A randomized trial comparing the 52-mg levonorgestrel system with combination oral contraceptives for treatment of heavy menstrual bleeding.

BACKGROUND: The levonorgestrel intrauterine system and combined oral contraceptives are the 2 most commonly used nonsurgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life. OBJECTIVE: This study aimed to compare the effectiveness of the 52-mg levonorgestrel intrauterine system with that of combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 and 12 months after treatment. STUDY DESIGN: We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a nonstructural cause of heavy menstrual bleeding. Eligible and consenting participants were randomly assigned in a 1:1 ratio to receive a 52-mg levonorgestrel intrauterine system or a monophasic 30- or 35-µg ethinyl estradiol-containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range, 0-75) at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed-effects regression; 24 participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the levonorgestrel intrauterine system and those treated with combined oral contraceptives at each follow-up time point. RESULTS: A total of 62 individuals were randomly assigned to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses; 19 of 29 received the levonorgestrel intrauterine system and 31 of 33 received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar among study groups. Bleeding-related quality of life increased in both study arms, as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6-week follow-up. In the main intention-to-treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=-2.5; 95% confidence interval, -10.0 to +5.0) or 12 months (difference=-1.1; 95% confidence interval, -8.7 to +6.5). Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was observed in the levonorgestrel intrauterine system arm at 6 months after treatment (difference=-7.0; 95% confidence interval, -13.8 to -0.2) but not at 12 months (difference=-4.8; 95% confidence interval, -11.8 to 2.3) compared with the combined oral contraceptive arm. CONCLUSION: No differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life.

Impact of coronavirus disease 2019 (COVID-19) vaccination on menstrual bleeding quantity: An observational cohort study.

OBJECTIVE: To assess whether coronavirus disease 2019 (COVID-19) vaccination impacts menstrual bleeding quantity. DESIGN: Retrospective cohort. SETTING: Five global regions. POPULATION: Vaccinated and unvaccinated individuals with regular menstrual cycles using the digital fertility-awareness application Natural Cycles°. METHODS: We used prospectively collected menstrual cycle data, multivariable longitudinal Poisson generalised estimating equation (GEE) models and multivariable multinomial logistic regression models to calculate the adjusted difference between vaccination groups. All regression models were adjusted for confounding factors. MAIN OUTCOME MEASURES: The mean number of heavy bleeding days (fewer, no change or more) and changes in bleeding quantity (less, no change or more) at three time points (first dose, second dose and post-exposure menses). RESULTS: We included 9555 individuals (7401 vaccinated and 2154 unvaccinated). About two-thirds of individuals reported no change in the number of heavy bleeding days, regardless of vaccination status. After adjusting for confounding factors, there were no significant differences in the number of heavy bleeding days by vaccination status. A larger proportion of vaccinated individuals experienced an increase in total bleeding quantity (34.5% unvaccinated, 38.4% vaccinated; adjusted difference 4.0%, 99.2% CI 0.7%-7.2%). This translates to an estimated 40 additional people per 1000 individuals with normal menstrual cycles who experience a greater total bleeding quantity following the first vaccine dose' suffice. Differences resolved in the cycle post-exposure. CONCLUSIONS: A small increase in the probability of greater total bleeding quantity occurred following the first COVID-19 vaccine dose, which resolved in the cycle after the post-vaccination cycle. The total number of heavy bleeding days did not differ by vaccination status. Our findings can reassure the public that any changes are small and transient.

Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set.

OBJECTIVE: To develop a core outcome set for heavy menstrual bleeding (HMB). DESIGN: Core outcome set (COS) development methodology described by the COMET initiative. SETTING: University hospital gynaecology department, online international survey and web-based international consensus meetings. POPULATION OR SAMPLE: An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents. METHODS: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. MAIN OUTCOME MEASURES: Outcome importance was assessed in the Delphi survey on a 9-point scale. RESULTS: From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. CONCLUSIONS: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy.

Menstruation: science and society.

