Pictorial Blood Assessment Chart Score Research Articles

Efficacy of Regular Prophylaxis with a Plasma-Derived Von Willebrand Factor/Factor VIII Concentrate in Reducing Heavy Menstrual Bleeding in Females with Von Willebrand Disease

Background: Heavy menstrual bleeding (HMB) is the dominant symptom affecting ~80-90% of women with VWD and is a common cause of outpatient visits and hospitalizations. Long-term prophylaxis with a von Willebrand factor (VWF) concentrate is recommended in von Willebrand disease (VWD) patients with a history of severe, frequent bleeds, and for women with VWD who experience HMB. A recent prospective study found that recombinant VWF was not superior to tranexamic acid at reducing HMB in women with VWD. The WIL-31 study demonstrated the efficacy of prophylaxis with a plasma-derived VWF/factor VIII (pdVWF/FVIII) concentrate containing VWF and FVIII in a 1:1 activity ratio (wilate ®) in adults and children with VWD of all types. The primary endpoint was met, showing a decrease of 84% in the mean total annualized bleeding rate (ABR) compared with prior on-demand treatment. The impact of pdVWF/FVIII prophylaxis on HMB was evaluated as a secondary endpoint of the WIL-31 study. Aims: To investigate the efficacy of regular prophylaxis with a pdVWF/FVIII concentrate in reducing the incidence of HMB in females with VWD who had previously been treated on demand. Methods: WIL-31 (NCT04052698) was a prospective, non-controlled, international, multicenter phase 3 trial that enrolled male/female patients, aged ≥6 years old with VWD type 1 (VWF:RCo <30 IU/dL), type 2 (except 2N) or type 3. Prior to entering the WIL-31 study, all patients had received on-demand treatment with a VWF-containing product during a 6-month, prospective, observational, run-in study (WIL-29). Patients in WIL-31 received regular pdVWF/FVIII prophylaxis 2-3 times per week at a dose of 20-40 IU/kg for 12 months. Exploratory analyses included comparison of heavy menstrual ABR (HMABR). HMB was defined as any menstrual bleed that impeded the ability to perform daily activities (such as work, housework, exercise, or social activities) during menstrual periods. Criteria for HMB included changing pads more frequently than hourly, menstrual bleeding lasting 7 or more days, or the presence of clots >1 cm combined with a history of flooding or a Pictorial Blood Assessment Chart (PBAC) score ≥185. PBAC scores were reviewed from patient diaries at each study visit. Results: Of the 33 patients included in the overall population, 14 (42%) were female and half (n=7; 13-43 years old) were of childbearing age. In these females, all VWD types were represented: type 1 (n=2), type 2 (n=1); and type 3 (n=4). Six (86%) females were on hormonal birth control during WIL-31. Prophylaxis with pdVWF/FVIII reduced the mean HMABR by 64% compared with on-demand treatment (3.0 vs 8.3 in WIL-31 and WIL-29, respectively). During on-demand treatment, 86% (6/7) of females experienced ≥1 HMB episode, which was reduced to 29% (2/7) during prophylaxis with four patients experiencing no HMB (Figure 1). During on-demand treatment, 6 females experienced 32 HMB episodes; of these, 7 (22%) required further treatment with pdVWF/FVIII and 2 (6%) required concomitant medication. Under prophylaxis, two patients (aged ≥17 years), experienced 12 HMBEs; of these, only one (8%) impeded daily activity and none required additional pdVWF/FVIII treatment, hospitalization, or concomitant medication. Mean (SD) intra-individual median PBAC scores (N=4) decreased by 43% from 227 (91.7) during on-demand treatment to 131 (59.9) with prophylaxis, a 96-point reduction. Conclusion: Prophylaxis with pdVWF/FVIII was efficacious in reducing HMB compared with on-demand treatment in 7 female patients with VWD. None of the cases of HMB during prophylaxis was severe enough to require additional treatment. Among women with VWD, HMB remains a major burden and further research is required.

Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study

ObjectiveTo assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD). Study designSingle-center, evaluator-masked, randomized study conducted in women aged 18–45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability. ResultsWe included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p < 0.001; (2) mean bleeding intensity: 1.7 for both, p = 0.66, and 0.7 and 2.2, p < 0.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6; 84.7) versus 130.4 (95.7; 165.0) at month 1, and 7.9 (−26.7; 42.6) versus 126 (90.7; 161.2), p < 0.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19; 53) versus 30 (19; 45), p = 0.70, and 59 (42; 84) versus 21 (8; 39). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected. ConclusionsLNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD. ImplicationsWomen eligible for a levonorgestrel 13.5 mg intrauterine device (IUD) or a copper 380 mm2 IUD should be informed of the differences in bleeding profiles—one of the main causes for IUD discontinuation—so they can compare this information against their bleeding expectations.

Recombinant von Willebrand factor and tranexamic acid for heavy menstrual bleeding in patients with mild and moderate von Willebrand disease in the USA (VWDMin): a phase 3, open-label, randomised, crossover trial

Heavy menstrual bleeding occurs in 80% of women with von Willebrand disease and is associated with iron deficiency and poor response to current therapies. International guidelines indicate low certainty regarding effectiveness of hormonal therapy and tranexamic acid. Although von Willebrand factor (VWF) concentrate is approved for bleeds, no prospective trials guide its use in heavy menstrual bleeding. We aimed to compare recombinant VWF with tranexamic acid for reducing heavy menstrual bleeding in patients with von Willebrand disease. VWDMin, a phase 3, open-label, randomised crossover trial, was done in 13 haemophilia treatment centres in the USA. Female patients aged 13-45 years with mild or moderate von Willebrand disease, defined as VWF ristocetin cofactor less than 0·50 IU/mL, and heavy menstrual bleeding, defined as a pictorial blood assessment chart (PBAC) score more than 100 in one of the past two cycles were eligible for enrolment. Participants were randomly assigned (1:1) to two consecutive cycles each of intravenous recombinant VWF, 40 IU/kg over 5-10 min on day 1, and oral tranexamic acid 1300 mg three times daily on days 1-5, the order determined by randomisation. The primary outcome was a 40-point reduction in PBAC score by day 5 after two cycles of treatment. Efficacy and safety were analysed in all patients with any post-baseline PBAC scores. The trial was stopped early due to slow recruitment on Feb 15, 2022, by a data safety monitoring board request, and was registered at ClinicalTrials.gov, NCT02606045. Between Feb 12, 2019, and Nov 16, 2021, 39 patients were enrolled, 36 of whom completed the trial (17 received recombinant VWF then tranexamic acid and 19 received tranexamic acid then recombinant VWF). At the time of this unplanned interim analysis (data cutoff Jan 27, 2022), median follow-up was 23·97 weeks (IQR 21·81-28·14). The primary endpoint was not met, neither treatment corrected PBAC score to the normal range. Median PBAC score was significantly lower after two cycles with tranexamic acid than with recombinant VWF (146 [95% CI 117-199] vs 213 [152-298]; adjusted mean treatment difference 46 [95% CI 2-90]; p=0·039). There were no serious adverse events or treatment-related deaths and no grade 3-4 adverse events. The most common grade 1-2 adverse events were mucosal bleeding (four [6%] patients during tranexamic acid treatment vs zero during recombinant VWF treatment) and other bleeding (four [6%] vs two [3%]). These interim data suggest that recombinant VWF is not superior to tranexamic acid in reducing heavy menstrual bleeding in patients with mild or moderate von Willebrand disease. These findings support discussion of treatment options for heavy menstrual bleeding with patients based on their preferences and lived experience. National Heart Lung Blood Institute (National Institutes of Health).

Analysis of management efficacy in patients with heavy menstrual bleeding associated with antithrombotic therapy

