Pregnant Patients Research Articles

P061 A comparative analysis of Systemic Lupus Erythematosus, Rheumatoid arthritis and Juvenile Idiopathic Arthritis pregnancy outcomes: Results from a three-year prospective, case-controlled, single centre study of 183 patients

Abstract Background/Aims Patients with inflammatory rheumatic diseases (IRD) have an increased risk of adverse pregnancy outcomes (APO), although the comparative risk of APO in rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) and systemic lupus erythematosus (SLE) pregnancies has not been directly compared. Therefore, this study examined pregnancy outcomes (PO) of subjects with RA, JIA, and SLE, who had all received pre-pregnancy counselling to ensure disease control, to identify whether there are any differences in APO between each individual IRD group. Pregnancy outcomes were compared with healthy pregnant subjects lacking IRD, to determine the comparative risk of APO in RA, JIA and SLE pregnancies. Methods A prospective case-controlled study was conducted at University College London Hospital from February 2018 to February 2021. A total of 183 patients were enrolled into the study, consisting of 120 pregnant patients including 60 patients with an IRD (n = 29 RA, n = 12 JIA and n = 19 SLE), 60 pregnant patients without any IRD and 63 non-pregnant patients with IRD (n = 30 RA, n = 12 JIA, n = 21 SLE). Pregnancy outcome data was obtained from all pregnant patients and the individual IRD groups’ outcomes were compared to each other and against outcomes from pregnancies without an IRD. Results Patients were predominantly Caucasian, ranging from 17-45 years of age. Of 111 reported PO, 99.09% (n = 110) resulted in a live birth (n = 27 (100.00%) RA, n = 11 (100.00%) JIA, n = 18 (94.74%) SLE versus n = 54 (100.00%) pregnancies without IRD). Overall, 5.56% (n = 1 SLE pregnancy) resulted in a spontaneous early trimester miscarriage, 6.36% (n = 7) were pre-term births (n = 3 (11.11%) RA, n = 1 (9.09%) JIA, n = 2 (11.11) SLE pregnancies versus n = 1 (1.85%) pregnancy without IRD). No stillbirths/foetal deaths were reported. Only two maternal complications were reported (n = 1 Group B strep infection, n = 1 gestational diabetes in RA pregnancies). In total six foetal complications were observed in four RA (n = 1 each for enlarged kidney, tongue tied, neonatal jaundice and Group B strep infection), n = 1 JIA (tongue tied) and n = 1 SLE (prolapsed cord) pregnancies. In relation to disease activity statuses in pregnancy, the majority of IRD pregnant patients were in remission (n = 42 (73.68%), n = 18 RA, n = 6 JIA and n = 18 SLE), 28 (49.12%) IRD patients had low disease activity (n = 8 RA, n = 2 JIA and n = 18 SLE) and nine (15.79%) had moderate/high disease activity (n = 6 RA, n = 2 JIA and n = 1 SLE). Only two (3.51%) RA patients reported disease flares during pregnancy, whereas no JIA/SLE patients experienced any flares. Conclusion This first prospective case-controlled study of RA, JIA, SLE and healthy pregnancies has identified favourable and comparable PO between IRD pregnancies with good disease control. This study highlights the importance and need for IRD pregnant women to undergo pre-pregnancy counselling and maintenance of disease control during pregnancy to enhance the chances of successful pregnancy outcomes. Disclosure H. Nguyen: None. D.A. Isenberg: Consultancies; AstraZeneca, Merck Serono, Eli Lilly, Servier, Genentech. D.J. Williams: Grants/research support; National Institute for Health Research University College London Hospitals Biomedical Research Centre. I. Giles: Grants/research support; UCB Pharma.

