OBJECTIVE:To validate an objective photo-based electronic method of quantifying menstrual blood loss against the current gold standard alkaline hematin method. METHODS:In this multicenter, prospective cohort study, 79 participants (33 in the training phase, 46 in the validation phase) 18-50 years of age who were premenopausal with self-reported heavy menstrual bleeding were recruited from February to November 2023. Participants provided demographic and medical history details at baseline and then used study-provided pads, photo mats, and smartphones to capture images of menstrual blood loss per pad in one menstrual cycle. A photo-based smartphone application used image analysis software to convert the surface area of blood staining on each menstrual pad into menstrual blood loss volume. The outcome measures were menstrual blood loss per pad and per cycle measured in milliliters, with the alkaline hematin method as the reference standard. Bland-Altman analysis was used with 46 participants from the validation phase to construct limits of agreement between the photo-based and alkaline hematin methods for measuring menstrual blood loss. The sensitivity and specificity of the photo-based method for diagnosing heavy menstrual bleeding (menstrual blood loss more than 80 mL per cycle) were also evaluated. RESULTS:The photo-based method correlated strongly with the alkaline hematin reference standard for both per-pad (R 2=0.75) and per-cycle (R 2=0.83) blood loss. Agreement was high, with minimal bias and limits of agreement within clinically acceptable ranges. For identifying heavy menstrual bleeding, the method achieved 100.0% sensitivity, 93.5% specificity, and 100.0% negative predictive value. CONCLUSION:A photo-based method provides a valid, practical, and accessible alternative to the alkaline hematin standard, enabling accurate diagnosis and monitoring of heavy menstrual bleeding in both clinical and research settings.

OBJECTIVE:To evaluate whether there is an association between a maternal classification of Long COVID and adverse pregnancy outcomes. METHODS:RECOVER (Researching COVID to Enhance Recovery)-Adult is a multicenter prospective longitudinal cohort study of adults with and without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection enrolled from October 2021 to January 2024. This analysis included participants with a SARS-CoV-2 infection and at least one symptom survey for classification of Long COVID status recorded before or during pregnancy. Participants were classified as either likely having Long COVID (LCRI [Long COVID Research Index] score of 11 or higher) or as having Long COVID-indeterminate (LCRI score 0-10), with comparisons made between groups. The primary outcome was preterm birth before 37 weeks of gestation. Secondary outcomes included hypertensive disorders of pregnancy, cesarean delivery, neonatal intensive care admission, and small-for-gestational-age birth weight (below the 10th percentile). Propensity score methods with full matching were used to balance differences in baseline characteristics in estimating an average treatment effect, with a sensitivity analysis estimating the average treatment effect among the treated. RESULTS:Among 603 participants, 118 (19.6%) were classified as likely having Long COVID before or during pregnancy. Participants classified as likely having Long COVID were more likely to have specific adverse social determinants of health (difficulty covering expenses and paying bills, food insecurity, missed care because of cost, medical discrimination) and had higher prepregnancy body mass index (BMI) than those who were classified as having Long COVID-indeterminate. In the primary average treatment effect analysis, there was no association between likely Long COVID and preterm delivery (adjusted outcome rate 8.1% exposed vs 9.6% unexposed, absolute risk reduction [ARR] 0.82, 95% CI, 0.36-1.90) or secondary outcomes. In average treatment effect among the treated sensitivity analyses, likely Long COVID was similarly not associated with preterm delivery (ARR 1.11, 95% CI, 0.60-2.06) but was associated with an increased risk of hypertensive disorders of pregnancy (adjusted outcome rate 39.0% exposed vs 25.9% unexposed, ARR 1.51, 95% CI, 1.12-2.03) but not with other secondary outcomes. CONCLUSION:A classification of likely Long COVID was not significantly associated with preterm birth or several other adverse pregnancy outcomes. However, the association with hypertensive disorders of pregnancy in the average treatment effect among the treated analysis highlights the need for further research.

