Mycoplasmoides genitalium nucleic acid semi-quantitation and molecular macrolide resistance detection via automated assays: gender and specimen source considerations.

A laboratory-developed test (LDT) using analyte-specific reagents has been optimized on a commercial platform to detect macrolide resistance-associated mutations (MRM) in 23S rRNA from Mycoplasmoides genitalium from primary clinical specimens. In this study, MRM-LDT was applied to a multi-specimen source study set. One thousand four hundred ninety-five primary specimens testing positive for M. genitalium by commercial transcription-mediated amplification (TMA) were initially titered by the TMA assay using serial 10-fold dilutions to semi-quantitate target nucleic acid burden. Primary specimens were then processed for MRM detection using the MRM-LDT. Findings were stratified by gender and specimen source. The mean log10 target nucleic acid titer of a TMA-positive specimen was 3.51 (median 3; range 0-10). Male specimens (n = 1145) demonstrated a mean log10 M. genitalium TMA titer of 3.67; that value observed in 350 female specimens was 2.98 (P < 0.0001). The MRM-LDT detection rate (88.7%) from specimens with log10 M. genitalium TMA titers ≥ 4 was increased over specimens with log10 titers ≤ 1 (4.5%; P < 0.0002). In females, MRM-LDT was positive from 51.3% of vaginal swab and 34.7% of urine specimens (P = 0.01). In males, MRM-LDT was positive from 65.0% of rectal swab and 55.7% of urine specimens (P = 0.002). Differences were also observed in log10 M. genitalium TMA titers as a function of specimen source. M. genitalium macrolide resistance rates among multiple specimen sources, as determined by MRM-LDT, are high in the United States and can be consistent with target nucleic acid burden within the primary specimen. Caveats experienced within subgroupings support MRM reflex testing on primary M. genitalium-positive specimens. IMPORTANCE: First-line macrolide treatment failure is of increasing concern with Mycoplasmoides genitalium in multiple settings. Recent sexually-transmitted infection treatment guidelines from the United States Centers for Disease Control and Prevention have predicated therapeutic approaches on the availability of a macrolide resistance/susceptibility result from a primary clinical specimen. In this report, we investigate potential correlation between macrolide resistance mutation detection rates (identified by a molecular amplified laboratory-developed test) and transcription-mediated amplification-based rRNA target semi-quantitation. Data reveal that rRNA semi-quantitation and laboratory-developed test detection rate differences exist as a function of gender and specimen source. These data can guide providers in proper specimen selection not only for the laboratory diagnosis of M. genitalium but also macrolide resistance mutation determination from primary clinical specimens.

Health Care Disparities and the Emergency Management of Postpartum Patients with Cardiovascular Complaints.

OBJECTIVE: This study aimed to determine health care disparities in evaluation and admission among underserved racial and ethnic minority groups presenting with cardiovascular complaints during the first postpartum year according to patient and provider demographics. STUDY DESIGN: A retrospective cohort study was performed on all postpartum patients who sought emergency care between February 2012 and October 2020 in a large urban care center in Southeastern Texas. Patient information was collected according to International Classification of Diseases 10th Revision codes and individual chart analysis. Race, ethnicity, and gender information were self-reported for both patients on hospital enrollment forms and emergency department (ED) providers on their employment records. Statistical analysis was performed with logistic regression and Pearson's chi-square test. RESULTS: Of 47,976 patients who delivered during the study period, 41,237 (85.9%) were black, Hispanic, or Latina and 490 (1.1%) presented to the ED with cardiovascular complaints. Baseline characteristics were similar between groups; however, Hispanic or Latina patients were more likely to have had gestational diabetes mellitus during the index pregnancy (6.2 vs. 18.3%). There was no difference in hospital admission between groups (17.9% black vs. 16.2% Latina or Hispanic patients). There was no difference in the hospital admission rate by provider race or ethnicity overall (p = 0.82). There was no difference in the hospital admission rate when a patient was evaluated by a provider of a different race or ethnicity (relative risk [RR] = 1.08, CI: 0.6-1.97). There was no difference in the rate of admission according to the self-reported gender of the provider (RR = 0.97, CI: 0.66-1.44). CONCLUSION: This study illustrates that disparities did not exist in the management of racial and ethnic minority groups who presented to the ED with cardiovascular complaints during the first postpartum year. Patient-provider discordance in race or gender was not a significant source of bias or discrimination during the evaluation and treatment of these patients. KEY POINTS: · Adverse postpartum outcomes disproportionately affect minorities.. · There was no difference in admissions between minority groups.. · There was no difference in admissions by provider race and ethnicity..

