Management of Patients with Hypersensitivity to Platinum Salts and Taxane in Gynecological Cancers: A Cross-Sectional Study by the European Network of Young Gynaecologic Oncologists (ENYGO).

Platinum and taxane chemotherapy is associated with the risk of hypersensitivity reactions (HSRs), which may require switching to less effective treatments. Desensitization to platinum and taxane HSRs can be used to complete chemotherapy according to the standard regimen. Therefore, we aimed to investigate the current management of HSRs to platinum and/or taxane chemotherapy in patients with gynecologic cancers. We conducted an online cross-sectional survey among gynecological and medical oncologists consisting of 33 questions. A total of 144 respondents completed the survey, and 133 respondents were included in the final analysis. Most participants were gynecologic oncologists (43.6%) and medical oncologists (33.8%), and 77.4% (n = 103) were involved in chemotherapy treatment. More than 73% of participants experienced >5 HSRs to platinum and taxane per year. Premedication and a new attempt with platinum or taxane chemotherapy were used in 84.8% and 92.5% of Grade 1-2 HSRs to platinum and taxane, respectively. In contrast, desensitization was used in 49.4% and 41.8% of Grade 3-4 HSRs to platinum and taxane, respectively. Most participants strongly emphasized the need to standardize the management of platinum and taxane HSRs in gynecologic cancer. Our study showed that HSRs in gynecologic cancer are common, but management is variable and the use of desensitization is low. In addition, the need for guidance on the management of platinum- and taxane-induced HSRs in gynecologic cancer was highlighted.

Best original research presented at the 24th European Congress on Gynaecological Oncology-Best of ESGO 2023.

The 'Best of ESGO 2023' manuscript comprises a compilation of the best original research presented during the European Society of Gynaecologic Oncology annual congress held in Istanbul between September 28 and October 1, 2023. Out of 1030 submitted abstracts, 33 studies presented during the Best Oral Sessions, Mini Oral Sessions, and Young Investigator Session were selected by the ESGO Abstract Committee and the European Network of Young Gynae Oncologists (ENYGO) authors. There was a strong focus on surgical de-escalation, immunotherapy, maintenance therapy, and molecular profiling in gynecologic oncology. With this manuscript, ENYGO and ESGO aim to disseminate the valuable research results to readers interested in our field.

Is mid-trimester cervical length screening effective for reduction of threatened preterm labor?

OBJECTIVE: To assess the incidence of threatened preterm labor and preterm labor admissions and treatment of women with singleton gestations and no prior preterm birth before and after implementation of the universal mid-trimester transvaginal ultrasound cervical length screening. MATERIALS AND METHODS: A retrospective cohort study included of singleton gestations without a history of preterm birth presenting with threatened preterm labor between 24 0/7 and 36 6/7 gestational week in two study periods: before and after the implementation of the universal cervical length screening. Women with cervical length <25 mm were considered being at high risk for preterm birth and were prescribed a treatment with vaginal progesterone daily. The primary outcome was the incidence of threatened preterm labor. Secondary outcomes were the incidence of preterm labor. RESULTS: We have found a significant increase in the incidence of threatened preterm labor from 6.42% (410/6378) in 2011 to 11.61% (483/4158) in 2018 (p < 0.0001). Gestational age at triage consult was lower in than in 2011, although the rate of admission for threatened preterm labor was similar in both periods. There was a significant decrease in the incidence of preterm delivery <37 weeks from 25.60% in 2011 to 15.94% in 2018 (p < 0.0004). Although there was a reduction in preterm delivery ≤34 weeks, this reduction was not significant. CONCLUSION: The universal mid-trimester cervical length screening in asymptomatic women is not associated with a reduction in the frequency of threatened preterm labor or the admission rate for preterm labor, but reduces the rate of preterm births.

Management of patients with advanced epithelial ovarian cancer: a European survey.

