A model-based analysis of the health impacts of COVID-19 disruptions to primary cervical screening by time since last screen for current and future disruptions.

We evaluated how temporary disruptions to primary cervical cancer (CC) screening services may differentially impact women due to heterogeneity in their screening history and test modality. We used three CC models to project the short- and long-term health impacts assuming an underlying primary screening frequency (i.e., 1, 3, 5, or 10 yearly) under three alternative COVID-19-related screening disruption scenarios (i.e., 1-, 2-, or 5-year delay) versus no delay in the context of both cytology-based and human papillomavirus (HPV)-based screening. Models projected a relative increase in symptomatically detected cancer cases during a 1-year delay period that was 38% higher (Policy1-Cervix), 80% higher (Harvard), and 170% higher (MISCAN-Cervix) for underscreened women whose last cytology screen was 5 years prior to the disruption period compared with guidelines-compliant women (i.e., last screen 3 years prior to disruption). Over a woman's lifetime, temporary COVID-19-related delays had less impact on lifetime risk of developing CC than screening frequency and test modality; however, CC risks increased disproportionately the longer time had elapsed since a woman's last screen at the time of the disruption. Excess risks for a given delay period were generally lower for HPV-based screeners than for cytology-based screeners. Our independent models predicted that the main drivers of CC risk were screening frequency and screening modality, and the overall impact of disruptions from the pandemic on CC outcomes may be small. However, screening disruptions disproportionately affect underscreened women, underpinning the importance of reaching such women as a critical area of focus, regardless of temporary disruptions.

Hands-On Training Courses for Cervical Cancer Screening, Diagnosis, and Treatment Procedures in Low- and Middle-Income Countries.

In 2018, there were approximately 570,000 new cases of cervical cancer worldwide. More than 85% of cases occurred in low- and middle-income countries (LMICs), primarily because of poor access to screening and a limited number of medical providers trained to diagnose and treat cervical precancerous lesions. Our objective was to provide locally arranged, hands-on training courses for medical providers in LMICs to learn to perform cervical cancer screening, diagnosis, and treatment procedures. The courses included didactic lectures and hands-on training stations using low-cost simulation models developed by bioengineers and students at Rice University in Houston, TX, United States, and the Malawi Polytechnic in Blantyre, Malawi. The hands-on training stations included visual inspection with acetic acid (VIA), colposcopy, cervical biopsy, endocervical curettage, loop electrosurgical excision procedure (LEEP), and thermal ablation. Provider pre- and postcourse confidence levels in performing the procedures were evaluated. From February 2017 to January 2020, we arranged 15 hands-on training courses in seven cities across six countries (El Salvador, Mozambique, Trinidad and Tobago, Lesotho, Malawi, and Nepal). Overall, there were 506 participants. The average number of participants per course was 38 (range 19-92). The participants included doctors, nurses, and midwives. The course duration varied from 1 to 3 days. Increased confidence in performing VIA, colposcopy and cervical biopsy, ablation, and LEEP was reported by 69%, 71%, 61%, and 76% of participants, respectively. Our findings suggest that locally arranged, hands-on cervical cancer prevention training courses in LMICs can improve provider confidence in performing cervical cancer screening, diagnosis, and treatment procedures. These courses are part of a larger strategy to build local capacity for delivering and improving cervical cancer prevention services in LMICs.

A randomized trial of synthetic osmotic cervical dilator for induction of labor vs dinoprostone vaginal insert.

