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1.
Maternal Fatigue after Postpartum Anemia Treatment with Intravenous Ferric Carboxymaltose vs. Intravenous Ferric Derisomaltose vs. Oral Ferrous Sulphate: A Randomized Controlled Trial
Bombač Tavčar, L., Hrobat, H., Gornik, L., Preložnik Zupan, I., Vidmar Šimic, M., Pečlin, P., Kavšek, G., Lučovnik, M.
Journal of clinical medicine. 2024;13(3)
Abstract
(1) Background: Postpartum anemia is a common maternal complication and is recognized as a cause of impaired quality of life, reduced cognitive abilities, and fatigue. Efficient iron supplementation for the treatment of postpartum anemia is an essential component of high-quality maternal care. The optimal mode of iron supplementation has not been determined yet, whether oral or intravenous. The objective of this study was to compare postpartum anemia treatment with intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate. (2) Methods: A single-center, open-label, randomized controlled trial. Women with hemoglobin < 100 g/L within 48 h postpartum were randomly allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose, or oral ferrous sulfate. Intravenous iron was given in one or two doses, while ferrous sulfate was given as two 80 mg tablets once daily. The primary outcome was maternal fatigue measured by the Multidimensional Fatigue Inventory (MFI) six weeks postpartum. Hemoglobin, ferritin, and transferrin saturation levels were analyzed as secondary outcomes. A Kruskal-Wallis test was used for group comparison (p < 0.05 significant). (3) Results: Three hundred women were included. The MFI score at six weeks postpartum did not differ between groups (median 38 (inter-quartile range (IQR) 29-47) in the ferric carboxymaltose group, median 34 (IQR 26-42) in the ferric derisomaltose group, and median 36 (IQR 25-47) in the ferrous sulfate group; p = 0.26). Participants receiving oral iron had lower levels of hemoglobin (135 (131-139) vs. 134 (129-139) vs. 131 (125-137) g/L; p = 0.008), ferritin (273 (198-377) vs. 187 (155-246) vs. 24 (17-37) µg/L; p < 0.001) and transferrin saturation (34 (28-38) vs. 30 (23-37) vs. 24 (17-37) %; p < 0.001) than those receiving ferric carboxymaltose or ferric derisomaltose. (4) Conclusions: Intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate had similar impacts on maternal fatigue at six weeks postpartum despite improved laboratory parameters in the intravenous groups.
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2.
A 52 mg levonorgestrel-releasing intrauterine system versus bipolar radiofrequency non-resectoscopic endometrial ablation in women with heavy menstrual bleeding: long-term follow-up of a multi-center randomized controlled trial
Huijs, D. P. C., Derickx, A. J. M., Beelen, P., Leemans, J. C., Van Kuijk, S. M. J., Bongers, M. Y., Geomini, Pmaj
American journal of obstetrics and gynecology. 2024
Abstract
BACKGROUND The symptom of heavy menstrual bleeding has a significant impact on professional, physical and social functioning. In 2021, results from a randomized controlled trial comparing a 52 mg levonorgestrel-releasing intrauterine system and radiofrequency non-resectoscopic endometrial ablation as treatments for women with heavy menstrual bleeding were published. Both treatment strategies were equally effective in treating heavy menstrual bleeding during a two-year follow-up. However, long-term results are also relevant for both patients and health care providers. OBJECTIVE The aim of this study was to assess long-term differences in reintervention risk and menstrual blood loss in women with the symptom of heavy menstrual bleeding treated according to a strategy starting with a 52 mg levonorgestrel-releasing intrauterine system or radiofrequency non-resectoscopic endometrial ablation. STUDY DESIGN This study was a long-term follow-up study of a multi-center randomized controlled trial (MIRA trial) in which women were allocated to either a 52 mg levonorgestrel-releasing intrauterine device (n=132) or radiofrequency non-resectoscopic endometrial ablation (n=138). Women from the original trial were contacted to fill out six questionnaires. The primary outcome was reintervention rate after allocated treatment. Secondary outcomes included surgical reintervention rate, menstrual bleeding measured by the Pictorial Blood Loss Assessment Chart, (disease-specific) quality of life, sexual