Impact of Simulation Exercises on Total Laparoscopic Hysterectomy Surgical Outcomes: A Systematic Review and Meta-Analysis.

BACKGROUND: As resources into gynecological surgical simulation training increase, research showing an association with improved clinical outcomes is needed. OBJECTIVE: To evaluate the association between surgical simulation training for total laparoscopic hysterectomy (TLH) and rates of intraoperative vascular/visceral injury (primary outcome) and operative time. SEARCH STRATEGY: We searched Medline OVID, Embase, Web of Science, Cochrane, and CINAHL databases from the inception of each database to April 5, 2022. Selection Critera: Randomized controlled trials (RCTs) or cohort studies of any size published in English prior to April 4, 2022. DATA COLLECTION AND ANALYSIS: The summary measures were reported as relative risks (RR) or as mean differences (MD) with 95% confidence intervals using the random effects model of DerSimonian and Laird. A Higgins I2 >0% was used to identify heterogeneity. We assessed risk of bias using the Cochrane Risk of Bias tool 2.0 (for RCTs) and the Newcastle Ottawa Scale (for cohort studies). MAIN RESULTS: The primary outcome of this systematic review and meta-analysis was to evaluate the impact of simulation training on the rates of vessel/visceral injury in patients undergoing TLH. Of 989 studies screened 3 (2 cohort studies, 1 randomized controlled trial) met the eligibility criteria for analysis. There was no difference in vessel/visceral injury (OR 1.73, 95% CI 0.53-5.69, p=0.36) and operative time (MD 13.28, 95% CI -6.26 to 32.82, p=0.18) when comparing before and after simulation training. CONCLUSION: There is limited evidence that simulation improves clinical outcomes for patients undergoing TLH.

Management of Essential Thrombocythemia in a Patient With a History of Thrombotic Thrombocytopenic Purpura.

This case presents a patient with two transposed rare diagnoses developed within 10 years. Thrombotic thrombocytopenic purpura (TTP) and essential thrombocythemia (ET) are disease processes that present with opposite clinical and laboratory findings. The patient was diagnosed with ET over a decade after the initial TTP diagnosis when she was found to have extreme thrombocytosis during routine laboratory monitoring. The patient was found to have the calreticulin (CALR) mutation variant of ET which is associated with increased platelet production and she was started on hydroxyurea and aspirin. Subsequent management of the patient's TTP relapses and large fluctuations in her platelet counts necessitated adjustments to the standard ET treatment regimen. There is little to no literature on this rare comorbidity and further investigation is needed for the association between these diseases and modifications to standard treatment to prevent relapses and sequelae.

Large for Gestational Age and Adverse Outcomes: Stratified By Diabetes Status.

OBJECTIVE: To examine the association of adverse outcomes among parturients with large for gestational age (LGA; birth weight ≥ 90th) newborns, stratified by diabetes status. Additionally, we described the temporal trends of adverse outcomes among LGA neonates. STUDY DESIGN: This retrospective cohort study used the U.S. Vital Statistics dataset between 2014 and 2020. The inclusion criteria were singleton, nonanomalous LGA live births who labored and delivered at 24 to 41 weeks with known diabetes status. The coprimary outcomes were composite neonatal adverse outcomes of the following: Apgar score < 5 at 5 minutes, assisted ventilation > 6 hours, seizure, or neonatal or infant mortality, and maternal adverse outcomes of the following: maternal transfusion, ruptured uterus, unplanned hysterectomy, admission to intensive care unit, or unplanned procedure. Multivariable Poisson regression models were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI). Average annual percent change (AAPC) was calculated to assess changes in rates of LGA and morbidity over time. RESULTS: Of 27 million births in 7 years, 1,843,467 (6.8%) met the inclusion criteria. While 1,656,888 (89.9%) did not have diabetes, 186,579 (10.1%) were with diabetes. Composite neonatal adverse outcomes (aRR = 1.48, 95% CI = 1.43, 1.52) and composite maternal adverse outcomes (aRR = 1.37, 95% CI = 1.36, 1.38) were significantly higher among individuals with diabetes, compared with those without diabetes. From 2014 to 2020, the LGA rate was stable among people without diabetes. However, there was a downward trend of LGA in people with diabetes (AAPC = - 2.4, 95% CI = - 3.5, -1.4). CONCLUSION: In pregnancies with LGA newborns, composite neonatal and maternal morbidities were higher in those with diabetes, compared with those without diabetes. KEY POINTS: · Large for gestational age stratified by diabetes status.. · Composite neonatal and maternal adverse outcomes are worse among individuals with diabetes as compared to those without.. · During 2014 to 2020, the trend of LGA in individuals without diabetes increased..

