UNASSIGNED: We aimed to identify the incidence and risk factors of spontaneous preterm birth in pessary carriers with singleton pregnancies and a short cervix in the mid-trimester of pregnancy.
UNASSIGNED: Patient data were obtained from the PECEP Trial. We analyzed singleton pregnancies in pessary carriers with a short cervix (≤25 mm) between 18 and 22 gestational weeks. Demographics and obstetric history were compared to identify risk factors for spontaneous preterm birth < 34 gestational weeks. Each demographic and obstetric variable was compared between spontaneous preterm birth < 34 and ≥ 34 weeks of gestation.Regression analysis was used to identify risk factors. A risk score model was generated using the odds ratio for significant factors. The risk score model and spontaneous preterm birth risk were assessed using the receiver operating characteristic curve. Perinatal outcomes were compared by risk score.
UNASSIGNED: Among 190 pregnant individuals, 12 (6.3%) had spontaneous preterm birth < 34 gestational weeks. In the bivariate analysis, statistically significant differences between those with and without spontaneous preterm birth were only observed for mean cervical length at diagnosis and mean cervical length after pessary placement. By multiple logistic regression analysis, maternal age (OR 0.818; 95% CI 0.69-0.97; P 0.020), cervical length at diagnosis (OR 0.560; 95% CI 0.43-0.73; P < 0.001) and smoking status (OR 7.276; 95% CI 1.02-51.80; P 0.048) remained significantly associated with spontaneous preterm birth.The ROC curve from the multiple logistic regression analysis, including cervical length, maternal age and smoking status, had an area under the curve (AUC) of 0.952 (P < 0.001). The ROC curve for the risk score model incorporating all three variables had an AUC of 0.864 (95% CI 0.77-0.96; P < 0.001). A high-risk score was predictive of spontaneous preterm birth with a sensitivity of 75%, specificity of 84%, positive predictive value of 24%, and negative predictive value of 98%.Women with a high-risk score had a significantly reduced latency to delivery and poorer neonatal outcomes than those with a low-risk score.
UNASSIGNED: Patients at a high risk for spontaneous preterm birth despite pessary therapy may be identified using cervical length at diagnosis added to maternal age and smoking status.

Both progestogens and cerclage are individually effective in preterm birth prevention in high risk pregnancies. However, national and international guidelines cite a lack of data available to comment on the potential benefit of concurrent progestogen therapy after cerclage has been placed. Studies to date have been small with mixed results regarding benefit of concurrent progestogen with cerclage leaving uncertainty regarding best clinical practice.
This study aimed to evaluate whether cerclage with progestogen therapy was superior to cerclage alone in the prevention of spontaneous preterm birth in singleton pregnancies.
This is an international retrospective cohort study of singleton pregnancies, without major anomaly or aneuploidy, and with cerclage placed at 10 different institutions in the United States and Colombia from June 2016 to June 2020. Exclusion criteria were lack of documentation regarding whether progestogen was prescribed, unavailable delivery outcome, and pregnancy termination (spontaneous or induced) before 16 weeks\' gestation. The exposure of interest was progestogen use with cerclage placement, which included those who continued to use progestogen or who started progestogen after cerclage. The comparison group consisted of those without progestogen use after cerclage placement, which included those who had no progestogen use during the entire pregnancy or who initiated progestogen and then stopped it after cerclage placement. Progestogen type, cerclage indication, maternal baseline characteristics, and maternal/neonatal outcomes were collected. The primary outcome was spontaneous preterm birth at <37 weeks. The secondary outcomes were spontaneous preterm birth at <34 weeks, gestational age at delivery, and a composite neonatal outcome including ≥1 of the following: perinatal mortality, confirmed sepsis, grade III or IV intraventricular hemorrhage, retinopathy of prematurity, respiratory distress syndrome, and bronchopulmonary dysplasia. There were planned subgroup analyses by cerclage indication, progestogen type (vaginal progesterone vs 17-hydroxyprogesterone caproate), preterm birth history, and site. Continuous variables were compared in adjusted analyses with analysis of covariance, and categorical variables were compared with multivariable logistic regression, adjusting for potential confounders with adjusted odds ratio. A Cox regression survival curve was generated to compare latency to spontaneous delivery, censored after 37 weeks.
During the study period, a total of 699 singletons met the inclusion criteria: 561 in the progestogen with cerclage group and 138 with cerclage alone. Baseline characteristics were similar, except the higher likelihood of previous spontaneous preterm birth in the progestogen group (61% vs 41%; P<.001). Within the progestogen group, 52% were on 17-hydroxyprogesterone caproate weekly, 44% on vaginal progesterone daily, and 3% on oral progesterone daily. Progestogen with cerclage was associated with a significantly lower frequency of spontaneous preterm birth <37 weeks (31% vs 39%; adjusted odds ratio, 0.59 [0.39-0.89]; P=.01) and <34 weeks (19% vs 27%; adjusted odds ratio, 0.55 [0.35-0.87]; P=.01), increased latency to spontaneous delivery (hazard ratio for spontaneous preterm birth <37 weeks, 0.66 [0.49-0.90]; P=.009), and lower frequency of perinatal death (7% vs 16%; adjusted odds ratio, 0.37 [0.20-0.67]; P=.001). In planned subgroup analyses, association with reduced odds of preterm birth <37 weeks persisted in those on vaginal progesterone, those without a previous preterm birth, those with ultrasound- or examination-indicated cerclage, those who started progestogen therapy before cerclage, and in sites restricted to the United States.
Use of progestogen with cerclage was associated with reduced rates of spontaneous preterm birth and early spontaneous preterm birth compared with cerclage alone. Although this study was not sufficiently powered for subgroup analysis, the strength of evidence for benefit appeared greatest for those with ultrasound- or examination-indicated cerclage, and with vaginal progesterone. El resumen está disponible en Español al final del artículo.