Disparities between US Hispanic and non-Hispanic women in obesity-related perinatal outcomes: a prospective cohort study.

BACKGROUND: Mortality figures and national health surveillance data have demonstrated that Hispanics have a 24% lower risk of all-cause mortality compared to their non-Hispanic counterparts despite increased rates of obesity and related illnesses. OBJECTIVE: The aim of this study is to evaluate if this paradox exists for obesity-related perinatal outcomes in otherwise low-risk Hispanic women. MATERIALS AND METHODS: A prospective cohort study of low-risk women across all BMI classes with a singleton, non-anomalous term pregnancy admitted in active labor or undergoing induction of labor between May 2014 and April 2017. All demographic, obstetric, and neonatal outcomes were recorded, and the body mass index (BMI) closest to delivery was used for analysis. Data including composites of adverse maternal and neonatal outcomes were compared across BMI classes and between individuals of Hispanic and non-Hispanic ethnicity. Women with antenatal complications, prior cesarean delivery, and cesarean for non-reassuring fetal status were excluded. RESULTS: Of the 11,369 women who met inclusion criteria, 6303 (55%) were Hispanic. Eight percent of Hispanic women were normal weight (BMI: 18.5-24.9), 34% were overweight (BMI: 25-29.9), and 58% were obese (BMI > 30). Fourteen percent of non-Hispanic women were normal weight, 42% were overweight, and 44% were obese. The majority (65%) of women were multiparous. Rate of induction and birthweight increased across BMI for Hispanic and non-Hispanic groups, however the route of delivery was not significantly different (p = .22, 0.16, respectively). Although the association between BMI and composite perinatal complications did not differ by BMI class and ethnicity, the newborns of non-Hispanic women were more likely to be admitted to the neonatal intensive care unit with increasing maternal weight class (<0.001), even after adjusting for age, parity, marital status, prenatal visits, current tobacco use, type of labor, mode of delivery, and birthweight. CONCLUSION: There were no demonstrable differences in composite adverse maternal or neonatal outcomes between Hispanic and non-Hispanic obese women. However, newborns of non-Hispanic obese women were more likely to be transferred to the neonatal intensive care unit with increasing maternal BMI.

Association between Maternal Obesity Class, Adherence to Labor Guidelines, and Perinatal Outcomes.

Background Data are limited concerning rates of perinatal complications in women with a body mass index (BMI) ≥40 kg/m2 compared to women with other BMI classes when guidelines for the safe prevention of the primary cesarean delivery are applied. Objective The aim of the study is to evaluate labor guideline adherence by BMI class and to compare perinatal outcomes across BMI classes with guideline adherent management. Study Design This retrospective study included low-risk women admitted for delivery between April 2014 and April 2017 after the labor guidelines were implemented. BMI closest to delivery was used for analysis. Women with cesarean for nonreassuring fetal status were excluded. Results Guideline adherence decreased with increasing BMI, with 93% adherence among women of normal weight compared to 81% for class III obese women ( p < 0.0001). Among women who had guideline-adherent management, there was increased rates of cesarean among class III versus other obesity classes; however, there were no differences in rates of infectious morbidity ( p = 0.98) or hemorrhage ( p = 0.93). Although newborns of women with class III obesity had higher rates of meconium at birth, neonatal outcomes were not different with increasing maternal BMI ( p = 0.65). Conclusion There were no differences in adverse perinatal outcomes with increasing BMI.

Retrospective analysis of infection and antimicrobial resistance patterns of Mycoplasma genitalium among pregnant women in the southwestern USA.