Women's health concerns are generally underrepresented in basic and translational research, but reproductive health in particular has been hampered by a lack of understanding of basic uterine and menstrual physiology. Menstrual health is an integral part of overall health because between menarche and menopause, most women menstruate. Yet for tens of millions of women around the world, menstruation regularly and often catastrophically disrupts their physical, mental, and social well-being. Enhancing our understanding of the underlying phenomena involved in menstruation, abnormal uterine bleeding, and other menstruation-related disorders will move us closer to the goal of personalized care. Furthermore, a deeper mechanistic understanding of menstruation-a fast, scarless healing process in healthy individuals-will likely yield insights into a myriad of other diseases involving regulation of vascular function locally and systemically. We also recognize that many women now delay pregnancy and that there is an increasing desire for fertility and uterine preservation. In September 2018, the Gynecologic Health and Disease Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development convened a 2-day meeting, "Menstruation: Science and Society" with an aim to "identify gaps and opportunities in menstruation science and to raise awareness of the need for more research in this field." Experts in fields ranging from the evolutionary role of menstruation to basic endometrial biology (including omic analysis of the endometrium, stem cells and tissue engineering of the endometrium, endometrial microbiome, and abnormal uterine bleeding and fibroids) and translational medicine (imaging and sampling modalities, patient-focused analysis of menstrual disorders including abnormal uterine bleeding, smart technologies or applications and mobile health platforms) to societal challenges in health literacy and dissemination frameworks across different economic and cultural landscapes shared current state-of-the-art and future vision, incorporating the patient voice at the launch of the meeting. Here, we provide an enhanced meeting report with extensive up-to-date (as of submission) context, capturing the spectrum from how the basic processes of menstruation commence in response to progesterone withdrawal, through the role of tissue-resident and circulating stem and progenitor cells in monthly regeneration-and current gaps in knowledge on how dysregulation leads to abnormal uterine bleeding and other menstruation-related disorders such as adenomyosis, endometriosis, and fibroids-to the clinical challenges in diagnostics, treatment, and patient and societal education. We conclude with an overview of how the global agenda concerning menstruation, and specifically menstrual health and hygiene, are gaining momentum, ranging from increasing investment in addressing menstruation-related barriers facing girls in schools in low- to middle-income countries to the more recent "menstrual equity" and "period poverty" movements spreading across high-income countries.

Chronic opioid use in women following hysterectomy: Patterns and predictors.

BACKGROUND: Most women are prescribed an opioid after hysterectomy. The goal of this study was to determine the association between initial opioid prescribing characteristics and chronic opioid use after hysterectomy. METHODS: This study included women enrolled in a commercial health plan who had a hysterectomy between 1 July 2010 and 31 March 2015. We used trajectory models to define chronic opioid use as patients with the highest probability of having an opioid prescription filled during the 6 months post-surgery. A multivariable logistic regression was applied to examine the association between initial opioid dispensing (amount prescribed and duration of treatment) and chronic opioid use after adjusting for potential confounders. RESULTS: A total of 693 of 50 127 (1.38%) opioid-naïve women met the criteria for chronic opioid use following hysterectomy. The baseline variables and initial opioid prescription characteristics predicted the pattern of long-term opioid use with moderate discrimination (c statistic = 0.70). Significant predictors of chronic opioid use included initial opioid daily dose (≥60 MME vs <40 MME, aOR: 1.43, 95% CI: 1.14-1.79) and days' supply (4-7 days vs 1-3 days, aOR: 1.28, 95% CI: 1.06-1.54; ≥8 days vs 1-3 days, aOR: 1.41, 95% CI: 1.05-1.89). Other significant baseline predictors included older age, abdominal or laparoscopic/robotic hysterectomy, tobacco use, psychiatric medication use, back pain, and headache. CONCLUSION: Initial opioid prescribing characteristics are associated with the risk of chronic opioid use after hysterectomy. Prescribing lower daily doses and shorter days' supply of opioids to women after hysterectomy may result in lower risk of chronic opioid use.