BACKGROUND: The aim of this study was to assess current European practices in the management of patients with advanced epithelial ovarian cancer in 2021. METHODS: A 58-question electronic survey was distributed anonymously to the members of six European learned societies. Initial diagnostic workup and staging, pathological data, surgical data, treatments and follow-up strategies were assessed. RESULTS: A total of 171 participants from 17 European countries responded to emailed surveys. Most participants were experienced practitioners (superior than 15 years of experience) specializing in gynecology-obstetrics (29.8%), surgical oncology (25.1%), and oncogynecology (21.6%). According to most (64.8%) participants, less than 50% of patients were eligible for primary debulking surgery. Variations in the rate of primary debulking surgery depending on the country of origin of the practitioners were observed in this study. The LION study criteria were applied in 70.4% of cases during PDS and 27.1% after chemotherapy. In cases of BRCA1-2 mutations, olaparib was given by 75.0-84.8% of respondents, whereas niraparib was given in cases of BRCA wild-type diseases. CONCLUSIONS: This study sheds light on current practices and attitudes regarding the management of patients with advanced epithelial ovarian cancer in Europe in 2021.

Best original research presented at the 23rd European Congress on Gynaecological Oncology-Best of ESGO 2022.

Best of ESGO 2022 includes a selection of best original research presented during the 23rd European Congress on Gynaecological Oncology between October 27 and 30, 2022 in Berlin. Out of 1107 submitted abstracts, authors of studies which obtained the highest scores in a blinded review process were invited to present their results during four oral sessions, young investigators session, and oral poster sessions. By means of this publication, we aim to provide readers with an overview of the best quality research presented at the European Society of Gynaecological Oncology (ESGO) 2022.

European Enhanced Recovery After Surgery (ERAS) gynecologic oncology survey: Status of ERAS protocol implementation across Europe.

OBJECTIVE: To acquire a comprehensive assessment of the current status of implementation of Enhanced Recovery After Surgery (ERAS) protocols across Europe. METHODS: The survey was launched by The European Network of Young Gynecologic Oncologists (ENYGO). A 45-item survey was disseminated online through the European Society of Gynecological Oncology (ESGO) Network database. RESULTS: A total of 116 ESGO centers participated in the survey between December 2020 and June 2021. Overall, 80 (70%) centers reported that ERAS was implemented at their institution: 63% reported a length of stay (LOS) for advanced ovarian cancer surgery between 5 and 7 days; 57 (81%) centers reported a LOS between 2 and 4 days in patients who underwent an early-stage gynecologic cancer surgery. The ERAS items with high reported compliance (>75% "normally-always") included deep vein thrombosis prophylaxis (89%), antibiotic prophylaxis (79%), prevention of hypothermia (55%), and early mobilization (55%). The ERAS items that were poorly adhered to (less than 50%) included early removal of urinary catheter (33%), and avoidance of drains (25%). CONCLUSION: This survey shows broad implementation of ERAS protocols across Europe; however, a wide variation in adherence to the various ERAS protocol items was reported.

Clinician attitude towards sexual counseling in women with gynecologic malignancies: European Network of Young Gynaecological Oncologists (ENYGO) survey.

OBJECTIVE: Both the location of primary disease and treatment side effects may have an impact on sexual function in oncogynecological patients. The aim of this study was to examine the prevalence, strategies, difficulties, and ideas for improvement in sexual counseling among specialists managing patients with gynecologic malignancies. METHODS: This was a cross-sectional survey study performed among healthcare professionals treating patients with gynecologic malignancies. A self-prepared questionnaire included 61 questions concerning general demographic information and different aspects of sexual counseling in the gynecologic oncology practice. Analysis included attitudes, behaviors, management strategies, difficulties, and ideas for possible systemic improvements. Statistical analysis involved descriptive statistics, two-sided chi-square test, and Fisher's exact test. RESULTS: A total of 150 respondents from 46 countries answered the survey. The majority of survey participants stated that sexual counseling of oncological patients is very important (n=73, 49%) or important (n=46, 31%). One hundred and two (68%) respondents agreed that sexual counseling of gynecologic oncology patients should be routinely provided by the specialist managing the primary disease. However, collecting information concerning sexual function is performed often or always by only 21% of respondents and 19% discuss the topic rarely or never. The most frequently indicated barriers leading to difficulties in sexual counseling include lack of time (74%), lack of specialist knowledge (55%), and patient embarrassment (48%). One hundred and seven (71%) respondents expressed interest in participating in sexual counseling workshops organized by the European Society of Gynaecological Oncology (ESGO)/European Network of Young Gynaecological Oncologists (ENYGO), 74 (49%) would like to access webinars on the topic, and 120 (80%) would be interested in materials in the ESGO online educational resources. CONCLUSION: One of the proposed solutions to insufficient access to sexual care for women with gynecologic malignancies is providing access to specialist educational programs for both patients and healthcare specialists.