Coronavirus disease 2019 in pregnancy: clinical manifestations, maternal, and perinatal outcomes

Background and objective: The current COVID-19 pandemic has become a main health threat worldwide and concerns have been raised regarding the effect of the Covid-19 infection on the wellbeing of pregnant women and their unborn baby. This study aimed to determine the clinical manifestations in addition to maternal and perinatal outcomes in pregnant women with confirmed COVID-19. Methods: A cross sectional study conducted in the Maternity Teaching Hospital and some private obstetric clinics in Erbil city/Kurdistan region, Iraq. The study started from the 1st April 2020 until the end of April of 2021. Seventy-one women who represent all infectedwithCOVID-19 during that period during pregnancy who were 16 years old or more were included in the study. Swabs were taken from nasopharynx by citoswab were diagnosed by quantitative real-time polymerase chain (qRT-PCR) at central laboratory of Erbil city/Iraq. The data were collected through direct interview with the patients using a special questionnaire, prepared for this purpose. Results: More than half (53.5%) of participants were 25-34 years old, 80.3% of women were housewives and 29.6% of them were illiterate. The majority (87.3%) of women did not have chronic illnesses and 43.7% of them were in second trimester during COVID-19 infection. The following symptoms were reported: fever (91.5%), cough (80.3%), headache (77.5%), weakness (73.2%), loss of smell (69%), aguesia (67.6%), sore throat (66.2%), arthralgia and myalgia (64.8%), flu like illness (62%), dyspnea (39.4 %), and diarrhea and/or vomiting (26.8%). The majority (84.51%) of women did notreport any fetal complications or none has happened and 1.4% of the fetuses suffered from fetal distress and FGR. Caesarean section was the commonest mode of delivery. A significant statistical association was found between age group and fetal complications suggesting that fetal complications increased with becoming older. Conclusion: Manifestations such as fever, sore throat, cough, headache, fatigue, loss of smell and taste, arthralgia and myalgia were commonly observed in Covid-19 pregnant patients. Cough was still the highest reported symptom followed by weakness and dyspnea even six months post Covid-19 infection. Adverse maternal and neonatal outcomes were observed in pregnant patients infected with Covid-19.

Immune Responses of Healthy Pregnant Women following an Elective Cesarean Section: Effects of Anesthetic Procedures.

A weakened immune system and more inflammatory cytokines being released are possible effects of the surgical stress that a cesarean section induces. This kind of reaction, in addition to the altered reaction to catecholamines, has the potential to significantly affect the immune system of the mother and the patients' general postoperative course. This prospective study compared the plasma levels of catecholamines and cytokines in healthy pregnant patients having cesarean sections under spinal anesthesia versus general anesthesia. A total of 30 pregnant women undergoing elective cesarean sections were divided into two groups: 15 who received general anesthesia (GA) and 15 who received spinal anesthesia (SA). Blood samples were collected from all subjects before anesthesia induction (pre-OP), 6 h postoperatively (6 h post-OP), and 12 h (12 h post-OP), to measure levels of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), IL-8, IL-4, IL-10, norepinephrine (NE), and epinephrine (EPI). When we compared the two groups, we discovered that only IL-6 and IL-4 had significantly higher levels pre-OP, whereas all studied cytokines exhibited an increase in the GA versus SA group at 6 and 12 h post-OP. In the case of catecholamines, we discovered that serum levels are positively related with pro-inflammatory or anti-inflammatory cytokines, depending on the time of day and type of anesthetic drugs. Compared to SA, GA has a more consistent effect on the inflammatory response and catecholamine levels. The findings of this study confirm that the type of anesthesia can alter postoperative immunomodulation to various degrees via changes in cytokine and catecholamine production. SA could be a preferable choice for cesarean section because it is an anesthetic method that reduces perioperative stress and allows for less opioid administration, impacting cytokine production with proper immunomodulation.

P017 Planned infliximab use during pregnancy for pakistani patients with immune-mediated inflammatory disease - case series of 12 patients