Characteristics of women without a postpartum checkup among PRAMS participants, 2009-2011.

Introduction For uncomplicated pregnancies in the United States, a healthcare visit 4 to 6 weeks postpartum is recommended to assess a woman's mental, social, and physical health. We studied whether sociodemographic characteristics and pregnancy and delivery factors were related to the likelihood of missing a postpartum checkup. Methods We conducted a cross-sectional analysis of 64,952 women who completed the United States Centers for Disease Control Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 6 survey in 2009-2011 from 17 states and New York City that included a Yes/No question about receiving a maternal postpartum checkup. We calculated risk ratios (RR) with 95% confidence intervals (CI) to assess the association between maternal factors and lack of a postpartum checkup. Results Compared to women who attended a postpartum checkup (89.4%), women who missed the visit (10.6%) were younger, unmarried, less educated, with lower income, without insurance, and smokers (all p < 0.05). Compared to women with adequate prenatal care, women with intermediate (RR 1.79 (95% CI 1.70-1.88)) or inadequate (RR 2.71 (95% CI 2.53-2.91)) care were more likely to miss the checkup. Women were more likely to miss this checkup if their infant was born at a residence compared to a hospital (RR 2.27 (95% CI 1.71-3.01)), and were less likely to miss the checkup if their newborn had a 1-week well visit (RR 0.70 (95% CI 0.61-0.81)). Discussion Sociodemographic factors and noncompliance with other medical care were associated with missing a postpartum checkup. Women with a high-risk of not attending a postpartum visit should be targeted for interventions to increase their accessibility to care.

Prenatal depression screening and antidepressant prescription: obstetrician-gynecologists' practices, opinions, and interpretation of evidence.

Obstetrician-gynecologists (ob-gyns) are well-positioned to detect symptoms of perinatal depression; however, little is known about how ob-gyns respond. The purpose of this study was to evaluate ob-gyns' beliefs and practices related to prenatal depression screening and antidepressant prescription during pregnancy. A larger survey on prenatal medication was developed at the American College of Obstetricians and Gynecologists (ACOG) and distributed to a sample of 1000 Fellows. The overall response rate was 37.9% (N = 379). Two hundred eighty-eight provided care to pregnant patients and therefore, responded to questions on prenatal depression screening and antidepressant prescription. Most ob-gyns (87.8%) routinely screened patients for depression at least once during pregnancy. When symptoms of depression were reported, 52.1% "sometimes" prescribed an antidepressant medication with 22.5% doing so "usually or always". While 84.0% prescribed selective serotonin reuptake inhibitors (SSRIs) to pregnant patients, only 31.9% prescribed non-SSRIs. Ob-gyns felt comfortable prescribing SSRIs (78.1%) and counseled patients that the benefits of treating depression pharmacologically outweigh the risks (83.0%), and the use of SSRIs during pregnancy is relatively safe (87.5%). Prescribing SSRIs to pregnant patients was not significantly associated with interpretation of evidence on fetal and neonatal outcomes. Findings suggest most ob-gyns in the USA at least sometimes prescribe antidepressants in response to patient reports of depression symptoms during pregnancy. Mixed interpretations of evidence regarding the effects of SSRIs on fetal and neonatal outcomes reflect a critical need for high-quality safety data upon which to base treatment recommendations.

Nonurgent and urgent emergency department use during pregnancy: an observational study.

