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Cureus Oct 2023Vaccination has a fundamental role in protecting against and modifying the severity of several infectious diseases, including COVID-19. Several immune and non-immune...
INTRODUCTION
Vaccination has a fundamental role in protecting against and modifying the severity of several infectious diseases, including COVID-19. Several immune and non-immune adverse events have been reported post-COVID-19 vaccine. The aim of this study was to assess the effect of the COVID-19 vaccine on women's menstrual bleeding.
METHODS
A cross-sectional study was conducted among 399 vaccinated women in the Eastern Province of Saudi Arabia. Data were collected using a direct interview-based questionnaire including four sections.
RESULTS
A total of 399 women were recruited, with a mean age of 25.54 ± 6.177 years. More than half (53.9%) of the participants reported post-vaccination menstrual bleeding abnormality in terms of a heavy or irregular cycle. Out of the total number, 40 (21.4%) women reported having heavy menstrual flow, and 67 (16.8%) had non-menstrual bleeding after receiving the COVID-19 vaccine. Fully vaccinated women were at a greater risk of post-vaccination menstrual bleeding abnormality (p = 0.058). However, there was no correlation between booster shot type and menstrual bleeding abnormality (p > 0.05). In addition, there was no significant association between non-menstrual bleeding and the type of booster shot, the type of the first dose, and prior history of COVID-19 infection (p > 0.05).
CONCLUSION
Despite vaccination being the most effective way to prevent COVID-19, it does have an impact on menstrual bleeding in terms of menorrhagia and metrorrhagia. Therefore, more studies are needed to understand the mechanism and the long-term impact of COVID-19 vaccines on the hemostatic system.
PubMed: 38021843
DOI: 10.7759/cureus.47360 -
Life (Basel, Switzerland) Nov 2023Blood clot formation in blood vessels (thrombosis) is a major cause of life-threatening cardiovascular diseases. These clots are formed by αA-, βB-, and ϒ-peptide... (Review)
Review
Blood clot formation in blood vessels (thrombosis) is a major cause of life-threatening cardiovascular diseases. These clots are formed by αA-, βB-, and ϒ-peptide chains of fibrinogen joined together by isopeptide bonds with the help of blood coagulation factor XIIIa. These clot structures are altered by various factors such as thrombin, platelets, transglutaminase, DNA, histones, and red blood cells. Various factors are used to dissolve the blood clot, such as anticoagulant agents, antiplatelets drugs, fibrinolytic enzymes, and surgical operations. Fibrinolytic enzymes are produced by microorganisms (bacteria, fungi, etc.): streptokinase of nattokinase of YF 38, bafibrinase of sp. AS-S20-I, longolytin of , versiase of ZLH-1, etc. They act as a thrombolytic agent by either enhancing the production of plasminogen activators (tissue or urokinase types), which convert inactive plasminogen to active plasmin, or acting as plasmin-like proteins themselves, forming fibrin degradation products which cause normal blood flow again in blood vessels. Fibrinolytic enzymes may be classified in two groups, as serine proteases and metalloproteases, based on their catalytic properties, consisting of a catalytic triad responsible for their fibrinolytic activity having different physiochemical properties (such as molecular weight, pH, and temperature). The analysis of fibrinolysis helps to detect hyperfibrinolysis (menorrhagia, renal failure, etc.) and hypofibrinolysis (diabetes, obesity, etc.) with the help of various fibrinolytic assays such as a fibrin plate assay, fibrin microplate assay, the viscoelastic method, etc. These fibrinolytic activities serve as a key aspect in the recognition of numerous cardiovascular diseases and can be easily produced on a large scale with a short generation time by microbes and are less expensive.
PubMed: 38004336
DOI: 10.3390/life13112196 -
Blood Advances Dec 2023Innovation in therapies for patients with von Willebrand disease (VWD) has lagged far behind that for hemophilia, creating inequity in the bleeding disorder community....
Innovation in therapies for patients with von Willebrand disease (VWD) has lagged far behind that for hemophilia, creating inequity in the bleeding disorder community. Although currently existing treatments of antifibrinolytics, desmopressin, and plasma-derived von Willebrand factor replacement are considered effective, multiple studies report poor quality of life in patients with VWD, especially those with heavy menstrual bleeding (HMB). This disconnect underscores the need for novel therapies that are safe and effective and that consider a patient's specific contraceptive and reproductive needs. Recombinant von Willebrand factor is the most recent new therapy for VWD; the data specific to women are reviewed. We also present emerging data on emicizumab for the treatment of VWD, BT200 (rondoraptivon pegol), generalized hemostatic therapies (VGA039 and HMB-011), as well as treatments based on nanotechnology (platelet-inspired nanoparticles and KB-V13A12). We are optimistic as we move toward pivotal clinical trials for these elegant and innovative treatments.