The association between maternal insurance status on maternal and neonatal outcomes in women with hypertensive disorders of pregnancy.

The objective of this study was to examine the association between maternal insurance status and maternal and neonatal adverse outcomes in women who had hypertensive disorders in pregnancy. A population-based retrospective cohort study was undertaken using the US Vital Statistics dataset on Period Linked Birth-Infant Data from 2016-2020. The study population was restricted to non-anomalous births from women whose pregnancies were complicated by hypertensive disorders. Insurance status was categorized as private, Medicaid, self-pay and other. The primary outcome was a composite of maternal adverse outcomes, which included admission to the intensive care unit, unplanned hysterectomy, maternal blood transfusion or uterine rupture. We examined the role of prenatal care in these relationships using a mediation analysis with Kotelchuck's Adequacy of Prenatal Care Utilization Index. Multivariable logistic regression models were used to estimate the association between maternal insurance status and adverse outcomes (using adjusted odds ratios [aOR] and 99% confidence interval [CI]). Of the 18,999,865 live births in the five-year study, 1,642,654 (8.6%) met the inclusion criteria. The frequency of the composite maternal adverse outcome was 1.3%. The maternal composite occurred more frequently in women with Medicaid (aOR = 1.11, 99% CI: 1.06, 1.16) or self-pay (aOR = 1.40, 99% CI: 1.25, 1.55) when compared to private insurance. Adjusting for prenatal care slightly attenuated this association, but remained significant. Among women with hypertensive disorders in pregnancy, women with Medicaid insurance or self-pay were more likely to experience maternal and neonatal adverse outcomes than women with private insurance.

Maternal education and its association with maternal and neonatal adverse outcomes in live births conceived using medically assisted reproduction (MAR).

BACKGROUND: To examine the association between maternal education and adverse maternal and neonatal outcomes in women who conceived using medically assisted reproduction, which included fertility medications, intrauterine insemination, or in vitro fertilization. METHODS: We conducted a retrospective cohort study utilizing the US Vital Statistics data set on national birth certificates from 2016 to 2020. Women with live, non-anomalous singletons who conceived using MAR and had education status of the birthing female partner recorded were included. Patients were stratified into two groups: bachelor's degree or higher, or less than a bachelor's degree. The primary outcome was a composite of maternal adverse outcomes: intensive care unit (ICU) admission, uterine rupture, unplanned hysterectomy, or blood transfusion. The secondary outcome was a composite of neonatal adverse outcomes: neonatal ICU admission, ventilator support, or seizure. Multivariable modified Poisson regression models with robust error variance adjusted for maternal age, race, marital status, prenatal care, smoking during pregnancy, neonatal sex, and birth year estimated the relative risk (RR) of outcomes with a 95% confidence interval (CI). RESULTS: 190,444 patients met the inclusion criteria: 142,943 had a bachelor's degree or higher and 47,501 were without a bachelor's degree. Composite maternal adverse outcomes were similar among patients with a bachelor's degree (10.1 per 1,000 live births) and those without a bachelor's degree (9.4 per 1,000 live births); ARR 1.05, 95% CI (0.94-1.17). However, composite adverse neonatal outcomes were significantly lower in women with a bachelor's degree or higher (94.1 per 1,000 live births) compared to women without a bachelor's degree (105.9 per 1,000 live births); ARR 0.91, 95% CI (0.88-0.94). CONCLUSIONS: Our study demonstrated that lower maternal education level was not associated with maternal adverse outcomes in patients who conceived using MAR but was associated with increased rates of neonatal adverse outcomes. As access to infertility care increases, patients who conceive with MAR may be counseled that education level is not associated with maternal morbidity. Further research into the association between maternal education level and neonatal morbidity is indicated.