BACKGROUND: Emergency department use is common among pregnant women. Nonurgent emergency department use may represent care that would be better provided by an established obstetric provider in an ambulatory setting. OBJECTIVE: The objective of the study was to identify sociodemographic factors associated with nonurgent emergency department use in pregnancy. STUDY DESIGN: This is a cross-sectional study of women recruited during their postpartum hospitalization. Data regarding prenatal care and emergency department visits were collected from medical records; participants completed a survey with questions regarding demographics and emergency department use. Urgency of an emergency department visit was prespecified based on a priori criteria abstracted from medical record review. Women with any nonurgent emergency department use were compared with women without nonurgent emergency department use. Logistic regression was performed to identify factors associated with nonurgent emergency department use. RESULTS: Two hundred thirty-three women participated in this study; 197 (84%) received care in the emergency department during pregnancy. Eighty-three women (35.6%) had at least 1 visit to the emergency department that was nonurgent. In a regression analysis, the increased odds of nonurgent emergency department use was associated with a preferred language other than English (odds ratio, 2.02; 95% confidence interval,1.01-4.05) and lack of private insurance (odds ratio, 5.55; 95% confidence interval, 2.54-12.12). The 2 most common reasons for presentation to the emergency department were concern that there was an emergency (45%) or being referred by a health care provider (36%). CONCLUSION: Women frequently use the emergency department during pregnancy, including visits for nonurgent indications. Identifying risk factors for nonurgent emergency department use in pregnancy is important for identifying women likely to use the emergency department, including for nonurgent visits, and the development of strategies to decrease nonurgent emergency department utilization in pregnancy.

Sexual Behavior and Contraceptive Use at Brown University: 1975-2011.

OBJECTIVE: To assess sexual behaviors and contraceptive use in a sample of Brown University students. STUDY DESIGN: A total of 255 undergraduate students responded to an anonymous online survey in May 2011. The survey addressed level of sexual activity, behaviors, and contraceptive use. Female responders were compared to results from surveys conducted in 1975, 1986, 1989, and 1995. RESULTS: Of the surveyed undergraduates 62% were sexually active. Sexual activity among women was similar to that of previous survey years. Contraceptive pills were the most common primary contraceptive method, reported by 59% of students, and 32% used dual method contraceptive use for sexually transmitted disease (STD) and pregnancy prevention. We observed a plateau in condom use among women in 2011 after an increase from 1975-1995. Use of long-acting reversible contraception (LARC) was uncommon (3%). CONCLUSION: Educational efforts should emphasize the effectiveness of LARC and dual method contraceptive use to reduce the risk of STDs and unintended pregnancies.

Comparison of antiemetics for nausea and vomiting of pregnancy in an emergency department setting.

OBJECTIVE: To compare time from medication administration to disposition from the Emergency Department (ED) between women treated for nausea and vomiting of pregnancy with different antiemetic agents. DESIGN: We performed a retrospective cohort study of women 13 weeks gestation or less treated in our Women and Infants Hospital ED for nausea and vomiting of pregnancy between 2009 and 2011. Data was collected on patient demographics, antiemetics used, and time to disposition. We analyzed time of administration of the antiemetic used first line (ondansetron versus metoclopramide versus promethazine or prochlorperazine) to time the discharge order was placed. RESULTS: We analyzed data from 439 women treated in the ED for nausea and vomiting of pregnancy. Forty-four percent received ondansetron alone, 47% received any other antiemetic alone, and 9% received more than one agent first line. Antiemetic agent selected did not differ by patient age, parity, current treatment for nausea and vomiting in pregnancy, orthostatics, ketonuria or disposition. We found no difference in time from medication administration to disposition between women who received ondansetron and women who received any other antiemetic (metoclopramide, prochlorperazine or promethazine). Adjusting for potential confounders, compared to patients who received any other first line therapy, patients who received ondansetron had 2.09 times the odds of having a time to disposition at or above the 75th percentile (95% CI 1.31-3.34). CONCLUSIONS: The use of ondansetron in the ED for nausea and vomiting of pregnancy was associated with similar mean time from administration to disposition as other antiemetics.

Preoperative uterine bleeding pattern and risk of endometrial ablation failure.