Topics: Humans; Female; von Willebrand Diseases; von Willebrand Factor; Quality of Life; Menorrhagia; Antifibrinolytic Agents
PubMed: 37967378
DOI: 10.1182/bloodadvances.2023010716 -
Health Technology Assessment... Oct 2023Heavy menstrual bleeding is a common problem that can significantly affect women's lives until menopause. There is a lack of evidence on longer-term outcomes after... (Observational Study)
Observational Study
BACKGROUND
Heavy menstrual bleeding is a common problem that can significantly affect women's lives until menopause. There is a lack of evidence on longer-term outcomes after seeking health care and treatment for heavy menstrual bleeding.
OBJECTIVES
To assess the continuation rates of medical treatments and the rates of ablative and surgical interventions among women who had participated in the ECLIPSE trial (ISRCTN86566246) 10 years after initial management for heavy menstrual bleeding in primary care. To explore experiences of heavy menstrual bleeding and influences on treatment for women.
DESIGN
This was a prospective observational cohort study, with a parallel qualitative study.
SETTING
Primary care.
PARTICIPANTS
A total of 206 women with heavy menstrual bleeding who had participated in the ECLIPSE trial consented to providing outcome data via a questionnaire approximately 10 years after original randomisation. Their mean age at follow-up was 54 years (standard deviation 5 years). A purposeful sample of 36 women also participated in semistructured qualitative interviews.
INTERVENTIONS
The ECLIPSE trial randomised participants to either the levonorgestrel-releasing intrauterine system (52 mg) or the usual medical treatment (oral tranexamic acid, mefenamic acid, combined oestrogen-progestogen or progesterone alone, chosen as clinically appropriate by general practitioners and women). Women could subsequently swap or cease their allocated treatment.
MAIN OUTCOME MEASURES
The main outcome measures were rates of ablative and surgical treatments; the rate of continuation of medical treatments; and quality of life using the Short Form questionnaire-36 items and EuroQol-5 Dimensions; women's experiences of heavy menstrual bleeding; and the influences on their decisions around treatment.
RESULTS
Over the 10-year follow-up period, 60 out of 206 (29%) women had received a surgical intervention [hysterectomy, = 34 (17%); endometrial ablation, = 26 (13%)]. Between 5 and 10 years post trial intervention, 89 women (43%) had ceased all medical treatments and 88 (43%) were using the levonorgestrel-releasing intrauterine system alone or in combination with other oral treatments. More women in the usual medical treatment group had also used the levonorgestrel-releasing intrauterine system than women in the levonorgestrel-releasing intrauterine system group. Fifty-six women (28%) used the levonorgestrel-releasing intrauterine system at 10 years. There was no statistically significant difference in generic quality-of-life scores between the two original trial groups, although small improvements in the majority of domains were seen in both groups across time. Women reported wide-ranging impacts on their quality of life and normalisation of their heavy menstrual bleeding experience as a result of the taboo around menstruation. Women's treatment decisions and experiences were influenced by the perceived quality of health-care interactions with clinicians and their climacteric status.
LIMITATIONS
Fewer than half of the original 571 participants participated; however, the cohort was clinically and demographically representative of the original trial population.
CONCLUSIONS
Medical treatments for women with heavy menstrual bleeding can be initiated in primary care, with low rates of surgical intervention and improvement in quality of life observed 10 years later. Clinicians should be aware of the considerable challenges that women with heavy menstrual bleeding experience at presentation and subsequently over time, and the importance and value to women of patient-centred communication in this context.
FUTURE WORK
Any further evaluation of treatments for heavy menstrual bleeding should include long-term evaluation of outcomes and adherence.
TRIAL REGISTRATION
The original ECLIPSE trial was registered as ISRCTN86566246.
FUNDING
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 27, No. 17. See the NIHR Journals Library website for further project information.
