Pub Date : 2023-08-01DOI: 10.1097/ogx.0000000000001185
H. Stepan, A. Galindo, M. Hund, D. Schlembach, J. Sillman, D. Surbek, M. Vatish
ABSTRACT Preeclampsia is a serious hypertensive disorder of pregnancy that can deteriorate into eclampsia or HELLP syndrome and ultimately result in severe maternal morbidity or mortality. In addition to possible complications for the mother, preeclampsia and its additional complications can lead to adverse outcomes for infants, both before and after birth. Because of the serious consequences associated with preeclampsia, current practice guidelines recommend the screening of all pregnant patients for risk of preeclampsia in the first trimester and consistent monitoring for the development of preeclampsia later in pregnancy. Recommendations also include that women who are diagnosed with preeclampsia are closely monitored to prevent further complications such as preterm birth, as well as monitoring for fetal growth restriction (FGR). There are serum markers that are known to be related to preeclampsia, such as proangiogenic placental growth factor (PlGF) and antiangiogenic soluble fms-like tyrosine kinase-1 (sFlt-1). This article is a review aiming to summarize current knowledge about PlGF and sFlt-1, their performance, and potential alteration in diagnosis and monitoring of preeclampsia. Factors such as these have trends that occur in normal pregnancy and different trends that tend to occur in a pregnancy that is abnormal. In a healthy pregnancy, sFlt-1 increases in the third trimester, but in patients who later develop preeclampsia or FGR, it tends to increase sooner. Recent studies have shown that the interaction between sFlt-1 and PlGF reduces the amount of PlGF in circulating in the blood, causing a cascade of other effects. In addition, a decrease in PlGF is known to be associated with the development of preeclampsia. Because of this interaction, the ratio of sFlt-1 to PlGF can be used as a diagnostic tool; an increasing ratio can indicate development of preeclampsia. In addition to predicting preeclampsia, sFlt-1 and PlGF have been shown to be helpful in managing preeclampsia that has already been diagnosed. Monitoring the ratio of sFlt-1 to PlGF has shown a correlation between a higher ratio and imminent preterm delivery due to preeclampsia. It has also proven to be a predictor of other adverse outcomes such as preterm delivery and FGR, as well as stillbirth and complications of multiple pregnancies. Recent data show robust enough associations between sFlt-1 and PlGF that it can reasonably be used for predicting short-term development of preeclampsia, monitoring preeclampsia that has been previously diagnosed and predicting other disorders of the placenta. These factors can be particularly useful in guiding treatment of those whose symptoms are not a clear enough indicator on their own for preeclampsia, but who may be in danger of complications if left untreated. In particular, the most impactful clinical outcome comes when both sFlt-1 and PlGF levels are monitored, as the interaction between the 2 gives the most relevant information, wher
{"title":"Clinical Utility of sFlt-1 and PlGF in Screening, Prediction, Diagnosis and Monitoring of Pre-eclampsia and Fetal Growth Restriction","authors":"H. Stepan, A. Galindo, M. Hund, D. Schlembach, J. Sillman, D. Surbek, M. Vatish","doi":"10.1097/ogx.0000000000001185","DOIUrl":"https://doi.org/10.1097/ogx.0000000000001185","url":null,"abstract":"ABSTRACT Preeclampsia is a serious hypertensive disorder of pregnancy that can deteriorate into eclampsia or HELLP syndrome and ultimately result in severe maternal morbidity or mortality. In addition to possible complications for the mother, preeclampsia and its additional complications can lead to adverse outcomes for infants, both before and after birth. Because of the serious consequences associated with preeclampsia, current practice guidelines recommend the screening of all pregnant patients for risk of preeclampsia in the first trimester and consistent monitoring for the development of preeclampsia later in pregnancy. Recommendations also include that women who are diagnosed with preeclampsia are closely monitored to prevent further complications such as preterm birth, as well as monitoring for fetal growth restriction (FGR). There are serum markers that are known to be related to preeclampsia, such as proangiogenic placental growth factor (PlGF) and antiangiogenic soluble fms-like tyrosine kinase-1 (sFlt-1). This article is a review aiming to summarize current knowledge about PlGF and sFlt-1, their performance, and potential alteration in diagnosis and monitoring of preeclampsia. Factors such as these have trends that occur in normal pregnancy and different trends that tend to occur in a pregnancy that is abnormal. In a healthy pregnancy, sFlt-1 increases in the third trimester, but in patients who later develop preeclampsia or FGR, it tends to increase sooner. Recent studies have shown that the interaction between sFlt-1 and PlGF reduces the amount of PlGF in circulating in the blood, causing a cascade of other effects. In addition, a decrease in PlGF is known to be associated with the development of preeclampsia. Because of this interaction, the ratio of sFlt-1 to PlGF can be used as a diagnostic tool; an increasing ratio can indicate development of preeclampsia. In addition to predicting preeclampsia, sFlt-1 and PlGF have been shown to be helpful in managing preeclampsia that has already been diagnosed. Monitoring the ratio of sFlt-1 to PlGF has shown a correlation between a higher ratio and imminent preterm delivery due to preeclampsia. It has also proven to be a predictor of other adverse outcomes such as preterm delivery and FGR, as well as stillbirth and complications of multiple pregnancies. Recent data show robust enough associations between sFlt-1 and PlGF that it can reasonably be used for predicting short-term development of preeclampsia, monitoring preeclampsia that has been previously diagnosed and predicting other disorders of the placenta. These factors can be particularly useful in guiding treatment of those whose symptoms are not a clear enough indicator on their own for preeclampsia, but who may be in danger of complications if left untreated. In particular, the most impactful clinical outcome comes when both sFlt-1 and PlGF levels are monitored, as the interaction between the 2 gives the most relevant information, wher","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135222838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/ogx.0000000000001193
{"title":"CME PROGRAM EXAM AND ANSWER SHEET","authors":"","doi":"10.1097/ogx.0000000000001193","DOIUrl":"https://doi.org/10.1097/ogx.0000000000001193","url":null,"abstract":"","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136106144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/01.ogx.0000967024.88312.e0
G. Nelson, C. Fotopoulou, J. Taylor, G. Glaser, J. Bakkum-Gamez, L. A. Meyer, R. Stone, G. Mena, K. M. Elias, A. D. Altman, S. P. Bisch, P. T. Ramirez, S. C. Dowdy
