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Journal of Clinical Medicine Sep 2023Heavy menstrual bleeding (HMB) is a common clinical condition affecting adolescent and adult women and compromising their quality of life. Primary hemostasis disorders,... (Review)
Review
Heavy menstrual bleeding (HMB) is a common clinical condition affecting adolescent and adult women and compromising their quality of life. Primary hemostasis disorders, affecting platelet plug formation, can be the underlying cause of HMB. They comprise a heterogeneous group of diseases with Von Willebrand disease (VWD) being the most commonly diagnosed; other disorders in this group that have been linked to HMB include (a) Glanzmann thrombasthenia, (b) Bernard-Soulier syndrome, (c) Hermansky-Pudlak syndrome, (d) immune thrombocytopenia (ITP), and (e) Ehlers-Danlos syndromes (EDS) and hypermobility spectrum disorders (HSD). Diagnosing these diseases can be challenging, as the basic laboratory investigations can be within the normal range. Thus, identification of specific clinical features and a thorough hematologic workup can be very important, providing the correct diagnosis. Proper diagnosis of the underlying disorder is important, as management may vary accordingly. Although disease-specific management guidelines exist for some of these disorders such as VWD and ITP, due to the rarity of most primary hemostasis disorders, the best approach for the management of HMB in these women remains elusive. The goal of this study was to create an informative, comprehensive review of the primary hemostasis disorders that have been linked to HMB. This study provides a summary of the basic published information regarding epidemiology, pathophysiology, clinical phenotype, diagnosis, and treatment of HMB in those diseases and serves as a reference guide for further reading.
PubMed: 37685769
DOI: 10.3390/jcm12175702 -
Journal of Mid-life Health 2023Primary uterine diverticula are a very rare congenital anomaly of the uterus with only 21 reported cases. Even rarer is the occurrence of primary cervical diverticula...
Primary uterine diverticula are a very rare congenital anomaly of the uterus with only 21 reported cases. Even rarer is the occurrence of primary cervical diverticula with only six cases reported so far. This is a unique case of a huge abdominopelvic mass arising from cervical fibroid around an infected cervical diverticulum. A 44 year-old, P4L4 came to the OPD with a eighteen weeks size abdomino-pelvic mass. She had a failed surgery 6 months back, attempted to remove the mass. Magnetic resonance imaging revealed a cervical diverticulum which possibly had a pus collection. Relaparotomy was done. It revealed a huge cervical fibroid with dense adhesions all around the mass. A pan hysterectomy was done. In the postoperative period, she developed high-grade fever owing to the development of a pelvic collection, which had to be drained by dilating the vault sutures. Histopathology report confirmed a cervical fibroid with an infected diverticulum within. Primary uterine or cervical diverticula are a very rare anamoly which possibly arise because of a weakness in the area where the two mullerian ducts fuse. Women with this rare condition may suffer from infertility, fever and pain abdomen, acute abdomen owing to torsion or hemoperitoneum, pregnancy complications, and menorrhagia. Diverticulectomy and cervical/uterine reconstruction can be done on nulliparous women while hysterectomy can be offered to perimenopausal women. To conclude, unless known by the gynecologists, radiologists, and the pathologists, this diagnosis can be easily missed out, leading to multiple preventable complications.
PubMed: 37680377
DOI: 10.4103/jmh.jmh_119_22 -
Radiology Case Reports Nov 2023Acquired arteriovenous malformations (AVM) of the uterus can cause life-threatening vaginal bleeding and are associated with previous pregnancy, abortion or pelvic...
Acquired arteriovenous malformations (AVM) of the uterus can cause life-threatening vaginal bleeding and are associated with previous pregnancy, abortion or pelvic trauma. The pathophysiology is not well understood and the diagnosis is usually made by greyscale ultrasound often with nonspecific imaging findings, hence making it difficult to establish a correct diagnosis and therefore also the true incidence. However, case reports have previously described a connection between AVM formation and placental invasive disorders. In this report we demonstrate a case of a woman diagnosed with an AVM by ultrasound, presenting with menorrhagia after a termination of pregnancy, resulting in an emergency hysterectomy where subsequently a vascular malformation was found in conjunction with a remnant of a placenta increta and a placental site nodule. We hence suggest the hypothesis that these conditions are part of the same pathological process in the spectrum of abnormal invasive placental disorders, and that in the setting of previous trophoblastic processes, vascular malformations may mimic AVMs and ought not in fact to be considered as true AVMs.
PubMed: 37670915
DOI: 10.1016/j.radcr.2023.08.035 -
American Journal of Obstetrics and... Dec 2023In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate) reduced menstrual blood loss volume and pain among women with uterine fibroids. Relugolix combination therapy was well tolerated with preservation of bone mineral density through 52 weeks.