Objective: To evaluate different methods' efficacy of controlling acute bleeding and managing long-term menstruation in patients with heavy menstrual bleeding (HMB) associated with antithrombotic therapy. Methods: The clinical data of 22 cases with HMB associated with antithrombotic therapy admitted to Peking University People's Hospital from January 2010 to August 2022 were analyzed, aged 39 years old (26-46 years). Changes in menstrual volume, hemoglobin (Hb), and quality of life were collected after control of acute bleeding and long-term menstrual management. Menstrual volume was assessed by pictorial blood assessment chart (PBAC), and quality of life was assessed by menorrhagia multi-attribute scale (MMAS). Results: (1) Treatment of acute bleeding: of the 22 cases with HMB associated with antithrombotic therapy, 16 cases were treated in our hospital and 6 in other hospital for emergency bleeding; of the 16 cases treated in our hospital, 3 underwent emergency intrauterine Foley catheter balloon compression due to severe bleeding (Hb decreased by 20 to 40 g/L within 12 hours). Of the 22 cases with antithrombotic therapy-related HMB, 15 (including 2 cases with severe bleeding) underwent emergency aspiration or endometrial resection, and intraoperative placement of levonorgestrel-releasing intrauterine system (LNG-IUS) followed by a significant reduction in bleeding volume; 3 cases had controlled acute bleeding after rivaroxaban dose reduction and continued observation; 2 cases were given gonadotropin-releasing hormone agonists to control acute bleeding in other hospital, of which 1 case was temporarily treated with periodic blood transfusion, and the other one patient underwent total hysterectomy; and 2 cases had temporary amenorrhea with oral mifepristone after intrauterine balloon compression or oral norethindrone. (2) Long-term menstrual management: of the 22 cases with antithrombotic therapy-related HMB, 15 had LNG-IUS placement and 12 had LNG-IUS placement for 6 months, and menstrual volume was significantly reduced [PBAC scores were 365.0 (272.5-460.0) vs 25.0 (12.5-37.5), respectively; Z=4.593, P<0.001], Hb was significantly increased [91.5 g/L (71.8-108.2 g/L) vs 128.5 g/L (121.2-142.5 g/L); Z=4.695, P<0.001], and quality of life was significantly improved [MMAS scores were 415.0 (327.5-472.5) vs 580.0 (570.0-580.0), respectively; Z=-3.062, P=0.002] before placement compared with 6 months after placement. Three rivaroxaban dose reduction patients' PBAC scores decreased by 20 to 35 but remained >100, and perceived quality of life did not change significantly. Two cases with temporary amenorrhea treated with oral mifepristone felt significantly improved quality of life, and the MMAS scores increased by 220 and 180, respectively. Conclusion: Intrauterine Foley catheter balloon compression, aspiration or endometrial ablation could be used to control acute bleeding in patients with antithrombotic therapy-related HMB, and LNG-IUS for long-term management could reduce menstrual volume, increase hemoglobin, and improve the quality of life of patients.

Treatment of abnormal uterine bleeding using levonorgestrel-releasing intrauterine devices: experience from a Turkish tertiary hospital.

We evaluated the efficacy of the levonorgestrel-releasing intrauterine device in treating menorrhagia using a pictorial blood assessment chart. We retrospectively examined 822 patients treated with a levonorgestrel-releasing intrauterine device for abnormal uterine bleeding between January 1, 2017, and December 31, 2020, at a Turkish tertiary hospital. A pictorial blood assessment chart was used to determine each patient's blood loss amount, which involves the use of an objective scoring system to determine the amount of bleeding in towels, pads, or tampons. Descriptive statistical values were presented as mean and standard deviation, and paired sample t-tests were used for within-group comparisons of normally distributed parameters. Moreover, in the part of the descriptive statistical analysis, the mean and median values for the non-normally distributed tests were not close to each other, indicating that the data obtained and analyzed in this study had a non-normal distribution. Of 822 patients, 751 (91.4%) exhibited a significant reduction in menstrual bleeding after device insertion. Moreover, a significant decrease was observed in the pictorial blood assessment chart scores 6 months postoperatively (p < 0.05). This study revealed that the levonorgestrel-releasing intrauterine device is an easy-to-insert, safe, and effective treatment option for abnormal uterine bleeding (AUB). Furthermore, the pictorial blood assessment chart is a simple and reliable tool for evaluating menstrual blood loss in women before and after the insertion of levonorgestrel-releasing intrauterine devices.