Preterm birth represents a significant clinical challenge, and the ability to predict it effectively is a priority in obstetrics. The cervix undergoes specific changes during pregnancy, and staging these changes may offer a valuable predictive model for preterm birth, particularly among women with a midtrimester short cervical length.
The study aimed to validate a proposed staging model for asymptomatic women with midtrimester short cervical length and to evaluate its potential for predicting preterm birth. The integration of cervical examination and inspection with cervical length measurement was a novel approach to be assessed.
This was a multicenter, retrospective cohort study that included 925 pregnant women with a singleton fetus and a midtrimester cervical length measurement of ≤25 mm. Cervical conditions were assessed using ultrasonography, a speculum, and a physical examination and were classified into 1 of 5 cervical stages to correlate with the likelihood of preterm birth. Statistical analyses included Kaplan-Meier survival analysis to illustrate the time-to-event characteristics across the 5 stages and density plot evaluation to visualize the distribution of the gestational ages within the stages.
The staging model included 5 stages based on cervical length, appearance, and dilatation. Among the 925 participants, 649 were classified as being stage 1, 245 as stage 2, 18 as stage 3, 10 as stage 4, and 3 as stage 5. The observed rates of preterm birth before 37 weeks for individuals classified in stages 1, 2, 3, 4, and 5 were 22.3%, 26.5%, 44.4%, 60%, and 66.7%, respectively (P=.005). The overall observed rates of preterm birth before 28, 32, 34, and 37 weeks\' gestation were 5.5%, 9.9%, 12.2%, and 24.1%, respectively (P=.005).
This study validated the proposed staging criteria as an effective predictor of preterm birth caused by cervical insufficiency. The results demonstrate a significant increase in the preterm birth rate with advancing stage classification, indicating that the staging effectively stratified women based on their risk for preterm birth and highlighting the potential use for targeted interventions. Implementing these staging criteria can potentially improve the counseling and management of pregnant women at risk for preterm birth.