Topics: Female; Humans; Middle Aged; Follow-Up Studies; Intrauterine Devices, Medicated; Levonorgestrel; Menorrhagia; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 37924269
DOI: 10.3310/JHSW0174 -
Cureus Oct 2023Background and objective The period spanning 1923-1927 was a turbulent period in Greek history following the catastrophic defeat of the Greek army in September 1922,...
Morbidity During the Early Interwar Period (1923-27): A Historical-Epidemiological Study of 15,146 Cases Treated at the "Agios Dimitrios" Hospital in Thessaloniki, Greece.
Background and objective The period spanning 1923-1927 was a turbulent period in Greek history following the catastrophic defeat of the Greek army in September 1922, known as the "Asia Minor Catastrophe". The massive settlement of refugees in Thessaloniki, Greece, entailed massive economic, public health, and social challenges. The present historical-epidemiological study aims to evaluate the diseases of individuals hospitalized at the "Agios Dimitrios" Hospital in Thessaloniki during the aforementioned period. Materials and methods This study involved 15,146 consecutive patients (January 1923-March 1927) treated at the hospital. Data were collected from the General Hospital of Thessaloniki "Agios Dimitrios" and were manually entered into a pre-coded database. Descriptive statistics were calculated. In addition, the case fatality rates (CFR) were calculated; the respective 95% confidence intervals (CI) were estimated. Results The most frequent causes for admission to the hospital were as follows: normal delivery/delivery without disclosed sequalae (n=1915, 12.7%), followed by tuberculosis (n=1514, 10.0%), malaria (n=1438, 9.5%), injuries/falls/fractures (n=1394, 9.2%), pneumonia/pleuritis (n=1010, 6.7%), appendicitis (n=623, 4.1%), dysentery/enterocolitis/typhoid (n=489, 3.2%), salpingitis/salpingo-oophoritis (n=358, 2.4%), soft tissue abscesses (n=309, 2.0%), hernias (n=295, 2.0%), rabies (n=239, 1.6%), metrorrhagia/menorrhagia (n=233, 1.5%), ocular cataract (n=225, 1.5%), postpartum infections/endometritis (n=181, 1.2%), uterine discomfort/uterine pain (n=162, 1.1%), nephritis/uremia (n=157, 1.0%), miscarriage (n=155, 1.0%), skin infections/inflammations excluding abscesses (n=152, 1.0%), otitis/mastoiditis/labyrinthitis (n=96, 0.6%), and peptic ulcer (n=93, 0.6%). Tuberculosis was particularly associated with high CFR (49.5%, 95% CI: 47.2-52.3%), followed by nephritis/uremia (CFR: 37.6%), dysentery/infectious enterocolitis/typhoid (CFR: 24.3%), peptic ulcer (CFR: 22.6%), pneumonia/pleuritis (CFR: 16.1%), postpartum infections/endometritis (CFR: 15.5%). Conclusions Infections predominated in the disease spectrum of the hospitalized population. The documented fatality rates were high; poor outcomes may reflect the socioeconomic adversities and limited medical means and resources available at that time.
PubMed: 37916245
DOI: 10.7759/cureus.48004 -
Journal of Pediatric Endocrinology &... Dec 2023
Topics: Female; Adolescent; Humans; Menarche; Menorrhagia; Estrogens
PubMed: 37899545
DOI: 10.1515/jpem-2023-0421 -
Cureus Oct 2023Spontaneous Coronary Artery Dissection (SCAD) is a non-atherosclerotic, non-iatrogenic cause of Acute Coronary Syndrome (ACS) resulting in a tear in the coronary artery...
Spontaneous Coronary Artery Dissection (SCAD) is a non-atherosclerotic, non-iatrogenic cause of Acute Coronary Syndrome (ACS) resulting in a tear in the coronary artery wall with subsequent myocardial infarction. Though rare, it has been increasingly recognized, especially in young women. This is a case report on SCAD where, fortuitously, the patient did not receive standard tissue plasminogen activator (TPA) on presentation of suspected ST-elevation Myocardial Infarction (STEMI). Subsequent investigations revealed a left ventricular thrombus on echocardiogram and SCAD on coronary angiogram.
PubMed: 37886652
DOI: 10.7759/cureus.47623 -
International Journal of Women's Health 2023This retrospective database claims analysis describes the clinical characteristics and treatment patterns of commercially insured United States women with uterine...
INTRODUCTION
This retrospective database claims analysis describes the clinical characteristics and treatment patterns of commercially insured United States women with uterine fibroids (UF) and heavy menstrual bleeding (HMB).
