Pub Date : 2025-01-01Epub Date: 2024-07-14DOI: 10.1016/j.ajog.2024.07.010
Catarina R Palma Dos Reis, Manu Vatish, Ana Sofia Cerdeira
{"title":"Soluble fms-like tyrosine kinase 1-to-placental growth factor ratio predicts time to delivery and mode of birth.","authors":"Catarina R Palma Dos Reis, Manu Vatish, Ana Sofia Cerdeira","doi":"10.1016/j.ajog.2024.07.010","DOIUrl":"10.1016/j.ajog.2024.07.010","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"e21"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-04-30DOI: 10.1016/j.ajog.2024.04.026
Ann Borders, Lauren Keenan-Devlin, Elissa H Oh, Danielle Young, William Grobman, Patricia Lee King
Background: Hypertensive disorders of pregnancy are a leading preventable cause of severe maternal morbidity and maternal mortality worldwide.
Objective: To assess the improvement in hospital care processes and patient outcomes associated with hypertensive disorders of pregnancy after introduction of a statewide Severe Maternal Hypertension Quality Improvement Initiative.
Study design: A prospective cohort design comparing outcomes before and after introduction of the Illinois Perinatal Quality Collaborative statewide hypertension quality improvement initiative among 108 hospitals across Illinois. Participating hospitals recorded data for all cases of new-onset severe hypertension (>160 mm Hg systolic or >110 mm Hg diastolic) during pregnancy through 6 weeks postpartum from May 2016 to December 2017. Introduction of the statewide quality improvement initiative included implementation of severe maternal hypertension protocols, standardized patient education and discharge planning, rapid access to medications and standardized treatment order sets, and provider and nurse education. The main outcome measure was the reduction of severe maternal morbidity for pregnant/postpartum patients with severe hypertension. Key process measures include time to treatment of severe hypertension, frequency of provider/nurse debriefs, appropriate patient education, and early postpartum follow-up.
Results: Data were reported for 8073 cases of severe maternal hypertension. The frequency of patients with new-onset severe hypertension treated within 60 minutes increased from 41% baseline to 87% (P<.001) at the end of the initiative. The initiative was associated with increased proportion of patients receiving preeclampsia education at discharge (41% to 89%; P<.001), scheduling follow-up appointments within 10 days of discharge (68% to 83%; P<.001), and having a care team debrief after severe hypertension was diagnosed (17% to 59%; P<.001). Conversely, severe maternal morbidity was reduced from 11.5% baseline to 8.4% (P<.002) at the end of the study period. Illinois hospitals have achieved time to treatment goal regardless of hospital characteristics including geography, birth volume, and patient mix.
Conclusion: Introduction of a statewide quality improvement effort was associated with improved time to treatment of severe hypertension and increased frequency of provider/nurse debriefs, appropriate patient education, and early postpartum follow-up scheduled at discharge, and reduced severe maternal morbidity.
{"title":"Reducing severe maternal morbidity for birthing persons with severe hypertension through a statewide quality improvement initiative.","authors":"Ann Borders, Lauren Keenan-Devlin, Elissa H Oh, Danielle Young, William Grobman, Patricia Lee King","doi":"10.1016/j.ajog.2024.04.026","DOIUrl":"10.1016/j.ajog.2024.04.026","url":null,"abstract":"<p><strong>Background: </strong>Hypertensive disorders of pregnancy are a leading preventable cause of severe maternal morbidity and maternal mortality worldwide.</p><p><strong>Objective: </strong>To assess the improvement in hospital care processes and patient outcomes associated with hypertensive disorders of pregnancy after introduction of a statewide Severe Maternal Hypertension Quality Improvement Initiative.</p><p><strong>Study design: </strong>A prospective cohort design comparing outcomes before and after introduction of the Illinois Perinatal Quality Collaborative statewide hypertension quality improvement initiative among 108 hospitals across Illinois. Participating hospitals recorded data for all cases of new-onset severe hypertension (>160 mm Hg systolic or >110 mm Hg diastolic) during pregnancy through 6 weeks postpartum from May 2016 to December 2017. Introduction of the statewide quality improvement initiative included implementation of severe maternal hypertension protocols, standardized patient education and discharge planning, rapid access to medications and standardized treatment order sets, and provider and nurse education. The main outcome measure was the reduction of severe maternal morbidity for pregnant/postpartum patients with severe hypertension. Key process measures include time to treatment of severe hypertension, frequency of provider/nurse debriefs, appropriate patient education, and early postpartum follow-up.