OBJECTIVE: The objectives of the study were to compare among women who had an endometrial ablation the risks of treatment failure and subsequent gynecological procedures between women with regular and irregular heavy uterine bleeding and to determine other characteristics associated with the risk of treatment failure. STUDY DESIGN: This study was a retrospective cohort of 968 women who underwent endometrial ablation between January 2007 and July 2009. Preoperative bleeding pattern was categorized as regular or irregular. Treatment failure was defined as reablation or hysterectomy. Subsequent gynecological procedures included endometrial biopsy, dilation and curettage, hysteroscopy, reablation, or hysterectomy. We calculated the odds of treatment failure and gynecological procedures using multiple logistic regression. RESULTS: Bleeding pattern prior to ablation was heavy and regular in 30% (n = 293), heavy and irregular in 36% (n = 352), and unspecified in 30% (n = 286). We found no differences in treatment failure (13% vs 12%, P = .9) or subsequent procedures (16% vs 18%, P = .7) between women with regular and irregular bleeding. Compared with the women with regular bleeding, the women with irregular bleeding were not at increased odds of treatment failure or subsequent procedures (odds ratio [OR], 1.07; 95% confidence interval [CI], 0.65-1.74 and OR, 1.17; 95% CI, 0.76-1.80, respectively). Factors associated with an increased odds of treatment failure and subsequent procedures included tubal ligation (OR, 1.94; 95% CI, 1.30-2.91 and OR, 1.71; 95% CI, 1.20-2.43, respectively); dysmenorrhea (OR, 2.42; 95% CI, 1.44-4.06 and OR, 1.93; 95% CI, 1.20-3.13, respectively); and obesity (OR, 1.82; 95% CI, 1.21-2.73 and OR, 1.75; 95% CI, 1.22-2.50, respectively). CONCLUSION: Preoperative bleeding pattern did not appear to affect failure rates or the need for gynecological procedures after endometrial ablation. Other risk factors for ablation failure identified included preoperative dysmenorrhea, prior tubal ligation, and obesity.

Postinterview communication with residency applicants: a call for clarity!

The residency match is an increasingly competitive process. Communication from medical student applicants to programs varies, and the effect this has on their rank status is unclear. We assessed how obstetrics and gynecology program directors interpret and act on postinterview communication initiated by applicants by conducting an anonymous cross-sectional web-based survey of allopathic obstetrics and gynecology program directors. One hundred thirty-seven program directors (55%) responded to the survey. Twenty-nine percent would consider ranking an applicant more favorably if the applicant expressed interest (beyond a routine thank you) or if a faculty mentor personally known to the program director stated that the applicant was ranking the program first. Fifty-two percent indicated that they would rank an applicant more favorably if a mentor known to them endorsed the applicant as outstanding. Approximately 30% responded that applicants who did not communicate with their program were disadvantaged compared with those who did. Approximately 17% stated it was desirable to create additional specialty-specific guidelines regarding postinterview contact between programs and applications. Based on the wide variation in how program directors interpret and act on postinterview communication from applicants, residency programs should formulate and communicate a clear policy about whether they request and how they respond to postinterview communication from applicants and their mentors. This will establish a more level playing field and eliminate potential inequities resulting from inconsistent communication practices.

Impact of obesity on outcomes of hysterectomy.

STUDY OBJECTIVES: To evaluate the impact of obesity on complications of hysterectomy. STUDY DESIGN: Retrospective cohort study (Canadian Task Force II-2). SETTING: The Department of Obstetrics and Gynecology, Women and Infants Hospital of Rhode Island, Providence, RI. PATIENTS: Patients who had a hysterectomy at WIH between July 2006 and January 2009. INTERVENTIONS: Hysterectomy by any mode. MEASUREMENTS AND MAIN RESULTS: We collected data from medical records of all laparoscopic hysterectomies during the time period and collected data from a random subset of abdominal and vaginal hysterectomies. The independent variable, body mass index, was grouped according to World Health Organization guidelines. A composite of surgical complications was generated. Multivariable logistic regression was used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). We collected data from 907 hysterectomies, and 29.9% (n = 267) of the population was obese. Eighteen percent of patients (n = 154) had at least 1 complication. Compared to non-obese women, obese women were at increased odds of having any complication (OR 1.62, 95% CI 1.12-2-34). Performing subgroup analyses by mode of hysterectomy and controlling for confounding factors, we were unable to detect differences odds of complications between obese and non-obese women who underwent either an abdominal, vaginal, or laparoscopic hysterectomy. CONCLUSION: In our study, we found that among women who had a hysterectomy, obese women had a higher rate of complications than nonobese women.

