Vitalba Gallitelli, Rita Franco, Sofia Guidi, Simona Zaami, Marco Parasiliti, Annalisa Vidiri, Federica Perelli, Francesco Plotti, Georgios Eleftheriou, Alberto Mattei, Giovanni Scambia, Anna Franca Cavaliere
Objective: The objective of this narrative review was twofold: to delineate the usage patterns of the main off-label drugs during pregnancy (i.e., misoprostol, nifedipine, and corticosteroids) and to offer a medical examiner's perspective on the use of these medications.
Methods: An extensive review of the literature was performed to assess the off-label use of corticosteroids, nifedipine, and misoprostol in pregnancy.
Results: Overall, 503 records about the use of off-label medicines during pregnancy were identified. After the exclusion of papers published in languages other than English and experimental studies in animals, 340 studies were considered eligible. Studies with medicines other than corticosteroids, misoprostol, and nifedipine were removed, leaving a total of 240 articles. From the remaining records, 24 reports were not retrieved. The research strategy allowed the final identification of 76 references.
Conclusion: Off-label drug use in obstetrics has transitioned from being an exception to a routine, scientifically validated practice. While its application is justified by clinical outcomes and international protocols, healthcare providers must navigate a strict framework of ethical and legal responsibility.
{"title":"Off-label use of drugs in pregnancy: A critical review of guidelines, current practices, and a clinical perspective.","authors":"Vitalba Gallitelli, Rita Franco, Sofia Guidi, Simona Zaami, Marco Parasiliti, Annalisa Vidiri, Federica Perelli, Francesco Plotti, Georgios Eleftheriou, Alberto Mattei, Giovanni Scambia, Anna Franca Cavaliere","doi":"10.1002/ijgo.70076","DOIUrl":"https://doi.org/10.1002/ijgo.70076","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this narrative review was twofold: to delineate the usage patterns of the main off-label drugs during pregnancy (i.e., misoprostol, nifedipine, and corticosteroids) and to offer a medical examiner's perspective on the use of these medications.</p><p><strong>Methods: </strong>An extensive review of the literature was performed to assess the off-label use of corticosteroids, nifedipine, and misoprostol in pregnancy.</p><p><strong>Results: </strong>Overall, 503 records about the use of off-label medicines during pregnancy were identified. After the exclusion of papers published in languages other than English and experimental studies in animals, 340 studies were considered eligible. Studies with medicines other than corticosteroids, misoprostol, and nifedipine were removed, leaving a total of 240 articles. From the remaining records, 24 reports were not retrieved. The research strategy allowed the final identification of 76 references.</p><p><strong>Conclusion: </strong>Off-label drug use in obstetrics has transitioned from being an exception to a routine, scientifically validated practice. While its application is justified by clinical outcomes and international protocols, healthcare providers must navigate a strict framework of ethical and legal responsibility.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ai Miyoshi, Fumiaki Isohashi, Makoto Fujii, Tadashi Iwamiya, Masahiko Takemura, Yoshikazu Nagase, Takeshi Yokoi, Emi Yoshioka, Kimihiko Ito, Eri Yamabe, Kanji Masuhara, Tomoko Tsujie, Tadashi Kimura, Michiko Kodama
Objective: Systemic platinum-based chemotherapy is the first-line treatment of choice for metastatic cervical cancer. While subsequent radiotherapy after primary chemotherapy is a potential option, its benefit remains unclear. This multicenter retrospective study aimed to evaluate whether post-chemotherapy radiotherapy improves the prognosis of metastatic cervical cancer.
Methods: We retrospectively analyzed 46 eligible patients, including 22 patients receiving chemotherapy-alone and 24 patients receiving chemotherapy followed by subsequent radiotherapy. Medical records were retrospectively reviewed for patient characteristics, subsequent treatment modality, adverse events during the treatment course, metastasis site, recurrence or progression, and recurrence sites. Fisher exact test or chi-squared test, the Mann-Whitney U test, log-rank test, and Cox proportional hazards model were used.
Results: The 2-year overall survival (OS) rate for all patients was 47%, with the median OS of 24.8 months. Patients receiving chemotherapy alone (chemotherapy-alone group) had a 2-year OS rate of 23%, while those receiving subsequent radiotherapy (chemotherapy-radiotherapy group) had a significantly higher OS rate of 67% (HR = 2.83, P = 0.006). The 2-year progression-free survival (PFS) rates were 9% and 33%, respectively (HR = 3.25, P = 0.010). Serious adverse events occurred in 46.2% of the chemotherapy-alone group and 29.2% of the chemotherapy-radiotherapy group during subsequent treatment (P = 0.249).
