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Background: Fetal Growth Restriction (FGR), often due to placental insufficiency, poses significant risks to perinatal outcomes. This review evaluates the efficacy of pentaerythritol tetranitrate (PETN), a nitric oxide donor, in preventing FGR. Methods: A systematic review and meta-analysis was conducted by searching PubMed, Embase, and CENTRAL up to July 2024. The inclusion criteria focused on randomized controlled trials comparing PETN to placebo in FGR prevention. Key outcomes were incidences of FGR, perinatal mortality, neonatal mortality, and intrauterine fetal demise (IUFD). Other outcomes were classified as maternal, fetal, neonatal and safety outcomes. We used Cochrane RoB 2.0 tool to assess risk of bias, and GRADE criteria for evidence quality. Results: Two eligible studies encompassing 417 pregnant women at risk of FGR were included. PETN did not significantly reduce incidence of FGR (RR 0.83, 95 % CI 0.66–1.04, 2 trials, 417 participants, low certainty) or perinatal mortality (RR 0.64, 95 % CI 0.26–1.58, 2 trials, 417 participants, very low certainty) compared to placebo. None of the studies reported neonatal mortality or IUFD. However, PETN treatment was associated with a reduction in preterm birth (RR 0.74, 95 % CI 0.58–0.93, 2 trials, 417 participants, moderate certainty). Other outcomes were similar between the groups. Conclusion: While PETN does not significantly impact FGR rates or perinatal mortality, it is associated with a reduction in preterm birth, suggesting potential benefits in high-risk pregnancies. Larger trials are necessary to substantiate these findings and clarify the role of PETN in FGR prevention.

ABSTRACT: Introduction: 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. Material and Methods: 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

Purpose: 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. Methods: 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. Results: 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%. Conclusion: 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of vaginal progesterone in preventing preterm birth in women with a singleton gestation and short cervical length and to determine which of the two formulations, micronized progesterone vaginal capsule versus vaginal gel containing micronized progesterone, is more effective for preventing preterm birth. Data sources: A systematic search was performed in the following databases: EMBASE, PubMed (MEDLINE), The Cochrane Library, and the Clinical Trials Registry (clinicaltrials.gov). Study eligibility criteria: Randomized controlled trials (RCTs), prospective and retrospective observational studies were included. We searched for progesterone administration to prevent preterm birth in asymptomatic women with a shortened cervix (<25 mm) measured by ultrasound in the second trimester of singleton pregnancy. Study appraisal and synthesis methods: Assessments of the risk of bias of RCTs were performed by applying the Cochrane Collaboration's Risk of Bias Tool; nonrandomized control trials were evaluated with the Newcastle-Ottawa Scale (NOS). The primary outcome was preterm birth =33 weeks of gestation. Pooled relative risks (RR) and 95% CI's were calculated for dichotomous outcomes. Heterogeneity of treatment effect was assessed with the I2 statistic. We pooled results of the primary outcome for individual studies using a random-effect model. We then performed a network meta-analysis to pool indirect comparisons between the two formulations (gel vs capsule). This analysis was performed using the network meta-analysis package within the R environment. Results: Five studies met the inclusion criteria (4 RCTs, one cohort study) including 1,048 women. The meta-analysis demonstrated that vaginal micronized progesterone significantly reduces preterm birth risk, Risk Ratio = 0.63; 95% CI, 0.48-0.82; p = 0.0006; with no heterogeneity between the studies: I2 = 0%. In the network meta-analysis, no significant difference was demonstrated (OR = 0.85; 95% CI, 0.43-1.69) between the effect of the two formulations of vaginal micronized progesterone (vaginal gel versus vaginal capsules) on the risk of PTB. Conclusion: Vaginal progesterone is associated with a decreased risk of premature birth in women with a shortened cervix in the second trimester of pregnancy. No differences were found between vaginal micronized progesterone in gel or capsule formulations. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of vaginal progesterone in preventing preterm birth in women with a singleton gestation and short cervical length and to determine which of the two formulations, micronized progesterone vaginal capsule versus vaginal gel containing micronized progesterone, is more effective for preventing preterm birth.Data sources: A systematic search was performed in the following databases: EMBASE, PubMed (MEDLINE), The Cochrane Library, and the Clinical Trials Registry (clinicaltrials.gov).Study eligibility criteria: Randomized controlled trials (RCTs), prospective and retrospective observational studies were included. We searched for progesterone administration to prevent preterm birth in asymptomatic women with a shortened cervix (