Timing of Coronavirus Disease 2019 (COVID-19) Vaccination and Effects on Menstrual Cycle Changes.

OBJECTIVE: To assess whether menstrual cycle timing (follicular or luteal phase) of coronavirus disease 2019 (COVID-19) vaccine administration is associated with cycle length changes. METHODS: We used prospectively collected (2021-2022) menstrual cycle tracking data from 19,497 reproductive-aged users of the application "Natural Cycles." We identified whether vaccine was delivered in the follicular or luteal phase and also included an unvaccinated control group. Our primary outcome was the adjusted within-individual change in cycle length (in days) from the average of the three menstrual cycles before the first vaccination cycle (individuals in the unvaccinated control group were assigned a notional vaccine date). We also assessed cycle length changes in the second vaccination cycle and whether a clinically significant change in cycle length (8 days or more) occurred in either cycle. RESULTS: Most individuals were younger than age 35 years (80.1%) and from North America (28.6%), continental Europe (33.5%), or the United Kingdom (31.7%). In the vaccinated group, the majority received an mRNA vaccine (63.8% of the full sample). Individuals vaccinated in the follicular phase experienced an average 1-day longer adjusted cycle length with a first or second dose of COVID-19 vaccine compared with their prevaccination average (first dose: 1.00 day [98.75% CI, 0.88-1.13], second dose: 1.11 days [98.75% CI, 0.93-1.29]); those vaccinated in the luteal phase and those in the unvaccinated control group experienced no change in cycle length (respectively, first dose: -0.09 days [98.75% CI, -0.26 to 0.07], second dose: 0.06 days [98.75% CI, -0.16 to 0.29], unvaccinated notional first dose: 0.08 days [98.75% CI, -0.10 to 0.27], second dose: 0.17 days [98.75% CI, -0.04 to 0.38]). Those vaccinated during the follicular phase were also more likely to experience a clinically significant change in cycle length (8 days or more; first dose: 6.8%) than those vaccinated in the luteal phase or unvaccinated (3.3% and 5.0%, respectively; P <.001). CONCLUSION: COVID-19 vaccine-related cycle length increases are associated with receipt of vaccination in the first half of the menstrual cycle (follicular phase).

Longitudinal impact of a residency-based postplacental levonorgestrel intrauterine device insertion program: Expulsion rates in years 1, 2, and 3.

OBJECTIVE: To evaluate expulsion rates in the first 3 years of an academic postplacental levonorgestrel intrauterine device (LNG-IUD) insertion program. STUDY DESIGN: Retrospective case series, January 2016 to December 2018. We measured LNG-IUD expulsion rates by 12 weeks postpartum. RESULTS: Of 235 LNG-IUD insertions, in years 1, 2, and 3, expulsion rates were 11/39 (28%), 9/94 (10%), and 15/102 (15%) (p = 0.03). After vaginal delivery, manual insertion was associated with a higher expulsion rate than ring-forceps (10/28 [36%] vs 17/105 [16%], p = 0.04). CONCLUSIONS: LNG-IUD expulsion rates decreased after program year 1, suggesting program maturity may be associated with a lower expulsion risk.

Ectopic pregnancy after hysterectomy: a case report.

BACKGROUND: Ectopic pregnancy after hysterectomy is an unusual diagnosis that may lead to significant morbidity, especially when diagnosis is not timely. CASE: A 41-year-old woman presenting with abdominal pain and vaginal bleeding 5 years after a vaginal hysterectomy was found to have a tubal ectopic pregnancy, which required emergent surgical intervention. CONCLUSION: Ectopic pregnancy after hysterectomy represents a challenging diagnosis because it is counter-intuitive and very uncommon. The diagnosis of posthys-terectomy ectopic pregnancy, though exceptionally rare, should be considered for women presenting with abdominal pain after hysterectomy.