Conclusion: Post-chemotherapy radiotherapy may improve the prognosis of metastatic cervical cancer without increasing serious adverse events. Further prospective studies are warranted to validate these findings.
{"title":"The association between additional radiotherapy after systemic chemotherapy and the prognosis of stage FIGO 2018 IVB cervical cancer.","authors":"Ai Miyoshi, Fumiaki Isohashi, Makoto Fujii, Tadashi Iwamiya, Masahiko Takemura, Yoshikazu Nagase, Takeshi Yokoi, Emi Yoshioka, Kimihiko Ito, Eri Yamabe, Kanji Masuhara, Tomoko Tsujie, Tadashi Kimura, Michiko Kodama","doi":"10.1002/ijgo.70077","DOIUrl":"https://doi.org/10.1002/ijgo.70077","url":null,"abstract":"<p><strong>Objective: </strong>Systemic platinum-based chemotherapy is the first-line treatment of choice for metastatic cervical cancer. While subsequent radiotherapy after primary chemotherapy is a potential option, its benefit remains unclear. This multicenter retrospective study aimed to evaluate whether post-chemotherapy radiotherapy improves the prognosis of metastatic cervical cancer.</p><p><strong>Methods: </strong>We retrospectively analyzed 46 eligible patients, including 22 patients receiving chemotherapy-alone and 24 patients receiving chemotherapy followed by subsequent radiotherapy. Medical records were retrospectively reviewed for patient characteristics, subsequent treatment modality, adverse events during the treatment course, metastasis site, recurrence or progression, and recurrence sites. Fisher exact test or chi-squared test, the Mann-Whitney U test, log-rank test, and Cox proportional hazards model were used.</p><p><strong>Results: </strong>The 2-year overall survival (OS) rate for all patients was 47%, with the median OS of 24.8 months. Patients receiving chemotherapy alone (chemotherapy-alone group) had a 2-year OS rate of 23%, while those receiving subsequent radiotherapy (chemotherapy-radiotherapy group) had a significantly higher OS rate of 67% (HR = 2.83, P = 0.006). The 2-year progression-free survival (PFS) rates were 9% and 33%, respectively (HR = 3.25, P = 0.010). Serious adverse events occurred in 46.2% of the chemotherapy-alone group and 29.2% of the chemotherapy-radiotherapy group during subsequent treatment (P = 0.249).</p><p><strong>Conclusion: </strong>Post-chemotherapy radiotherapy may improve the prognosis of metastatic cervical cancer without increasing serious adverse events. Further prospective studies are warranted to validate these findings.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143676855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elizabeth Svoboda, Mélanie Benoit, Chelsea Almadin, Valérie Archer-Déjoie, Coralie Michaud, Julie Lacaille, Laurence Simard-Émond, Annick Pina, François Gougeon, Marie-Hélène Mayrand
Objectives: To compare topical imiquimod with CO2 laser therapy for the treatment of a first episode of vulvar high-grade squamous intraepithelial lesions (vHSIL), to identify serious adverse effects of both treatment modalities, and to examine risk factors for treatment failure.
Methods: This retrospective chart-based cohort study included 47 patients initially treated with topical imiquimod or CO2 laser therapy between 2017 and 2021. The primary outcome was treatment failure, defined as the need for repeat treatment. Cumulative incidence curves were used to compare the probability of treatment failure over time by treatment group. Potential risk factors for treatment failure, including age, treatment type, lesion focality, and smoking, were examined using Cox proportional hazards models to estimate adjusted hazard ratios (aHRs) and 95% confidence intervals (95% CIs).
Results: Sixty-six percent (31/47) of patients were initially treated with topical imiquimod and 34% (16/47) with CO2 laser. Both groups were similar in age, lesion focality, human papillomavirus vaccination, and smoking status. During a follow-up of 62.3 person-years, 52% (16/31) of patients treated with imiquimod and 56% (9/16) of patients treated with CO2 laser experienced treatment failure. Age over 52 years was associated with a higher risk of treatment failure (aHR 3.07, 95% CI 1.25-7.53). The association was positive but not significant for multifocal versus unifocal lesions and for smokers versus non-smokers. No serious adverse effects were observed with either treatment modality.