Abstract Background/Aims Immune-mediated inflammatory diseases (IMIDs) affect mostly young females during their reproductive age. Therefore, a better understanding is needed about the possible disease effects in pregnancy, as well as the risks of fetal exposure to the medications used. Studies have shown that anti-TNF are considered safe and do not increase the risk of adverse events during pregnancy. Nevertheless, the data is quite limited, hence fall in FDA pregnancy category B. We wish to report a series of 12 pregnant women with IMIDs who were intentionally being treated with infliximab for the treatment of active intractable IMIDs. Methods The study included pregnant patients with IMIDs who were treated using anti-TNF between January 2021 to July 2023 at Fatima Memorial Hospital and Doctors Hospital & Medical Centre, Lahore. All patients receiving infliximab were reviewed by a dedicated medical team, who maintained a detailed medical record of each visit. The patients were prospectively followed up and the neonatal outcome was also recorded. Results 12 pregnant women with IMIDs received Infliximab during this study. All these patients required >7.5mg of deltacortil to control their arthritis and hence decision was made to add bDMARDs. 10 patients successfully completed their pregnancies uneventfully and two additional patients are in the later stages of pregnancy. Seven patients had complete remission of their underlying IMIDs and the rest had overall good improvement but continued to have low grade active disease. All our patients presented a satisfactory response to treatment and the pregnancy progressed without any complications. Median gestational week of birth was 38 with a median birth weight of 3490 grams. Conclusion This is the first reported series from Pakistan of intentional infliximab use throughout pregnancy. Our data, combined with many other studies, suggests that anti-TNF is safe during pregnancy and its benefits in achieving control of IMIDs may outweigh the risk of foetal exposure to the drug. This is further supported by the available data suggesting the inflammatory activity as the main risk factor for unfavourable outcome. However, the benefits and risks must be discussed with the patient and management decisions should be taken on individual basis. Disclosure Z. Tayyab: None. M. Haroon: None.

Hemophagocytic lymphohistiocytosis in pregnancy—a case report

Hemophagocytic lymphohistiocytosis (HLH) is a life-threatening condition that is a rare occurrence in pregnancy and can be elusive in its diagnosis thereby delaying treatment. We report the case of a 30-year-old female patient at 36 weeks of pregnancy who presented with a persistent fever that did not respond to antibiotics. After we investigated her thoroughly, considering the persistent fever, we performed a bone marrow biopsy as part of the workup for prolonged pyrexia. We diagnosed her with HLH secondary to cytomegalovirus pneumonia. As her laboratory investigations fulfilled the criteria for HLH we treated her with the appropriate therapy using a multidisciplinary approach, resulting in her complete recovery. HLH should be considered a potential differential diagnosis in pregnant patients complaining of persistent fever, cytopenia, or declining clinical condition despite delivery of the baby.

Effect of Ureaplasma/Mycoplasma genital tract infection on preterm labor.

Genitourinary tract infections in pregnant women are one of the causes of abnormal pregnancy development including miscarriages, premature labor or premature rupture of membranes (PPROM). Atypical bacteria responsible for reproductive tract infections include Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum. Identification of pathogens and appropriately selected therapy can improve obstetric outcomes in patients with symptoms of threatened miscarriage or threatened preterm labor. The purpose of our study is to analyze the impact of reproductive tract infections with ureaplasma and mycoplasma bacteria during pregnancy. In the presented study, we retrospectively analyzed the cases of 201 pregnant patients hospitalized in the Obstetrics and Gynecology Department of Poznan Regional Hospital in 2019-2022, who had a swab taken from external os area of the cervix for atypical bacteria - Ureaplasma and Mycoplasma. Only patients with symptoms of threatened miscarriage or threatened preterm labor were included in the study group. Microbiological tests were performed in the hospital laboratory with the Mycoplasma IST 3 test from Biomerieux. We found a higher incidence of preterm labor in patients with symptoms of threatened preterm labor and a genital tract infection with Ureaplasma/Mycoplasma bacteria, compared to patients not infected with Mycoplasma/Ureaplasma - 31.1% vs 20% (p = 0.098). This observation in the case of Ureaplasma/Mycoplasma monoinfection group applied to 6 patients. - 75% of the group. Pregnant patients who had co-infection with other types of bacteria (48 patients in total) gave birth before 37 weeks of pregnancy in 27.1% of cases. We obtained a significant difference (p = 0.007) when comparing groups with positive and negative cultures for Ureaplasma/Mycoplasma by the presence of monoinfection/coinfection and the week of pregnancy in which delivery occurred. We also noted the effect of atypical bacterial infection for PPROM - this complication preceded preterm delivery in 40% of ureaplasma-positive patients, compared to 20% of PPROM without infection. We found a similar rate of preterm labor and pregnancy loss in Ureaplasma/Mycoplasma-positive patients who received antibiotic therapy (35.7%) compared to a group of pregnant women who did not receive treatment (31.6%). Infection of the genital tract with atypical bacteria Ureaplasma and Mycoplasma has a negative impact on the course of pregnancy. Identification of the type of microorganisms in cervical canal secretions of pregnant patients with symptoms of threatened miscarriage or preterm labor seems crucial. The impact of antibiotic therapy though, requires further analysis.