</p><p><strong>Results: </strong>Data were reported for 8073 cases of severe maternal hypertension. The frequency of patients with new-onset severe hypertension treated within 60 minutes increased from 41% baseline to 87% (P<.001) at the end of the initiative. The initiative was associated with increased proportion of patients receiving preeclampsia education at discharge (41% to 89%; P<.001), scheduling follow-up appointments within 10 days of discharge (68% to 83%; P<.001), and having a care team debrief after severe hypertension was diagnosed (17% to 59%; P<.001). Conversely, severe maternal morbidity was reduced from 11.5% baseline to 8.4% (P<.002) at the end of the study period. Illinois hospitals have achieved time to treatment goal regardless of hospital characteristics including geography, birth volume, and patient mix.</p><p><strong>Conclusion: </strong>Introduction of a statewide quality improvement effort was associated with improved time to treatment of severe hypertension and increased frequency of provider/nurse debriefs, appropriate patient education, and early postpartum follow-up scheduled at discharge, and reduced severe maternal morbidity.</p>","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"128.e1-128.e9"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140846906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-07-14DOI: 10.1016/j.ajog.2024.07.009
Victoria Kinkaid, Kirsten Morris, Ruth Guest
{"title":"Hormonal contraception and medical readiness for female service members: a comment.","authors":"Victoria Kinkaid, Kirsten Morris, Ruth Guest","doi":"10.1016/j.ajog.2024.07.009","DOIUrl":"10.1016/j.ajog.2024.07.009","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"e18"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Considerations for large-scale implementation of out-of-hospital treatment models for postpartum hypertension.","authors":"Alisse Hauspurg, Hyagriv Simhan, Malamo Countouris","doi":"10.1016/j.ajog.2024.07.035","DOIUrl":"10.1016/j.ajog.2024.07.035","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"e25-e26"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141791668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-07-30DOI: 10.1016/j.ajog.2024.07.027
Francesca Ciccarone, Antonella Biscione, Eleonora Robba, Tina Pasciuto, Diana Giannarelli, Benedetta Gui, Riccardo Manfredi, Gabriella Ferrandina, Daniela Romualdi, Francesca Moro, Gian Franco Zannoni, Domenica Lorusso, Giovanni Scambia, Antonia Carla Testa
Background: Differential diagnosis between benign uterine smooth muscle tumors and malignant counterpart is challenging.
Objective: To evaluate the accuracy of a clinical and ultrasound based algorithm in predicting mesenchymal uterine malignancies, including smooth muscle tumors of uncertain malignant potential.
Study design: We report the 12-month follow-up of an observational, prospective, single-center study that included women with at least 1 myometrial lesion ≥3 cm on ultrasound examination. These patients were classified according to a 3-class diagnostic algorithm, using symptoms and ultrasound features. "White" patients underwent annual telephone follow-up for 2 years, "Green" patients underwent a clinical and ultrasound follow-up at 6, 12, and 24 months and "Orange" patients underwent surgery. We further developed a risk class system to stratify the malignancy risk.
Results: Two thousand two hundred sixty-eight women were included and target lesion was classified as benign in 2158 (95.1%), as other malignancies in 58 (2.6%) an as mesenchymal uterine malignancies in 52 (2.3%) patients. At multivariable analysis, age (odds ratio 1.05 [95% confidence interval 1.03-1.07]), tumor diameter >8 cm (odds ratio 5.92 [95% confidence interval 2.87-12.24]), irregular margins (odds ratio 2.34 [95% confidence interval 1.09-4.98]), color score=4 (odds ratio 2.73 [95% confidence interval 1.28-5.82]), were identified as independent risk factors for malignancies, whereas acoustic shadow resulted in an independent protective factor (odds ratio 0.39 [95% confidence interval 0.19-0.82[). The model, which included age as a continuous variable and lesion diameter as a dichotomized variable (cut-off 81 mm), provided the best area under the curve (0.87 [95% confidence interval 0.82-0.91]). A risk class system was developed, and patients were classified as low-risk (predictive model value <0.39%: 0/606 malignancies, risk 0%), intermediate risk (predictive model value 0.40%-2.2%: 9/1093 malignancies, risk 0.8%), high risk (predictive model value ≥2.3%: 43/566 malignancies, risk 7.6%).
Conclusion: The preoperative 3-class diagnostic algorithm and risk class system can stratify women according to risk of malignancy. Our findings, if confirmed in a multicenter study, will permit differentiation between benign and mesenchymal uterine malignancies allowing a personalized clinical approach.