Unpublished completed obstetric randomized clinical trials registered at ClinicalTrials.gov: how big is this issue?

BACKGROUND: A portion of obstetrical randomized clinical trials registered on ClinicalTrials.gov are not published in peer-reviewed journals. OBJECTIVE: This study aimed to compare the characteristics of completed published vs unpublished randomized clinical trials in obstetrics registered on ClinicalTrials.gov and to identify barriers to publication. STUDY DESIGN: This cross-sectional study queried ClinicalTrials.gov for all completed obstetrical randomized clinical trials registered between January 1, 2009, and December 31, 2018. For each completed obstetrical randomized clinical trial, we abstracted the following registration fields from ClinicalTrials.gov: ClinicalTrials.gov identifier, recruitment status, trial start and completion dates, study results, type of intervention, study phase, enrollment size, funder type, location, and facilities. Calculated variables included time to completion. In May 2021, we used PubMed and Google Scholar to identify the publication status of completed trials, and we compared the characteristics of published vs unpublished randomized clinical trials. The corresponding authors' e-mail addresses for the unpublished studies were collected from ClinicalTrials.gov and departmental websites. Between September 2021 and March 2022, the authors of these completed but unpublished obstetrical randomized clinical trials were contacted and invited to respond to a survey examining perceptions of barriers to publication, responses of which were collected and presented as counts and percentages. RESULTS: Of the 647 obstetrical randomized clinical trials marked as completed on ClinicalTrials.gov, 378 (58%) were published, and 269 (42%) were unpublished. Unpublished trials were more likely to have an enrollment size of <50 participants (14.5% published vs 25.3% unpublished; P<.001) and less likely to be conducted at multiple sites (25.4% published vs 17.5% unpublished; P<.02). The main barriers to publication reported in the survey by authors whose trials were not published included lack of time (30%), change in employment or completion of training (25%), and results that were not of statistical significance (15%). CONCLUSION: Among the obstetrical randomized clinical trials registered and marked as completed on ClinicalTrials.gov, more than 40% were unpublished. Unpublished trials were more likely to be smaller studies, conducted by researchers who reported experiencing a lack of time as the most common barrier to study publication.

The association between trial of labor after cesarean in obese patients and adverse maternal outcomes.

PURPOSE: We hypothesized that among obese patients with a history of cesarean birth, a TOLAC is associated with decreased composite maternal adverse outcomes (CMAO) compared to planned repeat low transverse cesarean section (RLTCS). METHODS: In this population-based cross-sectional study using the National Birth Certificate database from 2016 to 2020, we compared obese patients who attempted TOLAC at term (≥ 37 weeks estimated gestational age) to planned RLTCS. The primary outcome was a CMAO, defined as delivery complications, including intensive care unit (ICU) admission, uterine rupture, unplanned hysterectomy, or maternal blood transfusion. RESULTS: Overall, 794,278 patients met inclusion criteria for the study; 126,809 underwent a TOLAC, and 667,469 had a planned RLTCS. The overall CMAO was significantly higher for patients undergoing TOLAC (9.0 per 1000 live births) compared to RLTCS (5.3 per 1000 live births; aRR 1.64, 95% CI 1.53-1.75). CONCLUSION: This data demonstrate that in obese patients with prior cesarean birth, a trial of labor is associated with increased maternal morbidity when compared to a planned repeat cesarean birth.

Sickle Cell Crises in Pregnancy: Fetal and Neonatal Implications.

Sickle cell disease (SCD) is the most common inherited condition worldwide. In the United States, SCD affects 100,000 births every year, mostly persons of African descent. In SCD, red blood cells assume a sickle shape when deoxygenated. This leads to the occlusion of small blood vessels and decreased oxygenated blood flow, resulting in ischemic and thrombotic injury to various organs, which further leads to organ dysfunction. In pregnancy, patients with SCD are at an increased risk of vaso-occlusive crises, which further increases the risks of maternal, fetal, and neonatal morbidity and mortality.