OBJECTIVE: To evaluate whether cervical pessary effectively reduces the preterm birth < 37 weeks rate in patients who have not delivered after an episode of arrested preterm labor. PATIENTS AND METHODS: Retrospective cohort study was conducted on singleton pregnant patients admitted to our institution between January 2016 and June 2021 for threatened preterm labor and who had a cervical length < 25 mm. Women in whom a cervical pessary was placed were considered as exposed, while women in whom expectant management was preferred were considered as unexposed. The primary outcome was the rate of preterm birth before 37 weeks. A targeted maximum likelihood estimation was used to estimate the average treatment effect of cervical pessary by adjusting for a-priori-defined confounders. RESULTS: A cervical pessary was placed in 152 (36.6%) patients (exposed), while the remaining 263 (63.4%) were managed expectantly (unexposed). The adjusted average treatment effect was -14% (-18 to -11%), -17% (-20 to -13%), and -16% (-20 to -12%) for preterm birth < 37 weeks, < 34 weeks, and < 32 weeks, respectively. The average treatment effect for adverse neonatal outcomes was -7% (-8 to -5%). No difference in gestational weeks at delivery between exposed and unexposed emerged when gestational age at first admission was > 30.1 gestational weeks. CONCLUSIONS: The positioning of a cervical pessary placement may be evaluated to reduce the risk of a subsequent preterm birth after an episode of arrested preterm labor in pregnant patients with onset of symptoms before 30 gestational weeks. [ABSTRACT FROM AUTHOR]

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.Conclusion: 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. [ABSTRACT FROM AUTHOR]

Objective: To identify healthcare managers’ perspectives on the barriers to implementing cervical length screening to prevent preterm births. Methods: In Phase I, 10 healthcare managers were interviewed. Phase II comprised questionnaire development and data validation. In Phase III, the questionnaire was administered to 40 participants, and responses were analyzed. Results: Their average related work experience was (21.0±7.2) years; 39 (97.5%) respondents also had healthcare management responsibilities at their respective hospitals. Most hospitals were reported to have enough obstetricians (31 cases, 77.5%) and to be able to accurately perform cervical length measurements (22 cases, 55.0%). However, no funding was allocated to universal cervical length screening (39 cases, 97.5%). Most respondents believed that implementing universal screening, as per Ministry of Public Health policies, would prevent preterm births (28 cases, 70.0%). Moreover, they suggested that hospital fees for cervical length measurements should be waived (34 cases, 85.0%). Three main perceived barriers to universal screening at tertiary hospitals were identified. They were heavy obstetrician workloads (20 cases, 50.0%); inadequate numbers of medical personnel (24 cases, 60.0%); not believing that the screening test could prevent preterm birth (8 cases, 20%) and lack of free drug support for preterm birth prevention in high-risk cases (29 cases, 72.5%). Conclusions: The main obstacles to universal cervical length screening are heavy staff workloads and inadequate government funding for ultrasound scanning and hormone therapy. The healthcare managers do not believe that the universal cervical length screening can help to reduce preterm birth.

Cervical cerclage is a surgical intervention aimed at preventing previable birth by providing mechanical support to the cervix through the placement of a suture. This procedure is primarily indicated for cases of cervical incompetence, where the cervix is prone to premature dilation and can lead to early miscarriage or preterm birth. This review seeks to comprehensively analyze rescue cervical cerclage (RCC), focusing on its indications, techniques, and outcomes. The goal is to offer an in-depth understanding of its effectiveness in preventing previable birth and to guide clinical decision-making in managing pregnancies at risk of premature delivery. A thorough literature review examined recent studies and clinical data on RCC. Key aspects evaluated include the criteria for intervention, various surgical techniques employed, and the associated maternal and fetal outcomes. Comparative analysis was also performed with other preventive measures, such as progesterone therapy and bed rest. RCC has demonstrated efficacy in reducing the incidence of previable births, particularly when performed in cases of identified cervical incompetence or shortening. The review highlights variations in the technique, such as McDonald and Shirodkar cerclage, and discusses their relative success rates and potential complications. The procedure is associated with improved pregnancy outcomes and reduced risk of previable birth, though it carries some risks, including infection and cervical laceration. RCC remains a valuable intervention for preventing previable births in selected patients. This review underscores its importance in managing pregnancies at risk due to cervical incompetence and provides a detailed evaluation of its indications, techniques, and outcomes. Future research should optimize criteria for cerclage placement and explore novel strategies to enhance its effectiveness and safety., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Ughade et al.)