ABSTRACT Implementation of the Enhanced Recovery after Surgery (ERAS) Society Guidelines in 2016 has resulted in an approximate decrease in hospital length of stay (LOS), reduction in complications and readmission, and cost saving. Recent publications however have demonstrated that barriers and gaps in understanding may result in many ERAS recommendations being poorly adhered to in gynecologic oncology patients. The aims of this second update to the ERAS Society Guidelines for gynecologic oncology is to summarize and update the evidence investigating specific implementation challenges to increase ERAS uptake and improve clinical outcomes for patients. A literature search was conducted for topics specified to 9 ERAS implementation challenges identified: perioperative oral intake safety, preoperative medication importance, penicillin allergies, intraoperative analgesia, how to manage urinary drainage, venous thromboembolism prophylaxis, postoperative opioid prescription practices, same-day discharge programs, and how can I overcome barriers to ERAS implementation. The quality of evidence and recommendations was evaluated, and recommendations graded as strong or weak based on quality, balance between desirable and undesirable effects on holistic clinical outcomes, and on values and preferences of practitioners. Regarding perioperative oral intake safety, patients should be encouraged to consume clear liquids in 2 hours before surgery and preoperative carbohydrate loading improves satisfaction and comfort. Optimal preoperative medications include nonsteroidal anti-inflammatory drugs, acetaminophen, and gabapentinoids. Patients with penicillin allergies should receive standard surgical antibiotic prophylaxis. For intraoperative analgesia, wound infiltration with local anesthetic and TAP block are preferred over thoracic epidural analgesia. Indwelling bladder catheters should be removed as early as possible in the postoperative period such as on the day of surgery for minimally invasive procedures and no later than postoperative day 1 for laparotomy. Patients at increased risk of venous thromboembolism should receive dual prophylaxis with compression and medications, and extended chemoprophylaxis should be prescribed to those with high-risk criteria or after laparotomy. Multimodal opioid-reduction is critical for all patients, and decreased postdischarge opioid proscribing is improved with a team approach and does not affect pain control or patient satisfaction. Patient controlled analgesia is a last resort for those requiring repeated treatment with intravenous opioids. Multidisciplinary same-day discharge programs should be considered in minimally invasive surgeries, and implementation requires a multidisciplinary team approach with patient education, case selection, and ERAS principles. Overcoming barriers to ERAS principles is more successful with changes at the management level and education. Communication of the economic benefits of ERAS to admin
{"title":"Enhanced Recovery After Surgery (ERAS®) Society Guidelines for Gynecologic Oncology: Addressing Implementation Challenges - 2023 Update","authors":"G. Nelson, C. Fotopoulou, J. Taylor, G. Glaser, J. Bakkum-Gamez, L. A. Meyer, R. Stone, G. Mena, K. M. Elias, A. D. Altman, S. P. Bisch, P. T. Ramirez, S. C. Dowdy","doi":"10.1097/01.ogx.0000967024.88312.e0","DOIUrl":"https://doi.org/10.1097/01.ogx.0000967024.88312.e0","url":null,"abstract":"ABSTRACT Implementation of the Enhanced Recovery after Surgery (ERAS) Society Guidelines in 2016 has resulted in an approximate decrease in hospital length of stay (LOS), reduction in complications and readmission, and cost saving. Recent publications however have demonstrated that barriers and gaps in understanding may result in many ERAS recommendations being poorly adhered to in gynecologic oncology patients. The aims of this second update to the ERAS Society Guidelines for gynecologic oncology is to summarize and update the evidence investigating specific implementation challenges to increase ERAS uptake and improve clinical outcomes for patients. A literature search was conducted for topics specified to 9 ERAS implementation challenges identified: perioperative oral intake safety, preoperative medication importance, penicillin allergies, intraoperative analgesia, how to manage urinary drainage, venous thromboembolism prophylaxis, postoperative opioid prescription practices, same-day discharge programs, and how can I overcome barriers to ERAS implementation. The quality of evidence and recommendations was evaluated, and recommendations graded as strong or weak based on quality, balance between desirable and undesirable effects on holistic clinical outcomes, and on values and preferences of practitioners. Regarding perioperative oral intake safety, patients should be encouraged to consume clear liquids in 2 hours before surgery and preoperative carbohydrate loading improves satisfaction and comfort. Optimal preoperative medications include nonsteroidal anti-inflammatory drugs, acetaminophen, and gabapentinoids. Patients with penicillin allergies should receive standard surgical antibiotic prophylaxis. For intraoperative analgesia, wound infiltration with local anesthetic and TAP block are preferred over thoracic epidural analgesia. Indwelling bladder catheters should be removed as early as possible in the postoperative period such as on the day of surgery for minimally invasive procedures and no later than postoperative day 1 for laparotomy. Patients at increased risk of venous thromboembolism should receive dual prophylaxis with compression and medications, and extended chemoprophylaxis should be prescribed to those with high-risk criteria or after laparotomy. Multimodal opioid-reduction is critical for all patients, and decreased postdischarge opioid proscribing is improved with a team approach and does not affect pain control or patient satisfaction. Patient controlled analgesia is a last resort for those requiring repeated treatment with intravenous opioids. Multidisciplinary same-day discharge programs should be considered in minimally invasive surgeries, and implementation requires a multidisciplinary team approach with patient education, case selection, and ERAS principles. Overcoming barriers to ERAS principles is more successful with changes at the management level and education. Communication of the economic benefits of ERAS to admin","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136107080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/01.ogx.0000967020.48960.63
Anne Høy Seemann Vestergaard, Mette Asbjoern Neergaard, Lars Ulrik Fokdal, Christian Fynbo Christiansen, Jan Brink Valentin, Søren Paaske Johnsen
ABSTRACT Although chemotherapy and short-course radiotherapy play important roles in the palliative management of gynecological cancers, these may be associated with significant discomfort and minimal symptom control in advanced disease. Terminally ill patients approaching death may have complex palliative care needs that cannot be resolved in general care practices and require multidisciplinary specialist palliative care services (SPC). Timely access to SPCs is associated with improved quality of life and reduced high-intensity care during the end-of-life phase; however, the role of palliative care on high-intensity interventions at the end of life in patients with gynecological cancers has not been examined in large-scale studies. This nationwide registry-based study aimed to examine the temporal trends, predictors of use, and relationship with high-intensity treatments in hospital-based SPC utilization among patients with gynecological malignancies. All adults in Denmark who died of gynecological cancer between 2010 and 2016 were included. Demographic, financial, and oncological data were obtained for each patient. Utilization of SPC included care provided during hospital admissions, in outpatient