BACKGROUND: Mycoplasma genitalium is a sexually transmitted infection (STI) pathogen. There have been no published studies concerning symptomatology, prevalence data, antibiotic resistance profiling or reports of co-infection with other STI in pregnant women. OBJECTIVE: To describe these characteristics among pregnant women attending prenatal clinics in a large tertiary care centre. DESIGN: Remnant genital samples collected from pregnant women between August 2018 and November 2019 were tested for M. genitalium and Trichomonas vaginalis by the transcription-mediated amplification technique. Specimens with detectable M. genitalium RNA were sequenced for 23S rRNA mutations associated with azithromycin resistance and parC and gyrA mutations associated with resistance to moxifloxacin. Demographic, obstetric and STI co-infection data were recorded. RESULTS: Of the 719 samples, 41 (5.7 %) were positive for M. genitalium. M. genitalium infection was associated with black race, Hispanic ethnicity and young age (p=0.003, p=0.008 and p=0.004, respectively). M. genitalium infection was also associated with T. vaginalis co-infection and Streptococcus agalactiae (group B Streptococcus) colonisation (p≤0.001 and p=0.002, respectively). Of the 41 positive samples, 26 (63.4%) underwent successful sequencing. Eight (30.8%) had 23S rRNA mutations related to azithromycin resistance. One of 26 (3.8%) positive samples with sequencing results had the gyrA gene mutation and 1 of 18 sequenced samples (5.6%) had the parC gene mutation associated with moxifloxacin resistance. CONCLUSIONS: Prevalence rates of M. genitalium in pregnant women was 5.7%. M. genitalium infection disproportionately affects young black women co-infected with T. vaginalis. Pregnant women remain at risk for persistent infection with M. genitalium due to decreased azithromycin susceptibility.

The coronavirus disease 2019 vaccine in pregnancy: risks, benefits, and recommendations.

The coronavirus disease 2019 has caused over 2 million deaths worldwide, with over 412,000 deaths reported in Unites States. To date, at least 57,786 pregnant women in the United States have been infected, and 71 pregnant women have died. Although pregnant women are at higher risk of severe coronavirus disease 2019-related illness, clinical trials for the available vaccines excluded pregnant and lactating women. The safety and efficacy of the vaccines for pregnant women, the fetus, and the newborn remain unknown. A review of maternal and neonatal coronavirus disease 2019 morbidity and mortality data along with perinatal vaccine safety considerations are presented to assist providers with shared decision-making regarding vaccine administration for this group, including the healthcare worker who is pregnant, lactating, or considering pregnancy. The coronavirus disease 2019 vaccine should be offered to pregnant women after discussing the lack of safety data, with preferential administration for those at highest risk of severe infection, until safety and efficacy of these novel vaccines are validated.

Amniotic fluid embolism syndrome: analysis of the Unites States International Registry.

BACKGROUND: Incidence, risk factors, and perinatal morbidity and mortality rates related to amniotic fluid embolism remain a challenge to evaluate, given the presence of differing international diagnostic criteria, the lack of a gold standard diagnostic test, and a significant overlap with other causes of obstetric morbidity and mortality. OBJECTIVE: The aims of this study were (1) to analyze the clinical features and outcomes of women using the largest United States-based contemporary international amniotic fluid embolism registry, and (2) to investigate differences in demographic and obstetric variables, clinical presentation, and outcomes between women with typical versus atypical amniotic fluid embolism, using previously published and validated criteria for the research reporting of amniotic fluid embolism. MATERIALS AND METHODS: The AFE Registry is an international database established at Baylor College of Medicine (Houston, TX) in partnership with the Amniotic Fluid Embolism Foundation (Vista, CA) and the Perinatology Research Branch of the Division of Intramural Research of the NICHD/NIH/DHHS (Detroit, MI). Charts submitted to the registry between August 2013 and September 2017 were reviewed, and cases were categorized into typical, atypical, non-amniotic fluid embolism, and indeterminate, using the previously published and validated criteria for the research reporting of AFE. Demographic and clinical variables, as well as outcomes for patients with typical and atypical AFE, were recorded and compared. Student t tests, χ2 tests, and analysis of variance tables were used to compare the groups, as appropriate, using SAS/STAT software, version 9.4. RESULTS: A total of 129 charts were available for review. Of these, 46% (59/129) represented typical amniotic fluid embolism and 12% (15/129) atypical amniotic fluid embolism, 21% (27/129) were non-amniotic fluid embolism cases with a clear alternative diagnosis, and 22% (28/129) had an uncertain diagnosis. Of the 27 women misclassified as an amniotic fluid embolism with an alternative diagnosis, the most common actual diagnosis was hypovolemic shock secondary to postpartum hemorrhage. Ten percent (6/59) of the women with typical amniotic fluid embolism had a pregnancy complicated by placenta previa, and 8% (5/61) had undergone in vitro fertilization to achieve pregnancy. In all, 66% (49/74) of the women with amniotic fluid embolism reported a history of atopy or latex, medication, or food allergy, compared to 34% of the obstetric population delivered at our hospital over the study period (P < .05). CONCLUSION: Our data represent a series of women with amniotic fluid embolism whose diagnosis has been validated by detailed chart review, using recently published and validated criteria for research reporting of amniotic fluid embolism. Although no definitive risk factors were identified, a high rate of placenta previa, reported allergy, and conceptions achieved through in vitro fertilization was observed.