Quality of training in cervical cancer radical surgery: a survey from the European Network of Young Gynaecologic Oncologists (ENYGO).

BACKGROUND: The European Society of Gynaecological Oncology (ESGO) and partners are committed to improving the training for gynecologic oncology fellows. The aim of this survey was to assess the type and level of training in cervical cancer surgery and to investigate whether the Laparoscopic Approach to Cervical Cancer (LACC) trial results impacted training in radical surgery for gynecologic oncology fellows. METHODS: In June 2020, a 47-question electronic survey was shared with European Network of Young Gynaecologic Oncologists (ENYGO) members. Specialist fellows in obstetrics and gynecology, and gynecologic oncology, from high- and low-volume centers, who started training between January 1, 2017 and January 1, 2020 or started before January 1, 2017 but finished their training at least 6 months after the LACC trial publication (October 2018), were included. RESULTS: 81 of 125 (64.8%) respondents were included. The median time from the start of the fellowship to completion of the survey was 28 months (range 6-48). 56 (69.1%) respondents were still fellows-in-training. 6 of 56 (10.7%) and 14 of 25 (56.0%) respondents who were still in training and completed the fellowship, respectively, performed ≥10 radical hysterectomies during their training. Fellows trained in an ESGO accredited center had a higher chance to perform sentinel lymph node biopsy (60.4% vs 30.3%; p=0.027). There was no difference in the mean number of radical hysterectomies performed by fellows during fellowship before and after the LACC trial publication (8±12.0 vs 7±8.4, respectively; p=0.46). A significant reduction in number of minimally invasive radical hysterectomies was noted when comparing the period before and after the LACC trial (38.5% vs 13.8%, respectively; p<0.001). CONCLUSION: Exposure to radical surgery for cervical cancer among gynecologic oncology fellows is low. Centralization of cervical cancer cases to high-volume centers may provide an increase in fellows' exposure to radical procedures. The LACC trial publication was associated with a decrease in minimally invasive radical hysterectomies performed by fellows.

Gender-related differences in career development among gynecologic oncology surgeons in Europe. European Network of Young Gynecologic Oncologists' Survey based data.

Introduction: Gender-related differences in career development are well known issues in various professions. An international survey on gender-related differences was performed among young gynecologic oncology surgeons in Europe to identify potential gender inequalities in career development. Material and methods: A survey on demographics, clinical and academic working environment, family/parenting, career development, salary and leadership was sent to all members of the European Network of Young Gynecologic Oncologists (ENYGO), which is a network within the European Society of Gynecologic Oncology (ESGO). Gynecologic oncology surgeons and obstetricians/gynecologists who actively work in this field in Europe were included in the study. Results: Responses were analyzed from 192 gynecologic oncology surgeons of whom 65.1% (125/192) were female (median age 37, IQR: 34 - 42) and 34.9% (67/192) were male (median age 38, IQR: 36 - 41). Male reported to perform a median of 15 and female a median of 10 operations per month (p = .007). Among female, 24.8% had a leadership position vs. 44.8% among male, crude OR = 2.46, 95% CI 1.31-4.62, p<.01. When stratifying for age under 41 and having children, 36.7% of male and 5.6% of female had a leadership position, adjusted OR 10.8, 95% CI 3.28-35.64, p<.001. A significantly higher proportion of female compared to male believed they earned less than their gender counterparts at the same clinical position and with same qualifications (30.4% vs. 2.5%, p<.001). There was not a statistically significant gender difference in the academic qualification PhD degree or professorship (p = .92 and p = .64, respectively). In the previous year, male published more peer-reviewed articles than female (median 3 vs. median 2; p = .017). Conclusion: This first comprehensive survey on gender-differences in gynecologic oncology in Europe revealed that there are gender gaps concerning several aspects during the critical time of career development in the young generation of gynecologic oncology surgeons. These gender gaps are particularly reflected by a lower rate of female leadership positions. ENYGO and ESGO are dedicated to work on solution to overcome the identified obstacles and to support closing gender gaps.