Utilizing International Classification of Diseases Codes to Identify Shoulder Dystocia and Neonatal Brachial Plexus Injury.

BACKGROUND: The utilization of International Classification of Diseases, Ninth or Tenth Revision, (ICD-9/10) coding to identify the incidence of disease is frequently performed in medical research. This study attempts to assess the validity of using ICD-9/10 codes to identify patients with shoulder dystocia (SD) with concurrent neonatal brachial plexus palsy (NBPP). METHODS: This retrospective cohort study examined patients evaluated at the University of Michigan Brachial Plexus and Peripheral Nerve Program (UM-BP/PN) from 2004 to 2018. We reported the percentage of patients with reported NBPP ICD-9/10 and SD ICD-9/10 discharged at birth who were later diagnosed with NBPP by a specialty clinic by interdisciplinary faculty and staff utilizing physical evaluations and ancillary testing such as such as electrodiagnostics and imaging. The relationship of reported NBPP ICD-9/10, SD ICD-9/10, extent of NBPP nerve involvement, and NBPP persistence at age two years were examined via chi-square or Fischer exact test. RESULTS: Of the 51 mother-infant dyads with complete birth discharge records evaluated at the UM-BP/PN, 26 (51%) were discharged without an ICD-9/10 code documenting NBPP; of these 26 patients, only four had ICD-9/10 documentation of SD at discharge, which left 22 patients with no ICD-9/10 code documentation of either SD or NBPP (43%). Patients with pan-plexopathy were more likely to be discharged with an NBBP ICD-9/10 code than those infants with upper nerve involvement (77% vs 39%, P < 0.02). CONCLUSION: Use of ICD-9/10 codes for the identification of NBPP appears to undercount the true incidence. This underestimation is more pronounced for milder forms of NBPP.

Effect of a Multimedia Educational Tool on Contraception Use 1 Year Postpartum.

FUNDING SOURCE: Supported in part by a research grant from Investigator-Initiated Studies program of Organon. The opinions expressed in this paper are those of the authors and do not necessarily represent Organon. CLINICAL TRIAL REGISTRAION: ClinicalTrials.gov , NCT04291040.

Sexual and Reproductive Health Care Visits as a Venue for Preexposure Prophylaxis Service Delivery Among Women in the United States: Results From a Nationally Representative Survey.

BACKGROUND: Preexposure prophylaxis (PrEP) for HIV is disproportionately underprescribed to women. Centers for Disease Control and Prevention guidelines identify a group of women at risk of HIV acquisition who should be offered PrEP, but opportunities remain to improve patient awareness of and provider counseling about PrEP and to expand service delivery of PrEP. METHODS: Using nationally representative data from the 2017-2019 National Survey of Family Growth, we compared women with (n = 689) and without (n = 5,452) Centers for Disease Control and Prevention indications for PrEP on measures of PrEP awareness, counseling by a provider, and interaction with the health care system. RESULTS: Women with PrEP indications were no more likely to report awareness of PrEP (odds ratio [OR], 1.03; 95% confidence interval [CI], 0.82-1.29) or PrEP counseling by a provider (OR, 1.32; 95% CI, 0.77-2.27), compared with those without PrEP indications. However, women with PrEP indications were more likely than those without to report a birth control visit (OR, 1.82; 95% CI, 1.39-2.38) or an abortion within the last 12 months (OR, 5.93; 95% CI, 1.48-23.73), and to currently use prescription contraception (OR, 1.45; 95% CI, 1.19-1.78). A majority of both groups reported accessing prenatal care within the last 12 months. CONCLUSIONS: There remains a gap in PrEP awareness and counseling among women at highest risk for HIV acquisition. Sexual and reproductive health visits represent a logical and feasible venue for PrEP provision. Obstetrician-gynecologists and other family planning providers may be able to aid in service delivery innovations by providing PrEP alongside other sexual and reproductive health care.