OBJECTIVE
This study aimed to report the 2-year relugolix combination therapy efficacy and safety results of the phase 3 LIBERTY randomized withdrawal study.
STUDY DESIGN
Women with uterine fibroid-associated heavy menstrual bleeding who completed the 24-week LIBERTY 1 or 2 trials, followed by the 28-week long-term extension study (up to 52 weeks total treatment), and who met the responder criteria (menstrual blood loss volume <80 mL and ≥50% reduction from pivotal study baseline at week 48 [week 24 of long-term extension]) were randomized in a 1:1 ratio to either blinded treatment with relugolix combination therapy or placebo for 52 weeks (total treatment period, 104 weeks). For women who had a relapse of heavy menstrual bleeding during the study (menstrual blood loss volume ≥80 mL), open-label relugolix combination therapy was offered. The primary endpoint was the proportion of women who maintained menstrual blood loss volume <80 mL through week 76 (week 24 of randomized withdrawal study). Secondary endpoints included time to menstrual blood loss volume ≥80 mL, proportion of women who maintained a menstrual blood loss volume of <80 mL through week 104 (over the 52-week randomized treatment period), the proportion of women who achieved or maintained amenorrhea at week 76 at the end of treatment, and the change in Uterine Fibroid Symptom-Quality of Life Bleeding and Pelvic Discomfort Scale and symptom severity scores. Analyses were performed for the modified intent-to-treat population, including all randomized women who received ≥1 dose of the study drug.
RESULTS
Of the 229 randomized women (relugolix combination therapy, n=115; placebo, n=114), 228 received the study drug and 175 (76.7%) completed the randomized withdrawal study. Through week 76, 78.4% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 15.1% in the placebo group (difference, 63.4%; 95% confidence interval, 52.9%-73.9%; P<.0001). At week 104, 69.8% of women on relugolix combination therapy maintained menstrual blood loss volume <80 mL vs 11.8% in the placebo group (difference, 58.0%; 95% confidence interval, 47.0%-69.1%; P<.0001). Through week 104, 88.3% of women on placebo relapsed with heavy menstrual bleeding (median time to relapse, 5.9 weeks). Among the 89 women in the placebo group who relapsed and received open-label rescue treatment, 87 women responded to relugolix combination therapy with a menstrual blood loss volume <80 mL. The proportion of women who achieved or maintained amenorrhea were 57.4% vs 13.3% at week 76 (difference, 44.1%; 95% confidence interval, 33.10%-55.1%; P<.0001) and 58.3% vs 10.6% at week 104 (difference, 47.6%; 95% confidence interval, 37.0%-58.3%; nominal P<.0001) for relugolix combination therapy and the placebo group, respectively. Relugolix combination therapy was generally well tolerated; no new safety signals were identified, and the adverse event profile over the second year was consistent with that reported through the first year of treatment. Bone mineral density remained stable in women who received relugolix combination therapy from week 52 to week 104. In women continuously treated with relugolix combination therapy up to 2 years, bone mineral density was generally preserved.
CONCLUSION
After 2 years of treatment with relugolix combination therapy, there was evidence of durability of the effect in maintaining low menstrual blood loss volume in women with symptomatic uterine fibroids. Most women had return of heavy menstrual bleeding and associated symptoms after treatment cessation, which improved upon retreatment with relugolix combination therapy. Relugolix combination therapy was well tolerated, the adverse event profile remained consistent, and the mean bone mineral density was generally preserved through 2 years of treatment.
Topics: Female; Humans; Menorrhagia; Uterine Neoplasms; Amenorrhea; Quality of Life; Neoplasm Recurrence, Local; Leiomyoma; Uterine Hemorrhage; Recurrence
PubMed: 37666383
DOI: 10.1016/j.ajog.2023.08.030 -
Journal of Pharmacy & Bioallied Sciences Jul 2023Due to shame over discussing menstruation and fear of illness, many adolescent girls with monthly problems never visit their family doctor or gynecologist. The...
INTRODUCTION
Due to shame over discussing menstruation and fear of illness, many adolescent girls with monthly problems never visit their family doctor or gynecologist. The presentation can be delayed as a result. The current study's goal was to assess the sociodemographic characteristics of adolescent females experiencing menstruation issues and the nature of those problems, and how they were handled.
MATERIALS AND METHODS
The problems faced by the adolescent girls attending the Department of Obstetrics and Gynecology were analyzed retrospectively, and all their study characteristics and conditions were evaluated. The descriptive demographics are only represented in the current study.
RESULTS
Two hundred-two teenage girls with menstruation issues visited our hospital overall. 64% of them were late adolescents, 96% lived in cities, 89 were unmarried, and 50% belonged to the middle class socioeconomically. Amenorrhea, dysmenorrhea, and irregular menstrual periods affected 86 (61%) people, 38 (27%) people, and 17 (12%) people, respectively. Patients were treated with appropriate counseling and medicinal and/or surgical care.