function and patient satisfaction. RESULTS From the 270 women that were randomized in the original trial, 196 women (52 mg levonorgestrel-releasing intrauterine system group: n=94; radiofrequency non-resectoscopic endometrial ablation group: n=102) participated in this long-term follow-up study. Mean follow-up duration was 7.4 years (range 6-9 years). The cumulative reintervention rate (including both medical and surgical reinterventions) was 40.0% (34/85) in the 52 mg levonorgestrel-releasing intrauterine system group and 28.7% (27/94) in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 1.39; 95% confidence interval: 0.92-2.10). The cumulative rate of surgical reinterventions only was significantly higher for patients with a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system compared to radiofrequency non-resectoscopic endometrial ablation (35.3% [30/85] vs. 19.1% [18/94]; relative risk: 1.84; 95% confidence interval: 1.11-3.10). However, hysterectomy rate was similar: 11.8% [10/94] in the 52 mg levonorgestrel-releasing intrauterine system group and 18.1% [17/102] in the radiofrequency non-resectoscopic endometrial ablation group (relative risk: 0.65; 95% confidence interval: 0.32-1.34). Most reinterventions took place during the first 24 months of follow-up. A total of 171 Pictorial Blood Loss Assessment Chart scores showed a median bleeding score of 0.0. No clinically relevant differences were found regarding quality of life, sexual function and patient satisfaction. CONCLUSION The overall risk of reintervention after long-term follow-up was not different for women treated according to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system as compared to a strategy starting with radiofrequency non-resectoscopic endometrial ablation. Yet, women allocated to a treatment strategy starting with a 52 mg levonorgestrel-releasing intrauterine system had a significantly higher risk for surgical reintervention, which was driven by an increase in subsequent endometrial ablation. Both treatment strategies remain effective in lowering menstrual blood loss over the long-term. The results of this long-term follow-up study help physicians to optimize counseling of women suffering from the symptom of heavy menstrual bleeding. Optimized counseling will enable women to make a well-informed choice regarding treatment.
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3.
Effect and Safety of Diluted Vasopressin Injection for Bleeding Control During Robot-assisted Laparoscopic Myomectomy in Reproductive Women With Uterine Fibroids: A Randomized Controlled Pilot Trial (VALENTINE Trial)
Park, S. J., Lee, J. W., Hwang, D. W., Lee, S., Yim, G. W., Song, G., Lee, E. J., Kim, H. S.
In vivo (Athens, Greece). 2024;38(1):431-436
Abstract
BACKGROUND/AIM: Vasopressin injected during myomectomy is known to effectively reduce bleeding but is sometimes associated with intraoperative vasoconstriction and hypertension due to systemic absorption. Although there is a growing preference for the use of diluted vasopressin, evidence of its effect and safety is still lacking. PATIENTS AND METHODS We performed a randomized controlled pilot trial to evaluate the effect and safety of vasopressin diluted in a constant volume during robot-assisted laparoscopic myomectomy (RALM), where a total of 39 women with uterine fibroids were randomly assigned into the following three groups (group 1, 0.2 IU/ml; group 2, 0.1 IU/ml; group 3, 0.05 IU/ml with a total of 100 ml of normal saline). The primary endpoint was to compare estimated blood loss (EBL), and the secondary endpoints were to compare postoperative value and drop ratio of hemoglobin, operation time, transfusion, hospitalization, and complications among the three groups. RESULTS There were no differences in the number and largest size of uterine fibroids, total weight of uterine fibroids, console time, and volumes of intravenous fluid administered during RALM among the three groups, whereas combined operation was performed more commonly in group 2 than in groups 1 and 3 (53.9% vs. 0 to 7.7%; p=0.01). The primary and secondary endpoints were also not different among the three groups. However, two patients in group 1 (15.4%) showed vasopressin-related hypertension. CONCLUSION Vasopressin diluted in a volume of 100 ml showed an effective hemostatic effect and safety during RALM (Trial No. NCT04874246 in ClinicalTrial.gov).
