Cefazolin as the mainstay for antibiotic prophylaxis in patients with a penicillin allergy in obstetrics and gynecology.

Cefazolin is the most common antibiotic used for prophylaxis in obstetrics and gynecology. Among those with a penicillin allergy, alternative antibiotics are often chosen for prophylaxis, given fears of cross-reactivity between penicillin and cefazolin. Alternative antibiotics in this setting are associated with adverse sequelae, including surgical site infection, induction of bacterial resistance, higher costs to the healthcare system, and possible Clostridium difficile infection. Given the difference in R1 side chains between penicillin and cefazolin, cefazolin use is safe and should be recommended for patients with a penicillin allergy, including those who experience Immunoglobulin E-mediated reactions such as anaphylaxis. Cefazolin should only be avoided in those who experience a history of a severe, life-threatening delayed hypersensitivity reaction manifested as severe cutaneous adverse reactions (Steven-Johnson Syndrome), hepatitis, nephritis, serum sickness, and hemolytic anemia in response to penicillin administration. In addition, >90% of those with a documented penicillin allergy do not have true allergies on skin testing. Increased referral for penicillin allergy testing should be incorporated into routine obstetric care and preoperative assessment to reduce suboptimal antibiotic prophylaxis use. More education is needed among providers surrounding penicillin allergy assessment and cross-reactivity among penicillins and cephalosporins to optimize antibiotic prophylaxis in obstetrics and gynecology.

Pregnancy Care for Patients With Super Morbid Obesity.

The patient with obesity represents unique challenges to the medical community and, in the setting of pregnancy, additional risks to both mother and fetus. This document will focus on the risks and considerations needed to care for the women with obesity and her fetus during the antepartum, intrapartum, and immediate postpartum stages of pregnancy. Specific attention will be given to pregnancy in the setting of class III and super morbid obesity.

Diagnosis and Management of Trichomonas vaginalis: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines.

Trichomonas vaginalis is likely the most prevalent nonviral sexually transmitted infection, affecting an estimated 3.7 million women and men in the United States. Health disparities are prominent in the epidemiology of trichomoniasis, as African Americans are >4 times more likely to be infected than persons of other races. Since publication of the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines, additional data have bolstered the importance of T. vaginalis infection sequelae in women, including increased risk of human immunodeficiency virus (HIV) acquisition, cervical cancer, preterm birth, and other adverse pregnancy outcomes. Less is known about the clinical significance of infection in men. Newly available diagnostic methods, including point-of-care assays and multiple nucleic acid amplification tests, can be performed on a variety of genital specimens in women and men, including urine, allowing more accurate and convenient testing and screening of those at risk for infection. Repeat and persistent infections are common in women; thus, rescreening at 3 months after treatment is recommended. In vitro antibiotic resistance to 5-nitroimidazole in T. vaginalis remains low (4.3%) but should be monitored. High rates of T. vaginalis among sexual partners of infected persons suggest a role for expedited partner treatment. A randomized controlled trial in HIV-uninfected women demonstrated that multidose metronidazole 500 mg twice daily for 7 days reduced the proportion of women with Trichomonas infection at 1 month test of cure compared with women receiving single-dose therapy (2 g). The 2-g single-dose oral metronidazole regimen remains the preferred treatment in men.

Development of a Novel Railway Positioning System Using RFID Technology.

Currently, a number of positioning systems are in use to locate trains on the railway network; but these generally have limited precision. Thus, this paper focuses on testing and validating the suitability of radio frequency identification (RFID) technology, for aligning vehicles to switch and crossing (S&C) positions on the railway network. This offers the possibility of accurately knowing the position of vehicles equipped with monitoring equipment, such as the network rail track recording vehicle (TRV), and aligning the data with reference to the locations of the S&C (and ideally to key elements within a particular S&C). The concept is to install two tags, one on the switch-toe sleeper and the second on the crossing-nose sleeper, with an RFID reader that will be installed underneath the vehicle. Thus, the key features of the S&C, the switch toe and crossing nose, will be considered as a definitive reference point for the inspection vehicle's position. As a monitoring vehicle passes over a piece of S&C, the proposed positioning system will provide information about this S&C's ID, which is stored inside the RFID tags and will indicate the S&C's GPS coordinates. As part of the research in this paper, more than 400 tests have been performed to investigate two different RFID technologies, passive and semi-passive, tested in a variety of conditions: including different passage speeds, different distances between the RFID reader and the tags, and varied strength signal transmitted between the reader and the tags. Based on lab testing and analysis of the recorded data, it is concluded that passive RFID technology is the most suitable of the two technologies. The conclusions find that the proposed RFID-based solution can offer a more precise positioning solution to be a reference point for the train location within the network.