How do anticoagulants impact menstrual bleeding and quality of life? - The PERIOD study

BackgroundThere is increasing recognition that menstruating women prescribed anticoagulants experience heavy menstrual bleeding. ObjectivesThe aim of this study is to report the extent of bleeding in menstruating women after commencing anticoagulants and the impact it has on their quality of life. MethodsWomen aged 18 to 50, initiated on anticoagulant therapy, were approached to take part in the study. In parallel, a control group of women was also recruited. Women were asked to complete the menstrual bleeding questionnaire and a pictorial blood assessment chart (PBAC) during their next 2 menstrual cycles. Differences between the control and anticoagulated group were compared. Significance was considered at < .05. Ethics committee approval: REC reference: 19/SW/0211. ResultsFifty-seven women in the anticoagulation and 109 women in the control group returned their questionnaires. Women in the anticoagulated group reported an increase in the median length of their menstrual cycle from 5 to 6 days after commencing anticoagulation, compared to 5 days for women in the control group (P < .05). Anticoagulated women reported significantly higher PBAC scores as compared to the control group (P < .05), with two-thirds of women in the anticoagulation group reporting heavy menstrual bleeding. Women in the anticoagulation group reported worsening quality of life scores following the initiation of anticoagulation, compared with women in the control group (P < .05). ConclusionHeavy menstrual bleeding occurred in two-thirds of women commencing anticoagulants, who completed a PBAC, which had negative impact on their quality of life. Clinicians commencing anticoagulation therapy should be mindful of this, and recognized measures should be taken to help minimize this problem for menstruating individuals.

Assessing a cut-off point for the diagnosis of abnormal uterine bleeding using the Menstrual Bleeding Questionnaire (MBQ): a validation and cultural translation study with Brazilian women.

Abnormal uterine bleeding (AUB) is a common condition, and the Menstrual Bleeding Questionnaire (MBQ) is used for its assessment. To translate, assess the cut-off point for diagnosis, and explore psychometric properties of the MBQ for use in Brazilian Portuguese. Prospective cohort study including 200 women (100 with and 100 without AUB) at a tertiary referral center. MBQ translation involved a pilot-testing phase, instrument adjustment, data collection, and back-translation. Cut-off point was obtained using receiver operating curve analysis. Menstrual patterns, impact on quality of life due to AUB, internal consistency, test-retest, responsiveness, and discriminant validity were assessed. For construct validity, the Pictorial Blood Assessment Chart (PBAC) and World Health Organization Quality of Life - abbreviated version (WHOQOL-BREF) were applied. Women with AUB were older, had higher body mass indices, and had a worse quality of life during menstruation. Regarding the MBQ's psychometric variables, Cronbach's alpha coefficient was > 0.70 in all analyses, high intraclass correlation coefficient was found in both groups; no ceiling and floor effects were observed, and construct validity was demonstrated (correlation between MBQ score, PBAC score, and clinical menstrual cycle data). No difference between MBQ and PBAC scores were perceived after the test-retest. Significant differences were found between MBQ and PBAC scores before and after treatment. An MBQ score ≥ 24 was associated with a high probability of AUB; accuracy of 98%. The MBQ is a reliable questionnaire for Brazilian women. The cut-off ≥ 24 shows high accuracy to discriminate AUB.

To Study the Efficacy and Safety of Diosmin with Tranexamic Acid and Mefenamic Acid Versus only Tranexamic Acid and Mefenamic Acid in Medical Management of Abnormal Uterine Bleeding: A Randomized Controlled Trial.

