Notes

Indoxyl sulfate, any gut microbiome-derived uremic toxic, is associated with clairvoyant anxiousness and its functional magnetic resonance imaging-based neurologic unique.
ment-related, treatment-emergent adverse event was vulvovaginal candidiasis.

A new, single-dose clindamycin vaginal gel was highly effective, with excellent safety, in women disproportionately affected by bacterial vaginosis, with Nugent scores of 7-10 at study entry.

The study was funded by Daré Bioscience, Inc.

ClinicalTrials.gov, NCT04370548.
ClinicalTrials.gov, NCT04370548.
To evaluate whether a synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening.

In an open-label, noninferiority randomized trial, pregnant women undergoing induction of labor at 37 weeks of gestation or more with Bishop scores less than 6 were randomized to either mechanical cervical dilation or oral misoprostol. Participants in the mechanical dilation group underwent insertion of synthetic osmotic cervical dilator rods, and those in the misoprostol group received up to six doses of 25 micrograms orally every 2 hours. After 12 hours of ripening, oxytocin was initiated, with artificial rupture of membranes. Management of labor was at the physician's discretion. The primary outcome was the proportion of women achieving vaginal delivery within 36 hours of initiation of study intervention. Secondary outcomes included increase in Bishop score, mode of delivery, induction-to-delivery interval, total length of hospital stay, and patient satisfaction. On the basis of a noninfersoprostol for cervical ripening. Advantages of synthetic osmotic cervical dilator include a better safety profile and patient satisfaction, less tachysystole, lower pain scores, and U.S. Food and Drug Administration approval.

ClinicalTrials.gov, NCT03670836.

Medicem Technology s.r.o., Czech Republic.
Medicem Technology s.r.o., Czech Republic.
To assess the effect of once-daily relugolix combination therapy (relugolix-CT relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding.

Two replicate, multinational, double-blind, 24-week, randomized, phase 3 studies (LIBERTY 1 and 2) were conducted in premenopausal women with uterine leiomyoma-associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle). A predefined secondary objective was to determine the effect of relugolix-CT on moderate-to-severe uterine leiomyoma-associated pain in the pain subpopulation (women with maximum pain scores of 4 or higher on the 0-10 numerical rating scale at baseline, with pain score reporting compliance of 80% (ie, 28 days or more over the last 35 days of treatment). This key secondary endpoint was defined as the proportion of women achieving minimal-to-no uterine leiomyoma-associated pain (mduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma-associated pain.

ClinicalTrials.gov LIBERTY 1, NCT03049735; LIBERTY 2, NCT03103087.

Myovant Sciences GmbH.
Myovant Sciences GmbH.
To investigate which organizational factors, policies, and practices distinguish hospitals with high compared with low risk-adjusted rates of severe maternal morbidity (SMM).

Using a positive deviance approach, this qualitative study included 50 semistructured interviews with health care professionals (obstetrics and gynecology chairs, labor and delivery medical directors, nurse managers, frontline nurses, physicians or nurses responsible for quality and safety, and chief medical officers) in four low-performing and four high-performing hospitals in New York City. Hospital performance was based on risk-adjusted morbidity metrics from previous research. Major topics explored were structural characteristics (eg, staffing, credentialing), organizational characteristics (eg, culture, leadership, communication, use of data), labor and delivery practices (eg, use of standardized, evidence-based practices, teamwork), and racial and ethnic disparities in SMM. All interviews were audiotaped, professionally transcrces at multiple levels distinguish high-performing from low-performing hospitals for SMM. Findings illustrate the potential for targeted quality initiatives to improve maternal health and reduce obstetric disparities arising from delivery in low-performing hospitals.
Organizational factors, policies, and practices at multiple levels distinguish high-performing from low-performing hospitals for SMM. GDC-0973 Findings illustrate the potential for targeted quality initiatives to improve maternal health and reduce obstetric disparities arising from delivery in low-performing hospitals.
To evaluate the association between community-level social vulnerability and achieving glycemic control (defined as hemoglobin A1c [Hb A1c] less than 6.0% or less than 6.5%) among individuals with pregestational diabetes.

We conducted a retrospective cohort of individuals with pregestational diabetes with singleton gestations from 2012 to 2016 at a tertiary care center. Addresses were geocoded using ArcGIS and then linked at the census tract to the Centers for Disease Control and Prevention's 2018 SVI (Social Vulnerability Index), which incorporates 15 Census variables to produce a composite score and four scores across thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). Scores range from 0 to 1, with higher values indicating greater community-level social vulnerability. The primary outcome was Hb A1c less than 6.0%, and, secondarily, Hb A1c less than 6.5%, in the second or third trimesters. Multivariable Poisson pregestational diabetes living in an area with higher social vulnerability were less likely to achieve glycemic control, as measured by HgbA1c levels. Interventions are needed to assess whether addressing social determinants of health can improve glycemic control in pregnancy.
Pregnant individuals with pregestational diabetes living in an area with higher social vulnerability were less likely to achieve glycemic control, as measured by HgbA1c levels. Interventions are needed to assess whether addressing social determinants of health can improve glycemic control in pregnancy.
To estimate the association between timing of administration of adjunctive azithromycin for prophylaxis at unscheduled cesarean delivery and maternal infection and neonatal morbidity.