Impact of SARS-CoV-2 on training and mental well-being of surgical gynecological oncology trainees.

INTRODUCTION: The SARS-CoV-2 global pandemic has caused a crisis disrupting health systems worldwide. While efforts are being made to determine the extent of the disruption, the impact on gynecological oncology trainees/training has not been explored. We conducted an international survey of the impact of SARS-CoV-2 on clinical practice, medical education, and mental well-being of surgical gynecological oncology trainees. METHODS: In our cross-sectional study, a customized web-based survey was circulated to surgical gynecological oncology trainees from national/international organizations from May to November 2020. Validated questionnaires assessed mental well-being. The Wilcoxon rank-sum test and Fisher's exact test were used to analyse differences in means and proportions. Multiple linear regression was used to evaluate the effect of variables on psychological/mental well-being outcomes. Outcomes included clinical practice, medical education, anxiety and depression, distress, and mental well-being. RESULTS: A total of 127 trainees from 34 countries responded. Of these, 52% (66/127) were from countries with national training programs (UK/USA/Netherlands/Canada/Australia) and 48% (61/127) from countries with no national training programs. Altogether, 28% (35/125) had suspected/confirmed COVID-19, 28% (35/125) experienced a fall in household income, 20% (18/90) were self-isolated from households, 45% (57/126) had to re-use personal protective equipment, and 22% (28/126) purchased their own. In total, 32.3% (41/127) of trainees (16.6% (11/66) from countries with a national training program vs 49.1% (30/61) from countries with no national training program, p=0.02) perceived they would require additional time to complete their training fellowship. The additional training time anticipated did not differ between trainees from countries with or without national training programs (p=0.11) or trainees at the beginning or end of their fellowship (p=0.12). Surgical exposure was reduced for 50% of trainees. Departmental teaching continued throughout the pandemic for 69% (87/126) of trainees, although at reduced frequency for 16.1% (14/87), and virtually for 88.5% (77/87). Trainees reporting adequate pastoral support (defined as allocation of a dedicated mentor/access to occupational health support services) had better mental well-being with lower levels of anxiety/depression (p=0.02) and distress (p<0.001). Trainees from countries with a national training program experienced higher levels of distress (p=0.01). Mean (SD) pre-pandemic mental well-being scores were significantly higher than post-pandemic scores (8.3 (1.6) vs 7 (1.8); p<0.01). CONCLUSION: SARS-CoV-2 has negatively impacted the surgical training, household income, and psychological/mental well-being of surgical gynecological oncology trainees. The overall clinical impact was worse for trainees in countries with no national training program than for those in countries with a national training program, although national training program trainees reported greater distress. COVID-19 sickness increased anxiety/depression. The recovery phase must focus on improving mental well-being and addressing lost training opportunities.

Subspecialty training in Europe: a report by the European Network of Young Gynaecological Oncologists.