Successful Detection of Unrecognized Rickettsia typhi in Pregnancy Using Cell-Free Next-Generation Sequencing.

Flea-borne (murine) typhus is caused by Rickettsia typhi. Infection in pregnant women can lead to adverse outcomes when diagnosis and treatment is delayed. We describe how next-generation sequencing (NGS) using the Karius® test was used to rapidly diagnose murine typhus in two pregnant women admitted to a large tertiary care center in Houston, Texas, when all initial testing was nondiagnostic.

Congenital syphilis: A contemporary update on an ancient disease.

Congenital syphilis (CS) rates reached a 20-year high in the United States in 2018. Unlike previous years, most babies diagnosed with CS were born to mothers who received prenatal care, indicative of the need for better provider education and guideline adherence. Current rates suggest that screening for syphilis should be performed at the first prenatal care visit and twice during the third trimester. There are two diagnostic algorithms available for use in the United States (traditional and reverse) and providers must understand how to perform each algorithm. Treatment should be administered according to stage of syphilis per Centers for Disease Control recommendations with best neonatal outcomes seen when treatment is initiated >30 days before delivery. Benzathine Penicillin G remains the only recommended treatment of syphilis during pregnancy. In viable pregnancies, a pretreatment ultrasound is recommended to identify sonographic evidence of fetal infection and treatment should be initiated with continuous fetal monitoring to evaluate for the Jarisch-Herxheimer reaction which can cause preterm labor and fetal distress. After adequate syphilotherapy, a fourfold decline in maternal nontreponemal titers may not be observed by delivery and does not correlate with rates of CS.

Efficacy of different cerclage suture materials in reducing preterm birth.

Objective: To compare the efficacy of monofilament suture, braided polyester thread, and 5 mm tape suture in reducing preterm birth (PTB).Study design: Women who received a cerclage at Touro Infirmary, New Orleans, LA, USA, between 1 January, 2011 and 31 December, 2016 were identified using ICD-9/10 codes. All charts were reviewed for demographic and obstetrical variables including gestational age (GA) at delivery.Results: Of 145 women who received a cerclage, 36 were excluded due to incomplete charts leaving 109 for analysis. There was no significant difference in gestational age at cerclage placement or delivery among women with monofilament, braided, or 5 mm tape cerclages (p = .936 and p = .919, respectively) nor was there a difference in the proportion who delivered at ≥32, 34, or 37 weeks across groups with differing cerclage material (p = .270, p = .275, and p = .419, respectively). There was no difference in GA at delivery for patients who received 17-OHP compared to those who did not (p = .362). There were also no differences with respect to birth outcomes such as birthweight (p = .938), Apgar scores (p = .477, p = .430) or neonatal intensive care admission rates (NICU) (p = .304). Analysis revealed no difference in characteristics between groups including history of PTB or indication for removal (p = .371, p = .317).Conclusion: We found no difference in pregnancy prolongation when comparing different suture material used for indicated cerclages. We also found no differences with respect to rates of maternal infection or adverse neonatal outcomes among groups.RationaleThis study was conducted to evaluate the efficacy of different suture materials in increasing gestational age at delivery and reducing preterm birth.

