Clinical Trial Racial and Ethnic Disparities in Minimally Invasive Gynecologic Surgery.

STUDY OBJECTIVE: To study racial and ethnic disparities in randomized controlled trials (RCTs) in minimally invasive gynecologic surgery (MIGS). DESIGN: Cross-sectional study. SETTING: Online review of all published MIGS RCTs in high-impact journals from 2012 to 2023. PATIENTS: Journals included all first quartile obstetrics and gynecology journals, as well as The New England Journal of Medicine, The Lancet, The British Medical Journal, and The Journal of the American Medical Association. The National Institutes of Health's PubMed and the ClinicalTrials.gov websites were queried using the following search terms from the American Board of Obstetrics and Gynecology's certifying examination bulletin 2022 to obtain relevant trials: adenomyosis, adnexal surgery, abnormal uterine bleeding, cystectomy, endometriosis, fibroids, gynecology, hysterectomy, hysteroscopy, laparoscopy, leiomyoma, minimally invasive gynecology, myomectomy, ovarian cyst, and robotic surgery. INTERVENTIONS: The US Census Bureau data were used to estimate the expected number of participants. We calculated the enrollment ratio (ER) of actual to expected participants for US trials with available race and ethnicity data. MEASUREMENTS AND MAIN RESULTS: A total of 352 RCTs were identified. Of these, race and/or ethnicity data were available in 65 studies (18.5%). We analyzed the 46 studies that originated in the United States, with a total of 4645 participants. Of these RCTs, only 8 (17.4%) reported ethnicity in addition to race. When comparing published RCT data with expected proportions of participants, White participants were overrepresented (70.8% vs. 59.6%; ER, 1.66; 95% confidence interval [CI], 1.52-1.81), as well as Black or African American participants (15.4% vs. 13.7%; ER, 1.15; 95% CI, 1.03-1.29). Hispanic (6.7% vs. 19.0%; ER, 0.31; 95% CI, 0.27-0.35), Asian (1.7% vs. 6.1%; ER, 0.26; 95% CI, 0.20-0.34), Native Hawaiian or other Pacific Islander (0.1% vs. 0.3%; ER, 0.21; 95% CI, 0.06-0.74), and Indian or Alaska Native participants (0.2% vs. 1.3%; ER, 0.16; 95% CI, 0.08-0.32) were underrepresented. When comparing race/ethnicity proportions in the 20 states where the RCTs were conducted, Black or African American participants were underrepresented. CONCLUSION: In MIGS RCTs conducted in the United States, White and Black or African American participants are overrepresented compared with other races, and ethnicity is characterized in fewer than one-fifth of trials. Efforts should be made to improve racial and ethnic recruitment equity and reporting in future MIGS RCTs.

Accidental uterine extensions in cesarean deliveries - outcome of subsequent pregnancy.

OBJECTIVES: To explore the obstetric, maternal and neonatal outcome in the subsequent pregnancy after a pregnancy with an accidental uterine extension (AUE) during cesarean delivery (CD), as well as the relationship between the different types of AUE (inferior, lateral and superior). METHODS: A retrospective cohort study of all CD with AUE in a tertiary medical center between 01/2011-01/2022. Women with a prior CD with AUE were compared to a 1:3 ratio matched control group of women with a prior CD without AUE. All AUE were defined in their direction, size and mode of suturing. CD with deliberate uterine extensions were excluded. We evaluated obstetric, maternal and neonatal outcomes in the subsequent pregnancy after a pregnancy with AUE during CD. RESULTS: Comparing women with a prior CD with AUE (n=177) to the matched control group of women with a prior CD without AUE (n=528), we found no significant differences in proportions of uterine rupture or any other major complication or adverse outcome between the groups. There were no significant differences in the outcomes of the subsequent pregnancy in relation to the characteristics of the AUE (direction, size and mode of suturing). CONCLUSIONS: Subsequent pregnancies after AUE are not associated with higher maternal or neonatal adverse outcomes including higher proportions of uterine rupture compared to pregnancies without previous AUE. Different characteristics of the AUE do not impact the outcome.

Pregnancy Outcomes after Uterine Preservation Surgery for Placenta Accreta Spectrum: A Retrospective Cohort Study.