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4.
Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial
Ortuanya, K. E., Eleje, G. U., Ezugwu, F. O., Odugu, B. U., Ikechebelu, J. I., Ugwu, E. O., Eke, A. C., Awkadigwe, F. I., Ezenwaeze, M. N., Ofor, I. J., et al
Women's health (London, England). 2024;20:17455057231225311
Abstract
BACKGROUND Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN The study is a double-blind randomized controlled trial. METHODS The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.
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5.
Efficacy of Tranexamic Acid in Reducing Myomectomy-Associated Blood Loss among Patients with Uterine Myomas at Federal Teaching Hospital Abakaliki: A Randomized Control Trial
Olaleye, A. A., Adebayo, J. A., Eze, J. N., Ajah, L. O., Anikwe, C. C., Egede, J. O., Ebere, C. I.
International journal of reproductive medicine. 2024;2024:2794052
Abstract
BACKGROUND Myomectomy can be associated with life-threatening conditions such as bleeding. Excessive bleeding usually necessitates blood transfusion. Interventions to reduce bleeding during myomectomy will help reduce the need for blood transfusion with its associated complications. Tranexamic acid has been used to reduce bleeding in other surgical procedures, and its usage during myomectomy merits evaluation. OBJECTIVE To assess the efficacy of tranexamic acid in reducing myomectomy-associated blood loss. MATERIALS AND METHODS This is a prospective double-blinded randomized trial conducted on women who had abdominal myomectomy. Patients were randomized into two groups. The study group received perioperative intravenous tranexamic acid (TXA) while the control group received a placebo. Intraoperative blood loss was calculated by measuring the volume in the suction apparatus and weighing the surgical swabs. In addition, blood collected postoperatively from the wound drains and drapes were measured. Haemoglobin concentrations were determined preoperatively and on second postoperative day for all cases. Any adverse effect was noted in both groups. The data was processed using Epi Info software (7.2.1, CDC, Atlanta, Georgia). The relationships between categorical data were analyzed using X(2) and Student's t-test to determine relationships between continuous variables, with a P value of 0.05 considered statistically significant, and correlation coefficients were calculated using Pearson's formula, and probability of 0.05 was set for statistical significance. RESULTS Symptomatic uterine myomas constituted 17.3% of all gynaecological admissions and 21.3% of gynaecological operations at Federal Teaching Hospital Abakaliki. The mean intraoperative blood loss among patients that had perioperative tranexamic acid infusion was 413.6 ± 165.6 ml, while that of patients with placebo infusion was 713.6 ± 236.3 ml. Perioperative tranexamic acid infusion therefore reduced mean intraoperative blood loss by 300 ml, and this was statistically significant (SMD = -0.212, 95% CI: -403.932 to -196.067, P < 0.0001). Perioperative tranexamic acid reduced mean total blood loss by a value of 532.3 ml, and this is statistically significant (SMD = 30.622, 95% CI: 393.308 to 670.624, P < 0.0001). Tranexamic acid also improved postoperative haemoglobin concentration by 1.8 g/dl compared with placebo, and this is statistically significant (SMD = -0.122, 95% CI: 1.182 to 2.473, P < 0.0001). Tranexamic acid infusion decreased hospital stay by about 2 days, and this difference was statistically significant (SMD = -3.929, 95% CI: -3.018 to -0.983, P = 0.0003). There was no adverse drug reaction in the course of the study. CONCLUSION The use of tranexamic acid during myomectomy reduced intraoperative and postoperative blood loss. It is also associated with decreased hospital stay. This trial is registered with NCT04560465.
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6.