背景:良性子宫平滑肌瘤和恶性子宫平滑肌瘤的鉴别诊断具有挑战性。我们评估了一种基于临床和超声波的算法在预测子宫间质恶性肿瘤(MUMs),包括恶性潜能不确定的平滑肌瘤(STUMPs)方面的准确性:我们报告了一项观察性、前瞻性、单中心研究的12个月随访结果,该研究纳入了在超声检查中至少有一处子宫肌瘤病变≥3厘米的妇女。这些患者根据症状和超声波特征,按照三级诊断算法进行分类。"白色 "患者每年接受一次电话随访,为期 2 年;"绿色 "患者接受 6、12 和 24 个月的临床和超声随访;"橙色 "患者接受手术治疗。研究结果:共纳入了2268名妇女,2158名(95.1%)患者的目标病变被归类为良性,58名(2.6%)患者的目标病变被归类为其他恶性肿瘤,52名(2.3%)患者的目标病变被归类为间质子宫恶性肿瘤。在多变量分析中,年龄(OR 1.05 (95% CI 1.03-1.07))、肿瘤直径大于 8 厘米(OR 5.92 (95% CI 2.87-12.24))、边缘不规则(OR 2.34 (95% CI 1.09-4.98))、颜色评分=4(OR 2.73 (95% CI 1.28-5.82))被确定为恶性肿瘤的独立危险因素,而声影是一个独立的保护因素(OR 0.39 (95% CI 0.19-0.82))。将年龄作为连续变量、病变直径作为二分变量(截断值为 81 毫米)的模型提供了最佳的 AUC(0.87(95% CI 0.82-0.91))。风险分级系统被开发出来,患者被归类为低风险(预测模型值结论):术前三级诊断算法和风险分级系统可根据恶性肿瘤风险对妇女进行分层。我们的研究结果如能在多中心研究中得到证实,将有助于区分良性和恶性肿瘤,从而实现个性化临床治疗:无须声明。
{"title":"A clinical ultrasound algorithm to identify uterine sarcoma and smooth muscle tumors of uncertain malignant potential in patients with myometrial lesions: the MYometrial Lesion UltrasouNd And mRi study.","authors":"Francesca Ciccarone, Antonella Biscione, Eleonora Robba, Tina Pasciuto, Diana Giannarelli, Benedetta Gui, Riccardo Manfredi, Gabriella Ferrandina, Daniela Romualdi, Francesca Moro, Gian Franco Zannoni, Domenica Lorusso, Giovanni Scambia, Antonia Carla Testa","doi":"10.1016/j.ajog.2024.07.027","DOIUrl":"10.1016/j.ajog.2024.07.027","url":null,"abstract":"<p><strong>Background: </strong>Differential diagnosis between benign uterine smooth muscle tumors and malignant counterpart is challenging.</p><p><strong>Objective: </strong>To evaluate the accuracy of a clinical and ultrasound based algorithm in predicting mesenchymal uterine malignancies, including smooth muscle tumors of uncertain malignant potential.</p><p><strong>Study design: </strong>We report the 12-month follow-up of an observational, prospective, single-center study that included women with at least 1 myometrial lesion ≥3 cm on ultrasound examination. These patients were classified according to a 3-class diagnostic algorithm, using symptoms and ultrasound features. \"White\" patients underwent annual telephone follow-up for 2 years, \"Green\" patients underwent a clinical and ultrasound follow-up at 6, 12, and 24 months and \"Orange\" patients underwent surgery. We further developed a risk class system to stratify the malignancy risk.</p><p><strong>Results: </strong>Two thousand two hundred sixty-eight women were included and target lesion was classified as benign in 2158 (95.1%), as other malignancies in 58 (2.6%) an as mesenchymal uterine malignancies in 52 (2.3%) patients. At multivariable analysis, age (odds ratio 1.05 [95% confidence interval 1.03-1.07]), tumor diameter >8 cm (odds ratio 5.92 [95% confidence interval 2.87-12.24]), irregular margins (odds ratio 2.34 [95% confidence interval 1.09-4.98]), color score=4 (odds ratio 2.73 [95% confidence interval 1.28-5.82]), were identified as independent risk factors for malignancies, whereas acoustic shadow resulted in an independent protective factor (odds ratio 0.39 [95% confidence interval 0.19-0.82[). The model, which included age as a continuous variable and lesion diameter as a dichotomized variable (cut-off 81 mm), provided the best area under the curve (0.87 [95% confidence interval 0.82-0.91]). A risk class system was developed, and patients were classified as low-risk (predictive model value <0.39%: 0/606 malignancies, risk 0%), intermediate risk (predictive model value 0.40%-2.2%: 9/1093 malignancies, risk 0.8%), high risk (predictive model value ≥2.3%: 43/566 malignancies, risk 7.6%).</p><p><strong>Conclusion: </strong>The preoperative 3-class diagnostic algorithm and risk class system can stratify women according to risk of malignancy. Our findings, if confirmed in a multicenter study, will permit differentiation between benign and mesenchymal uterine malignancies allowing a personalized clinical approach.</p>","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"108.e1-108.e22"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141858769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-07-31DOI: 10.1016/j.ajog.2024.06.051
Sara Khamaiseh, Anna Äyräväinen, Maare Arffman, Siiri Reinikka, Miika Mehine, Päivi Härkki, Ralf Bützow, Annukka Pasanen, Pia Vahteristo
<p><strong>Background: </strong>Repeat leiomyoma occurrence or even reintervention is common after myomectomy. Little is known about the factors related to repeat interventions.</p><p><strong>Objective: </strong>This study aimed to determine the frequency of leiomyoma-related reintervention after an initial laparoscopic or abdominal myomectomy and to analyze both clinical and molecular risk factors for reinterventions. Another objective was to define the frequency of clonally related tumors from repeat operations.