Investigating demographic differences in patients' decisions to consent to COVID-19 research.

OBJECTIVE: COVID-19 disease severely impacted pregnant persons, resulting in a significant increase in poor maternal health outcomes, with a disproportionate impact on minority populations and individuals with low socioeconomic status. We sought to determine demographic differences between birthing parents with SARS-CoV-2 infections who consented to research study participation versus those who declined. By analyzing demographic differences, we are able to ensure the generalizability of study outcomes and to aid in future prospective research design, with the ultimate goal of recognizing and ameliorating research disparities. METHODS: We conducted a secondary analysis to investigate demographic differences in patients who consented to versus declined study participation, in an effort to confirm the external validity of the study results and ensure minority populations most affected by SARS-CoV-2 infection were accurately represented. An IRB waiver was obtained to conduct retrospective chart review for demographic data collection of all patients approached for the COVID-19 Analysis on Perinatal Specimens Related to ExpoSure (CARES) research study. Pregnant patients with SARS-CoV-2 infection were identified at a single hospital center and approached either in person or via phone, with a translator if primary language listed as non-English. Demographic variables including race, ethnicity, primary language, and insurance type were obtained from the electronic medical record and analyzed via Chi-square to determine significant differences between individuals who consented to participation and those who declined participation. RESULTS: One hundred and fifty-eight pregnant patients with SARS-CoV-2 infection were approached for CARES study participation. Eighty-nine patients consented to study participation, while 69 declined study participation. A retrospective chart review was conducted on all 158 patients. Patients who identified as Black race or non-White race were more likely to decline participation (23.2%, p = .031, 68.1%, p = .026), compared to patients who identified as White (31.9%) (Table 1). Patients with public insurance were also more likely to decline study participation (72.5%, p = .049) compared to those with private insurance (27.5%). There was no significant difference between primary language spoken or ethnicity in patients who participated or declined. There was no difference in study participation between patients who identified as Asian race or Other race, compared to patients who identified as White race. CONCLUSIONS: We found significant differences in race and insurance type between pregnant patients with SARS-CoV-2 infection who consented versus declined research study participation. Our study showed that patients who identify as Black race or have public insurance are less likely to consent to research study participation. However, when demographics of consented patients are compared to county, state, and national demographics of female patients age 18-49 with confirmed SARS-CoV-2 infection obtained from a dataset collected by the Center for Disease Control and Prevention (CDC), there was no significant difference between race representation of patients who consented to study participation. This suggests that though the external validity of the CARES study is confirmed, more efforts need to be made to address racial and socioeconomic disparities in research participation.

Prescription Opioid Use for Acute Pain and Persistent Opioid Use After Gynecologic Surgery: A Systematic Review.

OBJECTIVE: To assess the amount of opioid medication used by patients and the prevalence of persistent opioid use after discharge for gynecologic surgery for benign indications. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from inception to October 2020. METHODS OF STUDY SELECTION: Studies with data on gynecologic surgical procedures for benign indications and the amount of outpatient opioids consumed, or the incidence of either persistent opioid use or opioid-use disorder postsurgery were included. Two reviewers independently screened citations and extracted data from eligible studies. TABULATION, INTEGRATION, AND RESULTS: Thirty-six studies (37 articles) met inclusion criteria. Data were extracted from 35 studies; 23 studies included data on opioids consumed after hospital discharge, and 12 studies included data on persistent opioid use after gynecologic surgery. Average morphine milligram equivalents (MME) used in the 14 days after discharge were 54.0 (95% CI 39.9-68.0, seven tablets of 5-mg oxycodone) across all gynecologic surgery types, 35.0 (95% CI 0-75.12, 4.5 tablets of 5-mg oxycodone) after a vaginal hysterectomy, 59.5 (95% CI 44.4-74.6, eight tablets of 5-mg oxycodone) after laparoscopic hysterectomy, and 108.1 (95% CI 80.5-135.8, 14.5 tablets of 5-mg oxycodone) after abdominal hysterectomy. Patients used 22.4 MME (95% CI 12.4-32.3, three tablets of 5-mg oxycodone) within 24 hours of discharge after laparoscopic procedures without hysterectomy and 79.8 MME (95% CI 37.1-122.6, 10.5 tablets of 5-mg oxycodone) from discharge to 7 or 14 days postdischarge after surgery for prolapse. Persistent opioid use occurred in about 4.4% of patients after gynecologic surgery, but this outcome had high heterogeneity due to variation in populations and definitions of the outcome. CONCLUSION: On average, patients use the equivalent of 15 or fewer 5-mg oxycodone tablets (or equivalent) in the 2 weeks after discharge after major gynecologic surgery for benign indications. Persistent opioid use occurred in 4.4% of patients who underwent gynecologic surgery for benign indications. Our findings could help surgeons minimize overprescribing and reduce medication diversion or misuse. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020146120.