Reduction of anti-A and anti-B isoagglutinin titers of group O whole blood units employing an ABO antibody immune adsorption column.

BACKGROUND: Massive hemorrhage is a leading cause of death from trauma. There is growing interest in group O whole blood transfusions to mitigate coagulopathy and hemorrhagic shock. Insufficient availability of low-titer group O whole blood is a barrier to routine use. We tested the efficacy of the Glycosorb® ABO immunoadsorption column to reduce anti-A/B titers in group O whole blood. METHODS: Six group O whole blood units were collected from healthy volunteers, and centrifuged to separate platelet poor plasma. Platelet-poor plasma was filtered through a Glycosorb® ABO antibody immunoabsorption column, then reconstituted to prepare post-filtration whole blood. Anti-A/B titers, CBC, free hemoglobin, and thromboelastography (TEG) assays were performed on pre-and post-filtration whole blood. RESULTS: Mean( ± SEM) anti-A (224 ± 65 pre vs 13 ± 4 post) and anti-B (138 ± 38 pre vs 11 ± 4 post) titers were significantly reduced (p = 0.004) in post-filtration whole blood. No significant changes were detected in CBC, free hemoglobin, and TEG parameters on day 0. Free hemoglobin increased throughout storage (48 mg/dl ± 24 Day 0 vs 73 ± 35 Day 7 vs 96 ± 44 Day 14; p = 0.14). CONCLUSIONS: The Glycosorb® ABO column can significantly reduce anti-A/B isoagglutinin titers of group O whole blood units. Glycosorb® ABO could be employed to provide whole blood with lower risk of hemolysis and other consequences of infusing ABO incompatible plasma. Preparation of group O whole blood with substantially reduced anti-A/B would also increase the supply of low-titer group O whole blood for transfusion.

Factors associated with exclusive formula feeding among individuals with low-risk pregnancies in the United States.

BACKGROUND: Better understanding of the factors associated with formula feeding during the hospital stay can help in identifying potential lactation problems and promote early intervention. Our aim was to ascertain factors associated with exclusive formula feeding in newborns of low-risk pregnancies. METHODS: A population-based, retrospective study using the United States vital statistics datasets (2014-2018) evaluating low-risk pregnancies with a nonanomalous singleton delivery from 37 to 41 weeks. People with hypertensive disorders, or diabetes, were excluded. Primary outcome was newborn feeding (breast vs exclusive formula feeding) during hospital stay. Adjusted relative risks (aRRs) with 95% confidence intervals (CI) were calculated. RESULTS: Of the 19 623 195 live births during the study period, 11 605 242 (59.1%) met inclusion criteria and among them, 1 929 526 (16.6%) were formula fed. Factors associated with formula feeding included: age < 20 years (aRR 1.31 [95% CI 1.31-1.32]), non-Hispanic Black (1.42, 1.41-1.42), high school education (1.69, 1.69-1.70) or less than high school education (1.94, 1.93, 1.95), Medicaid insurance (1.52, 1.51, 1.52), body mass index (BMI) < 18.5 (1.10, 1.09-1.10), BMI 25-29.9 (1.09, 1.09-1.09), BMI 30-34.9 (1.19, 1.19-1.20), BMI 35-39.9 (1.31, 1.30-1.31), BMI ≥ 40 (1.43, 1.42-1.44), multiparity (1.29, 1.29-1.30), lack of prenatal care (1.49, 1.48-1.50), smoking (1.75, 1.74-1.75), and gestational age (ranged from 37 weeks [1.44, 1.43-1.45] to 40 weeks [1.11, 1.11-1.12]). CONCLUSIONS: Using a large cohort of low-risk pregnancies, we identified several modifiable factors associated with newborn feeding (eg, prepregnancy BMI, access to prenatal care, and smoking cessation). Improving the breast feeding initiation rate should be a priority in our current practice to ensure equitable care for all neonates.

Racial and Ethnic Disparities among Pregnancies with Chronic Hypertension and Adverse Outcomes.