METHODS
Women age 18-55 years with an incident UF diagnosis (index date) between 1/1/2012 and 12/31/2019 and ≥1 claim for HMB (UF-HMB), were identified from the Optum Clinformatics database. Outcomes included clinical characteristics, pharmacologic therapy use, and surgeries/procedures. Regression models were used to identify factors associated with time to post-diagnosis hormonal therapy and hysterectomy.
RESULTS
A total of 85,428 women had UF-HMB (mean [SD] age, 43.7 [6.4] years). The median follow-up was 3.2 years. After HMB, the most common symptoms were pelvic pressure/pain (27.6%) and backache (17.5%). Within 6 months of UF diagnosis, 40.2% of patients had received only pharmacologic therapy; 25.5% had received no treatment; 24.3% had a hysterectomy, and 10.0% had other procedures. By the end of follow-up, 50.0% had received a hysterectomy. Multiple factors were predictive of a higher likelihood of receiving hormonal therapy (geographic region, infertility, pre-index pregnancy) or hysterectomy (older age, prior hormonal treatment, specific bulk symptoms, White race).
CONCLUSION
Within 6 months of UF diagnosis, fewer than one-half of women with UF-HMB had received hormonal therapy, one-quarter received no treatment, and one-quarter had received a hysterectomy or another gynecologic procedure. Patients who received a hysterectomy were more likely to be older, White, and to have bulk symptoms.
PubMed: 37867928
DOI: 10.2147/IJWH.S420612 -
American Journal of Obstetrics and... Feb 2024In the LIBERTY Long-Term Extension study, once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) substantially improved... (Randomized Controlled Trial)
Randomized Controlled Trial
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.
Topics: Female; Humans; Amenorrhea; Black or African American; Leiomyoma; Menorrhagia; Phenylurea Compounds; Pyrimidinones; Quality of Life; Uterine Neoplasms; Adolescent; Young Adult; Adult; Middle Aged
PubMed: 37863160
DOI: 10.1016/j.ajog.2023.10.030 -
Contraception Mar 2024The levonorgestrel-releasing intrauterine device containing 13.5 mg of levonorgestrel (LNG 13.5 mg IUD), Jaydess, was approved for contraception by the European... (Observational Study)
Observational Study
OBJECTIVES
The levonorgestrel-releasing intrauterine device containing 13.5 mg of levonorgestrel (LNG 13.5 mg IUD), Jaydess, was approved for contraception by the European Medicines Agency in 2013. We aimed to describe the characteristics of new users of LNG 13.5 mg IUD in Sweden within the first 3 years after approval (2014-2016).
STUDY DESIGN
We conducted an observational, population-based study using data from the Swedish national registers. Women with the first pharmacy dispensation of LNG 13.5 mg IUD between 2014 and 2016 were followed until December 31, 2020. Descriptive analyses included demographic characteristics, duration of the use of first-time LNG 13.5 mg IUD, and contraceptive switching patterns.
RESULTS
We included 38,327 women, with mean age at first-time LNG 13.5 mg IUD use of 26 (SD: 7) years. Over 80% were prescribed LNG 13.5 mg IUD by a midwife. The most common comorbidities in the year prior to LNG 13.5 mg IUD use (2%-3% prevalence) were depression, anxiety, premenstrual syndrome, and menorrhagia. The median duration of first-time LNG 13.5 mg IUD use was 2.6 years, and after use, more than 50% of women opted to continue using a hormonal intrauterine device.
CONCLUSIONS
In this postmarketing drug utilization study, there were over 38,000 first-time LNG 13.5 mg IUD users in Sweden between 2014 and 2016, with an estimated median duration of use of 2.6 years. First-time LNG 13.5 mg IUD users consisted mostly of young, healthy individuals with a history of hormonal contraceptive use. Over half of the women continued using a hormonal IUD after the first LNG 13.5 mg IUD.
IMPLICATIONS
The median duration of LNG 13.5 mg IUD use was 2.6 years, approaching the 3-year indicated use limit. The majority of users continued with another hormonal intrauterine device after LNG 13.5 mg IUD use.
Topics: Female; Humans; Adult; Levonorgestrel; Sweden; Contraceptive Agents, Female; Hormonal Contraception; Intrauterine Devices, Medicated; Intrauterine Devices, Copper
PubMed: 37844683
DOI: 10.1016/j.contraception.2023.110309