Cervical Pessary versus Expectant Management for the Prevention of Delivery Prior to 36 Weeks in Women with Placenta Previa: A Randomized Controlled Trial.

Objective This multicenter randomized controlled trial compared cervical pessary (CP) versus expectant management (EM) in women with placenta previa between 22.0 and 32.0 in prolonging gestation until ≥ 36.0 weeks' gestation. Study Design This study took place from November 2016 to June 2018. Women were randomized to receive either the Bioteque CP or EM. The pessary was removed at ≥ 36.0 weeks unless indicated. The primary outcome was gestational age (GA) at delivery, with secondary outcomes including need for transfusion, number and duration of antepartum admissions, type of delivery, and neonatal outcomes. A total of 140 patients were needed to show a 3-week prolongation of pregnancy in the pessary group; however, the trial was stopped early due to budgetary issues. Results Of the 33 eligible women, 17 were enrolled. Although not statistically significant, the mean GA at delivery in the CP group was greater than women in the EM group (36.5 ± 1.23 vs. 36.0 ± 2.0; p = 0.1673). The number and duration of antepartum admissions was greater in the EM group (2.7 ± 0.58 vs. 16.0 ± 22.76 days; p = 0.1264) as well. Conclusion Although the study was underpowered to determine the primary outcome, safety and feasibility of CP in pregnancies complicated with previa were demonstrated.

Challenges in the Contemporary Management of Syphilis among Pregnant Women in New Orleans, LA.

Objective: The aim of this retrospective review is to evaluate trends in the management of maternal and congenital syphilis (CS) in a tertiary care center in New Orleans, LA. Study Design: All cases of maternal and neonatal syphilis over a five year period at Touro Infirmary, New Orleans, LA, were identified using ICD-9/10 codes. Charts were reviewed for demographic and obstetrical variables, stage of syphilis at diagnosis, lab values, and treatment regimen. Newborn treatment and other outcomes were recorded. Results: During the study period 106 infected mother-baby pairs were identified. Of these, 73 charts are available for review. 41% (n = 30) of women received inadequate therapy according to their stage of disease. 9% of newborns (n = 6) were found to be symptomatic for CS; however, only 83.3% of these were admitted to the neonatal intensive care unit. Only 20% (n = 6) of infants were adequately treated with an extended penicillin regimen if the mother was not adequately treated. Furthermore, only 63.0% of newborns had a nontreponemal titer performed. Conclusion: With rising rates of CS, strict adherence to the 2015 CDC guidelines for treatment of syphilis must be maintained.

The strong correlation between neonatal early-onset Group B Streptococcal disease and necrotizing enterocolitis.

BACKGROUND: Necrotizing enterocolitis (NEC) is a leading cause of newborn gastrointestinal emergencies, affecting 1-3 per 1000 live births. Although NEC has been linked to a microbial etiology, associations with maternal intrapartum and resultant newborn early-onset invasive Group B streptococcus (EO-GBS) have been weakly defined. OBJECTIVE: The study aim was to determine the relationship between EO-GBS and NEC. STUDY DESIGN: Data from 2008 to 2015 were collected from pediatric records with ICD diagnosis codes consistent with all stages of NEC, with the exception of neonatal EO-GBS data (only available 2011-2015). RESULTS: For the 131 newborns meeting inclusion criteria, the mean gestational age (GA) and birthweight at delivery was 30.2 weeks and 1449 g. Maternal comorbidities were not associated with a more advanced stage of NEC, however male gender (OR 3.2, p < .001), lower mean 1 (OR = 0.89, p = .045) and 5 min Apgar scores (OR = 0.84, p = .009) were significantly associated with higher NEC stage, after controlling for GA. Infectious morbidities including chorioamnionitis (OR = 1.5, p = .553) and intrapartum antibiotic administration (OR = 1.3, p = .524) were not significantly associated with higher NEC stage. Neither neonatal sepsis workup (OR = 0.27, p = .060) nor positive blood culture (OR = 0.97, p = .942) prior to NEC diagnosis were statistically significant. Type of feed prior to diagnosis (p = .530) was not significantly associated with NEC stage, however, expressed breast milk tended to be protective against higher stage of NEC (OR = 0.49, p = .055). Type of feed included total parenteral nutrition, mother's or donor expressed breast milk, trophic, full and high calorie feeds. Of the 579 newborns admitted from 2011 to 2015, 13 (2%) were diagnosed with EO-GBS and 64 met diagnostic criteria for NEC. GBS positive newborns had significantly higher odds of NEC (OR = 5.37, p = .009). NEC stage was not significantly different for patients with GBS positive vs. GBS negative mothers (p = .732), nor was there a significant difference in GA (p = .161). CONCLUSION: Our study is the first to describe a strong correlation between neonatal EO- GBS disease and NEC, with more than a five-fold increase in the odds of developing NEC in newborns of GBS positive mothers. PURPOSE: To investigate a possible relationship between EO-GBS disease and the neonatal diagnosis of NEC. Secondary analysis will determine if maternal antepartum and intrapartum factors along with neonatal variables contribute to a more advanced stage of NEC by retrospective chart review of patient data collected at Children's Hospital: New Orleans.