The Continued Challenges in the Diagnosis of Acute Pelvic Inflammatory Disease: Focus on Clinically Mild Disease.

Many women with lower genital tract infections associated with sexually transmitted pathogens have evidence of upper genital tract inflammation despite the absence of symptoms and signs traditionally associated with pelvic inflammatory disease (PID). New biomarkers are needed to identify these women with clinically mild PID or subclinical PID (silent salpingitis) to facilitate initiation of early treatment and ameliorate the sequelae associated with upper genital tract infection and inflammation.

Risks for Recurrent Vulvovaginal Candidiasis Caused by Non-Albicans Candida Versus Candida Albicans.

Background: Vulvovaginal candidiasis (VVC) is the second most common vulvovaginitis (VV). About 20% of women will experience recurrent infections in their lifetime with non-albicans Candida (NAC) species being one of the causative agents. Although studies have looked at risk factors for recurrent VVC they are limited in scope. In this study, we explore whether risks of recurrent VVC are increased with NAC infections compared to Candida albicans infections. Methods: Through an institutional review board-approved retrospective chart review, we identified 174 women with positive yeast cultures and followed their charts to assess recurrent visits and treatments. We also assessed several baseline variables such as race, age, body mass index (BMI), obstetric history, probiotic use, contraceptive use, mycological therapy, steroid use, hormone replacement therapy, menopausal status, and medical comorbidities. Results: Women with NAC VV were more likely to have multiple visits for recurring infections compared to women who had C. albicans VV (66% vs. 34%). The women with multiple recurrences were younger, had a lower BMI, had lower parity, and endorsed higher use of probiotics. Conclusion: Women with positive NAC cultures were more likely to have multiple visits to their physicians for VV complaints. Identifying the causative species using vaginal fungal cultures can more accurately guide therapy and lead to better outcomes for these patients.

Preincision adjunctive prophylaxis for cesarean deliveries a systematic review and meta-analysis.

OBJECTIVE: This study aimed to systematically review the relative effectiveness of preincision cefazolin with or without adjunctive prophylaxis (macrolides or metronidazole) vs cefazolin alone in decreasing the incidence of postcesarean delivery surgical site infections. DATA SOURCES: We performed a systematic search on PubMed, Ovid EMBASE, Google Scholar, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials from October 25, 2020, to November 25, 2020, to identify studies comparing cefazolin with adjunctive macrolides or metronidazole with cefazolin alone. The reference lists were reviewed, and a manual search of articles published after the last database search was performed. STUDY ELIGIBILITY CRITERIA: Overall, 3 randomized controlled trials and 1 prospective observational study of reproductive-age women undergoing cesarean deliveries were included in the study. We excluded studies of women who were immunocompromised (eg, patients who were HIV positive) or women with a diagnosis of chorioamnionitis before cesarean delivery. All patients received first-line cefazolin (either cefazolin 1 g or 2 g). We compared preincision cefazolin alone with preincision cefazolin plus adjunctive therapy (500 mg, oral or intravenous formulations of azithromycin, metronidazole, or clarithromycin). METHODS: A total of 6 review authors independently assessed the risk of bias for each study, using the Cochrane Risk of Bias criteria. Synthesis and further appraisal were done using the Grading of Recommendations, Assessment, Development, and Evaluation levels and the American College of Obstetricians and Gynecologists appraisal guidelines. Disagreements were resolved by discussion. Treatment effects were evaluated using meta-analysis, and pooled relative risks and 95% confidence intervals were generated using random-effects models using the Review Manager 5 software (version 5.4.1). RESULTS: Overall, 3 randomized controlled trials and 1 prospective observational study representing 2613 women met the criteria for inclusion. Significant reductions in surgical site infections (relative risk, 0.46; 95% confidence interval, 0.34-0.63; 3 randomized controlled trials) and the duration of hospital stay (weighted mean difference, -1.46; 95% confidence interval, -2.21 to -0.71; 2 randomized controlled trials) were observed with preincision cefazolin and adjunctive prophylaxis compared with cefazolin alone. No significant difference was observed in maternal febrile morbidity (relative risk, 0.38; 95% confidence interval, 0.11-1.25; 2 randomized controlled trials). CONCLUSION: Our findings have provided evidence for the use of preincision adjunctive extended-spectrum prophylaxis with cefazolin over cefazolin alone. However, future investigations are required to establish the relative efficacies of different adjunctive antibiotic options.