clinics, or in the patients' own home. High-intensity end of life care included invasive treatments (chemotherapy, surgery, and radiation), use of services such as emergency department visits, intensive care unit admissions, or more than 1 hospital admission within 30 days, as well as no hospice admissions in the prior year or a patient death in the hospital. Binary regression was used to estimate the chance of receiving hospital-based SPC and the adjusted relative risk of high-intensity end of life care by potential predictors including cancer type, age at death, comorbidity score, region of residence, marital status, income level, migrant status, and FIGO cancer stage. A total of 4502 patients with cervical cancer (n = 708), ovarian cancer (n = 2595), and endometrial cancer (n = 1199) were identified, of whom 179 (40.0%) accessed SPC. The proportion of patients dying of gynecological cancer and receiving SPC increased from 24.2% in 2010 to 50.7% in 2016. Each potential predictor studied was associated with receiving SPC at the end of life, with the strongest associations after adjustment for year of death between 2014 and 2016, younger age, 3 or more comorbidities, residence in Danish regions other than the Capital region, and being an immigrant or descendant. Patients aged 60 to 69 had a 24% decreased chance of receiving SPC compared with those aged 18 to 59 (adjusted relative risk [aRR], 0.76; 95% confidence interval [CI], 0.69–0.83), and as age increased, the proportion of those that received SPC decreased further. Those with 3 or more comorbidities had a 23% higher chance of receiving SPC (aRR 1.23; 95% CI, 1.13–1.34). Compared with nonimmigrants, immigrants and descendants were 29% more likely to receive SPC (aRR, 1.29; 95% CI, 1.14–1.96). Hos
{"title":"Utilisation of Hospital-Based Specialist Palliative Care in Patients With Gynaecological Cancer: Temporal Trends, Predictors and Association With High-Intensity End-of-Life Care","authors":"Anne Høy Seemann Vestergaard, Mette Asbjoern Neergaard, Lars Ulrik Fokdal, Christian Fynbo Christiansen, Jan Brink Valentin, Søren Paaske Johnsen","doi":"10.1097/01.ogx.0000967020.48960.63","DOIUrl":"https://doi.org/10.1097/01.ogx.0000967020.48960.63","url":null,"abstract":"ABSTRACT Although chemotherapy and short-course radiotherapy play important roles in the palliative management of gynecological cancers, these may be associated with significant discomfort and minimal symptom control in advanced disease. Terminally ill patients approaching death may have complex palliative care needs that cannot be resolved in general care practices and require multidisciplinary specialist palliative care services (SPC). Timely access to SPCs is associated with improved quality of life and reduced high-intensity care during the end-of-life phase; however, the role of palliative care on high-intensity interventions at the end of life in patients with gynecological cancers has not been examined in large-scale studies. This nationwide registry-based study aimed to examine the temporal trends, predictors of use, and relationship with high-intensity treatments in hospital-based SPC utilization among patients with gynecological malignancies. All adults in Denmark who died of gynecological cancer between 2010 and 2016 were included. Demographic, financial, and oncological data were obtained for each patient. Utilization of SPC included care provided during hospital admissions, in outpatient clinics, or in the patients' own home. High-intensity end of life care included invasive treatments (chemotherapy, surgery, and radiation), use of services such as emergency department visits, intensive care unit admissions, or more than 1 hospital admission within 30 days, as well as no hospice admissions in the prior year or a patient death in the hospital. Binary regression was used to estimate the chance of receiving hospital-based SPC and the adjusted relative risk of high-intensity end of life care by potential predictors including cancer type, age at death, comorbidity score, region of residence, marital status, income level, migrant status, and FIGO cancer stage. A total of 4502 patients with cervical cancer (n = 708), ovarian cancer (n = 2595), and endometrial cancer (n = 1199) were identified, of whom 179 (40.0%) accessed SPC. The proportion of patients dying of gynecological cancer and receiving SPC increased from 24.2% in 2010 to 50.7% in 2016. Each potential predictor studied was associated with receiving SPC at the end of life, with the strongest associations after adjustment for year of death between 2014 and 2016, younger age, 3 or more comorbidities, residence in Danish regions other than the Capital region, and being an immigrant or descendant. Patients aged 60 to 69 had a 24% decreased chance of receiving SPC compared with those aged 18 to 59 (adjusted relative risk [aRR], 0.76; 95% confidence interval [CI], 0.69–0.83), and as age increased, the proportion of those that received SPC decreased further. Those with 3 or more comorbidities had a 23% higher chance of receiving SPC (aRR 1.23; 95% CI, 1.13–1.34). Compared with nonimmigrants, immigrants and descendants were 29% more likely to receive SPC (aRR, 1.29; 95% CI, 1.14–1.96). Hos","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136107081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/01.ogx.0000967000.16402.41
Allie Sakowicz, Salwa J. Zahalka, Emily S. Miller
ABSTRACT Vacuum-assisted vaginal delivery (VAVD) is used to expedite vaginal delivery in cases of an arrest of descent, maternal exhaustion, or concern for fetal well-being. In 2015, the rate of VAVD was greater than the use of forceps in the United States (2.58% vs 0.56%). Several studies have examined various characteristics of vacuum devices, such as cup shape and material, number of pulls, and number of pop-ups, which is defined as the spontaneous dislodgment of the cup from the fetal scalp. Vacuum manufacturers, such as Kiwi and Mityvac, recommend abandoning VAVD as an intervention after 2 or 3 pop-offs; however, the American College of Obstetricians and Gynecologists acknowledges that there are not enough data to recommend guidelines on how many pop-offs should be allowed before discontinuing. Some studies have demonstrated an increased risk of adverse neonatal outcomes with any number of pop-offs versus no pop-offs, whereas other studies have shown no independent association between the number of pop-offs and neonatal head injury. In addition, compared with an increase in the number of pop-offs, a large multicenter study found that increased duration of VAVD has a stronger association with adverse outcomes. The aim of this study was to examine the association between the number of pop-offs and adverse neonatal outcomes. This was a retrospective cohort study conducted at a single tertiary care institution from October 1, 2005, to June 1, 2014. Data were collected from electronic medical records. Included were adult women with singleton pregnancies who delivered via VAVD or a trial of VAVD followed by cesarean delivery. Excluded were those who underwent sequential trials of both vacuum and forceps. Institutional policy recommended converting to cesarean delivery after >3 pop-offs, but the decision was left to the discretion of the physician. The primary outcome was a composite of severe adverse neonatal outcome, including brachial plexus injury, intracranial hemorrhage, convulsions, and central nervous system (CNS) depression. Other outcomes of study were scalp/facial lacerations, intracranial hemorrhage, seizures, CNS depression, and admission to the neonatal intensive care unit (NICU). A total of 1730 women were included in the analysis. Of these, 74.7% had no pop-offs, 13.9% had 1 pop-off, 7.4% had 2 pop-offs, and approximately 4% had ≥3 pop-offs. Approximately 94% delivered via VAVD. As the number of pop-offs increased, the number of scalp/facial lacerations, intracranial hemorrhage, subgaleal hemorrhage, convulsions, CNS depression, and NICU admissions significantly increased. However, there was no association with the composite outcome, as well as severe perinatal laceration, shoulder dystocia, brachial plexus injury, and cephalohematoma. Adjusting for confounders, having any number of pop-offs increased the likelihood of scalp/facial lacerations, intracranial hemorrhage, convulsions, CNS depression, and NICU admission. However, the