We conducted a secondary analysis of a randomized trial of adjunctive azithromycin prophylaxis in patients with singleton gestations who were undergoing unscheduled cesarean delivery. The primary exposure was the timing of initiation of the study drug (after skin incision or 0-30 minutes, more than 30-60 minutes, or more than 60 minutes before skin incision). The primary outcome was a composite of endometritis, wound infection, and other maternal infections occurring up to 6 weeks after cesarean delivery. Secondary outcomes included composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis. The association of azithromycin with outcomes was compared within each antibiotic timing group and presented as risk ratios (RRs) with 95% CIs. A Breslow-Day homogeneity test was ap were not significantly different for azithromycin compared with placebo across all timing groups.

Adjunctive azithromycin administration up to 60 minutes before or at a median of 3 minutes after skin incision was associated with reduced risks of maternal composite postoperative infection in unscheduled cesarean deliveries.

ClinicalTrials.gov, NCT01235546.
ClinicalTrials.gov, NCT01235546.Fetal therapies undertaken to improve fetal outcome or to optimize transition to neonate life often entail some level of maternal, fetal, or neonatal risk. A fetal therapy center needs access to resources to carry out such therapies and to manage maternal, fetal, and neonatal complications that might arise, either related to the therapy per se or as part of the underlying fetal or maternal condition. Accordingly, a fetal therapy center requires a dedicated operational infrastructure and necessary resources to allow for appropriate oversight and monitoring of clinical performance and to facilitate multidisciplinary collaboration between the relevant specialties. Three care levels for fetal therapy centers are proposed to match the anticipated care complexity, with appropriate resources to achieve an optimal outcome at an institutional and regional level. A level I fetal therapy center should be capable of offering fetal interventions that may be associated with obstetric risks of preterm birth or membrane rupture but that would be very unlikely to require maternal medical subspecialty or intensive care, with neonatal risks not exceeding those of moderate prematurity. A level II center should have the incremental capacity to provide maternal intensive care and to manage extreme neonatal prematurity. A level III therapy center should offer the full range of fetal interventions (including open fetal surgery) and be able manage any of the associated maternal complications and comorbidities, as well as have access to neonatal and pediatric surgical intervention including indicated surgery for neonates with congenital anomalies.
To quantify the extent to which neighborhood characteristics contribute to racial and ethnic disparities in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seropositivity in pregnancy.

This cohort study included pregnant patients who presented for childbirth at two hospitals in Philadelphia, Pennsylvania from April 13 to December 31, 2020. Seropositivity for SARS-CoV-2 was determined by measuring immunoglobulin G and immunoglobulin M antibodies by enzyme-linked immunosorbent assay in discarded maternal serum samples obtained for clinical purposes. Race and ethnicity were self-reported and abstracted from medical records. Patients' residential addresses were geocoded to obtain three Census tract variables community deprivation, racial segregation (Index of Concentration at the Extremes), and crowding. Multivariable mixed effects logistic regression models and causal mediation analyses were used to quantify the extent to which neighborhood variables may explain racial and ethnic disparities in atients. Investing in structural neighborhood improvements may reduce inequities in viral transmission.
Neighborhood deprivation and crowding were associated with SARS-CoV-2 seropositivity in pregnancy in the prevaccination era and may partially explain high rates of SARS-CoV-2 seropositivity among Black and Hispanic patients. Investing in structural neighborhood improvements may reduce inequities in viral transmission.Fertility-preservation counseling in the transgender patient population is recommended by multiple organizations, including the American Society for Reproductive Medicine, the World Professional Association for Transgender Health, and the Endocrine Society. The optimal time to pursue fertility preservation has not been established, and data on potential effects of testosterone therapy on future reproductive potential are limited. This Current Commentary seeks to elucidate the most appropriate time to perform oocyte cryopreservation in relation to time on and off testosterone therapy, age of the individual, and emotional effect of treatment. Although there have been multiple studies that have demonstrated successful oocyte cryopreservation regardless of testosterone exposure, the data on live-birth rates after oocyte cryopreservation are limited. Moreover, the process of oocyte cryopreservation may have a significant negative emotional effect on the transgender male given the feminizing effects of gonadotropin stimulation, as well as the invasiveness of pelvic ultrasonograms and the oocyte-retrieval procedure.
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