BACKGROUND: Induction of labor is a commonly performed obstetrical intervention. Vaginal prostaglandin E2 (dinoprostone) is a first-choice agent. Mechanical methods of induction are slower in achieving cervical ripening but have a lower risk of adverse effects. OBJECTIVE: This study aimed to compare the efficacy, maternal and neonatal safety, and maternal satisfaction of a synthetic osmotic cervical dilator (Dilapan-S) with those of dinoprostone. STUDY DESIGN: This was an open-label superiority randomized controlled trial in 4 English hospitals. Eligible participants were women ≥16 years of age undergoing induction of labor for a singleton pregnancy at ≥37 weeks' gestation with vertex presentation and intact membranes. The women were randomly assigned to receive either Dilapan-S or dinoprostone using a telephone randomization system minimized by hospital, parity, body mass index, and maternal age. The induction agent was replaced as required until the cervix was assessed as favorable for labor by the Bishop score. The primary outcome was failure to achieve vaginal delivery (ieor a cesarean delivery being performed). The secondary outcome measures included maternal and neonatal adverse events. Analysis was by intention-to-treat, adjusting for design variables where possible. RESULTS: Between December 19, 2017 and January 26, 2021, 674 women were randomized (337 to Dilapan-S, and 337 to dinoprostone). The trial did not reach its planned sample size of 860 participants because of restrictions on research during the COVID-19 pandemic. The primary outcome was missing for 2 women in the dinoprostone group. Failure to achieve vaginal delivery (or a cesarean delivery being performed) occurred in 126 women (37.4%) allocated to Dilapan-S and in 115 (34.3%) women allocated to dinoprostone (adjusted risk difference, 0.02; 95% confidence interval, -0.05 to 0.10). There were similar maternal and neonatal adverse events between the groups. CONCLUSION: Women undergoing induction of labor with Dilapan-S have similar rates of cesarean delivery and maternal and neonatal adverse events compared with dinoprostone.

Availability and use of fetal fibronectin testing and transvaginal ultrasound for preterm labor evaluation in the United States.

OBJECTIVE: Measure availability and use of fetal fibronectin (fFN) testing and transvaginal ultrasound to measure cervical length (TVCL) for symptomatic preterm labor (PTL) patients. Additionally, assess the presence and impact of PTL triage protocols. STUDY DESIGN: Cross-sectional online survey among clinicians from 255 unique hospitals regarding prior 12-month practices (pre-COVID-19). RESULTS: fFN testing was always available in 87% (221) of hospitals, while TVCL was always available in 69% (175) of hospitals. Utilization was lower: fFN specimens were often/always collected in 61% (156) of hospitals and TVCL was often/always performed in 43% (110) of hospitals. fFN testing was significantly more likely than TVCL to be available and used (p < .05). Written PTL protocols were available in 47% (121) of hospitals but not consistently followed. CONCLUSION: The most accurate risk assessment approach for imminent spontaneous preterm birth is the implementation of a universal screening program for symptomatic patients, including fFN testing and TVCL.

Out-of-Hospital Cervical Ripening With a Synthetic Hygroscopic Cervical Dilator May Reduce Hospital Costs and Cesarean Sections in the United States-A Cost-Consequence Analysis.

Objective: Out-of-hospital (outpatient) cervical ripening prior to induction of labor (IOL) is discussed for its potential to decrease the burden on hospital resources. We assessed the cost and clinical outcomes of adopting an outpatient strategy with a synthetic hygroscopic cervical dilator, which is indicated for use in preinduction cervical ripening. Methods: We developed a cost-consequence model from the hospital perspective with a time period from IOL to post-delivery discharge. A hypothetical cohort of women to undergo IOL at term with an unfavorable cervix (all risk levels) were assessed. As the standard of care (referred to as IP-only) all women were ripened as inpatients using the vaginal PGE2 insert or the single-balloon catheter. In the comparison (OP-select), 50.9% of low-risk women (41.4% of the study population) received outpatient cervical ripening using a synthetic hygroscopic cervical dilator and the remaining women were ripened as inpatients as in the standard of care. Model inputs were sourced from a structured literature review of peer-reviewed articles in PubMed. Testing of 2,000 feasible scenarios (probabilistic multivariate sensitivity analysis) ascertained the robustness of results. Outcomes are reported as the average over all women assessed, comparing OP-select to IP-only. Results: Implementing OP-select resulted in hospital savings of US$689 per delivery, with women spending 1.48 h less time in the labor and delivery unit and 0.91 h less in the postpartum recovery unit. The cesarean-section rate was decreased by 3.78 percentage points (23.28% decreased to 19.50%). In sensitivity testing, hospital costs and cesarean-section rate were reduced in 91% of all instances. Conclusion: Our model analysis projects that outpatient cervical ripening has the potential to reduce hospital costs, hospital stay, and the cesarean section rate. It may potentially allow for better infection-prevention control during the ongoing COVID-19 pandemic and to free up resources such that more women might be offered elective IOL at 39 weeks.

Congenital, Intrapartum and Postnatal Maternal-Fetal-Neonatal SARS-CoV-2 Infections: A Narrative Review.