Aim: The aim of this study is to compare pregnancy and neonatal results with regards to the thickness of the suture material used in the transvaginal cerclage operation. Materials and Methods: Patients who were subject to transvaginal cervical cerclage due to cervical insufficiency were evaluated in a secondary care center between 2103 and 2021 retrospectively. The demographic data, cerclage indications (ultrasound induced, prophylactic, or physical examination induced), number of pregnancy weeks at cerclage, type of cerclage suture (prolene, mersilene), type of cerclage (McDonald, Shirodkar), total pregnancy weeks, delivery method (cesarean (C/S), normal spontaneous vaginal delivery) of each patient were recorded. Additionally, birth weight, 1st and 5th minute APGAR scores, and neonatal intensive care unit (NICU) requirements were recorded as neonatal parameters. Patients were divided into two groups with regard to the type of cerclage suture (mersilene or prolene) and maternal, neonatal and pregnancy results were compared between these groups. Results: The study included 151 patients in total. Prolene sutures were used for 69 of the patients (45.7%) and mersilene sutures for 82 patients (54.3%) Cerclage was applied for 18 patients (11.9%) depending on the ultrasound findings, 121 patients (80.1%) depending on emergency and 12 patients (7.9%) depending on history. Gravida increased significantly in the prolene suture group (p=0.021). Pregnancy week was found to be significantly lower in the mersilene suture group [32.5 w (15-40)] compared to the prolene suture group [37.0 w (15-41)] [37.0 w (15-41)](p<0.001). Ratios of birthing below 34 weeks and 37 weeks for the mersilene suture group were found as 57.3% and 80.5%, and for the prolene suture group 11.6% and 40.6% respectively, and a statistically significant difference was observed (p<0.001). Fetal weight, 1st and 5th minute APGAR scores in the mersilene suture group were significantly lower (p<0.05). Ratios of newborn intensive care requirements and preterm premature rupture of membranes (PPROM) in the mersilene suture group were found to be significantly higher compared to the prolene suture group (p=0.016, p<0.001 respectively). Conclusion: Although mersilene suture is more preferred, its supply is not always possible in emergency situations. Therefore, the prolene suture should be kept in mind as an even stronger cerclage suture option. [ABSTRACT FROM AUTHOR]

BACKGROUND: Preterm birth complicates almost all triplet pregnancies and no preventive strategy has proven effective. OBJECTIVE: To determine, using individual patient data (IPD) meta-analysis, whether the outcome of triplet pregnancy is affected by prophylactic administration of 17-hydroxyprogesterone caproate (17OHPc). SEARCH STRATEGY: We searched literature databases, trial registries and references in published articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) of progestogens versus control that included women with triplet pregnancies. DATA COLLECTION AND ANALYSIS: Investigators from identified RCTs collaborated on the protocol and contributed their IPD. The primary outcome was a composite measure of adverse perinatal outcome. The secondary outcome was the rate of birth before 32 weeks of gestation. Other pre-specified outcomes included randomisation-to-delivery interval and rates of birth at

According to the official statistics, in Perm region a number of preterm births (PB) has declined by 1.5% over the last 10 years; however, PB is still a leading cause for neonatal mortality. Despite a lot of already performed research and studies that are being performed at the moment, there is still no clear understanding what etiological factors cause PB. The paper contains a literature review of research that focused on PB risk factors. Certain factors are generally recognized and included into «Preterm birth» clinical report (2013), but literature data analysis allowed revealing additional PB risk factors. Cervical incompetence (CI) is a generally recognized PB risk factor. In 2018 clinical recommendations were published; they contained a list of CI risk factors and some of them coincided with PB risk factors (bad habits, extreme anthropometric parameters, peculiarities in obstetric and gynecologic case history, certain extra-genital diseases, multiple pregnancy, application of assisted reproductive technologies, complicated pregnancy); some others are considered to cause only CI (application of anti-tumor hormonal preparations, CI in family case history, abnormal development and disorders in the structure of female genital organs, surgeries on ovaries in case history). We performed comparative analysis of PB and CI risk factors and it helped us substantiate a necessity to create a unified list of PB risk factors as it would allow optimizing not only procedures applied to rank female patients but also accomplishing relevant PB prevention.

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.)

Purpose: To identify patient perspectives of barriers to cervical length screening to prevent preterm births. Methods: In Phase I of this prospective descriptive implementation study, 40 pregnant women of up to 24 week gestation were interviewed. Phase II comprised questionnaire development and data validation. The questionnaire was subsequently administered to 400 participants in Phase III. Results: Most participants (74.3%) realised preterm babies have complications and high care costs (53%). They recognised that premature-birth risk identification enables appropriate pregnancy care (93.8%), but they were unaware that cervical length measurements indicate the risk (59.5%). The participants who were aware wanted to be examined (63.5%) because of concern about preterm birth (95.8%). Husbands were reported to influence decision-making about screening (81.3%) and subsequent treatment (42.5%). If the associated costs were subsidised, the majority of participants (67.3%) would undergo screening. Conclusion: Physicians do not explain ways to prevent preterm births. Government policy on preventing preterm births is not well established. Screening and treatment costs are major barriers. Trial registration: Thai Clinical Trials Registry (TCTR) number: TCTR20190813003 [ABSTRACT FROM AUTHOR]