Conclusion: Topical imiquimod has similar efficacy and safety to CO2 laser therapy for initial the treatment of vHSIL. Older age is associated with an increased risk of treatment failure.
{"title":"CO<sub>2</sub> laser therapy versus topical imiquimod for the treatment of vulvar high-grade intraepithelial lesions: A retrospective cohort study.","authors":"Elizabeth Svoboda, Mélanie Benoit, Chelsea Almadin, Valérie Archer-Déjoie, Coralie Michaud, Julie Lacaille, Laurence Simard-Émond, Annick Pina, François Gougeon, Marie-Hélène Mayrand","doi":"10.1002/ijgo.70083","DOIUrl":"https://doi.org/10.1002/ijgo.70083","url":null,"abstract":"<p><strong>Objectives: </strong>To compare topical imiquimod with CO<sub>2</sub> laser therapy for the treatment of a first episode of vulvar high-grade squamous intraepithelial lesions (vHSIL), to identify serious adverse effects of both treatment modalities, and to examine risk factors for treatment failure.</p><p><strong>Methods: </strong>This retrospective chart-based cohort study included 47 patients initially treated with topical imiquimod or CO<sub>2</sub> laser therapy between 2017 and 2021. The primary outcome was treatment failure, defined as the need for repeat treatment. Cumulative incidence curves were used to compare the probability of treatment failure over time by treatment group. Potential risk factors for treatment failure, including age, treatment type, lesion focality, and smoking, were examined using Cox proportional hazards models to estimate adjusted hazard ratios (aHRs) and 95% confidence intervals (95% CIs).</p><p><strong>Results: </strong>Sixty-six percent (31/47) of patients were initially treated with topical imiquimod and 34% (16/47) with CO<sub>2</sub> laser. Both groups were similar in age, lesion focality, human papillomavirus vaccination, and smoking status. During a follow-up of 62.3 person-years, 52% (16/31) of patients treated with imiquimod and 56% (9/16) of patients treated with CO<sub>2</sub> laser experienced treatment failure. Age over 52 years was associated with a higher risk of treatment failure (aHR 3.07, 95% CI 1.25-7.53). The association was positive but not significant for multifocal versus unifocal lesions and for smokers versus non-smokers. No serious adverse effects were observed with either treatment modality.</p><p><strong>Conclusion: </strong>Topical imiquimod has similar efficacy and safety to CO<sub>2</sub> laser therapy for initial the treatment of vHSIL. Older age is associated with an increased risk of treatment failure.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Noa Gonen, Liat Mor, Daniel Rabinovich, Ilia Kleiner, Letizia Schreiber, Giulia Barda, Eran Weiner, Elad Barber
Objective: Placental abruption is a major obstetrical complication bearing potentially life-threatening consequences. Though the diagnosis of placental abruption is a clinical one, the nonspecific nature of common presenting symptoms, mainly vaginal bleeding and contractions, pose a challenge, and the contribution of placental pathology has been debated. In this study, we assessed the clinical significance of related placental lesions by comparing obstetric and neonatal outcomes among cases of placental abruption with versus without supporting histopathologic placental lesions.
Methods: We retrospectively analyzed placental abruption cases diagnosed during an 8-year period at a single tertiary center. Maternal, neonatal, and placental outcomes were compared between cases of placental abruption with versus without histopathologic placental lesions. The primary outcome was a composite of severe neonatal morbidity and included 1 ≤ of the following: seizures, intraventricular hemorrhage, hypoxic-ischemic encephalopathy, periventricular leukomalacia, necrotizing enterocolitis, blood transfusion or neonatal death.
Results: A total of 305 clinical placental abruption cases were included: 95 in the placental abruption with histopathologic lesions group (31.3%) and 210 without such lesions (68.8%). The group with histopathologic lesions was characterized by higher rates of vaginal bleeding at presentation and prematurity (P = 0.012 and P < 0.001, respectively). Additionally, this group had substantially higher rates of composite severe neonatal outcomes (the primary outcome) (P = 0.005) and concurrent maternal vascular malperfusion lesions (P < 0.001).
Conclusion: Our findings shed light on the association between placental abruption-related histopathologic lesions and adverse obstetric and neonatal outcomes. Thus, histopathologic examination can be advocated in suspected placental abruption, as patients with related placental lesions may require closer follow-up in subsequent pregnancies.