</p><p><strong>Study design: </strong>This retrospective cohort study included 234 women who had undergone laparoscopic or abdominal myomectomy in 2009 to 2014. Information on repeat leiomyoma-related interventions as well as on other clinical factors was collected from medical records after a median follow-up time of 11.4 years (range 7.9-13.8 years) after the index procedure. The effect of clinical risk factors on the risk of reintervention was analyzed by the Kaplan-Meier estimator and the Cox proportional hazards model. For molecular analyses, we examined the mutation profiles of 133 formalin-fixed paraffin-embedded leiomyoma samples from 33 patients with repeat operations. We screened the tumors for the 3 primary leiomyoma driver alterations-mediator complex subunit 12 mutations, high mobility group AT-hook 2 overexpression, and fumarate hydratase-deficiency-utilizing Sanger sequencing and immunohistochemistry. To further assess the clonal relationship of the tumors, we executed whole-exome sequencing for 52 leiomyomas from 21 patients who exhibited the same driver alteration in tumors obtained from multiple procedures.</p><p><strong>Results: </strong>Reintervention rate at 11.4 years after myomectomy was 20% (46/234). Number of leiomyomas removed at the index myomectomy was a risk factor (hazard ratio 1.21; 95% confidence interval 1.09-1.34). Age at index myomectomy (hazard ratio 0.94; 95% confidence interval 0.89-0.99) and postoperative parity (hazard ratio 0.23; 95% confidence interval 0.09-0.60) were protective factors. Molecular characterization of tumors from index and nonindex operations confirmed a clonal relationship of the tumors in 3/33 (9%) patients. None of the leiomyomas harboring a mediator complex subunit 12 mutation-the most common leiomyoma driver-were confirmed clonally related. Fumarate hydratase-deficiency was detected in repeat leiomyomas from 3/33 (9%) patients. All these patients harbored a germline fumarate hydratase mutation, which is distinctive for the hereditary leiomyomatosis and renal cell cancer syndrome. Finally, we identified 3 (3/33; 9%) patients with 2 tumors each displaying somatic mutations in a recently identified novel leiomyoma driver gene, YEATS domain-containing protein 4. All YEATS domain-containing protein 4 mutations were different and thus the tumors were not clonally related.</p><p><strong>Conclusion: </strong>Our study shows that reintervention is common after surgical myomectomy. Ute
{"title":"Clinical and molecular risk factors for repeat interventions due to symptomatic uterine leiomyomas.","authors":"Sara Khamaiseh, Anna Äyräväinen, Maare Arffman, Siiri Reinikka, Miika Mehine, Päivi Härkki, Ralf Bützow, Annukka Pasanen, Pia Vahteristo","doi":"10.1016/j.ajog.2024.06.051","DOIUrl":"10.1016/j.ajog.2024.06.051","url":null,"abstract":"<p><strong>Background: </strong>Repeat leiomyoma occurrence or even reintervention is common after myomectomy. Little is known about the factors related to repeat interventions.</p><p><strong>Objective: </strong>This study aimed to determine the frequency of leiomyoma-related reintervention after an initial laparoscopic or abdominal myomectomy and to analyze both clinical and molecular risk factors for reinterventions. Another objective was to define the frequency of clonally related tumors from repeat operations.</p><p><strong>Study design: </strong>This retrospective cohort study included 234 women who had undergone laparoscopic or abdominal myomectomy in 2009 to 2014. Information on repeat leiomyoma-related interventions as well as on other clinical factors was collected from medical records after a median follow-up time of 11.4 years (range 7.9-13.8 years) after the index procedure. The effect of clinical risk factors on the risk of reintervention was analyzed by the Kaplan-Meier estimator and the Cox proportional hazards model. For molecular analyses, we examined the mutation profiles of 133 formalin-fixed paraffin-embedded leiomyoma samples from 33 patients with repeat operations. We screened the tumors for the 3 primary leiomyoma driver alterations-mediator complex subunit 12 mutations, high mobility group AT-hook 2 overexpression, and fumarate hydratase-deficiency-utilizing Sanger sequencing and immunohistochemistry. To further assess the clonal relationship of the tumors, we executed whole-exome sequencing for 52 leiomyomas from 21 patients who exhibited the same driver alteration in tumors obtained from multiple procedures.</p><p><strong>Results: </strong>Reintervention rate at 11.4 years after myomectomy was 20% (46/234). Number of leiomyomas removed at the index myomectomy was a risk factor (hazard ratio 1.21; 95% confidence interval 1.09-1.34). Age at index myomectomy (hazard ratio 0.94; 95% confidence interval 0.89-0.99) and postoperative parity (hazard ratio 0.23; 95% confidence interval 0.09-0.60) were protective factors. Molecular characterization of tumors from index and nonindex operations confirmed a clonal relationship of the tumors in 3/33 (9%) patients. None of the leiomyomas harboring a mediator complex subunit 12 mutation-the most common leiomyoma driver-were confirmed clonally related. Fumarate hydratase-deficiency was detected in repeat leiomyomas from 3/33 (9%) patients. All these patients harbored a germline fumarate hydratase mutation, which is distinctive for the hereditary leiomyomatosis and renal cell cancer syndrome. Finally, we identified 3 (3/33; 9%) patients with 2 tumors each displaying somatic mutations in a recently identified novel leiomyoma driver gene, YEATS domain-containing protein 4. All YEATS domain-containing protein 4 mutations were different and thus the tumors were not clonally related.</p><p><strong>Conclusion: </strong>Our study shows that reintervention is common after surgical myomectomy. Ute","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"110.e1-110.e23"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-07-20DOI: 10.1016/j.ajog.2024.07.022