OBJECTIVE: This study aimed to investigate maternal and neonatal outcomes in subsequent pregnancies of women with a history of placenta accreta spectrum (PAS) compared with women without history of PAS. STUDY DESIGN: A retrospective cohort study conducted at a single tertiary center between March 2011 and January 2022. We compared women with a history of PAS who had uterine preservation surgery and a subsequent pregnancy, to a control group matched in a 1:5 ratio. The primary outcome was the occurrence of a composite adverse outcome (CAO) including any of the following: uterine dehiscence, uterine rupture, blood transfusion, hysterectomy, neonatal intensive care unit admission, and neonatal mechanical ventilation. Multivariable logistic regression was performed to evaluate associations with the CAO. RESULTS: During the study period, 287 (1.1%) women were diagnosed with PAS and delivered after 25 weeks of gestation. Of these, 32 (11.1%) women had a subsequent pregnancy that reached viability. These 32 women were matched to 139 controls. There were no significant differences in the baseline characteristics between the study and control groups. Compared with controls, the proportion of CAO was significantly higher in women with previous PAS pregnancy (40.6 vs. 19.4%, p = 0.019). In a multivariable logistic regression analysis, previous PAS (adjusted odds ratio [aOR] = 3.31, 95% confidence interval [CI] = 1.09-10.02, p = 0.034) and earlier gestational age at delivery (aOR = 3.53, 95% CI = 2.27-5.49, p < 0.001) were independently associated with CAOs. CONCLUSION: A history of PAS in a previous pregnancy is associated with increased risk of CAOs in subsequent pregnancies. KEY POINTS: · The uterine-preserving approach for PAS delivery is gaining more attention and popularity in recent years.. · Women with a previous pregnancy with PAS had higher rates of CAOs in subsequent pregnancies.. · Previous PAS pregnancy is an independent factor associated with adverse outcomes..

Neonatal outcomes in pregnancies complicated by placenta accreta- a matched cohort study.

PURPOSE: Pregnancies complicated by placenta accreta spectrum (PAS) are associated with severe maternal morbidities. The aim of this study is to describe the neonatal outcomes in pregnancies complicated with PAS compared with pregnancies not complicated by PAS. METHODS: A retrospective cohort study conducted at a single tertiary center between 03/2011 and 01/2022, comparing women with PAS who underwent cesarean delivery (CD) to a matched control group of women without PAS who underwent CD. We evaluated the following adverse neonatal outcomes: umbilical artery pH < 7.0, umbilical artery base excess ≤ - 12, APGAR score < 7 at 5 min, neonatal intensive care unit (NICU) admission, mechanical ventilation, hypoxic ischemic encephalopathy, seizures and neonatal death. We also evaluated a composite adverse neonatal outcome, defined as the occurrence of at least one of the adverse neonatal outcomes described above. Multivariable regression analysis was used to determine which adverse neonatal outcome were independently associated with the presence of PAS. RESULTS: 265 women with PAS were included in the study group and were matched to 1382 controls. In the PAS group compared with controls, the rate of composite adverse neonatal outcomes was significantly higher (33.6% vs. 18.7%, respectively, p < 0.001). In a multivariable logistic regression analysis, Apgar score < 7 at 5 min, NICU admission and composite adverse neonatal outcome were independently associated with PAS. CONCLUSION: Neonates in PAS pregnancies had higher rates of adverse outcomes. Apgar score < 7 at 5 min, NICU admission and composite adverse neonatal outcome were independently associated with PAS.

Ectopic first pregnancy treated by methotrexate versus salpingectomy-Maternal and perinatal outcomes in a subsequent pregnancy: A retrospective study.

OBJECTIVE: To study obstetric outcomes of a second pregnancy among women with a first ectopic pregnancy (EP) treated with methotrexate compared with laparoscopic salpingectomy. METHODS: A retrospective cohort study including all women with a first EP and a following pregnancy that concluded by delivery at ≥24 weeks of gestation between March 2011 and April 2021. Second pregnancy outcomes were compared between women treated with methotrexate and those treated with salpingectomy in their first pregnancy. RESULTS: Overall, 125 women were included, of which 64 (51.2%) were treated with methotrexate and 61 (48.8%) were treated with salpingectomy. In women treated with salpingectomy, the proportion of women conceiving by in vitro fertilization and those with measured gestational sac diameter or ß-subunit human chorionic gonadotropin was higher. The proportion of women conceiving by in vitro fertilization in their second pregnancy was higher in the salpingectomy group (55.2% versus 18.0%, P < 0.001). All maternal and neonatal outcomes were similar in both groups. The rate of low birth weight < 2500 g was 7.8% in the methotrexate group versus 18% in the salpingectomy group (P = 0.111). CONCLUSION: Maternal and neonatal outcomes of a second pregnancy among women treated for EP in their first pregnancy are similar in women treated by methotrexate and those treated by salpingectomy.

Renal autoimmunity: The role of bacterial and viral infections, an extensive review.