{"title":"Obstetric and neonatal outcomes in clinically diagnosed placental abruption with and without placental histopathologic confirmation-A retrospective study.","authors":"Noa Gonen, Liat Mor, Daniel Rabinovich, Ilia Kleiner, Letizia Schreiber, Giulia Barda, Eran Weiner, Elad Barber","doi":"10.1002/ijgo.70079","DOIUrl":"https://doi.org/10.1002/ijgo.70079","url":null,"abstract":"<p><strong>Objective: </strong>Placental abruption is a major obstetrical complication bearing potentially life-threatening consequences. Though the diagnosis of placental abruption is a clinical one, the nonspecific nature of common presenting symptoms, mainly vaginal bleeding and contractions, pose a challenge, and the contribution of placental pathology has been debated. In this study, we assessed the clinical significance of related placental lesions by comparing obstetric and neonatal outcomes among cases of placental abruption with versus without supporting histopathologic placental lesions.</p><p><strong>Methods: </strong>We retrospectively analyzed placental abruption cases diagnosed during an 8-year period at a single tertiary center. Maternal, neonatal, and placental outcomes were compared between cases of placental abruption with versus without histopathologic placental lesions. The primary outcome was a composite of severe neonatal morbidity and included 1 ≤ of the following: seizures, intraventricular hemorrhage, hypoxic-ischemic encephalopathy, periventricular leukomalacia, necrotizing enterocolitis, blood transfusion or neonatal death.</p><p><strong>Results: </strong>A total of 305 clinical placental abruption cases were included: 95 in the placental abruption with histopathologic lesions group (31.3%) and 210 without such lesions (68.8%). The group with histopathologic lesions was characterized by higher rates of vaginal bleeding at presentation and prematurity (P = 0.012 and P < 0.001, respectively). Additionally, this group had substantially higher rates of composite severe neonatal outcomes (the primary outcome) (P = 0.005) and concurrent maternal vascular malperfusion lesions (P < 0.001).</p><p><strong>Conclusion: </strong>Our findings shed light on the association between placental abruption-related histopathologic lesions and adverse obstetric and neonatal outcomes. Thus, histopathologic examination can be advocated in suspected placental abruption, as patients with related placental lesions may require closer follow-up in subsequent pregnancies.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ruiheng Peng, He Bai, Yani Wu, Mingxia Qian, Jun Zhang, Liqiang Zheng
Objective: To develop a perinatal outcomes measurement tool by extending the Weighted Adverse Outcome Score (WAOS).
Methods: An open-ended survey of five experienced experts was conducted to compile an initial list of WAOS extension components in the preliminary round, and the results were consolidated to form a Delphi questionnaire. A two-round modified e-Delphi survey of 29 obstetricians, neonatologists, scientists, and policymakers was conducted. During Delphi rounds, panelists rated the importance, scientific evidence, and feasibility of the proposed component. Severity scores were also assigned based on the WAOS criteria. After consensus was reached, the extension components were integrated with the original WAOS to create the Composite Adverse Perinatal Outcome (CAPO).
Results: In the preliminary round, an initial list of nine potential extension outcomes for WAOS was proposed. Six outcomes were further proposed after Delphi round 1. Consensus was reached after two Delphi rounds, resulting in 13 additional outcomes apart from WAOS. Each outcome was assigned a severity score ranging from 75 to 490 points. The final CAPO included seven maternal outcomes (postpartum hemorrhage, severe pre-eclampsia, deep vein thrombosis, disseminated intravascular coagulation, amniotic fluid embolism, placenta previa, morbidly adherent placenta) and six neonatal outcomes (preterm birth, low birth weight, meconium peritonitis, meconium aspiration syndrome, congenital malformation, neonatal sepsis), in addition to the 10 outcomes included in the WAOS.
Conclusions: Our study developed the CAPO index, which includes 23 maternal and neonatal outcomes, for a comprehensive evaluation of perinatal health. Further implementation and validation in clinical and research settings are anticipated.