Abnormal uterine bleeding (AUB) is a common problem in reproductive age group and perimenopausal age group being responsible for many outpatient visits. Traditional management of AUB consists of giving mefenamic acid, tranexamic acid, or their combination with progestogens or hormonal intrauterine deviced levonorgestrel intrauterine system (LNG-IUS) for severe or nonresponsive cases. The objective of the current study was to study the efficacy and safety of adding diosmin along with tranexamic acid and mefenamic acid in reducing menstrual blood loss in AUB patients. It was a prospective double-blind randomized controlled trial in which 900 mg of diosmin was given once daily along with 500 mg tranexamic acid and 250 mg mefenamic acid during menstruation (Group I-92 patients), or only tranexamic acid and mefenamic acid during menstruation (Group II-92 patients). Mean age, parity, body mass index, and socioeconomic status were similar in the two groups. It was 35.68 years versus 36.78 years, 2.2 versus 2.3, 23.68 kg/m2 versus 24.62 kg/m2 respectively. Mean days of bleeding before this treatment were 6.8 versus 6.6 (P = 0.33) and were 3.5 versus 5.2 (P = 0.02) after treatment. There was a significant reduction in both groups as compared to before treatment (P = 0.021 in Group I, 0.027 in Group II) but the reduction was greater in Group I (P = 0.02). The amount of blood loss was 385 ml versus 390 ml (P = 0.7) before treatment which was significantly reduced in both groups to 68 ml versus 112 ml (P = 0.02 in Group I, 0.03 in Group II) with more decrease in Group I than in Group II (P = 0.01). Mean hemoglobin at beginning of the study was 8.4 versus 8.5 g/dl in Group I and Group II (P = 0.02) and significantly increased in both groups posttreatment to 10.9 and 9.8 g/dl in Group I and Group II (P = 0.012 in Group I, 0.011 in Group II) with increase being more in Group I than Group II (P = 0.03). Pictorial blood assessment chart score was 398 versus 406 (P = 0.35) before treatment and decreased significantly to 86.5 and 110.5 (P = 0.001 in Group I, 0.001 in Group II) with more decrease being in Group I than II (P = 0.01). There was significant decrease in dysmenorrhea with both treatments with no difference in the two groups. Various adverse effects such as nausea, vomiting, abdominal pain, diarrhea, constipation, and headache were equal in the two groups. Both the group's diosmin with tranexamic acid and mefenamic acid (Group I) and tranexamic acid and mefenamic acid (Group II) were efficacious in reducing menstrual blood loss, number of menstrual days and dysmenorrhea with effect being more by addition of diosmin. Adverse effects were equal in both the two groups.

The effect of transcervical resection of submucous fibroids on menstrual blood loss: A prospective cohort study

ObjectivesTranscervical resection of myoma (TCRM) is a widely implemented treatment for submucous fibroids. The aim of this study is to evaluate the effect of TCRM on menstrual bleeding, fibroid related symptoms and quality of life and hemoglobin (Hb) levels. Study designA prospective cohort study was conducted in three teaching hospitals and two academic hospitals in the Netherlands. Patients with HMB (PBAC score > 150) and submucous fibroids (type 0, 1, 2, 3, 4 and hybrid type 2–5) scheduled for TCRM were eligible. At baseline and 3 months after TCRM a Trans Vaginal Ultrasound (TVU) was performed and a Hb sample was taken. Patients filled out the Pictorial Blood Assessment Chart (PBAC) and the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire at baseline and up to 6 months after surgery. Primary outcome was improvement in PBAC score 6 months after surgery. Secondary outcomes were improvement in PBAC score and Hb level 3 months after surgery and UFS-QOL scores 3 and 6 months after surgery. Results126 patients were included and 104 were operated. PBAC were obtained from 98 patients. Six months after surgery, 56.6% of patients went from HMB to normal menstrual bleeding (PBAC < 150). A significant reduction in median PBAC scores of 427 (IQR 198 – 1392) (p <.0001) was found (86% improvement). UFS-QOL scores were obtained from 91 patients. Symptom severity improved from a median of 54 on a scale of 100 (IQR 44–66) at baseline to 22 (IQR 9–41) after 6 months (p <.0001) (59% improvement). Health related quality of life (HRQOL) improved from a median score of 44 on a scale of 100 (IQR 33–62) to 89 (IQR 67–97) 6 months after surgery (p <.0001) (102% improvement). ConclusionTCRM significantly reduces the amount of menstrual bleeding, severity of fibroid related symptoms and improves HRQOL in patients with submucous fibroids.

Effectiveness of Levonorgestrel Releasing Intrauterine System in Perimenopausal Women with Heavy Menstrual Bleeding: A Prospective Study at a Teaching Hospital in India.