OBJECTIVE:To assess associations between exposure to intrauterine SARS-CoV-2 and subsequent child neurodevelopment in a large, diverse cohort with confirmation of maternal SARS-CoV-2 status. STUDY DESIGN:The Researching COVID to Enhance Recovery (RECOVER) Pregnancy Cohort enrolled adults with and without SARS-CoV-2 during pregnancy and their offspring born January 2020 through December 2023 at 23 sites across the US. Neurodevelopment was assessed at 12 months with the Ages & Stages Questionnaire, 3rd edition (ASQ-3) and at 18 months with the ASQ Social-Emotional (ASQ-SE) and the Modified Checklist for Autism in Toddlers-Revised (M-CHAT-R). We compared exposed and unexposed infants' ASQ-3 total and subdomain scores, ASQ-SE and M-CHAT-R scores, and proportions meeting published referral thresholds, using multivariable linear and logistic regression. RESULTS:Among 1179 participants enrolled, 1008 (85.5%) had exposure, with 806 (80.0%) exposed during Omicron predominance. Of those with known timing, 349 (41.4%) and 295 (35.0%) were exposed in the second and third trimesters of pregnancy, respectively. Exposure was not associated with differences in the ASQ-3 (adjusted difference -0.61, 95% CI -10.03 to 8.81) or ASQ-3 subdomains at 12 months, ASQ-SE at 18 months (adjusted difference 0.19, 95% CI -4.02 to 4.41), or M-CHAT-R scores. Findings were similar for proportions meeting referral thresholds and when stratified by variant or by trimester. CONCLUSIONS:In this multicenter cohort largely exposed since Omicron and in second or third trimester, intrauterine SARS-CoV-2 exposure was not associated with neurodevelopmental screening outcomes through 18 months of age. Further assessments of the impact of intrauterine SARS-CoV-2 on neurodevelopment beyond 18 months of age are needed.

Importance Olfactory dysfunction is common after SARS-CoV-2 infection and has been associated with cognitive loss in other conditions. Formal testing is needed to characterize the presence, severity, and patterns of olfactory dysfunction. ObjectiveTo characterize long-term olfactory dysfunction after SARS-CoV-2 infection. Design, Setting, and Participants This prospective cohort study included adults enrolled in the Researching COVID to Enhance Recovery (RECOVER)-Adult study. All those with and a random sample of those without self-reported change or loss in smell or taste were offered olfactory testing, performed at 83 sites in 35 US states and territories. Participants included 2956 enrollees with prior infection (1393 with and 1563 without self-reported change or loss) and 569 without prior infection (9 with and 560 without self-reported change or loss in taste) who underwent olfactory testing a mean (SD) of 671.6 (417.8) days after the index date. Data were collected from October 29, 2021, to June 6, 2025.ExposureSARS-CoV-2 infection.Main Outcomes and Measures Olfactory function, as defined by age- and sex-standardized performance on the University of Pennsylvania Smell Identification Test (UPSIT), a well-validated test comprising 40 unique odors. ResultsThe study included 3525 participants with a mean (SD) age of 47.6 (15.2) years; of 3520 with data available, 2548 (72.4%) were female or intersex. Among 1393 infected participants with self-reported change or loss, 1111 (79.8%) had hyposmia on the UPSIT, including 321 (23.0%) with severe microsmia or anosmia. Among 1563 infected participants without self-reported change or loss, 1031 (66.0%) had hyposmia, including 128 (8.2%) with severe microsmia or anosmia. Participants with prior infection and self-reported change or loss scored at the 16th age- and sex-standardized UPSIT percentile, compared with the 23rd and 28th percentiles for those without self-reported change or loss with and without prior known infection, respectively. Younger women had scores corresponding to lower mean age- and sex-standardized percentiles. Among participants who self-reported change or loss in smell, those with abnormal UPSIT scores more often reported cognitive problems (742 of 1111 [66.8%]) than those with normal UPSIT scores (179 of 282 [63.5%]).Conclusions and RelevanceIn this cohort study of RECOVER-Adult participants, self-reported change or loss in smell or taste was an accurate signal of verified hyposmia, but a high rate of hyposmia among those with no reported change or loss was also observed. Formal smell testing may be considered in those with prior SARS-CoV-2 infection to diagnose occult hyposmia and counsel patients about risks.