CONCLUSION
Most of the teenage girls in our study had anemia. Therefore, it is essential to educate people on the importance of nutrition, different menstrual disorders, normal physiology, and the prevention and management of anemia. Adolescent-friendly health care has been attempted and partially developed in India's governmental and private systems. As a result, counseling and management of adolescent menstrual difficulties must be offered in the current health and medical care systems.
PubMed: 37654320
DOI: 10.4103/jpbs.jpbs_495_22 -
Gynecological Endocrinology : the... Aug 2023In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg)) reduced uterine fibroid (UF)-associated symptoms. This analysis assessed safety and efficacy of relugolix-CT in European women from L1/L2.
METHODS
Premenopausal women (aged 18-50 years) with UF-associated heavy menstrual bleeding (HMB) were randomized 1:1:1 in L1 ( = 388) and L2 ( = 382) to relugolix-CT or placebo for 24 weeks, or delayed relugolix-CT (relugolix 40 mg then relugolix-CT; 12 weeks each). Primary endpoint: proportion of responders (menstrual blood loss (MBL) <80 mL and reduction of ≥50% from baseline MBL volume) over the last 35 days of treatment. Secondary endpoints: MBL volume, amenorrhea, UF-associated pain, symptom severity, distress related to bleeding and pelvic discomfort, health-related quality of life (HRQoL). Safety endpoints included adverse event (AE) reporting and bone mineral density (BMD) assessment.
RESULTS
In European women from L1/L2 ( = 124, 16%), a significantly greater proportion of treatment responders was observed with relugolix-CT vs. placebo (85.4% vs. 19.1%, respectively; nominal < .0001). There were statistically significant improvements with relugolix-CT vs. placebo for several secondary endpoints: reduction in MBL volume, amenorrhea rate, proportion achieving mild-to-no pain, reduction in symptom severity and distress from bleeding and pelvic discomfort, and improvement in HRQoL. Incidence of AEs and percentage changes in BMD from baseline to week 24 were similar for relugolix-CT and placebo.
CONCLUSIONS
In European women with UF and HMB, once-daily relugolix-CT vs. placebo improved UF-associated symptoms and preserved BMD.
Topics: Female; Humans; Amenorrhea; Quality of Life; Menorrhagia; Leiomyoma; Pelvic Pain
PubMed: 37634528
DOI: 10.1080/09513590.2023.2249107 -
Hamostaseologie Aug 2023Inherited platelet disorders (IPDs) comprise a heterogeneous group of entities that manifest with variable bleeding tendencies. For successful treatment, the underlying...
Inherited platelet disorders (IPDs) comprise a heterogeneous group of entities that manifest with variable bleeding tendencies. For successful treatment, the underlying platelet disorder, bleeding severity and location, age, and sex must be considered in the broader clinical context. Previous information from the AWMF S2K guideline #086-004 (www.awmf.org) is evaluated for validity and supplemented by information of new available and future treatment options and clinical scenarios that need specific measures. Special attention is given to the treatment of menorrhagia and risk management during pregnancy in women with IPDs. Established treatment options of IPDs include local hemostatic treatment, tranexamic acid, desmopressin, platelet concentrates, and recombinant activated factor VII. Hematopoietic stem cell therapy is a curative approach for selected patients. We also provide an outlook on promising new therapies. These include autologous hematopoietic stem cell gene therapy, artificial platelets and nanoparticles, and various other procoagulant treatments that are currently tested in clinical trials in the context of hemophilia.
Topics: Pregnancy; Humans; Female; Blood Platelet Disorders; Blood Platelets; Hematopoietic Stem Cells; Hemophilia A; Hemostatics
PubMed: 37611608
DOI: 10.1055/a-2080-6602 -
Korean Journal of Anesthesiology Aug 2023Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that has been used for several decades to reduce blood loss during surgery and after trauma. TXA was...
Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that has been used for several decades to reduce blood loss during surgery and after trauma. TXA was traditionally used to reduce bleeding in various clinical settings such as menorrhagia, hemophilia, or other bleeding disorder . Numerous studies have demonstrated the efficacy of TXA in reducing blood loss and the need for transfusions. Interest in the potential applications of TXA beyond its traditional use has been growing recently, with studies investigating the use of TXA in postpartum hemorrhage, cardiac surgery, trauma, neurosurgery, and orthopedic surgery. Despite its widespread use and expanding indications, data regarding the safe and appropriate use of TXA is lacking. Recent clinical trials have found various potential risks and limitations in the long-term benefits of TXA. This narrative review summarizes the clinical applications and limitations of TXA.
PubMed: 37599607
DOI: 10.4097/kja.23530