Background: Progesterone is widely used in prenatal care. However, long‐term effects of prenatal progesterone treatment on child development are unclear. Objectives: To evaluate long‐term outcomes in children after prenatal progesterone treatment. Search strategy: MEDLINE, Embase and Cochrane Central Register of Controlled Trials from inception to 24 May 2020. Selection criteria: Randomised controlled trials (RCTs) reporting outcomes in children born to women who received progesterone treatment (compared with placebo or another intervention) during any trimester in pregnancy. Data collection and analysis: Two authors independently selected and extracted data. We used the Cochrane Risk of Bias tool for randomised trials and Quality In Prognosis Studies. Main results: Of 388 papers, we included seven articles based on five RCTs, comprising 4222 measurements of children aged 6 months to 8 years. All studies compared progesterone to placebo in second and/or third trimester for the prevention of preterm birth. Meta‐analysis (two studies, n = 890 children) showed no difference in neurodevelopment as assessed by the Bayley‐III Cognitive Composite score at 2 years between children exposed to progesterone versus placebo (Standardised Mean Difference −0.04, 95% Confidence Interval −0.26 to 0.19), I2 = 22%. Heterogeneity prohibited additional meta‐analyses. Other long‐term outcomes showed no differences. Conclusions: Our systematic review comprising a multitude of developmental measurements with a broad age range did not find evidence of benefit or harm in offspring prenatally exposed to progesterone treatment for the prevention of preterm birth. We identified an urgent need for follow‐up studies of prenatal progesterone administration in early pregnancy and effects in offspring beyond early childhood. Progesterone to prevent preterm birth: no effect on child development. Outcomes after first trimester progesterone are unclear. Progesterone to prevent preterm birth: no effect on child development. Outcomes after first trimester progesterone are unclear. [ABSTRACT FROM AUTHOR]

Background: Premature birth is responsible for approximately 38% of infant deaths as well as a host of complications, including abnormal lung development, infection, and long-term disabilities. For women with a history of spontaneous preterm birth in a singleton pregnancy, use of 17 alpha-hydroxyprogesterone caproate (17-OHP) can reduce the risk of a recurrent preterm birth by up to 42%. However, less than half of eligible women currently receive 17-OHP.Objectives: The purpose of this study was to understand the barriers to access and acceptability of 17-OHP use from the patient perspective.Study design: A qualitative study was conducted of women with a history of a prior spontaneous, singleton preterm birth who were eligible for 17-OHP during a subsequent singleton pregnancy. Researchers recruited 118 eligible women during the Spring and Summer of 2018 from a safety-net hospital in Denver, CO, USA, a hospital that provides healthcare for individuals regardless of their insurance status or ability to pay. Responses from 35 participants were analyzed, looking at themes surrounding knowledge of and counseling received regarding 17-OHP, hesitations, and barriers toward receiving the treatment.Results: Among respondents (34.0% response rate), the mean age was 31.5 years and mean gestational age at delivery was 32.1 weeks. Major themes from interviews included reasons that encouraged women to use 17-OHP, such as the desire to do anything for the health of their baby and reasons that women felt discouraged from using 17-OHP, including unknown complications and lack of information. Other barriers to this treatment method included the time commitment, specifically the length of clinic appointments and concerns about the safety of the 17-OHP injection.Conclusions: One of the strongest reasons for women choosing to use 17-OHP was a desire to do anything possible to support their babies. Somewhat surprisingly, there was not a significant relationship with the participants between gestational age of prior preterm deliveries and subsequent use of 17-OHP. There were two important reasons women cited most frequently for choosing not to use 17-OHP. One was feeling that they lacked information or knowledge about 17-OHP to make an informed decision, which is crucial because the study also showed that all eligible women are not being appropriately counseled on the option of 17-OHP. In terms of time commitment, it was the length of individual appointments, rather than frequency that was a barrier to receiving weekly injections. [ABSTRACT FROM AUTHOR]

Preterm birth prevention is multifaceted and produces many nuanced questions. This review addresses six important clinical questions about preterm birth prevention as voted for by members of the UK Preterm Clinical Network. The questions cover the following areas: preterm birth prevention in 'low‐risk' populations; screening for asymptomatic genital tract infection in women at high risk of preterm birth; cervical length screening with cerclage or vaginal pessary in situ; cervical shortening whilst using progesterone; use of vaginal progesterone in combination with cervical cerclage; and optimal advice about intercourse for women at high risk of preterm birth. What stumps preterm birth experts? Evidence summary and expert opinion on the top six clinical controversies as voted by members of the UK Preterm Clinical Network. This article includes Author Insights, a video abstract available at https://vimeo.com/rcog/authorinsights16544. [ABSTRACT FROM AUTHOR]

Background: 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., Objective: 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., Study Design: 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., Results: 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)., Conclusion: 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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: 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., Material and Methods: 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., Results: 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., Conclusions: 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., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (© 2024 Published by Elsevier B.V.)

The objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, placebo-controlled, randomized clinical trial (RCT) designed to assess the safety and efficacy of Makena (hydroxyprogesterone caproate injection, 250 mg/mL) in reducing the risk of preterm birth (PTB) and neonatal morbidity/mortality in women pregnant with a singleton gestation who had a previous singleton spontaneous PTB. The total sample size of the RCT will include 1,707 women. The trial has two coprimary outcomes: PTB less than 35 weeks and a composite neonatal morbidity and mortality index. This study sample size will provide 90% power to assess for a 35% reduction in neonatal morbidity and mortality. Secondary outcomes will include 2-year follow-up of infants. The trial is ongoing and targeted to complete recruitment in 2018. [ABSTRACT FROM AUTHOR]

Objective This article aims to evaluate whether midtrimester cervical length (CL) is associated with improved prediction of preterm delivery in women presenting with preterm labor. Study Design This is a retrospective cohort study of women with a singleton gestation who underwent routine CL screening between 18 and 24 weeks of gestation between 2010 and 2014 who were later evaluated for preterm labor. Women were stratified by midtrimester CL quartile. Bivariable and multivariable analyses were performed to identify factors independently associated with preterm birth <37 weeks, <34 weeks, and delivery within 7 days of evaluation. Receiver operating characteristic (ROC) curves were created for multivariable equations with and without CL quartile to determine whether addition of CL improved the predictive capacity of the model for predicting preterm birth. Results A total of 460 women were evaluated for preterm labor and had midtrimester CL measurements available. When CL quartile was incorporated into a regression model including demographic and clinical characteristics associated with preterm birth, the area under the ROC curve was not improved (0.775 vs. 0.786, p = 0.20). Conclusion While a shorter midtrimester CL quartile is associated with an increased incidence of preterm delivery in women evaluated for preterm labor, the addition of this variable to an existing model does not improve prediction of preterm birth. [ABSTRACT FROM AUTHOR]

Background: Although there is a call for patient-centred prenatal care, women's preferences for and concerns about preterm birth (PTB) prevention have not been well-studied. Therefore, we conducted a cross-sectional survey to determine women's preferences for PTB prevention and their likelihood of following their healthcare provider's recommendations for PTB prevention, as well as factors associated with these responses.Methods: A piloted self-administered questionnaire was completed by pregnant women who could read English. Data were collected about their preferences for and concerns about PTB prevention, and the likelihood of following their healthcare provider's recommendations, using multivariable logistic regression to control for other factors.Results: Three hundred and eleven women at a median of 32-weeks of gestation completed the survey, a response rate of 85.2%. Most women reported that if they were told they were at increased risk for PTB, they preferred not to use PTB prevention (65.8%), of whom almost all (93.4%) reported they preferred close-monitoring and 6.6% preferred neither monitoring nor prevention. A much smaller proportion of women reported that they would not follow their healthcare provider's recommendation for progesterone (10.9%) compared to pessary (28.7%) or cerclage (50.2%). Women who were neither married nor in a common-law relationship were more likely to report that they would not follow recommendations for progesterone (aOR = 5.88 [95% CI: 1.72, 20.00]). Most women (84.5%) reported they would use other sources of information other than their main healthcare provider to learn more about PTB prevention, with the most popular source being the internet.Conclusions: Most women reported that if they were told they were at increased risk of PTB, they preferred close-monitoring over using PTB prevention. Their reported likelihood of not following their healthcare provider's recommendations for PTB prevention varied from 10.9% for progesterone to 50.2% for cerclage. These findings suggest that more education about the risk of PTB, PTB preventions, as well as compliance with progesterone is needed and that the internet would be an important source of information. However as our study was completed by women at a median of 32 weeks of gestation, future surveys targeted at women earlier in their pregnancy are needed. [ABSTRACT FROM AUTHOR]

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Hassan et al.)

The number of multiple gestations has increased over the last several decades and preterm birth is one of the leading causes of perinatal morbidity and mortality for these pregnancies. While screening and treatment strategies have achieved moderate success in singleton gestations, screening strategies are less effective in multiple gestations. In addition, to date no intervention aimed at preventing preterm birth has been conclusively shown to either prolong gestation or improve neonatal outcomes for multiple gestations. As in singleton gestations, cervical length is one of the strongest predictors of preterm birth. While not conclusive, emerging data suggest that vaginal progesterone or cervical pessary may be able to prevent preterm birth in twin gestations with a short cervix. [ABSTRACT FROM AUTHOR]

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]