As more women are identified with BRCA genes, there has been increased attention paid to the role of risk reducing salpingo-oopherectomy (RRSO) in preventing ovarian cancer. Several studies have suggested a decrease in sexual function after RRSO that is not mitigated by hormone therapy treatment. This study is the first to prospectively study women over time from diagnosis, including those who chose whether or not to proceed with RRSO, and changes in sexual function. To determine the effects of RRSO vs ovarian conservation on sexual health in BRCA patients. This was a prospective study of 100 women with BRCA, 99 of whom filled out the Sexual Health outcomes in women survey tool, which assess sexual function even in non sexual active women and in those who have undergone a surgical procedure. Women were recruited after a BRCA diagnosis and categorized according to planned RRSO or ovarian conversation (non RRSO). They were followed for 5 years, completing surveys every 6 months. One hundred women completed this study, with 40 women planning RRSO at the beginning of the study and another 28 who underwent an RRSO during the study period. Over the course of 60 months, women who underwent RRSO were found to have lower sexual functioning scores at baseline in terms of sexual satisfaction and pelvic problem interface. Across all 60 months in the crossover analysis, every measure of sexual function was lower in the RRSO group, and this was not predicted by depression, hormone use, menopausal symptoms or other confounders. The lower sexual function appears to be explained by a lower baseline sexual function and not due to the surgery. This study is not consistent with previous research showing decreased sexual function after RRSO regardless of mental and physical health status and is the first of its kind to prospective study women with BRCA over time, starting prior to any RRSO and hormone therapy. These findings can be useful to providers and patients in understanding the effects of surgery and are reassuring that sexual function may in fact not be worsened by surgery. No.

ImportanceA substantial number of individuals worldwide experience long COVID, or post-COVID condition. Other postviral and autoimmune conditions have a female predominance, but whether the same is true for long COVID, especially within different subgroups, is uncertain.ObjectiveTo evaluate sex differences in the risk of developing long COVID among adults with SARS-CoV-2 infection.Design, Setting, and ParticipantsThis cohort study used data from the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER)–Adult cohort, which consists of individuals enrolled in and prospectively followed up at 83 sites in 33 US states plus Washington, DC, and Puerto Rico. Data were examined from all participants enrolled between October 29, 2021, and July 5, 2024, who had a qualifying study visit 6 months or more after their initial SARS-CoV-2 infection.ExposureSelf-reported sex (male, female) assigned at birth.Main Outcomes and MeasuresDevelopment of long COVID, measured using a self-reported symptom-based questionnaire and scoring guideline at the first study visit that occurred at least 6 months after infection. Propensity score matching was used to estimate risk ratios (RRs) and risk differences (95% CIs). The full model included demographic and clinical characteristics and social determinants of health, and the reduced model included only age, race, and ethnicity.ResultsAmong 12 276 participants who had experienced SARS-CoV-2 infection (8969 [73%] female; mean [SD] age at infection, 46 [15] years), female sex was associated with higher risk of long COVID in the primary full (RR, 1.31; 95% CI, 1.06-1.62) and reduced (RR, 1.44; 95% CI, 1.17-1.77) models. This finding was observed across all age groups except 18 to 39 years (RR, 1.04; 95% CI, 0.72-1.49). Female sex was associated with significantly higher overall long COVID risk when the analysis was restricted to nonpregnant participants (RR, 1.50; 95%: CI, 1.27-1.77). Among participants aged 40 to 54 years, the risk ratio was 1.42 (95% CI, 0.99-2.03) in menopausal female participants and 1.45 (95% CI, 1.15-1.83) in nonmenopausal female participants compared with male participants.Conclusions and RelevanceIn this prospective cohort study of the NIH RECOVER-Adult cohort, female sex was associated with an increased risk of long COVID compared with male sex, and this association was age, pregnancy, and menopausal status dependent. These findings highlight the need to identify biological mechanisms contributing to sex specificity to facilitate risk stratification, targeted drug development, and improved management of long COVID.

Introduction and HypothesisUterine leiomyomata are widely believed to contribute to lower urinary tract symptoms in women, but it is unclear whether leiomyoma size, position, and location have important implications for these symptoms. We assessed whether greater leiomyoma volume, anterior position, and subserosal location were associated with urinary incontinence and frequent urination in a racially diverse, nationwide sample of premenopausal women in the USA.MethodsA cross-sectional analysis of 477 premenopausal women from 12 USA sites undergoing evaluation for laparoscopic radiofrequency ablation or myomectomy for leiomyomata was carried out. Multivariable logistic regression models examined associations between leiomyoma volume, position, and location documented in clinical imaging reports and participant-reported urinary incontinence and distressing urination frequency, adjusting for age, race, parity, and body mass index.ResultsAmong the 477 participants, 27.9% reported at least weekly incontinence, 72.8% distressing daytime urination frequency, and 63.4% frequent night-time urination. Greater total leiomyoma volume was associated with at least weekly incontinence of any type (OR 1.05, 95% CI 1.02-1.07, per 20-ml increase) and at least weekly stress-predominant incontinence (OR 1.04, 95% CI 1.01-1.07, per 20-ml increase), but not distressing daytime or night-time urination frequency. Although subserosal leiomyoma position was associated with a 2.01-fold (95% CI 1.14-3.56) greater odds of frequent night-time urination, no significant associations between leiomyomata location or position and incontinence were detected.ConclusionIn this multicenter sample of women seeking treatment for symptomatic leiomyomata, greater leiomyomata volume was associated with weekly any-type and stress-type incontinence, but leiomyoma position and location were not independently associated with urinary incontinence.