{"title":"Enhancing perinatal outcome evaluation with the Composite Adverse Perinatal Outcome (CAPO) index: A modified Delphi study.","authors":"Ruiheng Peng, He Bai, Yani Wu, Mingxia Qian, Jun Zhang, Liqiang Zheng","doi":"10.1002/ijgo.70073","DOIUrl":"https://doi.org/10.1002/ijgo.70073","url":null,"abstract":"<p><strong>Objective: </strong>To develop a perinatal outcomes measurement tool by extending the Weighted Adverse Outcome Score (WAOS).</p><p><strong>Methods: </strong>An open-ended survey of five experienced experts was conducted to compile an initial list of WAOS extension components in the preliminary round, and the results were consolidated to form a Delphi questionnaire. A two-round modified e-Delphi survey of 29 obstetricians, neonatologists, scientists, and policymakers was conducted. During Delphi rounds, panelists rated the importance, scientific evidence, and feasibility of the proposed component. Severity scores were also assigned based on the WAOS criteria. After consensus was reached, the extension components were integrated with the original WAOS to create the Composite Adverse Perinatal Outcome (CAPO).</p><p><strong>Results: </strong>In the preliminary round, an initial list of nine potential extension outcomes for WAOS was proposed. Six outcomes were further proposed after Delphi round 1. Consensus was reached after two Delphi rounds, resulting in 13 additional outcomes apart from WAOS. Each outcome was assigned a severity score ranging from 75 to 490 points. The final CAPO included seven maternal outcomes (postpartum hemorrhage, severe pre-eclampsia, deep vein thrombosis, disseminated intravascular coagulation, amniotic fluid embolism, placenta previa, morbidly adherent placenta) and six neonatal outcomes (preterm birth, low birth weight, meconium peritonitis, meconium aspiration syndrome, congenital malformation, neonatal sepsis), in addition to the 10 outcomes included in the WAOS.</p><p><strong>Conclusions: </strong>Our study developed the CAPO index, which includes 23 maternal and neonatal outcomes, for a comprehensive evaluation of perinatal health. Further implementation and validation in clinical and research settings are anticipated.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Response: Comparing letters written by humans and ChatGPT: A preliminary study.","authors":"Shigeki Matsubara","doi":"10.1002/ijgo.70085","DOIUrl":"https://doi.org/10.1002/ijgo.70085","url":null,"abstract":"","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rebecca Luckett, Doreen Ramogola-Masire, Sikhulile Moyo, Annika Gompers, Anna Modest, Natasha Moraka, Thanolo Kashamba, Leabaneng Tawe, Farzad Noubary, Louise Kuhn, Surbhi Grover, Scott Dryden-Peterson, Greta Dreyer, Joseph Makhema, Matthys H Botha, Michele R Hacker, Roger Shapiro
Objective: The aim of this study was to evaluate the performance of HPV type restriction and cycle threshold (Ct)-limit setting to optimize detection of cervical intraepithelial neoplasia (CIN) with primary HPV testing.
Methods: Baseline cervical screening at time of entry into a prospective longitudinal cohort of women with and without HIV was conducted from February 2021 to July 2022 in Botswana. All women underwent HPV testing of 15 individual types using the AmpFire assay; all HPV-positive and a random subset of HPV negative had histopathology collected. Performance parameters of HPV type restriction groupings were calculated, and sensitivity by individual HPV type Ct-value limits were plotted.
Results: Among 2964 women who underwent primary HPV screening, 1293 (43.6%) tested HPV-positive. Among women with HIV (WWH), HPV types 16/18/33 were associated with the greatest burden of CIN2+/CIN3+ (53%/56%). In WWH, grouping by HPV types separately reported in commercial assays (16/18/45) had low sensitivity (44% [CI: 36%-52%]) but high specificity (86% [CI: 84%-88%]) for CIN2+; 8-type HPV restriction (16/18/31/33/35/45/52/58) improved sensitivity (79% [CI: 72%-86%]) and maintained reasonable specificity (67% [CI: 65%-70%]) for CIN2+. Similar results were seen in women without HIV. Ct-limit setting for medium oncogenic HPV types (31,33,35,52,58) maintained a sensitivity of 72% in WWH while reducing over-detection of non-pathogenic HPV.
Conclusion: Eight-type HPV restriction and Ct-limit setting are promising strategies for improving the performance of primary HPV screening. A potential strategy to improve 8-type HPV restriction would be to treat all with HPV 16/18/45; treat HPV 31/33/35/52/58 if below the type-specific Ct limit and repeat HPV testing in 1-year for other positive HPV results.
