more common in twin pregnancies than singleton pregnancies. Our results suggest that twins are more likely to have a very short cervical length identified in between 16-24 weeks. In addition, twin gestations with abnormal cervical shortening deliver at earlier gestational ages in comparison to singleton gestations with abnormal cervical shortening. Obtaining transvaginal cervical lengths at 16-24 weeks gestation allows for earlier identification of shortened cervical length. Ongoing research may identify interventions which are consistently effective in preterm birth prevention in twin gestation.

Diabetes Mellitus as a Risk Factor for Spontaneous Preterm Birth in Women with a Short Cervix after Ultrasound-Indicated Cerclage.

Background: Preterm birth (PTB) is a significant challenge in contemporary obstetrics, affecting over one in ten infants worldwide and accounting for 75% of perinatal mortality. Short cervical length during mid-trimester is well known to be associated with an increased risk of spontaneous preterm birth (sPTB). Ultrasound-indicated cerclage (UIC) is recommended to prevent sPTB in women with a short cervix at mid-trimester and a history of sPTB. Objectives: This retrospective observational study aimed to examine the impact of diabetes and obesity on the occurrence of sPTB in women who underwent UIC due to mid-trimester cervical shortening. Methods/Results: The analysis revealed that cervical length at the time of operation, preoperative erythrocyte sedimentation rate levels, and diabetes were independent risk factors for sPTB. Additionally, the presence of diabetes, particularly when combined with obesity, significantly elevated the risk of sPTB. Women with pregestational diabetes or those requiring insulin treatment had a higher propensity for preterm delivery compared to those with gestational diabetes managed through diet control alone. Conclusions: These findings emphasize the importance of considering maternal metabolic factors, such as diabetes and obesity, in women with a short cervix when planning for UIC and highlight the crucial role of optimizing maternal glucose control and weight management in reducing the risk of sPTB.

Prophylactic progesterone and preterm birth

This review summarises the present knowledge of prophylactic progesterone and preterm birth. Preterm birth (&lt; 37 weeks) is a leading cause of neonatal mortality and morbidity worldwide. The incidence varies globally but remains low in the Nordic countries (5-6%). Prediction and prevention are complicated due to diverse aetiology, but obstetric history and cervical length can improve prediction. Prophylactic vaginal progesterone initiated between 12 and 24 weeks of gestation is recommended to reduce preterm birth &lt; 33-35 weeks in singleton pregnancies with a history of preterm birth or with a short cervix (&lt; 25 mm) and can be considered for twin pregnancies with the same risk factors.

Asymptomatic short cervix and threatened preterm labor: A comparative study on perinatal outcomes

ObjectiveTo determine the rate of delivery within 15 days of admission among patients with an asymptomatic short cervix (ASC) compared to those admitted for threatened preterm labor (TPL). Material and methodsThis retrospective study conducted in a tertiary maternity hospital, included patients with a singleton pregnancy admitted with a cervical length of less than 25 mm between 24 and 34 weeks. The population was divided into two groups, patients with ASC (i.e., with no contractions at admission) and patients with TPL. The primary outcome was the delivery rate within 15 days of admission. Secondary outcomes included gestational age at delivery, preterm delivery rate before 37°/7 weeks and before 34°/7 weeks, admission to delivery interval, 5 min Apgar score and transfer to neonatal intensive care unit rate. The characteristics of the two groups and the primary and secondary outcomes were compared between the two groups using univariate analysis. Two subgroup analysis were performed, one restricted to patients with a mildly modified CL (15 ≤ CL < 25 mm), and one excluding patients at high risk of preterm birth. ResultsAmong the 247 included patients, 136 (55.1 %) had TPL, and 111 (44.9 %) ASC. There were no significant differences in the rate of patient who delivered within 15 days of admission between the groups, 13.2 % in the TPL group vs 8.0 % in the ASC group (p = 0.22). Patients in the TPL group had a significantly higher frequency of delivery before 34 weeks compared to those in the ASC group (19.9 % versus 9.0 %, p = 0.02 This finding persisted in the subgroup analysis excluding patients at high risk of preterm birth (16.5 % in the TPL subgroup vs. 6.9 % in the ASC subgroup, p = 0.04). There were no significant differences in the rates of preterm delivery before 37 weeks, the admission-to-delivery interval, or neonatal outcomes between the two groups or within the subgroup analyses. ConclusionThe frequency of delivery within 15 days of admission was not statistically different between patients with an asymptomatic short cervix and those with TPL. Nevertheless, these asymptomatic patients delivered significantly later and less frequently before 34 weeks, with only one in ten requiring corticosteroids.