Building the foundation for a community-generated national research blueprint for inherited bleeding disorders: research to advance the health of people with inherited bleeding disorders with the potential to menstruate.

BACKGROUND: People who have or had the potential to menstruate (PPM) with inherited bleeding disorders (BD) face particular challenges receiving appropriate diagnosis and care and participating in research. As part of an initiative to create a National Research Blueprint for future decades of research, the National Hemophilia Foundation (NHF) and American Thrombosis and Hemostasis Network conducted extensive all-stakeholder consultations to identify the priorities of PPM with inherited BDs and those who care for them. RESEARCH DESIGN AND METHODS: Working group (WG) 4 of the NHF State of the Science Research Summit distilled community-identified priorities for PPM with inherited BDs into concrete research questions and scored their feasibility, impact, and risk. RESULTS: WG4 identified important gaps in the foundational knowledge upon which to base optimal diagnosis and care for PPM with inherited BDs. They defined 44 top-priority research questions concerning lifespan sex biology, pregnancy and the post-partum context, uterine physiology and bleeding, bone and joint health, health care delivery, and patient-reported outcomes and quality-of-life. CONCLUSIONS: The needs of PPM will best be advanced with research designed across the spectrum of sex and gender biology, with methodologies and outcome measures tailored to this population, involving them throughout.

Up to 1% of cisgender women and girls have an inherited bleeding disorder (BD). Common symptoms include heavy menstrual bleeding (HMB), heavy bleeding after giving birth known as post-partum hemorrhage (PPH), nose bleeds, bleeding from the mouth, and excessive bleeding after surgery or procedures. They can also experience bleeding into their muscles, joints, and even into the brain. Uterine bleeding, such as from HMB and PPH, can impact the lives of anyone who has or had a uterus, a group we designate as people who have or had the potential to menstruate (PPM).Many PPM with an inherited BD do not receive diagnosis, treatment, and care needed due to a lack of expertise among health care professionals and the public, misunderstanding, and bias. Uncertainty about "normal" versus "abnormal" bleeding can contribute to a lack of diagnosis, treatment, and care. Language, such as the label of "carrier," can be a barrier to accessing treatment and care for PPM.People with inherited BDs, health care professionals with various expertise and focus, and researchers worked together to identify the research that would most improve the lives of PPM, in six focus areas where there are major gaps in knowledge and the lack of standards required for accurate diagnosis.

Vaginal cuff dehiscence: risk factors and management.

Vaginal cuff dehiscence and evisceration are rare but serious complications of pelvic surgery, specifically hysterectomy. The data on risks of vaginal cuff dehiscence are variable, and there is no consensus on how to manage this complication. In our review, we present a summary of the risk factors, with symptoms, precipitating events, and treatment options for patients with vaginal cuff dehiscence after pelvic surgery. In addition, we provide a review of the current literature on this important surgical outcome and suggestions for future research on the incidence and prevention of vaginal cuff dehiscence.