Reducing patient's perception of postoperative vaginal bleeding after laparoscopic hysterectomy via independent closure of the vaginal cuff angles (RCT)
Radtke, S., Arms, R., Son, M. A., Sanchez, S., Singh, V., Bencomo, M., McCall, E., Rodriguez, S., Olivas-Cardiel, K.
European journal of obstetrics, gynecology, and reproductive biology. 2024;294:111-116
Abstract
STUDY OBJECTIVE Determine if independently suturing the vaginal cuff angles in addition to running barbed suture has an effect on patients' perception of postoperative bleeding after laparoscopic hysterectomy. DESIGN Randomized controlled trial. SETTING University-based medical center. PATIENTS Females ages 18-60 undergoing laparoscopic hysterectomy. INTERVENTIONS Patients were randomly assigned to either cuff closure via single layer of barbed suture (control) vs adding figure-of-eight stitches at each angle (intervention). A survey was given between 10 and 25 days after surgery inquiring about bleeding and dyspareunia. A second survey was given between postoperative days 90-114. Chart review was performed to record emergency room visits, complications, infections, and reoperations during the first 90 postoperative days. RESULTS n = 117 patients were analyzed. 62 (control) and 55 (intervention). Groups were similar in terms of age (42.92 v 44.29p =.35), BMI (33.79 v 34.06p =.85), diabetes (5.26 % (3/55) v 15.09 % (8/53) p =.08) p =.97). Bleeding was decreased in intervention arm (24.19 % (15/62) v 9.09 % (5/55) p =.03). Median (IQR) pelvic pain score was similar (2.0 (0-5.0) v 2.0 (0-4.0) p =.26). Median total operative time (IQR) (129 min (102, 166) v 139 min (120, 163) p =.39) and median EBL (IQR) (50 mL (30-75) vs 50 mL (20-75) p =.43) were similar. Cuff closure in seconds (IQR) was higher in intervention group (373 sec (323, 518) v 571 sec (520, 715) p <.01). 8/60 control patients visited the ED (13.33 %) v 7/54 (12.96 %) p =.95. Readmissions (1.67 % (1/60) v 1.85 % (1/55) p = 1), re-operations (0 % (0/60) v 1.85 % (1/55) p =.47) and postoperative infections (5.0 % (3/60) v 1.85 % (1/54) p =.62) were similar. Secondary survey showed no significant difference in bleeding (15.38 % (4/26) v 4.35 % (1/23) p =.35) and SF-36 results were similar. CONCLUSION Independently suturing the vaginal cuff angles reduces patients' perception of vaginal bleeding in the early postoperative period. Incidence of complications, reoperations, and long-term quality of life are similar.
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7.
Tranexamic acid to reduce blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery-a randomized controlled trial
Neumann, B. G., Metgud, M. C., Hoffman, M. K., Patil, K., Savanur, M., Hanji, V., Ganachari, M. S., Somannavar, M., Goudar, S. S.
AJOG global reports. 2024;4(1):100316
Abstract
BACKGROUND Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied. OBJECTIVE This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage. STUDY DESIGN This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups. RESULTS A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (P<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (P<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (P<.001). No difference in the need for additional uterotonics (P=.26) or the need for postoperative parental iron (P=.18) was noted. No woman was transfused in either group. CONCLUSION High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.
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8.
Effectiveness of Autologous Platelet-Rich Plasma Therapy in Women with Repeated Implantation Failure: A Randomized Clinical Trial
Eftekhar, M., Neghab, N., Khani, P.