Outcomes of Minimally Invasive Management of Tubo-ovarian Abscess: A Systematic Review.

OBJECTIVE: To compare the success rate, complications, and hospital length-of-stay of 3 modalities of minimally invasive management of tubo-ovarian abscesses (TOAs): laparoscopy, ultrasound-guided drainage, and computed tomography-guided drainage. DATA SOURCES: Electronic-based search in PubMed, EMBASE, Ovid MEDLINE, Google Scholar, and Cochrane Central Register of Controlled Trials, using the following Medical Subject Heading terms: "minimally invasive surgical procedures," "drainage," "abscess," "tubo-ovarian," "ovarian diseases," and "fallopian tube diseases." METHODS OF STUDY SELECTION: Of the 831 articles in the initial results, 10 studies were eligible for inclusion in our systematic review. TABULATION, INTEGRATION, AND RESULTS: A total of 975 patients were included in our study; 107 (11%) had laparoscopic drainage procedures, and 406 (42%) had image-guided (ultrasound or computed tomography) drainage of TOAs. Image-guided TOA drainage had higher success rates (90%-100%) than laparoscopic drainage (89%-96%) and the use of antibiotic treatment alone (65%-83%). Patients treated with image-guided drainage had no complications (for up to 6 months of follow-up) and shorter lengths of hospital stay (0-3 days on average) compared with laparoscopic drainage (5-12 days) or conservative management with antibiotics alone (7-9 days). CONCLUSION: Although conservative management of TOAs with antibiotics alone remains first-line, our review indicates that better outcomes in the management of TOA were achieved by minimally invasive approach compared with conservative treatment with antibiotics only. Of the minimally invasive techniques, image-guided drainage of TOAs provided the highest success rates, the fewest complications, and the shortest hospital stays compared with laparoscopy. The low magnitude of evidence in the included studies calls for further randomized trials. This systematic review was registered in the International Prospective Register of Systematic Review (register, http://www.crd.york.ac.uk/PROSPERO;CRD 42020170345).

Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial.

BACKGROUND: This study evaluated the safety and immunogenicity of an investigational trivalent group B streptococcus (GBS) vaccine in US pregnant women, transplacental serotype-specific antibody transfer and persistence in infants, and serotype-specific antibodies in breast milk. METHODS: This randomized, observer-blind, placebo-controlled trial administered one dose of trivalent GBS vaccine (n = 49) or placebo (n = 26) to healthy pregnant 18-40-year-old women at 240/7-346/7 weeks' gestation. Women were enrolled from March 2014 to August 2015. Safety follow-up continued through postpartum day 180. Primary immunogenicity objectives were to evaluate serotype Ia/Ib/III-specific immunoglobulin G (IgG) levels in sera from women on day 1 (pre-vaccination), day 31, delivery and postpartum days 42 and 90, and from infants at birth (cord blood), days 42 and 90. Antibody transfer ratios (cord blood/maternal sera at delivery) and serotype-specific secretory immunoglobulin A (sIgA) and IgG in breast milk after delivery and on postpartum days 42 and 90 were evaluated. The planned sample size was not based on statistical assumptions for this descriptive study. RESULTS: Baseline characteristics were similar between groups. Serious adverse events were reported for 16% of GBS-vaccinated women and 15% of their infants, and 15% of placebo recipients and 12% of their infants; none were fatal or deemed vaccine-related. Serotype-specific IgG geometric mean concentrations (GMCs) were 13-23-fold higher in vaccine vs placebo recipients on day 31 and persisted until postpartum day 90. Median antibody concentrations were substantially higher in women with detectable pre-vaccination antibody concentrations. Antibody transfer ratios in the vaccine group were 0.62-0.82. Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints. CONCLUSIONS: Maternal immunization with the trivalent GBS vaccine in US women had a favorable safety profile, elicited antibodies that were transplacentally transferred and persisted in infants for a minimum of 3 months. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT02046148.