BACKGROUND:Accurate assessment of heavy menstrual bleeding is necessary to determine effectiveness of therapeutic interventions. There are limited quantitative methods for evaluating heavy menstrual bleeding, as the validated alkaline hematin method has practical limitations, so alternative methods are needed. OBJECTIVE:To evaluate the correlation between self-reported heavy menstrual bleeding, pad usage, and menstrual blood loss measured using the alkaline hematin method. STUDY DESIGN:In this multicenter, prospective cohort study, 79 participants aged 18-50 years, who self-reported heavy menstrual bleeding, were recruited from February to November 2023. Participants provided demographic and medical history details and used study-provided pads during one menstrual cycle. Study outcomes were number of pads used per cycle and quantified menstrual blood loss measured using the alkaline hematin method. Data were analyzed using descriptive statistics. RESULTS:The median menstrual blood loss per cycle was 66.1 mL (IQR 28.7-122.5 mL), with only 25.3 % (20/79) of participants exceeding the heavy menstrual bleeding threshold of 120 mL. Participants with heavy menstrual bleeding used a median of 21.5 pads per cycle (IQR 15.8-25.3 pads) while those with normal menstrual blood loss only used 11 pads per cycle (IQR 8-15 pads). CONCLUSION:This study found a discrepancy between self-reported and objectively measured heavy menstrual bleeding. Heavy menstrual bleeding is associated with greater pad usage per cycle, however there is overlap in pad usage between participants with normal and heavy menstrual bleeding. Accurate quantification of menstrual blood is crucial for clinical management and research, as self-reported measures may not reliably identify heavy menstrual bleeding.

OBJECTIVE:To evaluate whether the risk of long COVID among individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy differs from that of individuals who were not pregnant at time of virus acquisition.METHODS:We conducted a multicenter observational cohort study at 79 NIH RECOVER (Researching COVID to Enhance Recovery) sites. Individuals assigned female at birth aged 18-45 years with an index (first) SARS-CoV-2 infection on or after December 1, 2021, were included. The exposure was pregnancy (any gestational age) at the time of index SARS-CoV-2 infection. The primary outcome was long COVID 6 months after index infection, defined as RECOVER-Adult Long COVID Research Index score 11 or higher based on a detailed symptom survey. To account for confounding and differential selection between participants who were pregnant and not pregnant at infection, propensity score-matching methods were used to balance the groups on variables potentially associated with both pregnancy status and long COVID.RESULTS:Overall 2,423 participants were included; 580 (23.9%) were pregnant at index SARS-CoV-2 infection. The median age at infection was 33 years (interquartile range 28-38 years), and 2,131 of participants (90.0%) with known vaccination status were vaccinated. After propensity score matching, the adjusted long COVID prevalence estimates 6 months after index infection were 10.2% (95% CI, 6.2-14.3%) among those pregnant at infection and 10.6% (95% CI, 8.8-12.4%) among those not pregnant at infection. Pregnancy was not associated with a difference in adjusted risk of long COVID (adjusted risk ratio 0.96, 95% CI, 0.63-1.48).CONCLUSION:Acquisition of SARS-CoV-2 during pregnancy was not associated with a differential risk of long COVID at 6 months compared with similar-aged individuals who acquired SARS-CoV-2 outside of pregnancy.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3–61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1–70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7–64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0–78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT0210094.

