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1.
Arch Gynecol Obstet ; 309(5): 2057-2062, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38492083

RESUMO

PURPOSE: The objective of this study is to assess the correlation between bleeding irregularities and the accurate placement of the intrauterine device (IUD) device in the uterine cavity, determined through transvaginal ultrasonography and hysteroscopy. In addition, the study aims to examine the cytokine profile in the uterine cavity and serum of patients experiencing bleeding irregularities after the insertion of nonhormonal IUDs. METHODS: A prospective cohort study was conducted at a single tertiary medical center, wherein patients experiencing intermenstrual bleeding and spotting after the insertion of nonhormonal IUDs were enrolled. The study involved hysteroscopic and sonographic assessments of the uterine cavity and IUD placement, along with the analysis of blood and uterine cavity cytokine profiles. RESULTS: During the period between July 2019 and February 2020, a total of eight patients who experienced intermenstrual bleeding and spotting after the insertion of nonhormonal IUDs were enrolled the study. One case was excluded since a progestative device was detected by ultrasound. Out of the five cases that underwent a thorough ultrasonographic assessment, three cases (60%) showed an embedded IUD. However, these findings were excluded by the hysteroscopic evaluation. CONCLUSION: The results suggest that ultrasonographic assessment may lead to an overdiagnosis of IUD mispositioning compared to hysteroscopy. In addition, both ultrasound and hysteroscopy have limitations in diagnosing the cause of bleeding in most cases. The role of local reactive inflammatory cytokines should be further studied.


Assuntos
Dispositivos Intrauterinos , Menorragia , Metrorragia , Gravidez , Humanos , Feminino , Histeroscopia , Menorragia/diagnóstico por imagem , Menorragia/etiologia , Estudos Prospectivos , Hemorragia , Ultrassonografia , Citocinas
2.
Pediatr Ann ; 53(3): e104-e108, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38466333

RESUMO

Heavy menstrual bleeding has a high prevalence and is well documented in adult patients with hypermobile-type Ehlers-Danlos syndrome, but there is limited research surrounding work-up and treatment for the adolescent population. Excessive menstrual blood loss can significantly interfere with emotional and physical quality of life. A provider should acquire a comprehensive medical and menstrual history and focused physical examination, as well as baseline laboratory studies, to determine the presence of anemia or underlying bleeding disorder. Use of a pictorial blood assessment chart may be considered to help quantify the amount of bleeding. Treatment to reduce heavy menstrual flow and referral to specialty care should be initiated swiftly to improve quality of life for this population. [Pediatr Ann. 2024;53(3):e104-e108.].


Assuntos
Síndrome de Ehlers-Danlos , Instabilidade Articular , Menorragia , Adolescente , Feminino , Humanos , Síndrome de Ehlers-Danlos/complicações , Síndrome de Ehlers-Danlos/diagnóstico , Síndrome de Ehlers-Danlos/terapia , Instabilidade Articular/complicações , Instabilidade Articular/diagnóstico , Instabilidade Articular/terapia , Instabilidade Articular/congênito , Menorragia/diagnóstico , Menorragia/etiologia , Menorragia/terapia , Qualidade de Vida
3.
Pediatr Blood Cancer ; 71(5): e30926, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38449356