真空辅助阴道分娩(VAVD)是用来加快阴道分娩的情况下的下降，产妇疲惫，或胎儿健康的关注。2015年，美国VAVD使用率大于产钳使用率(2.58% vs 0.56%)。一些研究已经检查了真空装置的各种特征，比如杯子的形状和材料，拉动的次数，以及弹出的次数，弹出的定义是杯子从胎儿头皮上自发地脱落。真空制造商，如Kiwi和Mityvac，建议放弃VAVD作为2或3弹出后的干预措施;然而，美国妇产科学会承认，没有足够的数据来推荐在停止注射前应该允许注射多少次的指导方针。一些研究表明，与没有弹出弹相比，弹出弹的数量增加了新生儿不良结局的风险，而其他研究表明，弹出弹的数量与新生儿头部损伤之间没有独立的联系。此外，一项大型多中心研究发现，与突然发作次数的增加相比，VAVD持续时间的增加与不良后果的关联更强。本研究的目的是检查弹出次数和不良新生儿结局之间的关系。这是一项回顾性队列研究，于2005年10月1日至2014年6月1日在一家三级医疗机构进行。数据是从电子病历中收集的。包括通过VAVD或VAVD后剖宫产分娩的单胎妊娠成年妇女。排除那些同时进行真空和钳的连续试验的患者。机构政策建议在分娩后改为剖宫产，但这一决定由医生自行决定。主要结局是新生儿严重不良结局的综合，包括臂丛损伤、颅内出血、惊厥和中枢神经系统(CNS)抑制。研究的其他结果包括头皮/面部撕裂伤、颅内出血、癫痫发作、中枢神经系统抑制和入住新生儿重症监护病房(NICU)。共有1730名女性参与了分析。其中，74.7%无弹窗，13.9%有1个弹窗，7.4%有2个弹窗，约4%有≥3个弹窗。约94%通过VAVD交付。随着弹出次数的增加，头皮/面部撕裂伤、颅内出血、galeal下出血、惊厥、中枢神经系统抑制和新生儿重症监护病房入院的数量显著增加。然而，与围生期严重撕裂伤、肩部难产、臂丛损伤和脑血肿等复合结局无关联。调整混杂因素，有任何数量的弹出增加了头皮/面部撕裂，颅内出血，惊厥，中枢神经系统抑制和新生儿重症监护病房入院的可能性。然而，随着弹出次数的增加，不良结果的几率不存在剂量依赖关系。与没有弹出相比，有任何数量的弹出与不良新生儿结局的增加有关。此外，颅内出血和galeal下出血的发生率随爆裂物数量的增加而增加。
{"title":"The Association Between the Number of Vacuum Pop-Offs and Adverse Neonatal Outcomes","authors":"Allie Sakowicz, Salwa J. Zahalka, Emily S. Miller","doi":"10.1097/01.ogx.0000967000.16402.41","DOIUrl":"https://doi.org/10.1097/01.ogx.0000967000.16402.41","url":null,"abstract":"ABSTRACT Vacuum-assisted vaginal delivery (VAVD) is used to expedite vaginal delivery in cases of an arrest of descent, maternal exhaustion, or concern for fetal well-being. In 2015, the rate of VAVD was greater than the use of forceps in the United States (2.58% vs 0.56%). Several studies have examined various characteristics of vacuum devices, such as cup shape and material, number of pulls, and number of pop-ups, which is defined as the spontaneous dislodgment of the cup from the fetal scalp. Vacuum manufacturers, such as Kiwi and Mityvac, recommend abandoning VAVD as an intervention after 2 or 3 pop-offs; however, the American College of Obstetricians and Gynecologists acknowledges that there are not enough data to recommend guidelines on how many pop-offs should be allowed before discontinuing. Some studies have demonstrated an increased risk of adverse neonatal outcomes with any number of pop-offs versus no pop-offs, whereas other studies have shown no independent association between the number of pop-offs and neonatal head injury. In addition, compared with an increase in the number of pop-offs, a large multicenter study found that increased duration of VAVD has a stronger association with adverse outcomes. The aim of this study was to examine the association between the number of pop-offs and adverse neonatal outcomes. This was a retrospective cohort study conducted at a single tertiary care institution from October 1, 2005, to June 1, 2014. Data were collected from electronic medical records. Included were adult women with singleton pregnancies who delivered via VAVD or a trial of VAVD followed by cesarean delivery. Excluded were those who underwent sequential trials of both vacuum and forceps. Institutional policy recommended converting to cesarean delivery after >3 pop-offs, but the decision was left to the discretion of the physician. The primary outcome was a composite of severe adverse neonatal outcome, including brachial plexus injury, intracranial hemorrhage, convulsions, and central nervous system (CNS) depression. Other outcomes of study were scalp/facial lacerations, intracranial hemorrhage, seizures, CNS depression, and admission to the neonatal intensive care unit (NICU). A total of 1730 women were included in the analysis. Of these, 74.7% had no pop-offs, 13.9% had 1 pop-off, 7.4% had 2 pop-offs, and approximately 4% had ≥3 pop-offs. Approximately 94% delivered via VAVD. As the number of pop-offs increased, the number of scalp/facial lacerations, intracranial hemorrhage, subgaleal hemorrhage, convulsions, CNS depression, and NICU admissions significantly increased. However, there was no association with the composite outcome, as well as severe perinatal laceration, shoulder dystocia, brachial plexus injury, and cephalohematoma. Adjusting for confounders, having any number of pop-offs increased the likelihood of scalp/facial lacerations, intracranial hemorrhage, convulsions, CNS depression, and NICU admission. However, the","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136107084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/01.ogx.0000967028.09669.ba
Charlotte Sonigo, Noémi Amsellem, Anne Mayeur, Laetitia Laup, Barbara Pistilli, Suzette Delaloge, Florence Eustache, Christophe Sifer, Sophia Rakrouki, Alexandra Benoit, Maeliss Peigné, Michael Grynberg
ABSTRACT Approximately 5% of breast cancer cases occur in women younger than 40 years, and the 5-year overall survival for women between the ages of 15 and 44 years is 90%. As the childbearing age increases, so too does the proportion of women who wish to achieve pregnancy after breast cancer. The conception rate among these women is 40% lower than the general population, as a result of advanced age and the gonadal toxicity of chemotherapy. Fertility preservation (FP) techniques enable young patients to freeze gametes before treatment; however, the most recommended method of FP is oocyte or embryo vitrification after controlled ovarian hyperstimulation (COH), which has limited safety data in breast cancer patients. This retrospective cohort study aimed to evaluate disease-free survival (DFS) in a large cohort of women with breast cancer who underwent FP techniques with or without COH. Patients with breast cancer between 18 and 43 years old referred for FP to 2 university hospitals between July 2013 and July 2019 were included. Women not included in the FP program after oncofertility counseling, those with stage 4 disease at diagnosis or history of other invasive cancer, or those with gonadotoxic treatment have been excluded. Patients were split into 2 groups, with the STIM group receiving at least 1 COH protocol using a gonadotropin-releasing hormone antagonist with or without an aromatase inhibitor and the no STIM group not undergoing ovarian stimulation. Patient characteristics, obstetric variables, and oncology characteristics were collected from medical records. Disease-free survival and overall survival were estimated using Kaplan-Meier plots and compared between the 2 groups by log-rank test. A total of 740 women (76.7%) who attended oncofertility consultations for breast cancer were included. Of these, 328 (44.3%) underwent at least 1 ovarian stimulation cycle, and 412 (55.7%) had an FP technique without exogenous FSH administration. The STIM group was significantly older and had lower values in ovarian reserve tests, and more women in the no STIM group underwent a mastectomy and neoadjuvant chemotherapy. The proportion of patients with hormone receptor-positive tumors was equal in both groups. Letrozole was coadministered with exogenous gonadotropin in 39.3% of women in the STIM group (Let-COH). Overall, 16.8% of patients had a tumor still present on oocyte retrieval after COH, of which 55% received a Let-COH protocol. Follow-up data were available for 80.9% (559/740) of patients. Cancer recurrence was documented in 87 patients (27 in STIM, 60 in no STIM), and DFS was not statistically different between the groups (log-rank test P = 0.09). Neither difference in DFS nor overall survival was observed in the Let-COH group compared with those undergoing COH after breast surgery. Kaplan-Meier estimates of overall survival at 4 years were 97.6% in the STIM and 93.6% in the no STIM groups, and after adjusting for prognostic parameters, the risk