Background Preterm delivery is a significant contributor to neonatal and infant morbidity and mortality. Preventive methods are preferable to treatment protocols for reducing perinatal mortality and morbidity. The calcium channel blocker nifedipine has the potential to be employed as a tocolytic, whereas the phosphodiesterase inhibitor sildenafil citrate promotes smooth muscle relaxation. Objective This study aims to examine the tocolytic effect of nifedipine in combination with sildenafil citrate in managing preterm labour (PTL). Methods After approval from the ethical board, 160 patients fulfilling the selection criteria were enrolled in the study from the outpatient and emergency department of obstetrics and gynaecology, University of Lahore, Pakistan. After taking written informed consent, their demographic profile, i.e., name, age, gestational age at presentation, parity, and expected date of delivery was noted. Patients were randomly assigned in a 1:1 ratio to two study groups (Group A: sildenafil citrate + nifedipine) and (Group B: nifedipine) using a computer-generated random number table to obtain a trial sequence. In group A, each patient was given nifedipine 20 mg orally, followed by 10 mg orally every eight hours for 48 hours and vaginal administration of sildenafil citrate, 25 mg at eight-hour intervals, for 48 hours. In group B, females were given nifedipine 20 mg orally, followed by 10 mg orally every 8 hours for 48 hours. They were kept admitted for 72 hours. SPSS Statistics version 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) was used to enter and analyse the collected data. Mean and standard deviation was calculated for quantitative variables like age, gestational age at presentation, gestational age at delivery, and BMI. Frequency and percentage were calculated for parity and preterm delivery. Results The study involved 160 patients, with the average age in Group A being 29.60±4.9 years and in Group B being 30.96±4.98 years. In terms of gestational age at delivery, Group A had an average of 34.16±1.7 weeks, while Group B had an average of 33.5±1.8 weeks (p-value<0.05). Preterm delivery was observed in 68.5% of Group A and 41.3% of Group B, with a significant p-value of 0.001. The study also discovered that the duration of prolonged pregnancy was significantly higher in Group A compared to Group B, with averages of 14.96±10.37 days and 10.24±8.97 days, respectively (p-value=0.002). Conclusion The results of this study suggest that the combination of sildenafil citrate and nifedipine may offer a promising new approach to improving pregnancy outcomes in cases of PTL. In the present study, sildenafil citrate plus nifedipine showed a significant effect in the management of PTL and prolongation in mean gestational age at delivery.

The recent Society for Maternal-Fetal Medicine Consult Series #65 provides a comprehensive review of transabdominal cerclage. The current article condenses the Consult recommendations regarding patient selection, counseling, and management into 2 simple one-page checklists, one for the primary obstetrical provider and the other for the maternal-fetal medicine consultant or cerclage provider. Moreover, we provide sample templates for medical record notes to document preprocedure counseling and informed consent.

To evaluate patients\' acceptance of a universal transvaginal ultrasound cervical length (CL) screening program and the feasibility of initiating treatment with progesterone in a clinical setting in women found to have a short cervix.
An observational, pragmatic cohort study was conducted at one tertiary care facility from 2012-2015, involving eligible women with singleton pregnancies who accepted and underwent second-trimester CL screening. The primary outcomes were the percentage of women who were eligible and accepting of screening, compliance with progesterone treatment, and the screening value of TVCL in predicting SPTB. Secondary outcomes were the number of women who received progesterone treatment and the rates of SPTB.
Overall cervical length screening acceptance rate was found to be 82.5%. Of the 797 women that underwent screening, 21 women (2.6%) had a TVCL < 25 mm, of whom nine had a TVCL < 20.0 mm. Nineteen of the 21 women with a TVCL < 25 mm were treated with progesterone, with a 94.7% compliance rate. Delivery outcomes were obtained for 767 women. Of those with a TVCL < 25 mm, there was a 35% rate of SPTB as opposed to a 6.3% SPTB rate in those with TVCL > 25 mm. The negative predictive value for SPTB with a TVCL 25 mm or greater was 94.0%.
Universal cervical length screening was successfully implemented in 82.5% of the patient population with a high compliance rate with progesterone treatment. Furthermore, there was a higher rate of SPTB in those with a shorter cervix. Based on our outcomes obtained in an observational and pragmatic manner, we showed that incorporating second trimester transvaginal cervical length screening into routine clinical practice is readily accepted and, with the addition of vaginal progesterone treatment, may reduce the rate of prematurity.

BACKGROUND: Cervical pessary placement as an intervention for preterm birth prevention in women with a short cervix is a simple, painless procedure with few complications and a reasonable cost. Its efficacy depends on the expertise of the obstetrician performing the procedure. Therefore, it is reasonable to assume that untrained obstetricians with no expertise in pessary placement are more likely to insert the pessary incorrectly, thereby reducing its efficacy. Nevertheless, the impact of pessary placement expertise and training, as well as the accuracy of cervival length measurements, has never been evaluated.
OBJECTIVE: To evaluate the impact of providing training for pessary placement to obstetricians with no expertise in this intervention. To this end, the percentage of correct pessary placements and accuracy of cervical length measurements after pessary placement achieved by obstetricians who received such training was compared with the results achieved by obstetricians who did not receive any training.
METHODS: This prospective, double-blind, randomized clinical trial included 91 pregnant women requiring a cervical pessary due to a short cervix. Patients were assigned at random to a group treated by untrained obstetricians with no expertise in pessary placement (untrained group, n = 45) or to a group treated by trained obstetricians with no expertise in pessary placement (trained group, n = 46). The primary outcomes were the quality of pessary placement and the accuracy of cervical length measurements after pessary placement.
RESULTS: Obstetricians in the trained group achieved a significantly higher percentage of correct pessary placements than obstetricians in the untrained group (97.8 % and 65.2 %, respectively; p < 0.001). No significant differences were observed between groups in terms of the accuracy of cervical length measurements after pessary placement (p = 0.661), and both groups showed moderate to good agreement with the expert\'s measurements (intraclass correlation coefficient 0.840 and 0.749, respectively). No differences in pregnancy outcomes were observed between groups.
CONCLUSIONS: This study showed that providing training in pessary placement to obstetricians with no expertise in this procedure increases the quality of pessary placement. Furthermore, the inconsistent results found in pessary studies may be explained, in part, by a lack of training in pessary placement.