To evaluate the effect of levonorgestrel-releasing intrauterine system (LNG-IUS) on heavy menstrual bleeding in perimenopausal women. This was a prospective, observational clinical study conducted on 42 perimenopausal women with heavy menstrual bleeding who met the study eligibility criteria. LNG-IUS was inserted in the postmenstrual phase following baseline evaluation. The patients were followed up at the 4, 12, and 24 weeks. Pictorial blood assessment chart (PBAC) score, hemoglobin and serum ferritin levels, and endometrial thickness were assessed before insertion and during the follow-up visits. Two patients (4.8%) were lost to follow-up, three patients (7.1%) opted for hysterectomy, two women (4.8%) experienced spontaneous expulsion and 35 (83.3%) women continued the usage. Menstrual blood loss assessed using the median PBAC score (interquartile range) significantly reduced (P < 0.001) from the pre-insertion level of 280 (246-306) to 124 (60-200) at 4 weeks to 45 (34-76) at 12 weeks and further to 32 (20-50) at the end of 24 weeks. Simultaneously, a significant (P < 0.001) improvement in the mean hemoglobin and serum ferritin levels and a significant (P < 0.001) decrease in endometrial thickness were observed. The most common side effect was spotting (50.0%) and vaginal discharge (38.1%). LNG-IUS causes a remarkable reduction in menstrual blood loss and marked improvement in dysmenorrhea. It also reduces anemia by improving the hemoglobin and ferritin levels. Thus, it can serve as an effective treatment option for heavy menstrual bleeding in perimenopausal women and prevent the need for a hysterectomy.

Case report on treatment of Karuppai Naarthasai Kattigal (uterine fibroids) with Rasagandhi Mezhugu

Karuppai Naarthasai Kattigal (uterine fibroids) are benign tumors arising from the smooth muscles of the uterus. This study focuses over a case report of a patient with Karuppai Naarthasai Kattigal (uterine fibroids) treated with a classical Siddha drug, Rasagandhi Mezhugu (RGM) from the literature reference Pulippani Vaithiyam-500, for a period of 90 days, after receiving the informed consent, and the outcome was documented. A 40-year-old woman with a heavy menstrual bleeding, frequent urination, abdominal cramps, and bloating of abdomen often for 6 months and intermenstrual bleeding for 2 years was screened through an ultrasonogram, suspecting uterine fibroids. After Siddha clinical assessment and diagnosis, RGM was administered for a period of 90 days with 15 days drug holiday after 45 days of treatment. Later the treatment outcomes were measured and the patient is followed up for 6 months. This study reveals the outcome of the treatment of Karuppai Naarthasai Kattigal with RGM and the prognosis of the patient is calculated with, symptomatic improvement, reduction in size of fibroid and changes in pictorial blood assessment chart score from baseline visit to final visit and reduction in clinical symptoms of the patient by using uterine fibroid quality-of-life questionnaire, and the data were recorded.

Fibroid vascularisation assessed with 3D Power Doppler as predictor for fibroid related symptoms and quality of life; a pilot study.

Uterine fibroids present differently, from well vascularised up to calcified, with some causing heavy menstrual bleeding (HMB). To investigate the association between fibroid vascularisation and HMB, other fibroid related symptoms and quality of life (QOL). A single centre pilot study was carried out in the Netherlands. Women with a maximum of two fibroids who chose expectant management were included. 3D sonography including power doppler was performed at baseline and at 3, 6 and 12 months follow up. Women were asked to complete the Pictorial Blood Assessment Chart (PBAC) and Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaires at every visit. Main outcome measure: The association between fibroid vascularisation and HMB. 53 women were included in the study. Baseline fibroid vascularisation, measured as vascular index (VI) is associated with PBAC score; a 1% higher VI at baseline leads to an 11 point increase in PBAC score over time (RC 10.99, p=0.05, 95% CI -0.15 - 22.12). After correction for the baseline variables ethnicity and fibroid type the association becomes stronger (P<0.05). Fibroid volume at baseline and HMB are also associated: a 1 cm3 larger fibroid leads to 0.6 points increase in PBAC score over time (RC 0.56, p=0.03, 95% CI 0.05 - 1.07). Conclusions: This study highlights that both fibroid vascularisation and fibroid volume may be associated with an increase in menstrual blood loss, other fibroid related symptoms and QOL over time. What is new? We used 3D power doppler to predict symptomatic fibroids.

Screening hemostatic defects in Saudi University students with unexplained menorrhagia: a diagnosis, which could be missed.