Mingzhuo Pei, Carolyn J Gibson, Michael Schembri, Harini Raghunathan, Deborah Grady, Peter Ganz, Alison J Huang
<p><strong>Background: </strong>Hot flashes, common during menopause, affect up to 80% of the Western menopausal women and are reported to contribute to sleep disturbances in midlife. Few prospective data are available to confirm the specific role of hot flashes in disrupting sleep in midlife women, however, or confirm whether changes in hot flashes in response to clinical therapies result in improvement in sleep.</p><p><strong>Objective: </strong>To examine the effects of continuous nitroglycerin therapy on sleep quality in perimenopausal and postmenopausal women with frequent hot flashes (pre-specified secondary trial endpoint) and to examine prospective associations between hot flashes and sleep disruption in this population.</p><p><strong>Study design: </strong>Sleep data were analyzed from a randomized, double-blinded, placebo-controlled trial of continuous transdermal nitroglycerin (NTG) therapy to suppress nitric oxide-mediated vasodilation in perimenopausal or postmenopausal women with hot flashes. Participants were randomized to uninterrupted use of transdermal NTG (0.2-0.6 mg/hour) or placebo for 12 weeks. Nocturnal hot flashes awakening participants from sleep were evaluated using 7-day symptom diaries at baseline, 5 weeks, and 12 weeks. Sleep disruption (wakefulness after sleep onset, WASO) was assessed using validated sleep diaries, and global sleep quality was assessed by the validated Pittsburgh Sleep Quality Index (PSQI: range 0 [best] 21 [worst]) questionnaire. Mixed linear models examined changes in sleep quality and disruption, as well as the strength of associations between nocturnal hot flash frequency and sleep outcomes, over 5 and 12 weeks, adjusting for baseline values, age, race, and ethnicity.</p><p><strong>Results: </strong>Among the 141 participants (70 to NTG and 71 to placebo, mean age 54.6 [±3.9] years), the mean baseline hot flash frequency was 10.8 (±3.5) per day, including 2.6 (±1.7) nocturnal hot flashes awakening participants. At baseline, hot flashes were the most commonly reported reason for nocturnal awakening, with 62.6% of participants reporting waking due to hot flashes at least twice nightly. Over 5 and 12 weeks, mean frequency of nocturnal hot flashes causing awakenings decreased in both groups (NTG: -0.9 episodes/night, placebo: -1.0 episodes/night). Sleep disruption as measured by average nightly WASO also decreased (NTG: -10.1 minutes, placebo: -7.3 minutes), and mean PSQI score improved (NTG: -1.3 points, placebo: -1.2 points). No significant between-group differences in change in sleep outcomes were detected from baseline to 5 and 12 weeks, including PSQI sleep quality score as a prespecified secondary trial endpoint (P≥.05 for all). Greater improvement in nocturnal hot flash frequency over 5 and 12 weeks was associated with greater improvement in PSQI sleep quality score (β= -0.30, P=.01) and sleep disruption reflected by WASO (β= -1.88, P=.02) in the combined sample.</p><p><strong>Conclusion: </s
{"title":"Hot flashes and sleep disruption in a randomized trial in menopausal women.","authors":"Mingzhuo Pei, Carolyn J Gibson, Michael Schembri, Harini Raghunathan, Deborah Grady, Peter Ganz, Alison J Huang","doi":"10.1016/j.ajog.2024.07.022","DOIUrl":"10.1016/j.ajog.2024.07.022","url":null,"abstract":"<p><strong>Background: </strong>Hot flashes, common during menopause, affect up to 80% of the Western menopausal women and are reported to contribute to sleep disturbances in midlife. Few prospective data are available to confirm the specific role of hot flashes in disrupting sleep in midlife women, however, or confirm whether changes in hot flashes in response to clinical therapies result in improvement in sleep.</p><p><strong>Objective: </strong>To examine the effects of continuous nitroglycerin therapy on sleep quality in perimenopausal and postmenopausal women with frequent hot flashes (pre-specified secondary trial endpoint) and to examine prospective associations between hot flashes and sleep disruption in this population.