Abstract Introduction There is no study assessing the changes in sexual health after risk reducing oopherectomy in premenopausal women. Objective Objective: To evaluate the effect of risk-reducing salpingo-oophorectomy (RRSO) on change in sexual function in women aged 34-50 years with pathogenic variants in BRCA1 or BRCA2 (BRCA1/2). Methods Methods: The PROSper (Prospective Research of Outcomes after Salpingo-oophorectomy) study is a prospective cohort of women aged 34-50 years with BRCA1 or two germline pathogenic variants that compares health outcomes after RRSO to a non-RRSO control group with ovarian conservation. Women aged 34-50 years, who were planning either RRSO or ovarian conservation, were enrolled for 3 years of follow-up. Sexual Function was measured using the Sexual Health Outcomes in Women (SHOW-Q) a validated survey tool that measures sexual desire, frequency, satisfaction, orgasm, and discomfort specifically in patients with a history of a pelvic condition, including oophorectomy. Differences in sexual function between the RRSO and non-RRSO groups, were determined by using mixed effects multivariable linear regression models. Results Results: Of 100 PROSper participants, all completed SHOW Q. At baseline patients who had undergone RRSO before enrollment had lower SHOW-Q scores (71 vs 64). Across all 60 months of the study the SHOW-Q scores remained persistently lower in those undergoing RRSO raging from 6-13 points across the time studied (p <0.05) controlling for age, depression, partner, menopausal symptoms and hormone therapy Conclusions Conclusion: Women with pathogenic variants in BRCA1/2 who undergo RRSO before the age of 50 years have greater effects on sexual function than those that do not. The detrimental effect of rRRSO is not otherwise explained by hormone therapy, depression or menopausal symptoms. This information should be incorporated into counseling and post op management to consider options to improve sexual health post surgery Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: sprout pharma.

Background Pregnant people are vulnerable to new or worsening mental health conditions. This study aims to describe prevalence and course of depression and anxiety symptoms in pregnancy during the pre-vaccine COVID-19 pandemic. Methods This is a prospective cohort study of pregnant individuals with known or suspected COVID-19. Participants completed Edinburgh Postnatal Depression Scale (EPDS) and Generalized-Anxiety Disorder-7 (GAD-7) questionnaires, screening tools for depression and anxiety, at 34weeks gestational age, 6-8weeks postpartum, and 6months postpartum. Prevalence of elevated depressive and anxiety symptoms at each visit was described. Univariable logistic regression analysis was used to determine the association between demographic and clinical factors and those with elevated depression or anxiety symptoms. Results 317 participants were included. The prevalence of elevated antepartum depression symptoms was 14.6%, 10.3%, and 20.6% at 34weeks gestational age, 6-8weeks postpartum, and 6months postpartum, respectively. The rate of elevated anxiety symptoms was 15.1%, 10.0%, and 17.3% at 34weeks gestational age, 6-8weeks postpartum, and 6months postpartum, respectively. A prior history of depression and/or anxiety (p's < 0.03), as well as higher EPDS and GAD-7 scores at enrollment (p's < 0.04) associated with elevated depression and anxiety symptoms throughout pregnancy and the postpartum period. Quarantining during pregnancy was associated with elevated anxiety symptoms at 34weeks gestational age in univariate (P = 0.027) analyses. COVID-19 diagnosis and hospitalization were not associated with elevated depression or anxiety symptoms. Conclusions Elevated depression and anxiety symptoms were prevalent throughout pregnancy and the postpartum period, particularly in those with prior depression and/or anxiety and who quarantined. Strategies that target social isolation may mitigate potential adverse consequences for pregnant people, and continued vigilance in recognition of depression and anxiety in pregnancy should be considered.

OBJECTIVE: To estimate the prevalence of post–acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors. METHODS: In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC. RESULTS: Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9–10.9%) measured at a median of 10.3 months (interquartile range 6.1–21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12–2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79–3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05–2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00–3.44) were associated with increased prevalence of PASC. CONCLUSION: The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT05172024.