Autoimmunity is a process by which the loss of self-tolerance results in an immune attack against the body own tissues and organs. For autoimmunity to occur, various elements serving as triggers were described by which infections are considered one of the leading factors. In turn, renal involvement in autoimmune diseases, whether by an organ-specific attack, or as part of a systemic disease process, is well known. As bacterial and viral infections are considered to be common triggers for autoimmunity in general, we aimed to study their association with renal autoimmunity in particular. We performed an extensive search of the recent and relevant medical literature regarding renal autoimmunity syndromes such as infection-associated glomerulonephritis and vasculitis, associated with bacterial and viral infections. By utilizing PubMed and Google Scholar search engines, over 200 articles and case reports were reviewed. Among other mechanisms, direct infection of the renal parenchyma, molecular mimicry, induction of B-cells or secretion of superantigens, bacterial and viral pathogens were found to correlate with the development of renal autoimmunity. Nevertheless, this was not true for all pathogens, as some mimic autoimmune diseases and others show a surprisingly protective effect. The exact immunopathogenesis is yet to be determined, however. For conclusion, bacterial and viral infections are linked to renal autoimmunity by both direct damage and as mediators of systemic diseases. Further research particularly on the immunopathogenetic mechanisms of renal autoimmunity associated with infections is required.

COVID-19 Vaccination and the Rate of Immune and Autoimmune Adverse Events Following Immunization: Insights From a Narrative Literature Review.

Despite their proven efficacy and huge contribution to the health of humankind, vaccines continue to be a source of concern for some individuals around the world. Vaccinations against COVID-19 increased the number of distressed people and intensified their distrust, particularly as the pandemic was still emerging and the populations were encouraged to be vaccinated under various slogans like "back to normal life" and "stop coronavirus", goals which are still to be achieved. As fear of vaccination-related adverse events following immunization (AEFIs) is the main reason for vaccine hesitancy, we reviewed immune and autoimmune AEFIs in particular, though very rare, as the most worrisome aspect of the vaccines. Among others, autoimmune AEFIs of the most commonly administered COVID-19 vaccines include neurological ones such as Guillain-Barre syndrome, transverse myelitis, and Bell's palsy, as well as myocarditis. In addition, the newly introduced notion related to COVID-19 vaccines, "vaccine-induced immune thrombotic thrombocytopenia/vaccine-induced prothrombotic immune thrombotic thrombocytopenia" (VITT/VIPITT)", is of importance as well. Overviewing recent medical literature while focusing on the major immune and autoimmune AEFIs, demonstrating their rate of occurrence, presenting the cases reported, and their link to the specific type of COVID-19 vaccines represented the main aim of our work. In this narrative review, we illustrate the different vaccine types in current use, their associated immune and autoimmune AEFIs, with a focus on the 3 main COVID-19 vaccines (BNT162b2, mRNA-1273, and ChAdOx1). While the rate of AEFIs is extremely low, addressing the issue in this manner, in our opinion, is the best strategy for coping with vaccine hesitancy.

The mosaic of autoimmunity - A taste for more. The 12th international congress of autoimmunity 2021 (AUTO12) virtual.

Notwithstanding the fact that the 12th international congress of autoimmunity (AUTO12) was held virtual this year, the number of the abstracts submitted and those presented crossed the thousand marks. Leading investigators and researchers from all over the world presented the latest developments of their research in the domain of autoimmunity and its correlation with various diseases. In terms of mechanisms of autoimmunity, an update on the mechanisms behind the association of autoimmunity with systemic diseases focusing on hyperstimulation was presented during AUTO12. In addition, a new mechanism of ASIA syndrome caused by an intrauterine contraceptive device was revealed demonstrating a complete resolution of symptoms following device removal. In regard to the correlation between autoimmunity and neurogenerative diseases, the loss of structural protein integrity as the trigger of immunological response was shown. Schizophrenia as well, and its correlation to pro-inflammatory cytokines was also addressed. Furthermore, and as it was said AUTO12 virtual due to COVID-19 pandemic, various works were dedicated to SARS-CoV-2 infection and COVID-19 in terms of autoimmune mechanisms involved in the pathogenesis, treatment and complications of COVID-19. For instance, the correlation between autoimmunity and the severity of COVID-19 was viewed. Moreover, the presence and association of autoantibodies in COVID-19 was also demonstrated, as well as the clinical outcomes of COVID-19 in patients with rheumatic diseases. Finally, immune-mediated reactions and processes secondary to SARS-CoV-2 vaccination was displayed. Due to the immense importance of all of the topics addressed and while several hundreds of works were presented which cannot be summed up in one paper, we aimed hereby to highlight some of the outstanding abstracts and presentations during AUTO12.