Objective: 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., Data Sources: 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., Study Eligibility Criteria: 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., Methods: The primary outcome was preterm birth <34 weeks' gestation. The summary measures were reported as relative risks with 95% confidence intervals., Results: 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)., Conclusion: 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., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Preterm birth is the leading cause of neonatal morbidity and mortality, and previous preterm birth is one of the strongest risk factors for preterm birth. National and international obstetrical societies have different recommendations regarding progesterone formulation for the prevention of recurrent preterm birth.Objective: This study aimed to determine whether vaginal progesterone is superior to 17-hydroxyprogesterone caproate in the prevention of recurrent preterm birth in patients with singleton pregnancies who had a previous spontaneous preterm birth.Study Design: This was an open-label multicenter pragmatic randomized controlled trial at 5 US centers of patients with singleton pregnancies at <24 weeks of gestation who had a previous spontaneous preterm birth randomized 1:1 to either 200 mg vaginal progesterone suppository nightly or 250 mg intramuscular 17-hydroxyprogesterone caproate weekly from 16 to 36 weeks of gestation. Based on the estimated recurrent preterm birth rate of 36% with 17-hydroxyprogesterone caproate, 95 participants were needed in each arm to detect a 50% reduction in preterm birth rate with vaginal progesterone, with 80% power and 2-sided alpha of 0.05. The primary outcome was preterm birth at <37 weeks of gestation. Prespecified secondary outcomes included preterm birth at <34 and <28 weeks of gestation, mean gestational age at delivery, neonatal morbidity and mortality, and measures of adherence. Analysis was by intention to treat. The chi-square test and Student t test were used as appropriate. P<.05 was considered significant.Results: Overall, 205 participants were randomized; 94 participants in the vaginal progesterone group and 94 participants in 17-hydroxyprogesterone caproate group were included. Although gestational age at enrollment was similar, those assigned to vaginal progesterone initiated therapy earlier (16.9±1.4 vs 17.8±2.5 weeks; P=.001). Overall continuation of assigned formulation until delivery was similar (73% vs 69%; P=.61). There was no significant difference in preterm birth at <37 (31% vs 38%; P=.28; relative risk, 0.81 [95% confidence interval, 0.54-1.20]), <34 (9.6% vs 14.9%; P=.26; relative risk, 0.64 [95% confidence interval, 0.29-1.41]), or <28 (1.1% vs 4.3%; P=.37; relative risk, 0.25 [95% confidence interval, 0.03-2.20]) weeks of gestation. Participants in the vaginal progesterone group had a later mean gestational age at delivery than participants in the 17-hydroxyprogesterone caproate group (37.36±2.72 vs 36.34±4.10 weeks; mean difference, 1.02 [95% confidence interval, 0.01-2.01]; P=.047).Conclusion: Vaginal progesterone did not reduce the risk of recurrent preterm birth by 50% compared with 17-OHPC; however, vaginal progesterone may lead to increased latency to delivery. This trial was underpowered to detect a smaller, but still clinically significant, difference in the efficacy of preterm birth prevention. Patient factors that impact adherence and ability to obtain medication in a timely fashion should be included in counseling on progesterone selection. [ABSTRACT FROM AUTHOR]

Objective To determine whether 17-α-hydroxyprogesterone caproate (17P) reduces the incidence of preterm birth in women with a history-indicated cerclage. Study Design Retrospective cohort study of women who received a cerclage for a prior preterm birth, analyzed based on exposure to 17P. The primary outcome variable was delivery < 35 weeks. Secondary outcomes were preterm birth < 37, 32, 28, and 24 weeks; interval between cerclage placement and delivery; gestational age at delivery; and infant birth weight. Results Fourteen women received 17P and 80 did not. Baseline characteristics did not differ between these two groups. Preterm delivery at < 35 weeks did not differ between those who received 17P and those who did not (29% versus 15%, p = 0.46). There were no significant differences between the groups for any other outcome. Conclusion 17P does not appear to have an effect on preterm birth < 35 weeks in women with a history-indicated cerclage. [ABSTRACT FROM AUTHOR]

Objective To determine whether transabdominal cervical length screening could identify women at high risk for having a short cervix on transvaginal ultrasound. Design Retrospective cohort study. Setting Tertiary referral center. Population A total of 703 patients with a singleton pregnancy at 18 to 23+6 weeks of gestation who underwent transabdominal and transvaginal cervical length assessment during anatomy ultrasound at a single institution between January 2007 and October 2011. Methods Electronic medical records were reviewed to identify women who met the study criteria. Main outcome measures The primary outcome was the number of women with a short transabdominal cervical length (defined as ≤30 mm) who needed to undergo transvaginal ultrasound to detect one woman with a short transvaginal cervical length of ≤20 mm. Results In all, 703 patients were included in the primary analysis; 3.42 women with transabdominal cervical length ≤30 mm needed to undergo transvaginal ultrasound to detect one woman with transvaginal ultrasound cervical length ≤20 mm. Of women with short transvaginal cervical length ≤20 mm, 89.8% had a transabdominal measurement ≤30 mm and 96.7% had a transabdominal measurement ≤33 mm. Conclusions Screening of transabdominal cervical length may represent a useful strategy for detecting women with short cervix on transvaginal ultrasound. [ABSTRACT FROM AUTHOR]

Background: 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., Objective: 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., Study Design: 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., Results: 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)., Conclusion: 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., (Published by Elsevier Inc.)