</p><p><strong>Study design: </strong>Sleep data were analyzed from a randomized, double-blinded, placebo-controlled trial of continuous transdermal nitroglycerin (NTG) therapy to suppress nitric oxide-mediated vasodilation in perimenopausal or postmenopausal women with hot flashes. Participants were randomized to uninterrupted use of transdermal NTG (0.2-0.6 mg/hour) or placebo for 12 weeks. Nocturnal hot flashes awakening participants from sleep were evaluated using 7-day symptom diaries at baseline, 5 weeks, and 12 weeks. Sleep disruption (wakefulness after sleep onset, WASO) was assessed using validated sleep diaries, and global sleep quality was assessed by the validated Pittsburgh Sleep Quality Index (PSQI: range 0 [best] 21 [worst]) questionnaire. Mixed linear models examined changes in sleep quality and disruption, as well as the strength of associations between nocturnal hot flash frequency and sleep outcomes, over 5 and 12 weeks, adjusting for baseline values, age, race, and ethnicity.</p><p><strong>Results: </strong>Among the 141 participants (70 to NTG and 71 to placebo, mean age 54.6 [±3.9] years), the mean baseline hot flash frequency was 10.8 (±3.5) per day, including 2.6 (±1.7) nocturnal hot flashes awakening participants. At baseline, hot flashes were the most commonly reported reason for nocturnal awakening, with 62.6% of participants reporting waking due to hot flashes at least twice nightly. Over 5 and 12 weeks, mean frequency of nocturnal hot flashes causing awakenings decreased in both groups (NTG: -0.9 episodes/night, placebo: -1.0 episodes/night). Sleep disruption as measured by average nightly WASO also decreased (NTG: -10.1 minutes, placebo: -7.3 minutes), and mean PSQI score improved (NTG: -1.3 points, placebo: -1.2 points). No significant between-group differences in change in sleep outcomes were detected from baseline to 5 and 12 weeks, including PSQI sleep quality score as a prespecified secondary trial endpoint (P≥.05 for all). Greater improvement in nocturnal hot flash frequency over 5 and 12 weeks was associated with greater improvement in PSQI sleep quality score (β= -0.30, P=.01) and sleep disruption reflected by WASO (β= -1.88, P=.02) in the combined sample.</p><p><strong>Conclusion: </s","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"102.e1-102.e9"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-04-27DOI: 10.1016/j.ajog.2024.04.025
Clara Murillo, Elisenda Eixarch, Claudia Rueda, Marta Larroya, David Boada, Laia Grau, Júlia Ponce, Victoria Aldecoa, Elena Monterde, Silvia Ferrero, Vicente Andreu-Fernández, Gemma Arca, Laura Oleaga, Olga Ros, Maria Pilar Hernández, Eduard Gratacós, Montse Palacio, Teresa Cobo
<p><strong>Background: </strong>Brain injury and poor neurodevelopment have been consistently reported in infants and adults born before term. These changes occur, at least in part, prenatally and are associated with intra-amniotic inflammation. The pattern of brain changes has been partially documented by magnetic resonance imaging but not by neurosonography along with amniotic fluid brain injury biomarkers.</p><p><strong>Objective: </strong>This study aimed to evaluate the prenatal features of brain remodeling and injury in fetuses from patients with preterm labor with intact membranes or preterm premature rupture of membranes and to investigate the potential influence of intra-amniotic inflammation as a risk mediator.</p><p><strong>Study design: </strong>In this prospective cohort study, fetal brain remodeling and injury were evaluated using neurosonography and amniocentesis in singleton pregnant patients with preterm labor with intact membranes or preterm premature rupture of membranes between 24.0 and 34.0 weeks of gestation, with (n=41) and without (n=54) intra-amniotic inflammation. The controls for neurosonography were outpatient pregnant patients without preterm labor or preterm premature rupture of membranes matched 2:1 by gestational age at ultrasound. Amniotic fluid controls were patients with an amniocentesis performed for indications other than preterm labor or preterm premature rupture of membranes without brain or genetic defects whose amniotic fluid was collected in our biobank for research purposes matched by gestational age at amniocentesis. The group with intra-amniotic inflammation included those with intra-amniotic infection (microbial invasion of the amniotic cavity and intra-amniotic inflammation) and those with sterile inflammation. Microbial invasion of the amniotic cavity was defined as a positive amniotic fluid culture and/or positive 16S ribosomal RNA gene. Inflammation was defined by amniotic fluid interleukin 6 concentrations of >13.4 ng/mL in preterm labor and >1.43 ng/mL in preterm premature rupture of membranes. Neurosonography included the evaluation of brain structure biometric parameters and cortical development. Neuron-specific enolase, protein S100B, and glial fibrillary acidic protein were selected as amniotic fluid brain injury biomarkers. Data were adjusted for cephalic biometrics, fetal growth percentile, fetal sex, noncephalic presentation, and preterm premature rupture of membranes at admission.</p><p><strong>Results: </strong>Fetuses from mothers with preterm labor with intact membranes or preterm premature rupture of membranes showed signs of brain remodeling and injury. First, they had a smaller cerebellum. Thus, in the intra-amniotic inflammation, non-intra-amniotic inflammation, and control groups, the transcerebellar diameter measurements were 32.7 mm (interquartile range, 29.8-37.6), 35.3 mm (interquartile range, 31.2-39.6), and 35.0 mm (interquartile range, 31.3-38.3), respectively (P=.019), an