BACKGROUND: ESGO (European Society of Gynaecological Oncology) and partners are continually improving the developmental opportunities for gynaecological oncology fellows. The objectives of this survey were to evaluate the progress in the infrastructure of the training systems in Europe over the past decade. We also evaluated training and assessment techniques, the perceived relevance of ENYGO (European Network of Young Gynaecological Oncologists) initiatives, and unmet needs of trainees. METHODOLOGY: National representatives of ENYGO from 39 countries were contacted with an electronic survey. A graduation in well/moderately/loosely-structured training systems was performed. Descriptive statistical analysis and frequency tables, as well as two-sided Fisher's exact test, were used. RESULTS: National representatives from 33 countries answered our survey questionnaire, yielding a response rate of 85%. A national fellowship is offered in 22 countries (66.7%). A logbook to document progress during training is mandatory in 24 (72.7%) countries. A logbook of experience is only utilized in a minority of nations (18%) for assessment purposes. In 42.4% of countries, objective assessments are recognized. Trainees in most countries (22 (66.7%)) requested additional training in advanced laparoscopic surgery. 13 (39.4%) countries have a loosely-structured training system, 11 (33.3%) a moderately-structured training system, and 9 (27.3%) a well-structured training system. CONCLUSION: Since the last publication in 2011, ENYGO was able to implement new activities, workshops, and online education to support training of gynaecological oncology fellows, which were all rated by the respondents as highly useful. This survey also reveals the limitations in establishing more accredited centers, centralized cancer care, and the lack of laparoscopic training.

Report from the 21st meeting of the European Society of Gynaecological Oncology (ESGO 2019).

This is a report from the 21st Meeting of the European Society of Gynaecological Oncology (ESGO 2019) held in Athens, Greece, November 2-5, 2019. The conference offered state of the art educational sessions, and oral and poster abstract presentations. The general sessions throughout the meeting focused not only on prevention, screening, diagnosis, treatment, and translational research but also on emerging trends. Current innovations in gynecological cancers were also discussed. The new rare tumor guidelines project, a joint initiative with the ESGO-Gynecologic Cancer InterGroup, was officially presented for the first time. Moreover, other developments achieved with other societies, such as the European Society for Medical Oncology for ovarian cancer, the European Federation for Colposcopy for cervical cancer prevention and screening, and the European Society for Pediatric Oncology for gynecologic cancers in adolescents, were presented. Here we highlight the key results of the latest gynecological cancer trials that were presented for the first time at ESGO 2019 and added great value to this prestigious scientific congress.

Prediction of spontaneous preterm delivery in women presenting with premature labor: a comparison of placenta alpha microglobulin-1, phosphorylated insulin-like growth factor binding protein-1, and cervical length.

