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Background: 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., Objective: 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., Methods: 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., Results: 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., Conclusion: 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., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: 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.Objective: 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.Study Design: 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.Results: 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.Conclusion: 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. [ABSTRACT FROM AUTHOR]

Preterm birth is a major public-health problem in the USA, which has higher rates of preterm birth than most other developed countries. Attempts at the prevention of preterm birth have been largely unsuccesful. The recent publication of a large, multicenter, randomized trial of 17α-hydroxyprogesterone caproate, which showed efficacy in preventing recurrent preterm delivery, has sparked renewed interest in progestational drugs in general and this compound in particular for use in preventing preterm delivery. Although this drug is not currently commercially available, an application has been made to the US FDA to produce 17α-hydroxyprogesterone caproate, as Gestiva™ for the prevention of preterm delivery. [ABSTRACT FROM AUTHOR]

Background: Racial/ethnic disparities in preterm birth remain a major public health challenge in the United States. While 17-alpha hydroxyprogesterone caproate (17OHP-C) is recommended for preterm birth prevention in women with a prior preterm birth, non-Hispanic black women continue to experience higher rates of recurrent preterm birth than white women receiving the same treatment. Further investigation of disparities in 17OHP-C use and adherence is warranted.Objective: We sought to evaluate whether racial and ethnic disparities exist in the use of and adherence to 17OHP-C within a population of eligible women.Study Design: This was a retrospective cohort study of women with a prior spontaneous, singleton preterm birth who were eligible for 17OHP-C for preterm birth prevention and received care at a single institution from 2010 through 2014. Associations between self-identified race/ethnicity (non-Hispanic black vs women in all other racial/ethnic groups) and documented counseling about 17OHP-C, receipt of any 17OHP-C, and adherence to 17OHP-C administration were each estimated by bivariable analysis and multivariable logistic regression. Adherence to 17OHP-C was defined as not >1 missed dose, initiation <20 weeks' gestational age, and continuation until 37 weeks or delivery.Results: Of 472 women who were clinically eligible for 17OHP-C, 72% (N = 296) had documented 17OHP-C counseling and 48.9% (N = 229) received 17OHP-C. There were no differences in likelihood of 17OHP-C counseling or receipt of 17OHP-C based on race/ethnicity. While overall 83% (N = 176) of women were adherent to 17OHP-C, only 70% (N = 58) of non-Hispanic black women were adherent, compared to 91% (N = 118) of all other women (P < .001). Non-Hispanic black women had more missed doses (2.4 vs 0.4 doses, P < .001) and later initiation of care (12.0 vs 10.2 weeks, P < .001) than women in other racial/ethnic groups. After adjustment for potential confounders, non-Hispanic black women were significantly less likely to be adherent to 17OHP-C (adjusted odds ratio, 0.16; 95% confidence interval, 0.04-0.65). A significant interaction between non-Hispanic black race/ethnicity and public insurance was identified (adjusted odds ratio, 0.16; 95% confidence interval, 0.05-0.52).Conclusion: In a diverse cohort of women eligible for preterm birth prevention, non-Hispanic black women are at an increased risk of nonadherence to 17OHP-C. Non-Hispanic black women with public insurance are at a particularly increased risk of nonadherence. [ABSTRACT FROM AUTHOR]