RESUMO

BACKGROUND: Pediatric venous thromboembolism has increased by 130%-200%, specifically in hospitalized children, and direct oral anticoagulants (DOACs) offer several therapeutic advantages. METHODS: This study aims to evaluate the real-world epidemiological and outcome data from a retrospective review of pediatric patients treated with DOACs from January 1, 2013 to December 31, 2022. In this single-center, IRB-approved study, 65 patients were identified and analyzed using SPSS statistical software, and a descriptive statistical analysis was conducted. RESULTS: Of the 65 patients, 37% were on apixaban, 61.5% were on rivaroxaban, and 1.5% were on dabigatran. Per the 2023 ISTH outcome definitions, one (2%) patient had a major bleeding episode, six (9%) had clinically relevant non-major bleeding, three (5%) patients had patient-important heavy menstrual bleeding (HMB), and one (1.5%) patient had minor bleeding. Seven (19%) of 37 postmenarchal patients had evidence of HMB. Six (9.2%) patients had recurrent venous thromboembolism while on a DOAC (one was on apixaban, and five were on rivaroxaban) and were transitioned to other forms of anticoagulation. CONCLUSION: Thus, bleeding rates after DOAC therapy are comparable to previous DOAC trials, as well as other anticoagulants in pediatrics. HMB is an important outcome measure and should continue to be investigated. This study reports a higher rate of recurrent thrombosis (9.2%) compared to other trials. However, this observation may be attributed to patients who had ongoing risk factors, as well as a longer duration of study follow-up. Additional multicentered outcome studies evaluating DOAC use in children are needed to determine long-term recurrence and HMB risks.


Assuntos
Menorragia , Tromboembolia Venosa , Feminino , Humanos , Criança , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/complicações , Dabigatrana/efeitos adversos , Menorragia/complicações , Piridonas/efeitos adversos , Estudos Retrospectivos , Administração Oral
4.
Haemophilia ; 30 Suppl 3: 45-51, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38532560

RESUMO

Raising awareness and improving recognition, accurate classification, and enhanced access to new treatments represent current key challenges for carriers of haemophilia. Women and girls carrying genes for haemophilia often experience significant bleeding and/or low factor levels. The bleeding associated with female haemophilia is frequently overlooked, has a weak correlation with factor levels, and manifests differently than in males, with heavy menstrual bleeding being a predominant symptom. Recent changes in terminology now allow the diagnosis of haemophilia in females with low factor levels and differentiate between symptomatic and asymptomatic carriers of the gene. Observations from real-world experiences and limited clinical trial data have highlighted the positive impact of various new haemophilia treatments for women and girls with clotting factor deficiencies. There is an urgent need for initiatives that increase their access to these treatments and encourage well-designed clinical trials focusing on female-specific outcomes. In women with inherited bleeding disorders, early recognition and optimal management of heavy menstrual bleeding are crucial. However, treatment options and guidance from high-quality clinical trials are currently insufficient. Menstrual health assessment should be a regular part of monitoring women and girls with inherited bleeding disorders throughout their lives, emphasizing the importance of gathering data to improve future management.


Assuntos
Hemofilia A , Menorragia , Masculino , Feminino , Humanos , Hemofilia A/complicações , Hemofilia A/diagnóstico , Hemofilia A/genética , Menorragia/etiologia , Menorragia/genética , Hemorragia/genética
5.
BMJ Case Rep ; 17(3)2024 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-38538101

RESUMO

Uterine leiomyomas are rare in the paediatric population. This report describes a rare case of a submucous leiomyoma in an adolescent girl. The patient presented with a history of abnormal and painful period which was refractory to medical treatment. Sonographic findings revealed a uterine mass that protruded through the cervix until the upper third of the vagina. A hysteroscopic resection was performed, and a pathological examination confirmed a leiomyoma. 12 months after surgery, there were no signs of recurrence. Conservative sparing-fertility management, such as hysteroscopic resection, is the best option with a type 0 submucosal fibroid, especially in adolescents and young women.


Assuntos
Leiomioma , Menorragia , Neoplasias Uterinas , Adolescente , Feminino , Humanos , Gravidez , Dismenorreia , Histeroscopia/efeitos adversos , Leiomioma/complicações , Leiomioma/diagnóstico por imagem , Leiomioma/cirurgia , Menorragia/etiologia , Neoplasias Uterinas/patologia , Vagina/patologia
6.
BMC Womens Health ; 24(1): 136, 2024 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-38378571