{"title":"Disease-Free Survival Does Not Differ According to Fertility Preservation Technique for Young Women With Breast Cancer","authors":"Charlotte Sonigo, Noémi Amsellem, Anne Mayeur, Laetitia Laup, Barbara Pistilli, Suzette Delaloge, Florence Eustache, Christophe Sifer, Sophia Rakrouki, Alexandra Benoit, Maeliss Peigné, Michael Grynberg","doi":"10.1097/01.ogx.0000967028.09669.ba","DOIUrl":"https://doi.org/10.1097/01.ogx.0000967028.09669.ba","url":null,"abstract":"ABSTRACT Approximately 5% of breast cancer cases occur in women younger than 40 years, and the 5-year overall survival for women between the ages of 15 and 44 years is 90%. As the childbearing age increases, so too does the proportion of women who wish to achieve pregnancy after breast cancer. The conception rate among these women is 40% lower than the general population, as a result of advanced age and the gonadal toxicity of chemotherapy. Fertility preservation (FP) techniques enable young patients to freeze gametes before treatment; however, the most recommended method of FP is oocyte or embryo vitrification after controlled ovarian hyperstimulation (COH), which has limited safety data in breast cancer patients. This retrospective cohort study aimed to evaluate disease-free survival (DFS) in a large cohort of women with breast cancer who underwent FP techniques with or without COH. Patients with breast cancer between 18 and 43 years old referred for FP to 2 university hospitals between July 2013 and July 2019 were included. Women not included in the FP program after oncofertility counseling, those with stage 4 disease at diagnosis or history of other invasive cancer, or those with gonadotoxic treatment have been excluded. Patients were split into 2 groups, with the STIM group receiving at least 1 COH protocol using a gonadotropin-releasing hormone antagonist with or without an aromatase inhibitor and the no STIM group not undergoing ovarian stimulation. Patient characteristics, obstetric variables, and oncology characteristics were collected from medical records. Disease-free survival and overall survival were estimated using Kaplan-Meier plots and compared between the 2 groups by log-rank test. A total of 740 women (76.7%) who attended oncofertility consultations for breast cancer were included. Of these, 328 (44.3%) underwent at least 1 ovarian stimulation cycle, and 412 (55.7%) had an FP technique without exogenous FSH administration. The STIM group was significantly older and had lower values in ovarian reserve tests, and more women in the no STIM group underwent a mastectomy and neoadjuvant chemotherapy. The proportion of patients with hormone receptor-positive tumors was equal in both groups. Letrozole was coadministered with exogenous gonadotropin in 39.3% of women in the STIM group (Let-COH). Overall, 16.8% of patients had a tumor still present on oocyte retrieval after COH, of which 55% received a Let-COH protocol. Follow-up data were available for 80.9% (559/740) of patients. Cancer recurrence was documented in 87 patients (27 in STIM, 60 in no STIM), and DFS was not statistically different between the groups (log-rank test P = 0.09). Neither difference in DFS nor overall survival was observed in the Let-COH group compared with those undergoing COH after breast surgery. Kaplan-Meier estimates of overall survival at 4 years were 97.6% in the STIM and 93.6% in the no STIM groups, and after adjusting for prognostic parameters, the risk ","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136106140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/ogx.0000000000001184
Teresa K. L. Boitano, Peter W. Ketch, Isabel C. Scarinci, Warner K. Huh
ABSTRACT Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States in adults, and although most cases are transient, 10%–20% of infections can persist and progress to various forms of cancer. The HPV vaccine prevents more than 90% of HPV infections and HPV-associated cancers. The vaccine is most effective at preventing all types of HPV-related dysplasia in patients with no prior exposure to HPV. Reasons for decreased compliance include parent-specific factors such as education, safety concerns, absence of professional recommendation, and apprehension about supporting sexual behavior, whereas professional-level barriers include lack of time to discuss vaccination, knowledge gaps, vaccine access, and financial concerns. This clinical expert series highlights the evidence supporting the HPV vaccine as a safe and effective way to prevent cervical cancer. Most HPV infections are acquired in individuals aged 14–24 years with increasing prevalence with each year. Shared decision-making should be used for patients aged 27–45 years, in whom the vaccine has been demonstrated to be safe and effective, but the population advantage of vaccination is expected to be limited. Unvaccinated health care workers exposed to the virus in their practices should be vaccinated between the ages of 27 and 45 years. A previous HPV infection should not be a reason to not receive the vaccine, and it is not necessary to screen individual patients before vaccination. The vaccine is efficacious against other HPV types regardless of which HPV strain an individual may be positive for at the time of vaccination. Regarding women with HPV-related dysplasia such as high-grade squamous intraepithelial lesions that undergo excisional procedures, up to 15% will experience persistent or recurrent disease, and these women are at higher risk of developing a new HPV-associated lesion. Therefore, vaccination may provide a significant reduction in future disease in this patient population. The World Health Organization Strategic Advisory Group of Experts on Immunization recently evaluated the current scheduling regimens for the HPV vaccine and concluded that a single dose may provide enough protection in individuals younger than age 21; however, the Centers for Disease Control and Prevention is yet to comment. An ongoing large randomized, controlled, double-blinded, noninferiority trial (ESCUDDO) is currently evaluating a single-dose versus 2-dose regimen that will help elucidate whether vaccine scheduling in the United States may change to a single-dose paradigm. The strongest predictor of vaccine uptake is health care professional recommendation, and patients with prior infection or excision should still be offered the vaccine. Finally, although vaccination national guidelines are in place for individuals aged 9–26 years, certain patient populations older than 26 years may benefit from the vaccine.