{"title":"Evidence of brain injury in fetuses of mothers with preterm labor with intact membranes and preterm premature rupture of membranes.","authors":"Clara Murillo, Elisenda Eixarch, Claudia Rueda, Marta Larroya, David Boada, Laia Grau, Júlia Ponce, Victoria Aldecoa, Elena Monterde, Silvia Ferrero, Vicente Andreu-Fernández, Gemma Arca, Laura Oleaga, Olga Ros, Maria Pilar Hernández, Eduard Gratacós, Montse Palacio, Teresa Cobo","doi":"10.1016/j.ajog.2024.04.025","DOIUrl":"10.1016/j.ajog.2024.04.025","url":null,"abstract":"<p><strong>Background: </strong>Brain injury and poor neurodevelopment have been consistently reported in infants and adults born before term. These changes occur, at least in part, prenatally and are associated with intra-amniotic inflammation. The pattern of brain changes has been partially documented by magnetic resonance imaging but not by neurosonography along with amniotic fluid brain injury biomarkers.</p><p><strong>Objective: </strong>This study aimed to evaluate the prenatal features of brain remodeling and injury in fetuses from patients with preterm labor with intact membranes or preterm premature rupture of membranes and to investigate the potential influence of intra-amniotic inflammation as a risk mediator.</p><p><strong>Study design: </strong>In this prospective cohort study, fetal brain remodeling and injury were evaluated using neurosonography and amniocentesis in singleton pregnant patients with preterm labor with intact membranes or preterm premature rupture of membranes between 24.0 and 34.0 weeks of gestation, with (n=41) and without (n=54) intra-amniotic inflammation. The controls for neurosonography were outpatient pregnant patients without preterm labor or preterm premature rupture of membranes matched 2:1 by gestational age at ultrasound. Amniotic fluid controls were patients with an amniocentesis performed for indications other than preterm labor or preterm premature rupture of membranes without brain or genetic defects whose amniotic fluid was collected in our biobank for research purposes matched by gestational age at amniocentesis. The group with intra-amniotic inflammation included those with intra-amniotic infection (microbial invasion of the amniotic cavity and intra-amniotic inflammation) and those with sterile inflammation. Microbial invasion of the amniotic cavity was defined as a positive amniotic fluid culture and/or positive 16S ribosomal RNA gene. Inflammation was defined by amniotic fluid interleukin 6 concentrations of >13.4 ng/mL in preterm labor and >1.43 ng/mL in preterm premature rupture of membranes. Neurosonography included the evaluation of brain structure biometric parameters and cortical development. Neuron-specific enolase, protein S100B, and glial fibrillary acidic protein were selected as amniotic fluid brain injury biomarkers. Data were adjusted for cephalic biometrics, fetal growth percentile, fetal sex, noncephalic presentation, and preterm premature rupture of membranes at admission.</p><p><strong>Results: </strong>Fetuses from mothers with preterm labor with intact membranes or preterm premature rupture of membranes showed signs of brain remodeling and injury. First, they had a smaller cerebellum. Thus, in the intra-amniotic inflammation, non-intra-amniotic inflammation, and control groups, the transcerebellar diameter measurements were 32.7 mm (interquartile range, 29.8-37.6), 35.3 mm (interquartile range, 31.2-39.6), and 35.0 mm (interquartile range, 31.3-38.3), respectively (P=.019), an","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"114.e1-114.e24"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140848456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01Epub Date: 2024-07-15DOI: 10.1016/j.ajog.2024.07.006
Amira Quevedo, Shivani Parikh, Jonathan Reinstine, Petra Chamseddine, Jeremy T Gaskins, Cathy Whalen, Shan Biscette, Resad Paya Pasic
Background: Recent studies have shown that a disrupted microbiome is associated with endometriosis. Despite endometriosis affecting 1 in 10 reproductive-aged women, there is a lack of innovative and nonhormonal long-term effective treatments. Studies have reported an approximately 20% to 37.5% persistence of pain after fertility-sparing endometriosis surgery. Metronidazole has been shown to decrease inflammatory markers and the size of endometriosis lesions in animal studies.