RESUMO

BACKGROUND: Adolescent heavy menstrual bleeding(HMB), menorrhagia or abnormal uterine bleeding commonly occur in adolescent women. The differential diagnosis can be challenging. The pneumonic: PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified), is commonly used but it does not stratify as to the likelihood of a disorder. We have sought to develop a probability-based differential diagnosis for Adolescent HMB, menorrhagia or abnormal uterine bleeding. METHODS: A comprehensive literature search was conducted using PubMed, EMBASE, and SCOPUS databases. Case series describing adolescents from 10-19 years of age with HMB, menorrhagia or abnormal uterine bleeding was acceptable if: more than 10 patients were included; editorials, case reports, and secondary sources such as review articles, or book chapters were excluded. No language filter was used, but an English abstract was required. The etiology of HMB, menorrhagia or abnormal uterine bleeding, and the country of origin was extracted from articles that met inclusion criteria. Cumulative rate estimates were determined by Bayesian probability modeling. RESULTS: Seventeen full text articles were reviewed in detail; 2,770 patients were included. The most frequent causes of HMB were Ovarian Uterine Disorders (23.7%; 95% CredI 22-25.5%), Coagulation Disorders (19.4%; 95% CredI 17.8-21.1%), and Platelet Disorders (6.23%; 95% CredI 5.27-7.27%) with 45.9% (95% CredI 43.8-47.%9) of the cases of indeterminate origin. CONCLUSIONS: The leading causes of HMB in healthy adolescent females were varied. The sub-analysis identified distinct etiologies, suggesting that multiple factors must be considered in the evaluation of HMB. While PALM-COEIN (polyp, adenomyosis, leiomyoma, malignancy and hyperplasia, coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified) provides us with a comprehensive picture of the possible causes of HMB in females, this systematic review assigns probabilities to the etiologies of HMB in adolescent females, providing physicians with a more focused and efficient pathway to diagnosis.


Assuntos
Adenomiose , Leiomioma , Menorragia , Pólipos , Feminino , Adolescente , Humanos , Menorragia/etiologia , Teorema de Bayes , Hiperplasia , Doença Iatrogênica
7.
Arch Gynecol Obstet ; 309(5): 1765-1773, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38347252

RESUMO

OBJECTIVE: To analyze the efficacy of high-intensity focused ultrasound (HIFU) for adenomyosis and postoperative recurrence and its influencing factors. METHODS: Clinical and follow-up data of 308 patients with adenomyosis who were treated with HIFU in Haifu Center, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from September 2017 to January 2022 were retrospectively analyzed. The recurrence of adenomyosis and the efficacy of HIFU at 6 months after surgery were followed up. To explore factors influencing postoperative prognosis and recurrence, the following variables were analyzed: patients' age, course of disease, gravidity and parity, size of the uterus, duration of HIFU, duration of irradiation, treatment intensity, dysmenorrhea score, time of follow-up, combined treatment of traditional Chinese medicine (TCM), western medicine adjuvant treatment, lesion location and type, and menorrhagia. RESULTS: Among the 308 patients, 238 (77%) were followed up from 6 to 36 months, with an average follow-up time of 15.24 ± 9.97 months. The other 70 (23%) were lost to follow-up. At 6-month after surgery, efficacy rates of dysmenorrhea and menorrhagia management were 86.7% and 89.3%, respectively. Postoperative recurrence rates were 4.8% (1-12 months), 9.0% (12-24 months), and 17.0% (24-36 months) for dysmenorrhea; and 6.3% (1-12 months), 2.4% (12-24 months), and 12.2% (24-36 months) for menorrhagia. Multivariate logistic regression analyses showed that parity (P = 0.043, OR = 1.773, 95% CI 1.018-3.087), uterine size (P = 0.019, OR = 1.004, 95% CI 1.001-1.007), combined treatment of TCM (P = 0.047, OR = 1.846, 95% CI 1.008-3.381), diffuse lesion type (P = 0.013, OR = 0.464, 95% CI 0.254-0.848) and ablation rate (P = 0.015, OR = 0.481, 95%CI 0.267-0.868) were prognostic factors (P < 0.05). Age, course of disease, gravidity, duration of HIFU, duration of irradiation, treatment intensity, preoperative dysmenorrhea score, time of follow-up, western medicine adjuvant therapy, lesion location, and preoperative menstrual volume had no effect on prognosis (P > 0.05). CONCLUSION: HIFU can effectively relieve dysmenorrhea and reduce menstrual volume in patients with adenomyosis. Parity, uterine size, lesion type (diffuse), and ablation rate are risk factors for symptom recurrence after HIFU, while the combination of TCM therapy is a protective factor for relapse. We, therefore, recommend TCM in the adjuvant setting after HIFU according to patient condition.