{"title":"An Update on Human Papillomavirus Vaccination in the United States","authors":"Teresa K. L. Boitano, Peter W. Ketch, Isabel C. Scarinci, Warner K. Huh","doi":"10.1097/ogx.0000000000001184","DOIUrl":"https://doi.org/10.1097/ogx.0000000000001184","url":null,"abstract":"ABSTRACT Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States in adults, and although most cases are transient, 10%–20% of infections can persist and progress to various forms of cancer. The HPV vaccine prevents more than 90% of HPV infections and HPV-associated cancers. The vaccine is most effective at preventing all types of HPV-related dysplasia in patients with no prior exposure to HPV. Reasons for decreased compliance include parent-specific factors such as education, safety concerns, absence of professional recommendation, and apprehension about supporting sexual behavior, whereas professional-level barriers include lack of time to discuss vaccination, knowledge gaps, vaccine access, and financial concerns. This clinical expert series highlights the evidence supporting the HPV vaccine as a safe and effective way to prevent cervical cancer. Most HPV infections are acquired in individuals aged 14–24 years with increasing prevalence with each year. Shared decision-making should be used for patients aged 27–45 years, in whom the vaccine has been demonstrated to be safe and effective, but the population advantage of vaccination is expected to be limited. Unvaccinated health care workers exposed to the virus in their practices should be vaccinated between the ages of 27 and 45 years. A previous HPV infection should not be a reason to not receive the vaccine, and it is not necessary to screen individual patients before vaccination. The vaccine is efficacious against other HPV types regardless of which HPV strain an individual may be positive for at the time of vaccination. Regarding women with HPV-related dysplasia such as high-grade squamous intraepithelial lesions that undergo excisional procedures, up to 15% will experience persistent or recurrent disease, and these women are at higher risk of developing a new HPV-associated lesion. Therefore, vaccination may provide a significant reduction in future disease in this patient population. The World Health Organization Strategic Advisory Group of Experts on Immunization recently evaluated the current scheduling regimens for the HPV vaccine and concluded that a single dose may provide enough protection in individuals younger than age 21; however, the Centers for Disease Control and Prevention is yet to comment. An ongoing large randomized, controlled, double-blinded, noninferiority trial (ESCUDDO) is currently evaluating a single-dose versus 2-dose regimen that will help elucidate whether vaccine scheduling in the United States may change to a single-dose paradigm. The strongest predictor of vaccine uptake is health care professional recommendation, and patients with prior infection or excision should still be offered the vaccine. Finally, although vaccination national guidelines are in place for individuals aged 9–26 years, certain patient populations older than 26 years may benefit from the vaccine.","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136106141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/ogx.0000000000001179
Hillary Hosier, Sangini S. Sheth, Carlos R. Oliveira, Lauren E. Perley, Alla Vash-Margita
ABSTRACT The increasingly complicated nature of screening guidelines for cervical cancer includes multiple component tests (cytology, genotyping, and high-risk human papilloma virus [HPV] testing) and evolving recommendations. The aim of this study was assessing single-large-healthcare-system trends over time associated with adolescent females and unindicated cervical cancer screening tests. This repeated cross-sectional study analyzed electronic medical records of provider- and patient-specific variables from the Yale New Haven Health System. Included in the study were all 13- to 20-year-old Yale New Haven Health System patients who underwent screening for cervical cancer via either HPV testing or cytology between January 1, 2012 and December 31, 2018. Age, medical histories, surgical histories, self-reported race and ethnicity, and prescribed medications were all patient-specific variables. Provider-specific variables included clinical practice affiliation, clinical degree, and adolescent patient volume (number of medical visits completed by a patient less than 21 every 6 months). In terms of this study, definition of practice setting was either academic (low-income teaching hospitals) or community-based (private practice setting with primarily insured women). Cytologies were categorized as either unindicated or indicated, based on cervical cancer screening guidelines from 2012 (recorded as unindicated for index specimens collected before the 21st birthday in patients lacking immunocompromised conditions). Should an HPV test be performed, any results other than “atypical squamous cells of undetermined significance” received an unindicated status. The final sample size in the study included 794 women from 118 providers (53% community setting and 47% academic setting). Results from analysis of 900 cervical cancer screenings demonstrated that unindicated tests made up the majority of tests (90%), with 87% of these being unindicated cytology testing only and 14% with unindicated HPV testing as well. Reasons for obtaining unindicated tests as recorded in the original clinical history were lacking, as 62% had no justification listed for testing, and those with reasons failed current guideline compliance. The incidence rate (IR) of adolescent unindicated tests decreased by 33% between 2012 and 2018. Although a significantly lower IR of unindicated screening existed in the academic setting, the rate of decline in the IR of unindicated screening during this period was significantly greater in the community than in the academic setting by 11%. A strength of the study included its ability to calculate IRs in all encounters, including sexually transmitted infection or contraception screenings. Limitations included utilization of hospital system cytology reports for obtaining data, thereby hindering any access to data necessary for validation of screening or surveillance indications from previously performed antecedent cytology. Furthermore, the study faile
{"title":"Unindicated Cervical Cancer Screening in Adolescent Females Within a Large Healthcare System in the United States","authors":"Hillary Hosier, Sangini S. Sheth, Carlos R. Oliveira, Lauren E. Perley, Alla Vash-Margita","doi":"10.1097/ogx.0000000000001179","DOIUrl":"https://doi.org/10.1097/ogx.0000000000001179","url":null,"abstract":"ABSTRACT The increasingly complicated nature of screening guidelines for cervical cancer includes multiple component tests (cytology, genotyping, and high-risk human papilloma virus [HPV] testing) and evolving recommendations. The aim of this study was assessing single-large-healthcare-system trends over time associated with adolescent females and unindicated cervical cancer screening tests. This repeated cross-sectional study analyzed electronic medical records of provider- and patient-specific variables from the Yale New Haven Health System. Included in the study were all 13- to 20-year-old Yale New Haven Health System patients who underwent screening for cervical cancer via either HPV testing or cytology between January 1, 2012 and December 31, 2018. Age, medical histories, surgical histories, self-reported race and ethnicity, and prescribed medications were all patient-specific variables. Provider-specific variables included clinical practice affiliation, clinical degree, and adolescent patient volume (number of medical visits completed by a patient less than 21 every 6 months). In terms of this study, definition of practice setting was either academic (low-income teaching hospitals) or community-based (private practice setting with primarily insured women). Cytologies were categorized as either unindicated or indicated, based on cervical cancer screening guidelines from 2012 (recorded as unindicated for index specimens collected before the 21st birthday in patients lacking immunocompromised conditions). Should an HPV test be performed, any results other than “atypical squamous cells of undetermined significance” received an unindicated status. The final sample size in the study included 794 women from 118 providers (53% community setting and 47% academic setting). Results from analysis of 900 cervical cancer screenings demonstrated that unindicated tests made up the majority of tests (90%), with 87% of these being unindicated cytology testing only and 14% with unindicated HPV testing as well. Reasons for obtaining unindicated tests as recorded in the original clinical history were lacking, as 62% had no justification listed for testing, and those with reasons failed current guideline compliance. The incidence rate (IR) of adolescent unindicated tests decreased by 33% between 2012 and 2018. Although a significantly lower IR of unindicated screening existed in the academic setting, the rate of decline in the IR of unindicated screening during this period was significantly greater in the community than in the academic setting by 11%. A strength of the study included its ability to calculate IRs in all encounters, including sexually transmitted infection or contraception screenings. Limitations included utilization of hospital system cytology reports for obtaining data, thereby hindering any access to data necessary for validation of screening or surveillance indications from previously performed antecedent cytology. Furthermore, the study faile","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136106143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/ogx.0000000000001187
Megan S. Bradley, Amaanti Sridhar, Kimberly Ferrante, Uduak U. Andy, Anthony G. Visco, Maria E. Florian-Rodriguez, Deborah Myers, Edward Varner, Donna Mazloomdoost, Marie G. Gantz
ABSTRACT Commonly performed at the time of total vaginal hysterectomy to combat uterovaginal prolapse, uterosacral ligament suspension and sacrospinous ligament fixation are native tissue apical suspensions. Because recurrent pelvic organ prolapse increases over time after apical suspensions, nonmodifiable and modifiable risk factors have been explored. It is suggested by numerous studies that 1 risk factor for recurrent prolapse is an enlarged preoperative and postoperative genital hiatus (GH). An enlarged GH may be indicative of a caudal shift in pelvic viscera, increasing stress on vaginal supports. However, short-term follow-up, retrospective design, and lack of patient perspectives on prolapse outcomes limited the overall impact of those findings. The SUPeR trial (Study of Uterine Prolapse Procedures-Randomized) compared vaginal mesh hysteropexy with vaginal hysterectomy with uterosacral ligament suspension in a randomized trial design with long-term follow-up postoperatively. Postoperative assessments included the patient’s assessment of prolapse symptoms. The primary objective of this manuscript was to evaluate the efficacy of the vaginal hysterectomy with uterosacral ligament suspension amidst groups defined by surgical changes in GH size. The hypothesis predicted higher prolapse recurrence proportions for those with persistently enlarged GH size at 4–6 weeks postoperatively, compared with those with smaller preoperative and postoperative GH sizes. SUPeR participants included in this ancillary analysis underwent vaginal hysterectomy with uterosacral ligament suspension and then completed a 2-year follow-up. Based on preoperative to postoperative GH measurement changes, participants were divided into 3 groups. These groups were (1) persistently enlarged GH (“persistently enlarged”), (2) improved GH (“improved”), and (3) stable or normal GH preoperatively and postoperatively (“stably normal”). Prolapse was defined as any compartment with prolapse 1 cm or more beyond the hymen. The primary aim was comparison of composite surgical failure across the GH groups at 24 months, defined by any of the following conditions: anatomic failure, retreatment for prolapse, or symptoms of bothersome vaginal bulge. Secondary outcomes included the composite surgical failure components, postoperative complications, POP-Q measurements, and pain during intercourse. A total of 81 women were included in this secondary analysis. Predominant characteristics included a median age of 65.6 years, with 50 patients in the “improved group,” 14 patients in the “persistently enlarged” group, and 17 patients in the “stably normal” group. Notably, the prevalence of advanced anterior prolapse at baseline was greatest in the persistently enlarged group compared with that of both the improved and stably normal groups. Also, the prevalence of posterior colporrhaphy during the index procedure varied across groups and was more common in the improved group than the stably normal gro
{"title":"Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension","authors":"Megan S. Bradley, Amaanti Sridhar, Kimberly Ferrante, Uduak U. Andy, Anthony G. Visco, Maria E. Florian-Rodriguez, Deborah Myers, Edward Varner, Donna Mazloomdoost, Marie G. Gantz","doi":"10.1097/ogx.0000000000001187","DOIUrl":"https://doi.org/10.1097/ogx.0000000000001187","url":null,"abstract":"ABSTRACT Commonly performed at the time of total vaginal hysterectomy to combat uterovaginal prolapse, uterosacral ligament suspension and sacrospinous ligament fixation are native tissue apical suspensions. Because recurrent pelvic organ prolapse increases over time after apical suspensions, nonmodifiable and modifiable risk factors have been explored. It is suggested by numerous studies that 1 risk factor for recurrent prolapse is an enlarged preoperative and postoperative genital hiatus (GH). An enlarged GH may be indicative of a caudal shift in pelvic viscera, increasing stress on vaginal supports. However, short-term follow-up, retrospective design, and lack of patient perspectives on prolapse outcomes limited the overall impact of those findings. The SUPeR trial (Study of Uterine Prolapse Procedures-Randomized) compared vaginal mesh hysteropexy with vaginal hysterectomy with uterosacral ligament suspension in a randomized trial design with long-term follow-up postoperatively. Postoperative assessments included the patient’s assessment of prolapse symptoms. The primary objective of this manuscript was to evaluate the efficacy of the vaginal hysterectomy with uterosacral ligament suspension amidst groups defined by surgical changes in GH size. The hypothesis predicted higher prolapse recurrence proportions for those with persistently enlarged GH size at 4–6 weeks postoperatively, compared with those with smaller preoperative and postoperative GH sizes. SUPeR participants included in this ancillary analysis underwent vaginal hysterectomy with uterosacral ligament suspension and then completed a 2-year follow-up. Based on preoperative to postoperative GH measurement changes, participants were divided into 3 groups. These groups were (1) persistently enlarged GH (“persistently enlarged”), (2) improved GH (“improved”), and (3) stable or normal GH preoperatively and postoperatively (“stably normal”). Prolapse was defined as any compartment with prolapse 1 cm or more beyond the hymen. The primary aim was comparison of composite surgical failure across the GH groups at 24 months, defined by any of the following conditions: anatomic failure, retreatment for prolapse, or symptoms of bothersome vaginal bulge. Secondary outcomes included the composite surgical failure components, postoperative complications, POP-Q measurements, and pain during intercourse. A total of 81 women were included in this secondary analysis. Predominant characteristics included a median age of 65.6 years, with 50 patients in the “improved group,” 14 patients in the “persistently enlarged” group, and 17 patients in the “stably normal” group. Notably, the prevalence of advanced anterior prolapse at baseline was greatest in the persistently enlarged group compared with that of both the improved and stably normal groups. Also, the prevalence of posterior colporrhaphy during the index procedure varied across groups and was more common in the improved group than the stably normal gro","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136106142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-08-01DOI: 10.1097/01.ogx.0000967032.19580.48