Diagnosis, Treatment, Follow-up, and Persistence of Trichomonas vaginalis in Women 45 Years and Older According to HIV Status: A 10-Year Retrospective Cohort.

BACKGROUND: Trichomonas vaginalis is a common treatable sexually transmitted infection among older women. Persistent T. vaginalis infection after treatment is common among women with human immunodeficiency virus (HIV). We sought to determine if HIV-negative women were as likely as women with HIV to have persistent T. vaginalis infection. METHODS: We performed a retrospective cohort study of women 45 years or older with T. vaginalis infection. We evaluated differences in persistent T. vaginalis infection according to HIV status using χ analysis. We performed regression analyses to describe factors associated with persistent and recurrent infection in older women. RESULTS: Over a 10-year study period, we identified 282 women with T. vaginalis, 46 with HIV. Most women (240, 86%) were treated in accordance with 2015 Centers for Disease Control and Prevention Sexually Transmitted Diseases treatment guidelines. Half of the women (144, 53%) had a repeat T. vaginalis test 90 to 365 days after treatment, and one third had persistent infection (39/125, 31%). Persistent infection was similar between women with HIV and HIV-negative women treated according to Centers for Disease Control recommendations (17% vs 33%, P = 0.3). When adjusting for age and incidental diagnosis, tobacco use was associated with an increased risk of more than 1 or recurrent T. vaginalis infection during the study period (adjusted odds ratio, 2.8; 95% confidence interval, 1.5-4.9). CONCLUSIONS: The HIV status did not affect persistent T. vaginalis infection in women 45 years or older. Given over one third of women have a positive test within a year after the recommended treatment, our data support repeat testing in women 45 years and older treated for T. vaginalis.

Program Evaluation of an Integrated Behavioral Health Clinic in an Outpatient Women's Health Clinic: Challenges and Considerations.

Many women receive their regular check-ups and preventive care through a women's health clinic, including their behavioral health needs. Most of these clinics have not yet developed the capacity to adequately manage behavioral health concerns. We describe our clinical experience integrating behavioral health services into a women's health clinic. In one year, 108 women (54% White, Mage= 35) were referred for behavioral health treatment 47% were identified using a screening questionnaire, 51% were referred by their women's health provider and 2% were self-referred. The most common presenting concerns were anxiety (52%) and depressive symptoms (48%). Sixty-one (56%) patients completed an intake assessment, of whom 33 (54%) engaged in follow-up treatment (M = 3.7 treatment sessions, SD = 3.0). Behavioral health screening and treatment appears to be feasible and effective within a women's health setting. Further research is needed to overcome barriers to referrals and treatment engagement in this population.

Bacterial vaginosis and surgical site infections.

Bacterial vaginosis is the most common cause of abnormal vaginal discharge or malodor, affecting up to one third of US women. Most women with bacterial vaginosis are unaware of the infection, making it difficult to diagnose in the absence of a microscopic examination of vaginal discharge or using point-of-care testing. Untreated bacterial vaginosis elevates the risk of postoperative surgical infections in women undergoing obstetric and gynecological procedures. Treatment with antimicrobial agents that target bacterial vaginosis has been shown to reduce the rate of postoperative infections following hysterectomy and surgical abortions. Furthermore, in a cost-comparison model, screening for and treatment of bacterial vaginosis prior to hysterectomy was shown to be superior to no screening in terms of infection rates and cost. The bacterial vaginosis diagnostic criteria are simple and screening tests are inexpensive; bacterial vaginosis screening is a relatively fast process in patients who present for preoperative appointments. Treatment options approved by the Food and Drug Administration include metronidazole, clindamycin, tinidazole, and secnidazole. Given the prevalence of bacterial vaginosis and the risks associated with operating on a woman with untreated bacterial vaginosis, women undergoing hysterectomy, surgical abortion, and potentially cesarean delivery should be screened for bacterial vaginosis, and those who screen positive should be treated with an appropriate antimicrobial agent.

Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

OBJECTIVE: To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding. METHODS: Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assessed at baseline, and over one (VENUS I and II) and two (VENUS II) 12-week treatment courses using the Uterine Fibroid Symptom Health-Related Quality of Life questionnaire. In pooled VENUS I and II data, change from baseline to the end of the first course for each Uterine Fibroid Symptom Health-Related Quality of Life scale was analyzed, including a Revised Activities subscale that measured physical and social activities. The proportion of women achieving meaningful change in the Symptom Severity (20 or more points), Health-Related QOL Total (20 or more points), and Revised Activities (30 or more points) scales was calculated. In VENUS II data, change from baseline to the end of each course in each scale was analyzed for each treatment arm. RESULTS: In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uterine Fibroid Symptom Health-Related Quality of Life scales were observed with both ulipristal doses compared with placebo (P<.001). A meaningful change in Revised Activities was achieved by 51 patients receiving placebo (34.9%), compared with 144 (73.5%; OR 5.0 [97.5% CI 2.9-8.6]) and 141 (80.6%; OR 7.9 [97.5% CI 4.3-14.6]) patients receiving ulipristal 5 mg, and 10 mg, respectively. In VENUS II, at end of courses 1 and 2, both ulipristal doses demonstrated significant improvements from baseline compared with placebo for all Uterine Fibroid Symptom Health-Related Quality of Life scales (P<.01). Mean Revised Activities scores showed that beneficial ulipristal effects were maintained in course 2, and improvements occurred on switching to ulipristal; results for other scales were similar. CONCLUSION: Ulipristal was associated with significant improvements in health-related QOL and symptom severity compared with placebo for women with symptomatic uterine leiomyomas. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02147197 and NCT02147158. FUNDING SOURCE: Allergan plc, Dublin, Ireland.

Prevention of Cesarean Delivery Surgical Site Infections.

IMPORTANCE: Surgical site infection (SSI) is a common complication of cesarean delivery. Seen in up to 12% of cesarean deliveries, it is a major cause of prolonged hospital stay and a burden to the healthcare system. Interventions and techniques must be identified to decrease the risk of cesarean delivery SSIs. OBJECTIVE: We review the categories of SSI, current studies that have focused on various interventions to decrease SSI, and preoperative, intraoperative, and postoperative recommendations for cesarean delivery SSI prevention. EVIDENCE ACQUISITION: A thorough search of PubMed for all current literature was performed. Various surgical interventions and techniques were reviewed. We included studies that looked at preoperative, intraoperative, and postoperative interventions for SSI prevention. RESULTS: We have summarized several surgical interventions and techniques as well as current consensus statements to aid the practitioner in preventing SSIs after cesarean delivery. CONCLUSIONS AND RELEVANCE: Upon analysis of current data and consensus statements pertaining to cesarean deliveries, there are certain preoperative, intraoperative, and postoperative interventions and techniques that can be recommended to decrease the risk of cesarean delivery SSI.

Unexpected High Rates of Persistent Trichomonas vaginalis Infection in a Retrospective Cohort of Treated Pregnant Women.

BACKGROUND: Our primary objective was to determine the rate of persistent Trichomonas infection among pregnant women posttreatment. The secondary objective was to determine if oral multidose metronidazole was associated with fewer cases of persistent Trichomonas compared with single-dose treatment. METHODS: This is a retrospective cohort study of women diagnosed with genital Trichomonas vaginalis from 2008 to 2017. We calculated the rate of persistent Trichomonas by dividing the number of positive Trichomonas tests collected 21 days or longer posttreatment by the total number of women treated and retested. Bivariate analysis was performed to compare the rates of positive tests after single and multidose metronidazole. Multivariate logistic regression was used to evaluate factors associated with persistent infection. RESULTS: Five hundred forty-two women with 565 pregnancies were diagnosed with Trichomonas infection. The majority of subjects were prescribed either single-dose (n = 352) or multidose metronidazole (n = 74). Posttreatment Trichomonas tests were collected 21 days or longer in 326 subjects and 44% (143) were positive. Rates of positive Trichomonas tests among women receiving single-dose and multidose regimens were similar (45% vs. 40%, P = 0.50). Women who had ≥1 pregnancy affected by Trichomonas infection were more likely to have a positive test posttreatment (adjusted odds ratio, 20.1; 95% confidence interval, 1.9-215.3). Obese women were less likely to have a positive test posttreatment (adjusted odds ratio, 0.3; 95% confidence interval, 0.1-0.9). CONCLUSIONS: Given high rates of positive Trichomonas tests and increased detection with nucleic acid amplification tests (NAATs), all pregnant women should be retested with NAATs approximately 3 weeks posttreatment. Further studies are needed to determine the most effective treatment of Trichomonas infection in pregnant women.