{"title":"Improved cervical screening using HPV type restriction and cycle threshold limit setting with the AmpFire assay: A prospective screening cohort of women with and without HIV in Botswana.","authors":"Rebecca Luckett, Doreen Ramogola-Masire, Sikhulile Moyo, Annika Gompers, Anna Modest, Natasha Moraka, Thanolo Kashamba, Leabaneng Tawe, Farzad Noubary, Louise Kuhn, Surbhi Grover, Scott Dryden-Peterson, Greta Dreyer, Joseph Makhema, Matthys H Botha, Michele R Hacker, Roger Shapiro","doi":"10.1002/ijgo.70074","DOIUrl":"https://doi.org/10.1002/ijgo.70074","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to evaluate the performance of HPV type restriction and cycle threshold (Ct)-limit setting to optimize detection of cervical intraepithelial neoplasia (CIN) with primary HPV testing.</p><p><strong>Methods: </strong>Baseline cervical screening at time of entry into a prospective longitudinal cohort of women with and without HIV was conducted from February 2021 to July 2022 in Botswana. All women underwent HPV testing of 15 individual types using the AmpFire assay; all HPV-positive and a random subset of HPV negative had histopathology collected. Performance parameters of HPV type restriction groupings were calculated, and sensitivity by individual HPV type Ct-value limits were plotted.</p><p><strong>Results: </strong>Among 2964 women who underwent primary HPV screening, 1293 (43.6%) tested HPV-positive. Among women with HIV (WWH), HPV types 16/18/33 were associated with the greatest burden of CIN2+/CIN3+ (53%/56%). In WWH, grouping by HPV types separately reported in commercial assays (16/18/45) had low sensitivity (44% [CI: 36%-52%]) but high specificity (86% [CI: 84%-88%]) for CIN2+; 8-type HPV restriction (16/18/31/33/35/45/52/58) improved sensitivity (79% [CI: 72%-86%]) and maintained reasonable specificity (67% [CI: 65%-70%]) for CIN2+. Similar results were seen in women without HIV. Ct-limit setting for medium oncogenic HPV types (31,33,35,52,58) maintained a sensitivity of 72% in WWH while reducing over-detection of non-pathogenic HPV.</p><p><strong>Conclusion: </strong>Eight-type HPV restriction and Ct-limit setting are promising strategies for improving the performance of primary HPV screening. A potential strategy to improve 8-type HPV restriction would be to treat all with HPV 16/18/45; treat HPV 31/33/35/52/58 if below the type-specific Ct limit and repeat HPV testing in 1-year for other positive HPV results.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Detection algorithms targeting anatomic landmarks in three-dimensional (3D) ultrasound (US) volume (three-dimensional US) appear to be a relevant and easy-to-implement option to address junior and occasional operators' difficulties in probe positioning for two-dimensional (2D) fetal biometry.
Objectives: This study assesses the feasibility of complete automation for fetal biometry and the resulting agreement with standard 2D (US) measurements. The secondary objectives were to assess the impact of software-driven measurement on image quality scoring, reproducibility, and agreement with human-driven measurements issued from the same volumes.
Methods: Datasets were collected from a consecutive sample of women attending standard US follow-up (singleton, 16-30 weeks of gestation). Each dataset contained 2D measurements for reference (head and abdomen circumference and femoral length) and 3D US volume acquisitions of the fetal head, abdomen, and thigh. Both algorithm-based and operator-based detection of the targeted plans and calipers positioning were applied to the 3D volumes to produce software-driven and human-driven measurements. The resulting 3D measurements were assessed for completion rates, image quality, and reproducibility.
Results: On 175 datasets collected, completion rates in achieving software-driven 3D measurements ranged between 94% (abdomen) and 100% (head). A modest weakening in quality (of uncertain clinical significance) was notable for the head and abdomen measurements. Compared to the 2D measurements, the software-driven tended to slightly overestimate the estimated fetal weight (EFW; e.g., 95% confidence interval ranging from 445 to 635 g for a 525 g-sized fetus at 22 weeks of gestation). The random error tended to be inflated for fetuses >700 g. Intra- and inter-operator reproducibility were appropriate (intraclass correlation coefficient intervals ranged from 0.8 to 0.99).
Conclusion: Complete automation of US biometry appears feasible and presents appropriate reproducibility and image quality scoring, but third-trimester biometry needs improvement. Before clinical implementation, it is time to assess the impact of point-of-care use on large populations.