BACKGROUND: Few studies have directly compared different surgical procedures for uterine fibroids with respect to long-term health-related quality of life outcomes and symptom improvement.OBJECTIVE: We examined differences in change from baseline to 1-, 2-, and 3-year follow-up in health-related quality of life and symptom severity among patients who underwent abdominal myomectomy, laparoscopic or robotic myomectomy, abdominal hysterectomy, laparoscopic or robotic hysterectomy, or uterine artery embolization.STUDY DESIGN: The COMPARE-UF registry is a multiinstitutional prospective observational cohort study of women undergoing treatment for uterine fibroids. A subset of 1384 women aged 31 to 45 years who underwent either abdominal myomectomy (n=237), laparoscopic myomectomy (n=272), abdominal hysterectomy (n=177), laparoscopic hysterectomy (n=522), or uterine artery embolization (n=176) were included in this analysis. We obtained demographics, fibroid history, and symptoms by questionnaires at enrollment and at 1, 2, and 3 years posttreatment. We used the UFS-QoL (Uterine Fibroid Symptom and Quality of Life) questionnaire to ascertain symptom severity and health-related quality of life scores among participants. To account for potential baseline differences across treatment groups, a propensity score model was used to derive overlap weights and compare total health-related quality of life and symptom severity scores after enrollment with a repeated measures model. For this health-related quality of life tool, a specific minimal clinically important difference has not been determined, but on the basis of previous research, a difference of 10 points was considered as a reasonable estimate. Use of this difference was agreed upon by the Steering Committee at the time when the analysis was planned.RESULTS: At baseline, women undergoing hysterectomy and uterine artery embolization reported the lowest health-related quality of life scores and highest symptom severity scores compared with those undergoing abdominal myomectomy or laparoscopic myomectomy (P<.001). Those undergoing hysterectomy and uterine artery embolization reported the longest duration of fibroid symptoms with a mean of 6.3 years (standard deviation, 6.7; P<.001). The most common fibroid symptoms were menorrhagia (75.3%), bulk symptoms (74.2%), and bloating (73.2%). More than half (54.9%) of participants reported anemia, and 9.4% women reported a history of blood transfusion. Across all modalities, total health-related quality of life and symptom severity score markedly improved from baseline to 1-year with the largest improvement in the laparoscopic hysterectomy group (Uterine Fibroids Symptom and Quality of Life: delta= [+] 49.2; symptom severity: delta= [-] 51.3). Those undergoing abdominal myomectomy, laparoscopic myomectomy, and uterine artery embolization also demonstrated significant improvement in health-related quality of life (delta= [+]43.9, [+]32.9, [+] 40.7, respectively) and symptom severity (delta= [-]41.4, [-] 31.5, [-] 38.5, respectively) at 1 year, and the improvement persisted from baseline for uterine-sparing procedures during second (Uterine Fibroids Symptom and Quality of Life: delta= [+]40.7, [+]37.4, [+]39.3 SS: delta= [-] 38.5, [-] 32.0, [-] 37.7 and third year (Uterine Fibroids Symptom and Quality of Life: delta= [+] 40.9, [+]39.9, [+]41.1 and SS: delta= [-] 33.9, [-]36.5, [-] 33.0, respectively), posttreatment intervals, however with a trend toward decline in degree of improvement from years 1 and 2. Differences from baseline were greatest for hysterectomy; however, this may reflect the relative importance of bleeding in the Uterine Fibroids Symptom and Quality of Life, rather than clinically meaningful symptom recurrence among women undergoing uterus-sparing treatments.CONCLUSION: All treatment modalities were associated with significant improvements in health-related quality of life and symptom severity reduction 1-year posttreatment. However, abdominal myomectomy, laparoscopic myomectomy and uterine artery embolization indicated a gradual decline in symptom improvement and health-related quality of life by third year after the procedure.

IMPORTANCE:Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS:RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION:RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER:Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