Assuntos
Adenomiose , Ablação por Ultrassom Focalizado de Alta Intensidade , Menorragia , Gravidez , Feminino , Humanos , Dismenorreia/terapia , Dismenorreia/cirurgia , Menorragia/etiologia , Resultado do Tratamento , Estudos Retrospectivos , Adenomiose/cirurgia , Adenomiose/patologia
8.
Haemophilia ; 30(2): 490-496, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38385952

RESUMO

INTRODUCTION: There are a significant number of patients with mucocutaneous bleeding, specifically heavy menstrual bleeding (HMB), who do not have a diagnosed bleeding disorder. These patients receive nontargeted interventions and may have suboptimal treatments. Functional assays, particularly for fibrinolytic and rare platelet function defects, are not robust and not readily available. AIM: We aimed to prospectively evaluate the prevalence of genetic defects associated with rare bleeding disorders and describe alterations of coagulation and fibrinolysis in a cohort of adolescents with HMB. METHODS: We performed a prospective observational cohort study of patients with HMB and unexplained bleeding. The study utilized a next generation sequencing panel and investigational global assays of coagulation and fibrinolysis. Additionally, specific functional assays were performed to help characterize novel variants that were identified. RESULTS: In 10 of the 17 patients (∼59%), genetic variants were identified on molecular testing. Thrombin generation by calibrated thromboelastography was not significantly altered in this patient population. The clot formation and lysis assay showed a trend towards increased fibrinolysis with rapid phase of decline in 23% of the patients. Further corresponding functional assays and study population are described. CONCLUSION: Our study describes a unique correlative model in a homogenous cohort of patients with HMB and unexplained bleeding which may inform future diagnostic algorithms, genotype-phenotype correlations as well as aid in specific targeted treatment approaches. Larger future studies may inform risk stratification of patients and improve health related outcomes in patients with HMB.


Assuntos
Transtornos da Coagulação Sanguínea , Transtornos Hemorrágicos , Menorragia , Feminino , Humanos , Adolescente , Menorragia/complicações , Estudos Prospectivos , Hemorragia/complicações , Transtornos da Coagulação Sanguínea/diagnóstico , Transtornos Hemorrágicos/epidemiologia
9.
Eur Rev Med Pharmacol Sci ; 28(2): 469-476, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38305594

RESUMO

OBJECTIVE: The etiology of disorders may be attributable to multiple causal factors simultaneously. This study sought to investigate how frequently, and which causes coexist in patients with iron deficiency. PATIENTS AND METHODS: All patients who applied to the Iron Deficiency Outpatient Clinic between January and December 2021 were included in this cross-sectional study. The causes of iron deficiency were extracted from patient files. Analyses were conducted on the entire population as well as three subgroups: women of reproductive age, postmenopausal women, and males. Numbers and frequencies of causes of iron deficiency were calculated. The subgroups were compared using the Jamovi software. RESULTS: The study sample comprised a total of 331 patients. Women of reproductive age were the majority of patients admitted to the clinic (86.7%, n=287). Men represented 6.3% of the sample (n=21), and postmenopausal women accounted for 7.0% (n=23). The mean ages were 37.6±9.05, 49.2±15.49 and 57.8±10.84 years, respectively. The overall sample's rate of multiple iron deficiency causes coexisting was 33.5% (n=111) and the subgroups showed similar frequencies for the coexistence of multiple causes. Statistically, the number of simultaneous multiple causes varied between subgroups (χ2=118, df=10, p<0.001). Heavy menstrual bleeding and nonsteroidal anti-inflammatory drug use were the most common dual causes of multiple coexisting conditions (n=46, 41.4%). In terms of the number of causes, the coexistence of two causes of iron deficiency in women was notable, whereas the coexistence of three causes in males was remarkable. Furthermore, it has been found that some patients have up to five coexisting causes of iron deficiency. CONCLUSIONS: Some iron deficiency causes may coexist, and this must be taken into account for the effective management of iron deficiency.