{"title":"Volume-based complete automation for ultrasound fetal biometry: A pilot approach to assess feasibility, reliability, and perspectives.","authors":"Gaëlle Ambroise Grandjean, Matthieu Dap, Cybele Ciofolo-Veit, Laurence Rouet, Yohan Damas, Claire Banasiak, Laurence Bourguignon, Adeline Collin, Olivier Morel, Gabriela Hossu","doi":"10.1002/ijgo.70041","DOIUrl":"https://doi.org/10.1002/ijgo.70041","url":null,"abstract":"<p><strong>Background: </strong>Detection algorithms targeting anatomic landmarks in three-dimensional (3D) ultrasound (US) volume (three-dimensional US) appear to be a relevant and easy-to-implement option to address junior and occasional operators' difficulties in probe positioning for two-dimensional (2D) fetal biometry.</p><p><strong>Objectives: </strong>This study assesses the feasibility of complete automation for fetal biometry and the resulting agreement with standard 2D (US) measurements. The secondary objectives were to assess the impact of software-driven measurement on image quality scoring, reproducibility, and agreement with human-driven measurements issued from the same volumes.</p><p><strong>Methods: </strong>Datasets were collected from a consecutive sample of women attending standard US follow-up (singleton, 16-30 weeks of gestation). Each dataset contained 2D measurements for reference (head and abdomen circumference and femoral length) and 3D US volume acquisitions of the fetal head, abdomen, and thigh. Both algorithm-based and operator-based detection of the targeted plans and calipers positioning were applied to the 3D volumes to produce software-driven and human-driven measurements. The resulting 3D measurements were assessed for completion rates, image quality, and reproducibility.</p><p><strong>Results: </strong>On 175 datasets collected, completion rates in achieving software-driven 3D measurements ranged between 94% (abdomen) and 100% (head). A modest weakening in quality (of uncertain clinical significance) was notable for the head and abdomen measurements. Compared to the 2D measurements, the software-driven tended to slightly overestimate the estimated fetal weight (EFW; e.g., 95% confidence interval ranging from 445 to 635 g for a 525 g-sized fetus at 22 weeks of gestation). The random error tended to be inflated for fetuses >700 g. Intra- and inter-operator reproducibility were appropriate (intraclass correlation coefficient intervals ranged from 0.8 to 0.99).</p><p><strong>Conclusion: </strong>Complete automation of US biometry appears feasible and presents appropriate reproducibility and image quality scoring, but third-trimester biometry needs improvement. Before clinical implementation, it is time to assess the impact of point-of-care use on large populations.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura Puroski, Sophia Braund, Olivia Guerin, Eric Verspyck, Patrice Crochet, Salma Touleimat
Objective: This study aimed to explore the perceptions of French residents and academic teachers regarding residents' autonomy during training and their preparedness to perform standard gynecological procedures.
Methods: A national survey of French obstetrics and gynecology residents and their academic teachers was conducted using an online questionnaire distributed in 2023, which gathered opinions on the level of autonomy granted in the operating room for performing standard gynecological procedures and perceptions of preparedness upon graduation. The survey also examined perceptions on the impact of factors that improve surgical autonomy.
Results: The response rate was 43% (510/1197) for residents and 31% (42/137) for academic teachers. The opinions of residents and academic teachers regarding residents' surgical preparedness by graduation were similar, except for vaginal hysterectomy (30% vs. 57%, P < 0.001). Residents were thought prepared to perform hysteroscopy and adnexal surgery by laparoscopy by >90% of respondents. Regarding hysterectomy, opinions varied depending on the approach: the only approach for which more than two-thirds of residents (67%) were thought to be prepared by gradation was laparoscopy. Regarding factors promoting surgical autonomy, 99% of residents and 97% of teachers considered case volume and coaching quality essential. Only 37% of residents and 55% of teachers deemed the introduction of summative assessment relevant.
Conclusion: French residents and academic teachers reported adequate preparedness for hysteroscopy and adnexal surgery. There were concerns regarding preparedness for more complex surgeries, particularly laparotomic and vaginal hysterectomy. These findings underscore the need for revisions in training methods and residency objectives.