Jeffrey T. Jensen, Isabel Reinecke, Teun M. Post, Eeva Lukkari-Lax, Birte M. Hofmann
ABSTRACT With over 30 years of use, levonorgestrel-releasing intrauterine systems (LNG-IUSs) have proven to be highly effective methods of contraceptives. The active ingredient in LNG-IUS, levonorgestrel (LNG), is released directly into the uterine cavity, which causes suppression of endometrial maturation and thickened cervical mucus. A variety of LNG-IUS options exhibit well-established safety profiles and efficacy, providing anywhere between 2 and 18 times lower systemic exposure when compared with LNG-containing pills or implants. Patient-centered decision-making regarding product choice may be encouraged through standardized comparisons of LNG release and exposure during the time of their respective usage periods. Evaluation of the efficacy, safety, and PK of extended Mirena use from beyond 5 years to the conclusion of 8 years was designed in the Mirena Extension Trial (MET), thereby facilitating comparisons with LNG-IUS 19.5 mg and LNG-IUS 13.5 mg. Using validated liquid chromatography-tandem mass spectrometry methods and SHBG concentrations, the authors determined concentrations of plasma LNG levels. Dichloromethane was used for extracting residual LNG from the elastomer material from removed IUS devices, which was then quantified via liquid chromatography and external calibration on a reversed-phase column. Although previous models used measured LNG and SHBG (serum) concentrations, the population pharmacokinetics (popPK) allows for a uniform method of comparison among different pharmacologic studies. The popPK approach allows for a reliable estimates of in vivo LNG exposure and release during the entirety of the 8-year use period. The MET enrolled premenopausal women aged 18–35 years for a multicenter, single-arm study regarding patients who had used LNG-IUS 52 mg for the last 4.5–5 years for up to 8 years. The study took place from December 22, 2016 to May 28, 2021 throughout 54 US centers, with the primary outcome of contraceptive efficacy and failure rate. Participants each provided written, informed consent. Study strengths of the popPK approach included its robust methodology, its ability to provide in vivo release rate estimates, a stepwise demo of model suitability from use years 6 to 8, model-based estimation of unbound LNG, and the ability to provide estimates for both population and individual PK profiles from sparse available sampling. Limitations include the possibility of findings being group effects possibly inapplicable to all LNG-IUS users. In addition, the data fail to provide local endometrial and cervical LNG concentrations due to the systemic nature of the LNG exposure. Finally, the popPK Mondale should not be used for theoretical question addressing (such as creating rate release estimates outside of available data sets). In conclusion, a broad data set indicates that reliable LNG exposure is delivered by 8-year popPK and release models for up to 7 years of LNG-IUs 52 mg use. Efficacy is data-supported for 6–8 years o
{"title":"Extended Use of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) 52 mg: A Population Pharmacokinetic Approach to Estimate In Vivo Levonorgestrel Release Rates and Systemic Exposure Including Comparison With Two Other LNG-IUSs","authors":"Jeffrey T. Jensen, Isabel Reinecke, Teun M. Post, Eeva Lukkari-Lax, Birte M. Hofmann","doi":"10.1097/01.ogx.0000967032.19580.48","DOIUrl":"https://doi.org/10.1097/01.ogx.0000967032.19580.48","url":null,"abstract":"ABSTRACT With over 30 years of use, levonorgestrel-releasing intrauterine systems (LNG-IUSs) have proven to be highly effective methods of contraceptives. The active ingredient in LNG-IUS, levonorgestrel (LNG), is released directly into the uterine cavity, which causes suppression of endometrial maturation and thickened cervical mucus. A variety of LNG-IUS options exhibit well-established safety profiles and efficacy, providing anywhere between 2 and 18 times lower systemic exposure when compared with LNG-containing pills or implants. Patient-centered decision-making regarding product choice may be encouraged through standardized comparisons of LNG release and exposure during the time of their respective usage periods. Evaluation of the efficacy, safety, and PK of extended Mirena use from beyond 5 years to the conclusion of 8 years was designed in the Mirena Extension Trial (MET), thereby facilitating comparisons with LNG-IUS 19.5 mg and LNG-IUS 13.5 mg. Using validated liquid chromatography-tandem mass spectrometry methods and SHBG concentrations, the authors determined concentrations of plasma LNG levels. Dichloromethane was used for extracting residual LNG from the elastomer material from removed IUS devices, which was then quantified via liquid chromatography and external calibration on a reversed-phase column. Although previous models used measured LNG and SHBG (serum) concentrations, the population pharmacokinetics (popPK) allows for a uniform method of comparison among different pharmacologic studies. The popPK approach allows for a reliable estimates of in vivo LNG exposure and release during the entirety of the 8-year use period. The MET enrolled premenopausal women aged 18–35 years for a multicenter, single-arm study regarding patients who had used LNG-IUS 52 mg for the last 4.5–5 years for up to 8 years. The study took place from December 22, 2016 to May 28, 2021 throughout 54 US centers, with the primary outcome of contraceptive efficacy and failure rate. Participants each provided written, informed consent. Study strengths of the popPK approach included its robust methodology, its ability to provide in vivo release rate estimates, a stepwise demo of model suitability from use years 6 to 8, model-based estimation of unbound LNG, and the ability to provide estimates for both population and individual PK profiles from sparse available sampling. Limitations include the possibility of findings being group effects possibly inapplicable to all LNG-IUS users. In addition, the data fail to provide local endometrial and cervical LNG concentrations due to the systemic nature of the LNG exposure. Finally, the popPK Mondale should not be used for theoretical question addressing (such as creating rate release estimates outside of available data sets). In conclusion, a broad data set indicates that reliable LNG exposure is delivered by 8-year popPK and release models for up to 7 years of LNG-IUs 52 mg use. Efficacy is data-supported for 6–8 years o","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136107082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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