OBJECTIVE: We aimed to ascertain whether the risk of adverse pregnancy outcomes in the United States among individuals with chronic hypertension differed by maternal race and ethnicity and to assess the temporal trend. STUDY DESIGN: Population-based retrospective study using the U.S. Vital Statistics datasets evaluated pregnancies with chronic hypertension, singleton live births that delivered at 24 to 41 weeks. The coprimary outcomes were a composite maternal adverse outcome (preeclampsia, primary cesarean delivery, intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy) and a composite neonatal adverse outcome (preterm birth, small for gestational age, Apgar's score <5 at 5 minutes, assisted ventilation> 6 hours, seizure, or death). Multivariable Poisson regression models were used to estimate adjusted relative risks (aRRs) and 95% confidence intervals (CIs). RESULTS: Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased from 1.6 to 2.2%. After multivariable adjustment, an increased risk for the composite maternal adverse outcome was found in Black (aRR = 1.10, 95% CI = 1.09-1.11), Hispanic (aRR = 1.04, 95% CI = 1.02-1.05), and Asian/Pacific Islander (aRR = 1.07, 95% CI = 1.05-1.10), compared with White individuals. Compared with White individuals, the risk of the composite neonatal adverse outcome was higher in Black (aRR = 1.39, 95% CI = 1.37-1.41), Hispanic (aRR = 1.15, 95% CI = 1.13-1.16), Asian/Pacific Islander (aRR = 1.34, 95% CI = 1.31-1.37), and American Indian (aRR = 1.12, 95% CI = 1.07-1.17). The racial and ethnic disparity remained unchanged during the study period. CONCLUSION: We found a racial and ethnic disparity with maternal and neonatal adverse outcomes in pregnancies with chronic hypertension that remained unchanged throughout the study period. KEY POINTS: · Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased.. · Among people with chronic hypertension, there are racial and ethnic disparities in adverse outcomes.. · Black, Hispanic, and Asian/Pacific Islander have a higher risk of the adverse neonatal outcomes..

Factors associated with long-acting reversible contraception usage: Results from the National Survey of Family Growth.

OBJECTIVE: The authors aimed to identify factors associated with long-acting reversible contraception (LARC) usage. METHODS: The current cross-sectional study used data from the National Survey of Family Growth from 2011 to 2019. Respondents aged 15 to 44 years were included. Those with previous sterilization, infertility, or pregnant were excluded. The outcome evaluated was use of a LARC. RESULTS: Of 61 543 814 women, 44 287 911 (72.0%) met inclusion criteria. The rate of LARC use was 13.4%. Factors associated with an increased likelihood of LARC usage were married/living with a partner (adjusted relative risk [aRR], 1.18 [95% CI, 1.02-1.37]), perceived good health (aRR, 1.44 [95% CI, 1.13-1.84]), year of survey 2017 to 2019 (aRR, 1.53, [95% CI, 1.28-1.83]), one or two past pregnancies (aRR, 1.62 [95% CI, 1.24-2.12]) or three or more past pregnancies (aRR, 1.67 [95% CI, 1.22-2.28]), age at first live birth <20 years (aRR, 1.58 [95% CI, 1.20-2.08]) or 20 to 24 years (aRR, 1.45 [95% CI, 1.13-1.87]), age at onset of sexual activity 13-19 years (aRR, 1.50 [95% CI, 1.26-1.78]), and a 0- to 5-month period of nonintercourse in the past year (aRR, 1.63 [95% CI, 1.40-1.90]). Factors associated with decreased LARC usage were age ≥ 35 years (aRR, 0.74 [95% CI, 0.65-0.85]), being non-Hispanic Black (aRR, 0.75 [95% CI, 0.62-0.89]) or non-Hispanic other (aRR, 0.72 [95% CI, 0.59-0.88]), intending to have children (aRR, 0.65 [95% CI, 0.57-0.74]), and never being sexually active (aRR, 0.10 [95% CI, 0.06-0.16]). CONCLUSIONS: Using a nationally representative sample of women in the United States, the authors identified modifiable factors associated with LARC use. Results may be used to plan interventional trials to increase LARC usage.