{"title":"Gynecology residents' preparedness to perform standard gynecological procedures autonomously: A national survey among French residents and faculty.","authors":"Laura Puroski, Sophia Braund, Olivia Guerin, Eric Verspyck, Patrice Crochet, Salma Touleimat","doi":"10.1002/ijgo.70068","DOIUrl":"https://doi.org/10.1002/ijgo.70068","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to explore the perceptions of French residents and academic teachers regarding residents' autonomy during training and their preparedness to perform standard gynecological procedures.</p><p><strong>Methods: </strong>A national survey of French obstetrics and gynecology residents and their academic teachers was conducted using an online questionnaire distributed in 2023, which gathered opinions on the level of autonomy granted in the operating room for performing standard gynecological procedures and perceptions of preparedness upon graduation. The survey also examined perceptions on the impact of factors that improve surgical autonomy.</p><p><strong>Results: </strong>The response rate was 43% (510/1197) for residents and 31% (42/137) for academic teachers. The opinions of residents and academic teachers regarding residents' surgical preparedness by graduation were similar, except for vaginal hysterectomy (30% vs. 57%, P < 0.001). Residents were thought prepared to perform hysteroscopy and adnexal surgery by laparoscopy by >90% of respondents. Regarding hysterectomy, opinions varied depending on the approach: the only approach for which more than two-thirds of residents (67%) were thought to be prepared by gradation was laparoscopy. Regarding factors promoting surgical autonomy, 99% of residents and 97% of teachers considered case volume and coaching quality essential. Only 37% of residents and 55% of teachers deemed the introduction of summative assessment relevant.</p><p><strong>Conclusion: </strong>French residents and academic teachers reported adequate preparedness for hysteroscopy and adnexal surgery. There were concerns regarding preparedness for more complex surgeries, particularly laparotomic and vaginal hysterectomy. These findings underscore the need for revisions in training methods and residency objectives.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143648449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. This case study aims to assess current PPH at our study site hospital, identify strategies to enhance management based on audit findings, and pilot test the feasibility and acceptability of these strategies.
Methods: A criteria-based audit (CBA) was conducted at La Maternidad Renee Klang Viuda Guzman Hospital in Santiago, Dominican Republic from November 2021 to September 2022. The audit assessed current practice through surveys of 59 healthcare workers and a retrospective review of 10 PPH cases, using eight evidence-based criteria. Audit findings informed the development of a PPH toolkit, protocol, and simulation-based training program (SBT). The toolkit's impact was evaluated through surveys, and SBT effectiveness was assess through post-training feedback from participants.
Results: The baseline audit revealed 25% compliance with evidence-based criteria. Key gaps included maternal risk assessment, provider training, and protocol use. Targeted strategies, including a PPH toolkit, protocol and SBT, were implemented. Of the 13 toolkit users, 92% felt it improved timely management. Post-SBT surveys showed that participants rated the training highly, with significant improvements in communication, teamwork, and self-reported competence in PPH management.
Conclusion: CBAs are effective in identifying care barriers in middle-income settings. The PPH toolkit and SBT were well received and improved both technical and non-technical skills, offering a scalable model for improving PPH management in low-resource settings.
{"title":"Leveraging a criteria-based audit approach to identify challenges and develop strategies to improve management of postpartum hemorrhage: A case study from the Dominican Republic.","authors":"Paxton Voigt, Beralis Ramos, Sasha Hernandez, Roberlina Hernandez, Manuel Jimenez, Cayetano Collado, Taraneh Shirazian","doi":"10.1002/ijgo.70038","DOIUrl":"https://doi.org/10.1002/ijgo.70038","url":null,"abstract":"<p><strong>Objective: </strong>Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. This case study aims to assess current PPH at our study site hospital, identify strategies to enhance management based on audit findings, and pilot test the feasibility and acceptability of these strategies.</p><p><strong>Methods: </strong>A criteria-based audit (CBA) was conducted at La Maternidad Renee Klang Viuda Guzman Hospital in Santiago, Dominican Republic from November 2021 to September 2022. The audit assessed current practice through surveys of 59 healthcare workers and a retrospective review of 10 PPH cases, using eight evidence-based criteria. Audit findings informed the development of a PPH toolkit, protocol, and simulation-based training program (SBT). The toolkit's impact was evaluated through surveys, and SBT effectiveness was assess through post-training feedback from participants.</p><p><strong>Results: </strong>The baseline audit revealed 25% compliance with evidence-based criteria. Key gaps included maternal risk assessment, provider training, and protocol use. Targeted strategies, including a PPH toolkit, protocol and SBT, were implemented. Of the 13 toolkit users, 92% felt it improved timely management. Post-SBT surveys showed that participants rated the training highly, with significant improvements in communication, teamwork, and self-reported competence in PPH management.</p><p><strong>Conclusion: </strong>CBAs are effective in identifying care barriers in middle-income settings. The PPH toolkit and SBT were well received and improved both technical and non-technical skills, offering a scalable model for improving PPH management in low-resource settings.</p>","PeriodicalId":14164,"journal":{"name":"International Journal of Gynecology & Obstetrics","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143648452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}