SMFM Consult Series #70: Management of short cervix in individuals without a history of spontaneous preterm birth

The majority of deliveries before 34 weeks of gestation occur in individuals with no prior history of preterm birth. Mid-trimester cervical length assessment by transvaginal ultrasound is one of the best clinical predictors of spontaneous preterm birth. This Consult provides guidance for the diagnosis and management of short cervix in an individual without a history of preterm birth. The following are Society for Maternal-Fetal Medicine recommendations: (1) we recommend that all cervical length measurements used to guide therapeutic recommendations be performed using a transvaginal approach and in accordance with standardized procedures as described by organizations such as the Perinatal Quality Foundation or the Fetal Medicine Foundation (GRADE 1C); (2) we recommend using a midtrimester cervical length of ≤ 25 mm to diagnose short cervix in individuals with a singleton gestation and no prior history of spontaneous preterm birth (GRADE 1C); (3) we recommend that asymptomatic individuals with a singleton gestation and a transvaginal cervical length of ≤ 20 mm diagnosed prior to 24 weeks of gestation be prescribed vaginal progesterone to reduce the risk of preterm birth (GRADE 1A); (4) we recommend that treatment with vaginal progesterone be considered at a cervical length of 21 to 25 mm based on shared decision-making (GRADE 1B); (5) we recommend that 17-OHPC, including compounded formulations, not be prescribed for the treatment of a short cervix (GRADE 1B); (6) in individuals without a history of preterm birth who have a sonographic short cervix (10-25 mm), we recommend against cerclage placement in the absence of cervical dilation (GRADE 1B); (7) we recommend that cervical pessary not be placed for the prevention of preterm birth in individuals with a singleton gestation and a short cervix (GRADE 1B); (8) we recommend against routine use of progesterone, pessary, or cerclage for treatment of cervical shortening in twin gestations outside the context of a clinical trial (GRADE 1B).

Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies

IntroductionTwin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently...

The Association Between Maternal Body Mass Index and Spontaneous Preterm Birth Among Patients Prescribed Vaginal Progesterone for Short Cervix [ID 2683530

INTRODUCTION: Vaginal progesterone decreases the risk of spontaneous preterm birth (sPTB) and adverse neonatal outcomes in patients with short cervix (cervical length [CL] &lt;2.5 cm) between 16 and 24 weeks. Few studies have assessed the efficacy of this intervention in patients with obesity. We evaluate the association between maternal body mass index (BMI) and sPTB among patients prescribed vaginal progesterone for short cervix. METHODS: This was an IRB-approved retrospective cohort study of patients prescribed vaginal progesterone for short cervix at Mount Sinai Hospital. Exclusion criteria included prior PTB, cerclage, or progesterone treatment in prior pregnancy, and multifetal gestation. Logistic regression models assessed the association between BMI categories (BMI less than 25, BMI 25.0–29.9, BMI 30 or higher) and PTB less than 37 weeks, PTB less than 34 weeks, and neonatal intensive care unit (NICU) admission adjusting for nulliparity, CL at diagnosis, and insurance status. RESULTS: Of the 210 patients included, 86 had BMI of less than 25 (41%), 72 had BMI of 25.0–25.9 (34.4%), and 52 had BMI of 30 or higher (24.8%), and 79 experienced sPTB (37.6%). Although BMI was not associated with sPTB less than 37 weeks, the odds of sPTB at less than 34 weeks among individuals with BMI of 30 or higher was 3.03 times the odds for those with BMI of less than 25 (95% CI, 1.13–8.14). The odds of NICU admission among those with BMI of 30 or higher is 2.82 times the odds among those with BMI of less than 25 (95% CI, 1.23, 6.46). CONCLUSION: This study demonstrates obesity is associated with sPTB at less than 34 weeks and NICU admission among those prescribed vaginal progesterone for short cervix. Larger studies are needed to evaluate the effect of BMI on efficacy of vaginal progesterone.