Bleeding disorders are a common cause of unexplained menorrhagia in adolescents. However, there is lack of information provided on Arab girls. To estimate the prevalence of coagulation factor deficiencies and platelet dysfunction among Saudi university students with unexplained menorrhagia. In this cross sectional study, 463 adolescent girls surveyed for having heavy menses for further evaluation of underlying bleeding tendencies using screening standardized questionnaire. Only 109 girls out of the total 463 girls reported menorrhagia and were included in the evaluation. All girls with menorrhagia were evaluated by Pictorial blood assessment chart (PBAC) for precise evaluation of menstrual blood loss (PBAC score >100), had underwent pelvic ultrasonography and screening of hemostatic abnormalities (complete blood count, PFA-100, PT, aPTT, vWF:RCo, vWF:Ag, coagulation factors assay). On the basis of the score of PBAC more than 100, 25.6% (28/109) of adolescent women (age ranged: 17-25 years old) had confirmed menorrhagia. In 30.8% of them, an ultimate diagnosis of bleeding tendency or hemostatic abnormality was detected [five cases of probable von Willebrand disease (vWD) or low level of vWF:Ag and/or vWF:RCo, two cases of probable platelet dysfunction, and one case of factorV (FV) deficiency]. Anemia was found in 39.28% (11/28) of them; however, only 4 (36%) had received iron supplements. Our study demonstrated that hemostatic defects are not uncommon in Saudi adolescent women presenting with menorrhagia but mostly unrecognized and untreated. It is probably advisable to screen women with menorrhagia for these defects.

Management of uterine leiomyoma with mifepristone and its outcome in South Indian population

Introduction: Uterine Fibroids are common growth of female reproductive tract in women of reproductive age group. So this prospective observational study was conducted to evaluate the effect of low dose Mifepristone treatment for 6 months on the outcome of fibroid size and related symptom. Materials and Methods: The study was a prospective observational study conducted at Tertiary care Hospital, Tamil Nadu during the period of July 2016 to June 2017. Forty five patients with symptomatic fibroid, aged between 24-45 years were recruited for the study. Baseline data regarding fibroid volume, Hb value, PBAC (Pictorial Blood Assessment Chart) & VAS (Visual analogue Scheme) score were recorded. The follow-up data regarding above parameters again collected at the end of 6 months of therapy. All patients received 25mg mifepristone daily and comparison was made between pre and post treatment symptoms and leiomyoma volume. Results: After therapy with Mifepristone there was a significant reduction in mean volume of fibroid, menorrhagia and pain related symptoms. The mean leiomyoma volume was reduced from 104.3mm3 to 56.8 mm3 by the end of 6 months of mifepristone therapy. Similarly, at the end of six months of therapy mean hemoglobin value was also raised by 2.8gm/dl from the baseline mean value of 7.9gm/dl. There were no major side effects observed during the course of the study and the drug was well tolerated. Conclusion: Mifepristone is effective against low size uterine leiomyoma and can decrease its associated symptoms among women with symptomatic fibroids. Keywords: Mifepristone, Leiomyoma, Clinical treatment, Menorrhagia, Dysmenorrhea, Uterine fibroid, Volume of fibroid, Leiomyoma.

Comparative Study of Desogestrel- Containing Oral Contraceptive and Levonorgestrel- Containing Oral Contraceptive in Dysfunctional Uterine Bleeding

Dysfunctional uterine bleeding is a type of abnormal uterine bleeding where vaginal bleeding occurs outside of the menstrual cycle in the absence of any known pelvic pathology. Dysfunctional uterine bleeding can be treated safely with hormone therapy. Combined oral contraceptives help in increased menstrual cycle regularity and decreased blood loss. In this study, a reliable drug for the dysfunctional uterine bleeding with maximum effectiveness and minimal side effects were assessed. This study was conducted on 120 cases of dysfunctional uterine bleeding. Patients who were diagnosed with dysfunctional uterine bleeding were randomly assigned into two groups. Group D and group L included patients who were given Ethinyl estradiol 0.02mg + desogestrel 0.15mg and Ethinyl estradiol 0.03mg + levonorgestrel 0.15mg respectively for the four consecutive 28- day cycles. Menstrual blood loss was assessed using the pictorial blood assessment chart (PBAC) score on 2nd and 4th months of recruitment. Side effects such as weight gain, acne and headache were assessed in both groups. This study shows 56.68% reduction in mean PBAC score in 2 months in desogestrel group whereas only 44.96% reduction in levonorgestrel group and 79.87% reduction in mean PBAC score in desogestrel group in 4 months whereas only 74.46% reduction in levonorgestrel group. Side effects like weight gain, acne and headache were more prominent in the levonorgestrel group than desogestrel group. Desogestrel containing combined oral contraceptive can be a useful and safe treatment for dysfunctional uterine bleeding.