Assuntos
Anemia Ferropriva , Deficiências de Ferro , Menorragia , Masculino , Humanos , Feminino , Anemia Ferropriva/complicações , Anemia Ferropriva/epidemiologia , Estudos Transversais , Hospitalização
10.
Medicina (Kaunas) ; 60(2)2024 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-38399494

RESUMO

Background and Objectives: Menstrual changes, including altered cycle length and bleeding patterns, have been reported following COVID-19 vaccination. This study aimed to determine the prevalence and types of menstrual changes occurring after COVID-19 vaccination among female students and staff at a university in Saudi Arabia. Materials and Methods: A cross-sectional study was conducted among women aged 18-39 years who received at least one dose of a COVID-19 vaccine. Eligible participants, including university students and staff, were recruited between May 2022 and November 2022. Participants completed a questionnaire detailing their sociodemographic characteristics, general medical and reproductive history, and menstrual characteristics before and after vaccination. The prevalence of various menstrual changes (cycle length, bleeding days, flow, and mid-cycle spotting) was calculated. The demographic factors associated with menstrual changes were analyzed using chi-squared tests. Results: The 472 included participants had a mean age of 20.9 years, and 95.3% were unmarried. Changes in menstrual cycle characteristics after COVID-19 vaccination were reported by 54.7% of respondents overall. The most common change was in cycle length, followed by the number of menstruation days and bleeding flow. Menstrual changes were not associated with age, BMI, occupation, marital status, or medical history. Changes in intermenstrual bleeding were more frequently reported after the third dose of the Pfizer vaccine compared to the Moderna vaccine (p = 0.014). Conclusions: More than half of the recruited female students and staff reported menstrual changes following COVID-19 vaccination, with altered cycle length being the most common. The potential underlying mechanisms and implications of these menstrual alterations require further investigation. These findings provide evidence of the menstrual side effects of COVID-19 vaccines among women in Saudi Arabia.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Menorragia , Adulto , Feminino , Humanos , Adulto Jovem , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estudos Transversais , Menstruação , Vacinação
11.
Medicine (Baltimore) ; 103(2): e36866, 2024 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-38215109

RESUMO

Thrombocytopenia (TCP) is the second most common hematological change during pregnancy and is considered as a major source of maternal and neonatal morbidity and mortality. Despite its effects to morbidity and mortality, it is frequently ignored or disregarded, particularly in resource-limited nations. Thus, the purpose of this study was to determine the prevalence of thrombocytopenia and associated factors among pregnant women attending antenatal care at Hiwot Fana Comprehensive Specialized University Hospital, Eastern Ethiopia from June 20 to August 30, 2022. A hospital-based cross-sectional study was conducted among 199 pregnant women selected through a systematic sampling technique. Ethical approval was obtained from the Ethics Review Committee of Haramaya University. Data related to sociodemographic and reproductive variables were collected using structured questionnaires. Four milliliters of venous blood were collected from each study participant and a complete blood cell count was determined using UniCel DxH 800 hematology analyzer. Logistic regression analysis was done to assess the association between TCP and independent variables and P < .05 was considered statistically significant. In this study, the prevalence of TCP was 14.1% (95% CI: 9.6-19.7). Of them, 10 (35.7%), 12 (42.9%), and 4 (21.4%) had mild, moderate, and severe TCP, respectively. Having more than 3 children (adjusted odds ratio, AOR = 7.90, 95% CI: 2.60, 24.3), no antenatal care follow-up (AOR = 7.90, 95% CI: 2.40-26.2), being in the second and third trimester (AOR = 6.90, 95% CI: 1.70, 28.9 and AOR = 5.04, 95% CI: 1.12, 22.7, respectively), and history of heavy menstrual bleeding (AOR = 4.03, 95% CI: 1.25, 13.1) were significantly associated with TCP. TCP is a public health problem among pregnant women in the study area. Having more than 3 children, lack of antenatal care follow-up, being in the second and third trimesters, and having history of heavy menstrual bleeding was significantly associated with TCP. As a result, regular platelet count monitoring and appropriate intervention approaches based on identified predictors should be explored to mitigate adverse outcomes in pregnant women.