BACKGROUND: There is inconclusive evidence regarding congenital, intrapartum, and postnatal maternal-fetal-neonatal SARS-CoV-2 infections during the COVID-19 pandemic. A narrative review was conducted with the aim of guiding clinicians on the management of pregnant women with respect to congenital, intrapartum, and postnatal maternal-fetal-neonatal SARS-CoV-2 infections and breastfeeding during the COVID-19 pandemic. METHODS: Searches were conducted in Web of Science, PubMed, Scopus, Dialnet, CUIDEN, Scielo, and Virtual Health Library to identify observational, case series, case reports, and randomized controlled trial studies assessing the transmission of SARS-CoV-2 from mother to baby and/or through breastfeeding during the COVID-19 pandemic. RESULTS: A total of 49 studies was included in this review, comprising 329 pregnant women and 331 neonates (two pregnant women delivered twins). The studies were performed in China (n = 26), USA (n = 7), Italy (n = 3), Iran (n = 2), Switzerland (n = 1), Spain (n = 1), Turkey (n = 1), Australia (n = 1), India (n = 1), Germany (n = 1), France (n = 1), Canada (n = 1), Honduras (n = 1), Brazil (n = 1), and Peru (n = 1). Samples from amniotic fluid, umbilical cord blood, placenta, cervical secretion, and breastmilk were collected and analyzed. A total of 15 placental swabs gave positive results for SARS-CoV-2 ribonucleic acid (RNA) on the fetal side of the placenta. SARS-CoV-2 RNA was found in seven breastmilk samples. One umbilical cord sample was positive for SARS-CoV-2. One amniotic fluid sample tested positive for SARS-CoV-2. CONCLUSIONS: This study presents some evidence to support the potential of congenital, intrapartum, and postnatal maternal-fetal-neonatal SARS-CoV-2 infections during the COVID-19 pandemic. Mothers should follow recommendations including wearing a facemask and hand washing before and after breastfeeding.

Possible deferral of diagnostic and therapeutic procedures for patients with abnormal screening tests results in cervical cancer secondary prevention in current SARS-CoV-2 pandemic Interim guidelines of the Polish Society of Gynecologists and Obstetricians and the Polish Society of Colposcopy and Cervical Pathophysiology.

The Polish Society of Gynecologists and Obstetricians and Polish Society of Colposcopy and Cervical Pathophysiology Interim Guidelines goal at aiding gynecologists in providing a cervical cancer prevention care during the evolving SARS-CoV-2 pan-demic. Presented guidelines were developed on a review of limited data and updated when new relevant publications were revealed. Timing for deferrals of diagnostic-therapeutic procedures were mostly covered in the guidelines. Also, a support for the existing Polish recommendations on abnormal screening results in a subject of minor and major screening abnor-malities terminology were given. The guidelines are obligatory for the specified COVID-19 pandemic period only and they might be changed depending on the new available evidence.

SARS-CoV-2 infection and impact on female genital tract: An untested hypothesis.

COVID pandemic consists one of the most challenging medical realities. Apart from affecting respiratory system, current evidence has demonstrated multiorgan manifestations that SARS-Cov-2 infection may actually have. However, one of the medical hypotheses not yet thoroughly tested is the impact on female reproductive system and more specifically cervix. No large observational studies have been performed to test presence of SARS-Cov-2 in cervical samples, while potential correlation and impact on HPV infection has not yet been examined. In this context, our research team has already planned to begin a prospective observational study regarding detection rates of SARS-CoV-2 genetic material in cervical cytology. The collected specimen will be analyzed for the presence of COVID-19 genetic material and in case of positive results, HPV typing will be performed as well in order to detect potential correlations between SARS-CoV-2 infection and HPV-infection. We would therefore like to launch our idea to control for SARS-CoV-2 infection in cervical specimen as well as examine potential correlation with HPV infection. Potential scientific proof of such hypothesis would change much regarding follow-up of HPV-positive patients while also triggering further research regarding aitiopathogenetic pathways of COVID. Communication of such a medical hypothesis could potentially motivate colleagues worldwide to expand their interest also on the research of SARS-CoV-2 cervical infection, in an effort to optimize our level of knowledge towards this new threatening and unknown reality of SARS-CoV-2.