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial

SummaryBackgroundThe anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.MethodsMifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.FindingsBetween Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54–0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53–0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.InterpretationTreatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.FundingUK National Institute for Health Research Health Technology Assessment Programme.

Radiofrequency endometrial ablation with a novel endometrial tip for the management of heavy menstrual bleeding and abnormal uterine bleeding: a prospective study

Aim To evaluate the safety and efficacy of a radiofrequency ablation system with a novel endometrial tip (RFA-EMT) for the management of heavy menstrual bleeding (HMB) or abnormal uterine bleeding (AUB). Methods This is a prospective study including a total of 38 premenopausal women with heavy menstrual bleeding (HMB) or abnormal uterine bleeding (AUB) that failed to respond to medical therapy. Hysteroscopic evaluation and curettage biopsy were performed just before the procedure. The procedure was timed to occur during the early proliferative phase (cycle days 4–10). RFA-EMT procedures were performed by a single surgeon with the patient under general anesthesia with a laryngeal mask airway. Primary outcome was reduction in bleeding, reported as amenorrhea, hypomenorrhea, and eumenorrhea, which were measured via hemoglobin level and pictorial blood assessment chart (PBAC) score. Secondary outcomes were adverse events, dysmenorrhea with numeric rating scale (NRS) score, and endometrial thickening in the early proliferative phase, as assessed by transvaginal ultrasonography. Results There were no peri- or post-procedural complications. Combined amenorrhea, hypomenorrhea, and eumenorrhea rates at 3 and 6 months were 97.4% and 100%, respectively. The hemoglobin level was significantly increased, and the PBAC score, NRS score, and endometrial thickening were significantly decreased after 3 months. These trends were maintained for 6 months after the procedure. Conclusion RFA-EMT, a new technique, is safe and effective for women with HMB or AUB for which medical therapy has failed.

Von Willebrand Disease Minimize Menorrhagia (VWDMin) Trial

Von Willebrand Disease Minimize Menorrhagia (VWDMin) Trial

An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding.

Heavy menstrual bleeding (HMB) occurs in up to 40% of adolescent girls, significantly affecting their daily activities. Identifying alternative treatment strategies for HMB is particularly important for adolescents who prefer not to take hormonal contraception. Our objective was to determine whether use of tranexamic acid (TA) would increase health-related quality of life and decrease menstrual blood loss (MBL) in adolescents with HMB. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: In an open-label, multi-institutional, single-arm, efficacy study, patients 18years of age or younger with HMB were treated with oral TA 1300mg 3 times daily during the first 5days of menses and monitored over the course of 4 menstrual cycles (1 baseline; 3 treatment cycles). Assessment of MBL was performed using the Menorrhagia Impact Questionnaire (MIQ) and the Pictorial Blood Assessment Chart. The MIQ includes Likert scale items, validated to assess the influence of HMB on quality of life. In previous studies, a 1-point decrease or more in score correlated with clinically significant improvement. Thirty-two patients enrolled in the study, and 25 had sufficient follow-up data to be deemed evaluable. The mean age of the participants was 14.7years (range, 11-18years). There was an overall improvement in all items of the MIQ, with a greater than 1-point improvement in the MIQ perceived blood loss scale. When using TA, mean Pictorial Blood Assessment Chart score improved by 100 points. There were no medication-related serious adverse events. Use of TA in female adolescents with HMB is well tolerated and leads to clinically meaningful reduction in MBL.

Genotypic and Phenotypic Analysis of Adolescents with Heavy Menstrual Bleeding and Low Von Willebrand Activity - Interim Report of a Multi-Center Study

Genotypic and Phenotypic Analysis of Adolescents with Heavy Menstrual Bleeding and Low Von Willebrand Activity - Interim Report of a Multi-Center Study