Efficacy of maternal and neonatal chemoprophylaxis for early-onset group B streptococcal disease.

OBJECTIVE: To estimate the rate of early-onset group B streptococcal (GBS) neonatal sepsis with combined maternal and neonatal chemoprophylaxis. METHODS: Since 1995, GBS chemoprophylaxis at our institution has consisted of intrapartum antibiotic prophylaxis to all women with identified risk factors. In addition, a single dose of penicillin G was administered within 1 hour of birth to all newborns without clinical signs or symptoms of infection. All neonates born between January 1, 2000, and December 31, 2008, and who developed early-onset (occurring at 72 hours of age or younger) invasive bacterial disease were identified. Incidence rates for sepsis resulting from GBS and other organisms were estimated. Compliance with risk factor identification and appropriate treatment was also ascertained. Rates of ß-lactam resistance among cases of neonatal disease caused by Gram-negative organisms were calculated. RESULTS: Ninety-four cases of early-onset GBS sepsis were identified among 143,467 live births with a rate of 0.66 per 1,000 births (0.53-0.80 per 1,000). Of available GBS sensitivities, 8.8% demonstrated clindamycin resistance, and 26.6% were resistant to erythromycin. Thirty-four cases of non-GBS early-onset sepsis were identified for a rate of 0.24 per 1,000 live births. Of available sensitivity reports, 42.1% of Gram-negative isolates were sensitive to ß-lactams. No significant difference in rates of early-onset GBS disease was found between the years 1995 and 2008. CONCLUSION: The sustained rates in early-onset GBS sepsis from 1995 to 2008, along with the low rates of neonatal disease caused by other pathogens, confirms the continued feasibility and efficacy of a combined maternal and neonatal GBS chemoprophylaxis.

Intrapartum evidence of early-onset group B streptococcus.

OBJECTIVE: To estimate if neonates with early-onset group B streptococcus (GBS) sepsis have clinical evidence of fetal infection during labor or at delivery. METHODS: Retrospective cohort study of all neonates diagnosed with GBS sepsis by culture and clinical findings within the first 72 hours of life from January 1, 2000, through December 31, 2008, at Parkland Health and Hospital System. Medical records were reviewed and maternal, neonatal, and delivery data were ascertained. These neonates then were compared with all neonates delivered during the same time period. RESULTS: During the study period, 143,384 live-born neonates were delivered at our institution; 94 were diagnosed with early-onset GBS sepsis. The majority of these neonates (n=93) were diagnosed with early-onset GBS within the first hour of life. Neonates with early-onset GBS sepsis had a significant increase in preterm delivery, cesarean delivery (total and for fetal distress), 1- and 5-minute Apgar scores of 3 or lower, umbilical cord pH less than 7.0, and a base deficit of 12 mmol/L or higher. In addition, nulliparity differed between those with early-onset GBS and those without (74% compared with 33%, P<.001) as did chorioamnionitis rates (62% compared with 8%, P<.001). CONCLUSION: We believe that these findings are compelling evidence that fetuses with early-onset GBS may have signs of sepsis peripartum. We hypothesize that these data support the concept that early-onset GBS represents a spectrum of infection that often precedes birth.