BACKGROUND: Placental alpha microglobulin-1 and phosphorylated insulin-like growth factor-binding protein-1 have been studied in patients at risk for preterm birth with signs and symptoms of preterm labor. However, a direct comparison between these 2 biomarkers, alone or in combination with cervical length measurement with an adequate sample size, has been lacking to date. OBJECTIVE: The purpose of this study was to compare the placental alpha microglobulin-1 test and the phosphorylated insulin-like growth factor-binding protein-1 test alone and in combination with cervical length measurement for the prediction of imminent spontaneous preterm birth of testing in pregnant women with symptoms of preterm labor in a tertiary care setting. STUDY DESIGN: Four hundred three patients with intact amniotic membranes and cervical dilation ≤3 cm, without recent intercourse or cerclage, between gestational weeks of 20+0 and 36+6 were recruited prospectively from 3 international centers. Placental alpha microglobulin-1 and phosphorylated insulin-like growth factor-binding protein-1 tests were conducted before cervical length measurement via transvaginal ultrasound scanning. Caregivers were blinded to the biomarker test results. Medically indicated deliveries within 14 days of testing were excluded. Standard performance statistics with 95% confidence intervals were calculated and compared based on pairwise estimates from a generalized model. RESULTS: Of 403 subjects who were enrolled in the study cohort, 94% (383/403 women) met the inclusion criteria. Median gestational age and cervical length at presentation were 30+5 weeks and 27 mm, respectively; 6.8% women (26/383 women) had spontaneous birth ≤7 days from testing. The placental alpha microglobulin-1 test was positive in 7.8% of the women (30/383 women); the phosphorylated insulin-like growth factor-binding protein-1 test was positive in 29.5% women (113/383 women). Positive predictive value for placental alpha microglobulin-1, phosphorylated insulin-like growth factor-binding protein-1, and cervical length <25 mm for the prediction of spontaneous preterm birth in the overall cohort was 60.0% (18/30 women), 18.6% (21/113 women), 11.8% (18/152 women), respectively. The negative predictive value was 97.7% (345/353 women), 98.2% (265/270 women), 96.5% (223/231 women), respectively. The prevalence of spontaneous preterm birth in this group was 6.8% (26/383 women). The positive likelihood ratios were 20.6, 3.1, and 1.8, respectively. The negative likelihood ratio were 0.3, 0.3, and 0.5, respectively. Positive predictive values for placental alpha microglobulin-1 and phosphorylated insulin-like growth factor-binding protein-1 tests in patients with cervical length shortening of 15-30 mm for the prediction of spontaneous preterm birth were 60.9% (14/23 women) and 28.1% (16/57 women), respectively. The negative predictive values were 97.1% (168/173 women) and 97.8% (136/139 women), respectively. The prevalence of spontaneous preterm birth in the 15-30 mm cohort was 9.7% (19/196 women). The positive likelihood ratios were 14.5 and 3.6, respectively. The negative likelihood ratios were 0.3 and 0.2, respectively. CONCLUSION: Placental alpha microglobulin-1 is significantly more specific than phosphorylated insulin-like growth factor-binding protein-1 for the prediction of spontaneous preterm birth ≤7 days (P<.0001), whereas both tests have comparable sensitivity. In patients with cervical length 15-30 mm, although placental alpha microglobulin-1 has a significantly higher positive predictive value and specificity compared with phosphorylated insulin-like growth factor-binding protein-1 for the prediction of spontaneous preterm birth at ≤7 days (P<.01), both tests have a comparable sensitivity and negative predictive value. In conclusion, placental alpha microglobulin-1 is a better predictor of imminent spontaneous preterm birth when compared with phosphorylated insulin-like growth factor-binding protein-1 alone or in combination with cervical length measurement. In patients with shortening of cervical length of 15-30 mm, the placental alpha microglobulin-1 test is a significantly better predictor of imminent spontaneous preterm birth within 7 days of testing than is phosphorylated insulin-like growth factor-binding protein-1.

Report From the 20th Meeting of the European Society of Gynaecological Oncology (ESGO 2017).

This is a report from the 20th Meeting of the European Society of Gynaecological Oncology (ESGO) held in Vienna, Austria on November 4 to 7, 2017. The conference offered state-of-the-art educational sessions and oral and poster abstract presentations. The general sessions throughout the meeting focused not only on prevention, screening, diagnosis, treatment, and translational research but also emerging trends, and current innovations in gynecological cancers were discussed. The ESGO-European Society for Radiotherapy and Oncology-European Society of Pathology guidelines on management of cervical cancers were reported for the first time in public. Here, we highlight the key results of the latest trials for gynecological cancers presented for the first time at the ESGO 2017 Meeting and added great value to the congress scientific level.

Diagnostic performance of human epididymis protein 4 compared to a combination of biophysical and biochemical markers to differentiate ovarian endometriosis from epithelial ovarian cancer in premenopausal women.

AIM: This study is a comparison of human epididymis protein 4 (HE4) with cancer antigen 125 (CA125), using the Risk of Ovarian Malignancy Algorithm (ROMA), Copenhagen Index (CPH-I), Risk of Malignancy Index (RMI) and Morphology Index (MI) to differentiate ovarian endometriosis from epithelial ovarian cancer (EOC) in premenopausal women. METHODS: The study was performed at the University Clinic of Obstetrics and Gynecology in Skopje. One hundred and sixty-four premenopausal patients were divided into three study groups, including ovarian endometriosis (37), other benign pelvic masses (57) and EOCs (11), and a control group (59). After ultrasonography, all subjects underwent blood sampling. Surgery and histological verification was performed. Pelvic masses were classified based on histological findings. Mann-Whitney, receiver operating characteristic-area under the curve (AUC), sensitivity, specificity and Kruskal-Wallis tests were used for statistical analysis. The level of significance α was set at 5%. RESULTS: For each of the tested markers, sensitivity, specificity and accuracy to distinguish ovarian endometriosis from EOC were as follows: HE4 (81.82%, 100%, 95.83%); CA125 (81.82%, 48.65%, 56.25%); ROMA (90.91%, 83.78%, 85.42%); CPH-I (81.82%, 97.30%, 93.75%); RMI (90.91%, 35.14%, 47.92%); and MI (100%, 75.68%, 81.25%), respectively. The AUC for ovarian endometriosis compared to EOC for tested markers was as follows: HE4 (AUC = 0.934), CA125 (AUC = 0.821), ROMA (AUC = 0.929), CPH-I (AUC = 0.924) and RMI (AUC = 0.880), respectively. CONCLUSION: HE4 and CPH-I perform best to discriminate ovarian endometriosis from EOC in premenopausal women. MI has maximal sensitivity to detect EOC.