Objective: To assess whether type of suture material affects cerclage efficacy for preterm birth (PTB) prevention. Methods: Secondary analysis of a multicenter trial of ultrasound-indicated cerclage for short cervical length (CL), in which women with prior spontaneous PTB at 16-33 6/7 weeks, a singleton gestation and CL < 25 mm between 16-22 6/7 weeks, were randomized to McDonald cerclage or no cerclage. Outcomes of women who underwent cerclage were analyzed by type of suture material, comparing polyester braided thread (Mersilene™ or Ethibond™) to Mersilene tape™. Primary outcome was PTB < 35 weeks. Results: 138 women underwent McDonald cerclage: 84 (61%) received polyester braided thread and 46 (33%) Mersilene tape™. Eight (6%) received monofilament suture and were excluded from analysis. Rates of PTB < 35 weeks were similar, 35% for polyester braided thread vs 24% for Mersilene tape™ ( p = .24). Birth gestational age was also similar among the 2 groups ( p = .18). Conclusion: Type of suture material may not affect ultrasound-indicated cerclage efficacy in high-risk women with short CL, but further study is needed. Polyester braided thread (Mersilene™ or Ethibond™) and polyester braided Mersilene tape™ seem to have similar efficacy. [ABSTRACT FROM AUTHOR]

Objective: To examine pregnancy outcomes of women receiving weekly compounded 17 αhydroxyprogesterone caproate (17P) injections through a home nursing program compared with those reported in a multicenter trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Network. Methods: The study sample was comprised of patients receiving compounded 17P through a home nurse administration care management program. Included were women with current singleton gestation and prior spontaneous preterm birth (SPTB) initiating 17P between 16 and 20 weeks. Maternal characteristics and pregnancy outcomes were compared between study group and NICHD Network trial patients. Results: Women (n = 5493) received a mean of 16.9 ± 4.0 injections. Of the 92,700 injections, 98.4% were administered within the recommended 5- to 9-day interval. Recurrent SPTB occurred in 28.3%. The overall rate of SPTB at <37 weeks was similar for black and nonblack women (p = 0.592).Within black or nonblack groups, preterm birth rates at <37 weeks were similar regardless of gestational age at start of 17P (p = 0.894 and p = 0.374, respectively). These results were similar to those reported in the multicenter trial. Fetal and neonatal death occurred in 0.8% (46/5493). No significant difference was observed in rate of fetal or neonatal death by gestational age at initiation of 17P (p = 0.478). Conclusion: Home nurse administration of compounded 17P is safe and effective. [ABSTRACT FROM AUTHOR]

Globally, each year, an estimated 13 million infants are born before 37 completed weeks of gestation. Complications from these preterm births are the leading cause of neonatal mortality. Preterm birth is directly responsible for an estimated one million neonatal deaths annually and is also an important contributor to child and adult morbidities. Low- and middle-income countries are disproportionately affected by preterm birth and carry a greater burden of disease attributed to preterm birth. Causes of preterm birth are multifactorial, vary by gestational age, and likely vary by geographic and ethnic contexts. Although many interventions have been evaluated, few have moderate-to high-quality evidence for decreasing preterm birth: smoking cessation and progesterone treatment in women with a high risk of preterm birth in low- and middle-income countries and cervical cerclage for those in high-income countries. Antepartum and postnatal interventions (eg, antepartum maternal steroid administration, or kangaroo mother care) to improve preterm neonatal survival after birth have been demonstrated to be effective but have not been widely implemented. Further research efforts are urgently needed to better understand context-specific pathways leading to preterm birth; to develop appropriate, efficacious prevention strategies and interventions to improve survival of neonates born prematurely; and to scale-up known efficacious interventions to improve the health of the preterm neonate. [Copyright &y& Elsevier]

Objective. Evaluation of an outpatient 17 α-hydroxyprogesterone caproate (17P) administration programme. Methods. A retrospective analysis of data collected from patients with a history of preterm birth (PTB) and current singleton gestation enrolled between 16.0 and 20.9 weeks' gestational age (GA) for weekly outpatient 17P administration and nursing assessment between 7/2004 and 12/2007 was conducted ( n = 3139). Results. The population was mostly white (50.3%), 18–35 years old (77.7%), and married (67.0%). Median GA at 17P initiation and stop was 17.4 (16.0, 20.9) weeks and 35.1 (18.6, 37.4) weeks. Mean injections per patient were 16.5 ± 4.9, at an interval of 7.2 days. Median GA at delivery was 37.3 (18.6, 44.0) weeks. Rate of recurrent spontaneous PTB was 29.8%, with 15.5% and 7.0% with PTB at <35 and <32 weeks. Conclusions. This represents the largest cohort reported to date of patients prescribed 17P therapy in clinical practice to prevent recurrent spontaneous PTB. [ABSTRACT FROM AUTHOR]

