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.