The Impact of Delivery in a Rural County on a Cohort of Women Living with HIV Infection and Their Infants.

PURPOSE: We sought to determine if infants born in rural counties had an increased risk of contracting HIV. METHODS: Data were obtained from the South Carolina Department of Health and Environmental Control for all women living with HIV delivering from 2004 to 2014. In this retrospective cohort study, maternal and neonatal outcomes from urban and rural counties were compared. Binomial statistical analyses were conducted using Wilcoxon Rank Sum Tests, χ2 or Fisher's exact tests. Logistic regression analyses were performed to evaluate factors associated with perinatal HIV infection. FINDINGS: Six hundred and sixty-six women living with HIV had 868 pregnancies and delivered 885 infants; 17% (148) were born in rural counties. Eleven infants (1.2%) were diagnosed with perinatal HIV infection. The proportion of women taking antenatal antiretroviral therapy (ART) was similar between rural and urban counties (84% vs 87%; P = .3), but women in urban counties were more likely to have an HIV RNA viral load <40 copies/mL before delivery (32% vs 42%; P = .05). Factors associated with perinatal HIV infection were intra- and postpartum maternal HIV diagnosis (aOR 61.4 [95% CI: 6.7-562.5]; P < .001), parenteral drug use (aOR 7.5 [1.6-34.7]; P = .01), and preterm birth (<37 weeks gestation) (aOR 4.6 [1.2-17.8]; P = .3). CONCLUSIONS: Delivery in a rural county was not associated with an increased risk of perinatal HIV transmission. Women delivering in rural counties taking ART were less likely to have HIV viral suppression, which is a risk factor for perinatal HIV infection.

Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas. METHODS: This phase 3, double-blind, double-dummy, placebo-controlled trial randomized premenopausal women (18-50 years) with uterine leiomyomas and abnormal uterine bleeding to once-daily 5 mg ulipristal, 10 mg ulipristal, or placebo in two 12-week treatment courses separated by a drug-free interval of two menses. Coprimary end points were rates of and time to amenorrhea during course 1. Change from baseline to end of course 1 in the Revised Activities subscale of the Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire was a secondary end point. A sample size of 400 was planned to compare separately each ulipristal dose with placebo. RESULTS: From January 2014 through November 2016, 432 women were randomized. Demographic characteristics were similar across treatment groups. In course 1, 68 of 162 (42.0% [97.5% CI 33.3-51.1]) and 86 of 157 (54.8% [97.5% CI 45.5-63.8]) patients treated with 5 mg and 10 mg ulipristal, respectively, compared with 0 of 113 (0.0% [97.5% CI 0.0-3.8]) patients treated with placebo achieved amenorrhea (P<.001 for each dose); most women who achieved amenorrhea did so within 10 days (time to amenorrhea, P<.001 for each dose). Significantly greater improvements in Uterine Fibroid Symptom and Health-Related Quality of Life Revised Activities subscale scores were reported with 5 mg and 10 mg ulipristal compared with placebo (least squares mean change from baseline: 48.3, 56.7, and 13.0, respectively; P<.001 for each dose). Both ulipristal doses were well tolerated; in course 1, hot flush occurred in 7.5%, 11.6%, and 1.7% of patients treated with 5 mg ulipristal, 10 mg ulipristal, and placebo, respectively. CONCLUSION: Treatment with 5 mg or 10 mg ulipristal was superior to placebo in achieving amenorrhea and generally well tolerated for the medical management of symptomatic uterine leiomyomas. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02147158.