Randomized trials have found benefits of both vaginal progesterone and 17-alpha-hydroxyprogesterone caproate in the prevention of recurrent preterm birth. A previous meta-analysis directly comparing the two was limited by low-quality evidence, and national and international society guidelines remain conflicting regarding progestin formulation recommended for prevention of recurrent preterm birth. The aim of this updated systematic review with meta-analysis was to evaluate the efficacy of vaginal progesterone compared with 17-alpha-hydroxyprogesterone caproate in the prevention of spontaneous preterm birth in patients with singleton gestations and previous spontaneous preterm birth.
Searches were performed in MEDLINE, Ovid, Scopus, ClinicalTrials.gov, the International Prospective Register of Systematic Reviews (PROSPERO), SciELO, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) with the use of a combination of keywords and text words related to \"preterm birth,\" \"preterm delivery,\" \"singleton,\" \"cervical length,\" \"progesterone,\" \"progestogens,\" \"vaginal,\" \"17-alpha-hydroxy-progesterone caproate,\" and \"intramuscular\" from inception of each database to September 2021. No restrictions for language or geographic location were applied.
We included all randomized controlled trials of asymptomatic singleton gestations with previous spontaneous preterm birth that were randomized to prophylactic treatment with either vaginal progesterone (ie, intervention group) or intramuscular 17-alpha-hydroxyprogesterone caproate (ie, comparison group). Post hoc sensitivity analysis was performed for studies with low risk of bias and studies with protocol registration.
The primary outcome was preterm birth <34 weeks\' gestation. The summary measures were reported as relative risks with 95% confidence intervals.
Seven randomized controlled trials including 1910 patients were included in the meta-analysis. Patients who received vaginal progesterone had a significantly lower rate of preterm birth at <34 weeks (14.7% vs 19.9%; relative risk, 0.74; 95% confidence interval, 0.57-0.96), preterm birth at <37 weeks (36.0% vs 46.6%; relative risk, 0.76; 95% confidence interval, 0.69-0.85), and preterm birth at <32 weeks of gestation (7.9% vs 13.6%; relative risk, 0.58; 95% confidence interval, 0.39-0.86), compared with women who received intramuscular 17-alpha-hydroxyprogesterone caproate. There were no significant differences in the rate of preterm birth at <28 weeks\' gestation. Adverse drug reactions were significantly lower in the vaginal progesterone group than in the 17-alpha-hydroxyprogesterone caproate group (15.6% vs 22.2%; relative risk, 0.71; 95% confidence interval, 0.54-0.92). Perinatal mortality was lower in the vaginal progesterone group than in the 17-alpha-hydroxyprogesterone caproate group (2.2% vs 4.4%; relative risk, 0.51; 95% confidence interval, 0.25-1.01). In sensitivity analysis including trials rated with at least 4 Cochrane tools as of \"low risk of bias,\" 4 trials were included (N=575), and there was no longer a significant difference in preterm birth at <34 weeks\' gestation between vaginal progesterone and 17-alpha-hydroxyprogesterone caproate (12.2% vs 13.9%; relative risk, 0.87; 95% confidence interval, 0.57-1.32).
Overall, vaginal progesterone was superior to 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth at <34 weeks\' gestation in singleton pregnancies with previous spontaneous preterm birth. Although sensitivity analysis of high-fidelity studies showed the same trend, findings were no longer statistically significant.