Assuntos
Anemia , Menorragia , Trombocitopenia , Criança , Recém-Nascido , Feminino , Gravidez , Humanos , Cuidado Pré-Natal/métodos , Gestantes , Estudos Transversais , Etiópia/epidemiologia , Fatores de Risco , Anemia/epidemiologia , Hospitais , Trombocitopenia/epidemiologia
14.
Birth ; 51(1): 198-208, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37849409

RESUMO

BACKGROUND: Although gynecological health issues are common and cause considerable distress, little is known about their causes. We examined how birth history is associated with urinary incontinence (UI), severe period pain, heavy periods, and endometriosis. METHODS: We studied 7700 women in the Australian Longitudinal Study on Women's Health with an average follow-up of 10.9 years after their last birth. Surveys every third year provided information about birth history and gynecological health. Logistic regression was used to estimate how parity, mode of birth, and vaginal tears were associated with gynecological health issues. Presented results are adjusted odds ratios (OR) with 95% confidence intervals. RESULTS: UI was reported by 16%, heavy periods by 31%, severe period pain by 28%, and endometriosis by 4%. Compared with women with two children, nonparous women had less UI (OR 0.35 [0.26-0.47]) but tended to have more endometriosis (OR 1.70 [0.97-2.96]). Also, women with only one child had less UI (OR 0.77 [0.61-0.98]), but more severe period pain (OR 1.24 [1.01-1.51]). Women with 4+ children had more heavy periods (OR 1.42 [1.07-1.88]). Compared with women with vaginal birth(s) only, women with only cesarean sections or vaginal birth after cesarean section had less UI (ORs 0.44 [0.34-0.58] and 0.55 [0.40-0.76]), but more endometriosis (ORs 1.91 [1.16-3.16] and 2.31 [1.25-4.28]) and heavy periods (ORs 1.21 [1.00-1.46] and 1.35 [1.06-1.72]). Vaginal tear(s) did not increase UI after accounting for parity and birth mode. CONCLUSION: While women with vaginal childbirth(s) reported more urinary incontinence, they had less menstrual complaints and endometriosis.


Assuntos
Endometriose , Menorragia , Incontinência Urinária , Criança , Gravidez , Feminino , Humanos , Cesárea , Seguimentos , Estudos Longitudinais , Endometriose/epidemiologia , Endometriose/complicações , Menorragia/complicações , Austrália/epidemiologia , Paridade , Saúde da Mulher , Incontinência Urinária/epidemiologia , Incontinência Urinária/etiologia , Dor , Inquéritos e Questionários
15.
Am J Obstet Gynecol ; 230(2): 237.e1-237.e11, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37863160