International journal of fertility & sterility. 2024;18(2):162-166
Abstract
BACKGROUND Platelet-rich plasma (PRP) therapy has been shown to enhance tissue regeneration by expressing several cytokines and growth factors (GFs). This study investigated the effect of intrauterine infusion of PRP as a noninvasive autologous GF on pregnancy outcomes in women with repeated implantation failure. MATERIALS AND METHODS This randomized clinical trial was conducted to compare the pregnancy rates between two groups of women who were candidates for the frozen-thawed embryo transfer with a history of two or more implantation failures. The PRP group (n=33) was treated with hormone replacement therapy+0.5 cc to 1 cc PRP infused into the uterine cavity two days before the embryo transfer. The control group (n=33) was only treated with hormone replacement therapy. The endometrial preparation process was done similarly in both groups. The chemical, clinical, and ongoing pregnancy, and implantation rates were compared between the two groups. RESULTS Our results showed that the chemical pregnancy rate was not statistically higher in the PRP group in comparison with the control group (36.4 vs. 24.2%). In addition, the clinical pregnancy, ongoing pregnancy, and implantation rates were higher in the PRP group than the control group; however, the difference between the two groups was not statistically significant. CONCLUSION Administration of intrauterine PRP before embryo transfer in women with repeated implantation failure (RIF) does not affect assisted reproductive technology (ART) outcomes (registration number: IRCT2016090728950N3).
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9.
Validation of three models for prediction of blood transfusion during cesarean delivery admission
Bruno, A., Federspiel, J. J., McGee, P., Pacheco, L., Saade, G., Parry, S., Longo, M., Tita, A., Gyamfi-Bannerman, C., Chauhan, S., et al
American journal of perinatology. 2023
Abstract
OBJECTIVE Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery. METHODS This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative (CMQCC)), and two regression models (Ahmadzia et al and Albright et al). The primary outcome was red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared. RESULTS Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low-risk, 5,259 (48.8%) as medium-risk, and 3,556 (33.0%) as high-risk with corresponding transfusion rates of 2.1% (95% CI 1.5-2.9%), 2.2% (95% CI 1.8-2.6%), and 7.5% (95% CI 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI 0.76-0.81) and 0.79 (95% CI 0.77-0.82), respectively (p=0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion. CONCLUSION Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S. COHORT Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed.
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10.
Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial
Brown, E., Kroll, R., Li, H., Ng, J., Pinsky, B., Rodriguez, J. W., Thomas, J., Snabes, M. C.
Obstetrics and gynecology. 2023
Abstract
OBJECTIVE To evaluate the safety and efficacy of elagolix 150 mg once-daily monotherapy in patients with heavy menstrual bleeding associated with uterine leiomyomas. METHODS A phase 4, randomized, double-blind, placebo-controlled, 6-month treatment study was conducted in premenopausal patients aged 18-51 years with heavy menstrual bleeding (defined as menstrual blood loss greater than 80 mL during one menstrual cycle) associated with uterine leiomyomas. Patients were randomized 2:1 to receive elagolix 150 mg once daily or placebo. The primary endpoint was reduction in menstrual blood loss volume to less than 80 mL at the final month and at least a 50% reduction in menstrual blood loss volume from baseline to the final month. RESULTS Of 82 randomized patients, 54 received elagolix 150 mg and 28 received placebo. With elagolix, 49.4% (95% CI 35.1-63.8%) of patients met the primary endpoint, compared with 23.3% (95% CI 7.2-39.5%) of patients who received placebo (P=.035). Statistically significant differences between elagolix and placebo in mean reduction of menstrual blood loss from baseline were seen as early as month 1 (P<.05 for months 1-3 and 5). Significantly more patients receiving elagolix experienced suppression of bleeding compared with placebo (P=.036). Greater improvements were observed in the elagolix group (vs placebo) in the proportion of patients with amenorrhea, in hemoglobin concentrations, and in health-related quality of life. No serious or severe adverse events were reported for elagolix, compared with 7.1% of participants in the placebo group having serious adverse events (coronavirus disease 2019 [COVID-19] n=1, enlarged uvula n=1). Three patients (5.6%) discontinued elagolix due to adverse events. CONCLUSION Elagolix 150 mg once-daily monotherapy significantly improved heavy menstrual bleeding associated with uterine leiomyomas compared with placebo in premenopausal patients. Treatment with elagolix 150 mg once daily was generally well-tolerated in this study, with no new safety signals. FUNDING SOURCE AbbVie Inc. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03886220.