Objective: To determine if modulating the microbiome with oral metronidazole for 14 days after fertility-sparing endometriosis surgery decreases pain persistence postoperatively.
Study design: This was a randomized, multicenter, placebo-controlled, double-blind trial. Individuals 18 to 50 years old were prospectively randomized to placebo vs oral metronidazole for 14 days immediately after endometriosis fertility-sparing excision surgery. The primary outcome was binary, subjective pain persistence at 6 weeks postoperatively. Secondary outcomes included quality of life, sexual function, and endometriosis-associated pain scores according to the Endometriosis Health Profile-5, Female Sexual Function Index, and a visual analog scale.
Results: One hundred fifty-two participants were approached from October 2020 to October 2023 to enroll in the study. Sixty-four participants were excluded either because they did not meet inclusion or exclusion criteria or because they declined to participate. Eighty-eight participants were randomized in a 1:1 ratio to receive either the oral placebo or metronidazole after endometriosis excision surgery; 18.2% of participants were lost to follow-up or discontinued treatment and this was not significantly different between the 2 arms, yielding a final cohort of 72 participants. Baseline demographics of the 2 study groups were similar. There was no statistically significant improvement in the primary outcome of binary subjective pain persistence between the metronidazole group compared to placebo (84% vs 88%, P=.74) at 6 weeks postoperatively. Further, no significant differences between treatments were detected in the secondary outcomes.
Conclusion: A postoperative 14-day regimen of oral metronidazole immediately after fertility-sparing endometriosis surgery was not associated with any significant differences between treatment groups in the persistence of endometriosis-related pain symptoms compared to placebo at 6 weeks.
{"title":"The impact of metronidazole on pain persistence after fertility-sparing endometriosis surgery: METROFERT randomized study.","authors":"Amira Quevedo, Shivani Parikh, Jonathan Reinstine, Petra Chamseddine, Jeremy T Gaskins, Cathy Whalen, Shan Biscette, Resad Paya Pasic","doi":"10.1016/j.ajog.2024.07.006","DOIUrl":"10.1016/j.ajog.2024.07.006","url":null,"abstract":"<p><strong>Background: </strong>Recent studies have shown that a disrupted microbiome is associated with endometriosis. Despite endometriosis affecting 1 in 10 reproductive-aged women, there is a lack of innovative and nonhormonal long-term effective treatments. Studies have reported an approximately 20% to 37.5% persistence of pain after fertility-sparing endometriosis surgery. Metronidazole has been shown to decrease inflammatory markers and the size of endometriosis lesions in animal studies.</p><p><strong>Objective: </strong>To determine if modulating the microbiome with oral metronidazole for 14 days after fertility-sparing endometriosis surgery decreases pain persistence postoperatively.</p><p><strong>Study design: </strong>This was a randomized, multicenter, placebo-controlled, double-blind trial. Individuals 18 to 50 years old were prospectively randomized to placebo vs oral metronidazole for 14 days immediately after endometriosis fertility-sparing excision surgery. The primary outcome was binary, subjective pain persistence at 6 weeks postoperatively. Secondary outcomes included quality of life, sexual function, and endometriosis-associated pain scores according to the Endometriosis Health Profile-5, Female Sexual Function Index, and a visual analog scale.</p><p><strong>Results: </strong>One hundred fifty-two participants were approached from October 2020 to October 2023 to enroll in the study. Sixty-four participants were excluded either because they did not meet inclusion or exclusion criteria or because they declined to participate. Eighty-eight participants were randomized in a 1:1 ratio to receive either the oral placebo or metronidazole after endometriosis excision surgery; 18.2% of participants were lost to follow-up or discontinued treatment and this was not significantly different between the 2 arms, yielding a final cohort of 72 participants. Baseline demographics of the 2 study groups were similar. There was no statistically significant improvement in the primary outcome of binary subjective pain persistence between the metronidazole group compared to placebo (84% vs 88%, P=.74) at 6 weeks postoperatively. Further, no significant differences between treatments were detected in the secondary outcomes.</p><p><strong>Conclusion: </strong>A postoperative 14-day regimen of oral metronidazole immediately after fertility-sparing endometriosis surgery was not associated with any significant differences between treatment groups in the persistence of endometriosis-related pain symptoms compared to placebo at 6 weeks.</p>","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"106.e1-106.e9"},"PeriodicalIF":8.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}