RESUMO

BACKGROUND: In the LIBERTY Long-Term Extension study, once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) substantially improved uterine fibroid-associated heavy menstrual bleeding throughout the 52-week treatment period in the overall study population. OBJECTIVE: Black or African American women typically experience a greater extent of disease and symptom burden of uterine fibroids vs other racial groups and have traditionally been underrepresented in clinical trials. This secondary analysis aimed to assess the efficacy and safety of relugolix combination therapy in the subgroup population of Black or African American women with uterine fibroids in the LIBERTY Long-Term Extension study. STUDY DESIGN: Black or African American premenopausal women (aged 18-50 years) with uterine fibroids and heavy menstrual bleeding who completed the 24-week randomized, placebo-controlled, double-blind LIBERTY 1 (identifier: NCT03049735) or LIBERTY 2 (identifier: NCT03103087) trials were eligible to enroll in the 28-week LIBERTY Long-Term Extension study (identifier: NCT03412890), in which all women received once-daily, open-label relugolix combination therapy. The primary endpoint of this subanalysis was the proportion of Black or African American treatment responders: women who achieved a menstrual blood loss volume of <80 mL and at least a 50% reduction in menstrual blood loss volume from the pivotal study baseline to the last 35 days of treatment by pivotal study randomized treatment group. The secondary outcomes included rates of amenorrhea and changes in symptom burden and quality of life. RESULTS: Overall, 241 of 477 women (50.5%) enrolled in the LIBERTY Long-Term Extension study self-identified as Black or African American. In Black or African American women receiving continuous relugolix combination therapy for up to 52 weeks, 58 of 70 women (82.9%; 95% confidence interval, 72.0%-90.8%) met the treatment responder criteria for reduction in heavy menstrual bleeding (primary endpoint). A substantial reduction in menstrual blood loss volume from the pivotal study baseline to week 52 was demonstrated (least squares mean percentage change: 85.0%); 64.3% of women achieved amenorrhea; 59.1% of women with anemia at the pivotal study baseline achieved a substantial improvement (>2 g/dL) in hemoglobin levels; and decreased symptom severity and distress because of uterine fibroid-associated symptoms and improvements in health-related quality of life through 52 weeks were demonstrated. The most frequently reported adverse events during the cumulative 52-week treatment period were hot flush (12.9%), headache (5.7%), and hypertension (5.7%). Bone mineral density was preserved through 52 weeks. CONCLUSION: Once-daily relugolix combination therapy improved uterine fibroid-associated heavy menstrual bleeding in most Black or African American women who participated in the LIBERTY Long-Term Extension study. The safety and efficacy profile of relugolix combination therapy in Black or African American women was consistent with previously published results from the overall study population through 52 weeks. Findings from this subanalysis will assist shared decision-making by helping providers and Black or African American women understand the efficacy and safety of relugolix combination therapy as a pharmacologic option for the management of uterine fibroid-associated symptoms.


Assuntos
Leiomioma , Menorragia , Compostos de Fenilureia , Pirimidinonas , Neoplasias Uterinas , Feminino , Humanos , Amenorreia , Negro ou Afro-Americano , Leiomioma/complicações , Leiomioma/tratamento farmacológico , Menorragia/tratamento farmacológico , Menorragia/etiologia , Compostos de Fenilureia/uso terapêutico , Pirimidinonas/uso terapêutico , Qualidade de Vida , Neoplasias Uterinas/complicações , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade
17.
J Thromb Haemost ; 22(2): 315-322, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37709147

RESUMO

Women or people with a uterus are vulnerable to both normal and abnormal bleeding. During the reproductive years, the uterus is prepared physiologically to accept an embryo and support its growth and development during pregnancy, or in the absence of implantation of an embryo, recycle through the process of menstruation and accept an embryo a month or so later. If fertilization takes place and an embryo or embryos implant in the uterus, the fetal trophoblast, or outer cell layer of the embryo, invades and dilates the maternal spiral arteries and forms the placenta. No matter when in gestation a pregnancy ends, at the conclusion of pregnancy, the placenta should separate from the wall of the uterus and be expelled. Abnormal bleeding occurs during pregnancy or after delivery when the normal uteroplacental interface has not been established or is interrupted; during miscarriage; during ectopic pregnancy; during premature separation of the placenta; or during postpartum hemorrhage. Heavy menstrual bleeding, a subset of abnormal menstrual bleeding, can be quantitatively defined as >80 mL of blood loss per cycle. Unlike postpartum hemorrhage, heavy menstrual bleeding is significantly associated with an underlying bleeding disorder. While there is other reproductive tract bleeding in women, notably bleeding at the time of ovulation or with a life-threatening ruptured ectopic pregnancy, the unique bleeding that women experience is predominantly uterine in origin. Many of the unique aspects of uterine hemostasis, however, remain unknown.