Significant bone loss occurs after risk-reducing salpingo-oophorectomy at age 34–50 years that has the potential to be mitigated by use of hormonal therapy. OBJECTIVE: To evaluate the effect of risk-reducing salpingo-oophorectomy (RRSO) on change in bone mineral density (BMD) in women aged 34–50 years with pathogenic variants in BRCA1 or BRCA2 (BRCA1/2). METHODS: The PROSper (Prospective Research of Outcomes after Salpingo-oophorectomy) study is a prospective cohort of women aged 34–50 years with BRCA1 or two germline pathogenic variants that compares health outcomes after RRSO to a non-RRSO control group with ovarian conservation. Women aged 34–50 years, who were planning either RRSO or ovarian conservation, were enrolled for 3 years of follow-up. Spine and total hip BMD were measured by dual-energy X-ray absorptiometry (DXA) scans obtained at baseline before RRSO or at the time of enrollment for the non-RRSO group, and then at 1 and 3 years of study follow-up. Differences in BMD between the RRSO and non-RRSO groups, as well as the association between hormone use and BMD, were determined by using mixed effects multivariable linear regression models. RESULTS: Of 100 PROSper participants, 91 obtained DXA scans (RRSO group: 40; non-RRSO group: 51). Overall, total spine, and hip BMD decreased significantly from baseline to 12 months after RRSO (estimated percent change −3.78%, 95% CI −6.13% to −1.43% for total spine; −2.96%, 95% CI −4.79% to −1.14% for total hip) and at 36 months (estimated percent change −5.71%, 95% CI −8.64% to −2.77% for total spine; −5.19%, 95% CI −7.50% to −2.87% for total hip. In contrast, total spine and hip BMD were not significantly different from baseline for the non-RRSO group. The differences in mean percent change in BMD from baseline between the RRSO and non-RRSO groups were statistically significant at both 12 and 36 months for spine BMD (12-month difference −4.49%, 95% CI −7.67% to −1.31%; 36-month difference −7.06%, 95% CI −11.01% to −3.11%) and at 36 months for total hip BMD (12-month difference −1.83%, 95% CI −4.23% to 0.56%; 36-month difference −5.14%, 95% CI −8.11% to −2.16%). Across the study periods, hormone use was associated with significantly less bone loss at both the spine and hip within the RRSO group compared with no hormone use (P<.001 at both 12 months and 36 months) but did not completely prevent bone loss (estimated percent change from baseline at 36 months −2.79%, 95% CI −5.08% to −0.51% for total spine BMD; −3.93%, 95% CI −7.27% to −0.59% for total hip BMD). CONCLUSION: Women with pathogenic variants in BRCA1/2 who undergo RRSO before the age of 50 years have greater bone loss after surgery that is clinically significant when compared with those who retain their ovaries. Hormone use mitigates, but does not eliminate, bone loss after RRSO. These results suggest that women who undergo RRSO may benefit from routine screening for BMD changes to identify opportunities for prevention and treatment of bone loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01948609.

Objective: The aim of this study is to examine complementary and alternative medicine (CAM) use among women with symptomatic uterine fibroids in the United States. Materials and Methods: In this cross-sectional analysis of baseline data from a multicenter, prospective cohort study of premenopausal women undergoing surgery for symptomatic fibroids and who enrolled in the Uterine Leiomyoma Treatment with Radiofrequency Ablation study from 2017 to 2019, we contrast women indicating use of at least one CAM modality specifically for fibroid symptoms against women using CAM for other reasons and CAM nonusers. Multivariable logistic regression models were performed to identify participant characteristics independently associated with CAM use for fibroids. Results: Among 204 women, 55% were Black/African American and the mean age was 42 (standard deviation 6.6) years. CAM use was common (67%), with 42% (95% confidence interval [CI]: 35%-49%) reporting use of CAM specifically to treat fibroid symptoms. Most commonly, CAM treatments used for fibroids were diet (62%) and herbs (52%), while CAM treatments for other reasons were exercise (80%) and massage (43%). On average, each participant who reported CAM use utilized three different types of CAM modalities. In a multivariable model, participants were more likely to use CAM for fibroids if they had pelvic pressure (odds ratio [OR] 2.50, 95% CI: 1.07-5.87, p = 0.04), a body-mass index lower than average (OR 0.76, 95% CI: 0.60-0.97, p = 0.03), and a lower health-related quality of life score (OR 0.61, 95% CI: 0.46-0.81, p = 0.001). Conclusions: In this diverse sample of women with symptomatic fibroids, CAM use was highly prevalent. Our findings highlight the need for providers to query patients about CAM use and understand the role of CAM in fibroid management. ClinicalTrials.gov Identifier: NCT02100904.

Despite strong evidence of their effectiveness in reducing symptoms of posttraumatic stress disorder (PTSD), prolonged exposure therapy (PE) and cognitive processing therapy (CPT) remain challenging for some service members and veterans to access and complete. Delivering PE and CPT in time-condensed or "massed" formats may reduce barriers to receiving care. PE and CPT have now been implemented across a range of tempos (e.g., multiple sessions per day across 1 week, one session per day for 3 weeks) and to multiple target populations, in a variety of contexts from individual therapy alone to full intensive outpatient programs. A massed format of treatment delivery has advantages for both patients and providers, including quicker time to recovery, less opportunity for avoidance, and improved treatment completion rates. The time-limited nature of massed treatment also creates accompanying challenges, such as less time to practice homework and greater impact when factors delay or disrupt progress. This paper discusses lessons learned from providers across diverse settings who are experienced in both delivering massed PE and CPT and managing such programs, primarily with military populations.