Objective. To compare rates of recurrent preterm birth between women starting treatment with 17a-hydroxyprogesterone caproate (17P) at 16-20.9 weeks of gestation versus 21-26.9 weeks. Methods. Women enrolled in an outpatient program of education, nursing assessment and weekly 17P injections beginning at 16-26.9 weeks were eligible. Included were patients with singleton pregnancies and a history of preterm delivery (PTD). Pregnancy outcome was compared between women starting 17P at 16-20.9 weeks (n=156) and those starting 17P at 21-26.9 weeks (n=119) using Fisher's exact and Mann-Whitney U test statistics (p<0.05 considered significant). Results. Mean gestational age at delivery (36.8±3.0 vs. 36.7±2.5) and rates of PTD at <37 weeks (40.4% vs. 48.7%), <35 weeks (16.7% vs. 16.8%) and <32 weeks (5.1% vs. 5.0%) were similar between the groups; all p<0.05. Conclusions. Rates of preterm delivery were similar in patients initiating 17P at 16-20.9 or 21-26.9 weeks. A larger sample size is warranted in order to confirm our findings. [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]

Frequently missing from discussions of the high rates of preterm and low birthweight births in the United States are the voices of pregnant women. In this article, we share the voices of low-income pregnant women who were participants in a 5-year randomized clinical study of nurse telephone intervention to reduce preterm birth. Data were gathered from three sources: a log kept by the study nurses in which they recorded events as they occurred; a telephone survey of randomly selected participants using a structured interview after the program was completed; and spontaneous comments from notes and letters written by study participants. Patients commonly perceived barriers to care, and related them to the nurses. The most frequent barriers concerned communication: miscommunication and misunderstanding between a woman and provider; miscommunication and misunderstanding involving providers giving conflicting information to patients; inaccurate information from provider to patient; failure of a provider to respond to a patient's request for information; and a general feeling among patients that providers were unsympathetic or uncaring. The perspectives of these women raise important questions for nurses and for other healthcare providers about the way we communicate both information and attitudes of caring to pregnant women. [ABSTRACT FROM AUTHOR]

Background: Anemia during pregnancy is associated with increased risks of preterm birth, preeclampsia, cesarean delivery, and maternal morbidity. The most prevalent modifiable cause of pregnancy-associated anemia is iron deficiency. However, it is still unclear whether iron therapy can reduce the risks of adverse outcomes in women with anemia., Objective: This study aimed to determine whether response to iron therapy among women with anemia is associated with a change in odds of adverse maternal and neonatal outcomes., Study Design: This was a population-based cohort study (2011-2019) using an institutional database composed of obstetrical patients from 2 delivery hospitals. Patients with adequate prenatal care were classified as being anemic or nonanemic (reference). Patients with anemia were further stratified by success or failure of treatment with oral iron therapy using the American College of Obstetricians and Gynecologists criteria for anemia at the time of admission for delivery: successfully treated (Hgb≥11 g/dL) or unsuccessfully treated ("refractory;" Hgb<11 g/dL). All categories of women with anemia categories were compared with the reference group of women without anemia using chi-square and logistic regression analyses. The primary outcomes were preterm birth and preeclampsia., Results: Among the 20,690 women observed, 7416 (35.8%) were anemic. Among women with anemia, 1319 (17.8%) were refractory to iron therapy, 2695 (36.3%) had a successful response to therapy, and 3402 (45.9%) were untreated. Successfully treated patients with anemia had a significant reduction in the odds of preterm birth (5.1% vs 8.3%; adjusted odds ratio, 0.59; 95% confidence interval, 0.47-0.72) and preeclampsia (5.9% vs 8.3%; adjusted odds ratio, 0.75; 95% confidence interval, 0.61-0.91). Refractory and untreated patients had significantly increased odds of preterm birth (adjusted odds ratio, 1.44 [95% confidence interval, 1.16-1.76] and 1.45 [95% confidence interval, 1.26-1.67], respectively) and preeclampsia (adjusted odds ratio, 1.54 [95% confidence interval, 1.24-1.89] and 1.44 [95% confidence interval, 1.25-1.67], respectively). All groups of women with anemia had increased odds of postpartum hemorrhage and decreased odds of delivering a small for gestational age neonate. There was no difference in composite neonatal morbidity., Conclusion: Successful treatment of anemia with oral iron therapy was associated with a reduction in the odds of preterm birth and preeclampsia. Women with refractory anemia had similar outcomes to those who were untreated, emphasizing the importance of monitoring response to iron therapy during pregnancy., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)