Comparison of a novel test for placental alpha microglobulin-1 with fetal fibronectin and cervical length measurement for the prediction of imminent spontaneous preterm delivery in patients with threatened preterm labor.

OBJECTIVE: PartoSure is a bedside test for the prediction of time-to-spontaneous preterm delivery by the detection of placental alpha microglobulin-1 (PAMG-1). The objectives of this study were to further determine the test's efficacy in predicting delivery within 7 or 14 days from testing, and to compare it with fetal fibronectin (fFN) and cervical length (CL) measurement by transvaginal ultrasound. STUDY DESIGN: The study population consisted of 203 consecutively recruited women with singleton pregnancies between 200/7 and 366/7 weeks of gestation with symptoms of preterm labor, clinically intact membranes, and cervical dilatation of ≤3 cm. PartoSure and CL were performed on all patients and the test-to-spontaneous-delivery interval was calculated. In a sub-segment of patients, the QuikCheck fFN test was used. RESULTS: The sensitivities for PartoSure (n=203), fFN (n=66), and CL (n=203) for predicting imminent spontaneous preterm delivery within 7 days were 80%, 50%, and 57%, respectively. The specificities were 95%, 72%, and 73% for PartoSure, fFN and CL, respectively. The NPVs were 96%, 87%, and 89% for PartoSure, fFN and CL, respectively. The PPVs were 76%, 29%, and 30% for PartoSure, fFN and CL, respectively. CONCLUSION: PAMG-1 detection by PartoSure is the single best predictor of imminent spontaneous delivery within 7 days compared to fFN and CL. In settings where CL is used as an initial screen, PartoSure has the greatest clinical utility in patients with CL between 15 and 35 mm. In situations where CL is not an initial screen, PartoSure is the most accurate test compared to fFN and CL.

Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery.

OBJECTIVE: The PartoSure time-to-delivery (TTD) test (AmniSure International, Boston, MA, USA) is a newly available bedside test for the prediction of time to spontaneous preterm delivery via the detection of placental alpha microglobulin-1. The objective of this study was to determine the efficacy of the test in predicting imminent delivery in 7 or 14 days from the time of testing. METHODS: The study population consisted of 101 consecutively recruited pregnant women with singleton pregnancies between 20+0 and 36+6 weeks of gestation with symptoms of preterm labor, clinically intact amniotic membranes, and minimal cervical dilatation (≤3 cm). The PartoSure TTD test was performed on these patients and the test-to-spontaneous-delivery interval was calculated. RESULTS: The PartoSure TTD test predicted spontaneous preterm delivery within 7 days with 90.0% sensitivity, 93.8% specificity, 97.4% negative predictive value (NPV), and 78.3% positive predictive value (PPV). The test predicted spontaneous preterm delivery within 14 days with 80% sensitivity, 96.1% specificity, 93.6% NPV, and 87.0% PPV. CONCLUSION: A positive PartoSure TTD test in patients presenting with symptoms of preterm labor, intact membranes, and minimal cervical dilatation (≤3 cm) indicated spontaneous preterm delivery will occur within 7 days with a high degree of accuracy. A negative result indicated that spontaneous preterm delivery within 14 days is highly unlikely.