Universal transvaginal cervical length screening has been associated with a reduction in the frequency of preterm birth. However, there is no clinically set standard to guide the performance of a digital cervical examination in the setting of a sonographically short cervix.
To investigate the prevalence of cervical dilation at various midtrimester transvaginal cervical length thresholds. Furthermore, we sought to identify sonographic or clinical characteristics associated with cervical dilation that may inform who would benefit from a digital cervical examination in the setting of a sonographically short cervix.
This retrospective cohort study was conducted at an academic institution and included women with a singleton gestation and an ultrasonographically detected short cervix (defined as a transvaginally obtained cervical length ≤25 mm) who had a documented digital cervical examination within 1 week of the ultrasonography. Bivariable analyses were used to determine the relationship between cervical length and the presence of cervical dilation. Multivariable logistic regression and receiver operating characteristic curve were used to evaluate the relationship between clinical and sonographic risk factors and cervical dilation.
Of the 256 women who met eligibility criteria and had a sonographically detected short cervix, 103 (40.2%) were found to be dilated on digital cervical examination. The prevalence of cervical dilation increased as sonographic cervical length decreased; cervical dilation was identified in 15%, 39%, 53%, 64%, and 69% of women with a cervical length between 20.0 and 25.0 mm, 15.0 and 19.9 mm, 10.0 and 14.9 mm, 5.0 and 9.9 mm, and 0.0 and 4.9 mm, respectively. Maternal race or ethnicity (examined as a social construct), insurance status, nulliparity, previous cervical excisional procedure, funneling on ultrasonography, and sonographic cervical length were each associated with cervical dilation. However, including all of these variables into a regression yielded a model with only moderate predictive ability to identify cervical dilation, with receiver operating area under the curve of 0.77 (95% confidence interval, 0.71-0.83).
Consideration should be given to performing a digital cervical examination in the setting of a sonographically short cervix (especially <20 mm) to detect cervical dilation.

Preterm birth is a significant clinical and public health issue in the United States. Rates of preterm birth have remained unchanged, and racial disparities persist. Although a causal pathway has not yet been defined, it is likely that a multitude of clinical and social risk factors contribute to a pregnant person\'s risk. State-based public health and provider programmatic partnerships have the potential to improve care during pregnancy and reduce complications, such as preterm birth. In North Carolina, a state-based Medicaid-managed Pregnancy Medical Home Program screens pregnant individuals for psychosocial and medical risk factors and utilizes community-based care management, to offer support to those at highest risk.
This study aimed to examine the association between care-management and birth outcomes (low birthweight and preterm birth rates) among high-risk non-Hispanic White and Black pregnant people enrolled in the North Carolina Pregnancy Medical Home.
This was a quasi-experimental study of people in the Medicaid-managed North Carolina Pregnancy Medical Home who had singleton pregnancies and who enrolled in the program between January 2016 and December 2017. Black and White pregnant people were included in the analysis if they had singleton pregnancies, were enrolled in the Pregnancy Medical Home, and for whom there were data regarding care management involvement. Preterm birth and low birthweight were chosen as the outcomes of interest. Two different methodologies were used to test the effect of care management on outcomes: Method 1 evaluated the effect of intensive care management (≥5 face-to-face visits from a care manager) and Method 2 evaluated the effect of the implementation of a specific risk-stratification system. Chi-squared and multivariate logistic regressions were performed as appropriate.
From January 1, 2016 to December 31, 2017, a total of 3564 singleton pregnancies occurred among non-Hispanic Black and White pregnant Medicaid beneficiaries, who were a part of the Pregnancy Medical Home in North Carolina. White pregnant people comprised 57% and Black pregnant people comprised 43% of the sample. In the Method 1 analysis, intensive care management was significantly associated with reductions in preterm birth and low birthweight among Black and White pregnant people whereas in the Method 2 analysis, the implementation of a risk-stratification score only resulted in a significant reduction among Black pregnant people. In multivariable logistic modeling, race, number of prenatal visits, and intensive care management were all significantly associated with the outcomes of interest.
Care management is associated with reductions in preterm birth and low birthweight in the Medicaid-managed Pregnancy Medical Home in North Carolina. This study contributes to a growing body of literature on the role of state-based initiatives in reducing perinatal morbidity. These results are significant as it demonstrates the importance of care coordination and management, in identifying and providing resources for high-risk pregnant people. In the United States, where pregnancy-related outcomes are poor, programs that address the multitude of economic, social, and clinical complexities are becoming increasingly crucial and necessary.