Assuntos
Menorragia , Hemorragia Pós-Parto , Gravidez Ectópica , Gravidez , Humanos , Feminino , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/terapia , Menstruação/fisiologia
19.
Arch Gynecol Obstet ; 309(3): 949-959, 2024 03.
Artigo em Inglês | MEDLINE | ID: mdl-37831177

RESUMO

PURPOSE: This case series examined the safety and effectiveness of hysteroscopic myolysis using laser-induced interstitial thermo-therapy (LITT) for treating heavy menstrual bleeding (HMB) in premenopausal women with FIGO type 1 or 2 uterine fibroids, not planning for future fertility. Additionally, a comprehensive review of innovative, minimally invasive, incisionless myolysis techniques was conducted. METHODS: Women with HMB, sonographically diagnosed with a single FIGO type 1 or 2 fibroid, underwent hysteroscopic myolysis using the Leonardo® diode laser. Effectiveness was assessed via transvaginal ultrasound measurement of myoma size, volume and vascularization pre and post-procedure. Moreover, we also evaluated any improvements in symptoms using the Pictorial Blood Loss Assessment Chart (PBAC score) scores. RESULTS: The procedure resulted in significant HMB reductions and noticeable fibroid size, volume, and vascularization decrease in all three patients, with no reported complications. The literature review revealed both advantages and limitations of the minimally invasive, incisionless myolysis techniques. CONCLUSIONS: Hysteroscopic laser myolysis is a safe and effective therapeutic intervention for patients experiencing HMB, diagnosed with FIGO type 1 or 2 fibroids, and not planning for future fertility. The procedure resulted in significant reductions in menstrual blood loss and fibroid size. Despite the promising results, it is essential to note the limitations of this report, including its case series design, a small number of patients, and a short follow-up period. Further research is necessary to confirm these results.


Assuntos
Leiomioma , Menorragia , Mioma , Neoplasias Uterinas , Humanos , Feminino , Menorragia/cirurgia , Lasers Semicondutores/uso terapêutico , Leiomioma/complicações , Leiomioma/cirurgia , Leiomioma/tratamento farmacológico , Menstruação , Neoplasias Uterinas/complicações , Neoplasias Uterinas/cirurgia , Neoplasias Uterinas/tratamento farmacológico
20.
BMJ Sex Reprod Health ; 50(1): 21-26, 2024 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-37550075

RESUMO

BACKGROUND: Heavy menstrual bleeding affects up to one third of menstruating individuals and has a negative impact on quality of life. The diagnosis of heavy menstrual bleeding is based primarily on history taking, which is highly dependent on traditional disposable menstrual products such as pads and tampons. Only tampons undergo industry-regulated testing for absorption capacity. As use of alternative menstrual products is increasing, there is a need to understand how the capacity of these products compare to that of standard products. METHODS: A variety of commercially available menstrual products (tampons, pads, menstrual cups and discs, and period underwear) were tested in the laboratory to determine their maximal capacity to absorb or fill using expired human packed red blood cells. The volume of blood necessary for saturation or filling of the product was recorded. RESULTS: Of the 21 individual menstrual hygiene products tested, a menstrual disc (Ziggy, Jiangsu, China) held the most blood of any product (80 mL). The perineal ice-activated cold pack and period underwear held the least (<3 mL each). Of the product categories tested, on average, menstrual discs had the greatest capacity (61 mL) and period underwear held the least (2 mL). Tampons, pads (heavy/ultra), and menstrual cups held similar amounts of blood (approximately 20-50 mL). CONCLUSION: This study found considerable variability in red blood cell volume capacity of menstrual products. This emphasises the importance of asking individuals about the type of menstrual products they use and how they use them. Further understanding of capacity of newer menstrual products can help clinicians better quantify menstrual blood loss, identify individuals who may benefit from additional evaluation, and monitor treatment.


Assuntos
Menorragia , Feminino , Humanos , Menorragia/diagnóstico , Produtos de Higiene Menstrual , Higiene , Qualidade de Vida , Menstruação , Eritrócitos
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