Maternal and Fetal Outcomes in Pulmonary Hypertension During Pregnancy: A Contemporary Nationwide Analysis

BackgroundPulmonary hypertension (PH) disproportionately affects women, presenting challenges during pregnancy. Historically, patients with PH are advised to avoid pregnancy; however, recent reports have indicated that the incidence of adverse events in pregnant females with PH may be lower than previously reported. MethodsWe conducted a retrospective cohort study in pregnant patients with PH using the National Readmission Database from January 1, 2016, to December 31, 2020. PH was categorized according to the World Health Organization (WHO) classification. Primary endpoints include maternal mortality and 30-day non-elective readmission rate. Other adverse short term maternal (cardiovascular and obstetric) and fetal outcomes were also analyzed. ResultsAmong 9,922,142 pregnant women, 3,532 (0.04%) had pulmonary hypertension (PH), with Group 1 PH noted in 1,833 (51.9%), Group 2 PH in 676 (19.1%), Group 3 PH in 604 (17.1%), Group 4 PH in 23 (0.7%), Group 5 PH in 98 (2.8%), and multifactorial PH in 298 (8.4%). PH patients exhibited higher rates of adverse cardiovascular events (15.7% vs. 0.3% without PH, p < 0.001) and mortality (0.9% vs. 0.01% without PH, p < 0.001). Mixed PH and Group 2 PH had the highest prevalence of adverse cardiovascular events among WHO PH groups. Patients with PH had a significantly higher non-elective 30-day readmission rate (10.4% vs. 2.3%) and maternal adverse obstetric events (24.2% vs. 9.1%) compared to those without PH (p < 0.001) (Figure 1). ConclusionPregnant women with PH had significantly higher adverse event rates, including in-hospital maternal mortality (85-fold), compared to those without PH.

Editor’s Pick: Correlation of Cutaneous Manifestations with the Severity of Disease in Patients with Chronic Kidney Disease and Effect of Hemodialysis: An Observational Study

Aim: Chronic kidney disease is a non-communicable disease, and is the sixth fastest growing contributor of morbidity and mortality. Hemodialysis is one of the important therapeutic modalities that can improve survival in these patients, and can increase their life expectancy, but the cutaneous disorder can precede or follow the initiation of hemodialysis. Methods: This is a retrospective, observational study with a sample size of 250 patients, with a glomerular filtration rate &lt;60 mL/min/1.73 m2 for a minimum duration of 3 months or more, undergoing hemodialysis. Patients post-renal transplant, HIV-positive cases, and pregnant patients were excluded from the study. Studied cases were recruited equally into two groups: the dialytic group (Group A) and non-dialytic group (Group B). Results: In the authors’ study, the prevalence of dermatological manifestations was 79% in the dialytic group and 75% in the non-dialytic group. The most common finding overall was xerosis (58%), which was more common in the dialytic (66%) group, both in number of patients and severity. The second most common finding was pallor (55%), which was seen more in the dialytic group (60%). Other major findings were pruritus (49%) and hyperpigmentation (37%). The intensity of pruritus was higher in non-dialytic patients. Specific cutaneous manifestations, such as Kyrle’s disease, were seen only in eight patients. Skin infections were seen in 17% of patients overall, and there was no major difference seen in both groups. The prevalence of nail findings, mucosal changes, and hair changes was also high in the dialytic group. Other specific cutaneous manifestations, like calciphylaxis, uremic frost, and nephrogenic fibrosing dermopathy, were not seen in the authors’ study. Hemodialysis has increased the life expectancy of patients with end-stage renal disease and has also brought about a rise in the number of manifestations, by giving time for these changes to occur. The severity of symptoms was also higher in patients on dialysis. This could be because of the higher mean duration of disease in the dialytic group compared to the non-dialytic group. Conclusion: Dermatological manifestations of chronic kidney disease were significantly associated with the mean duration of disease, which was higher in patients on dialysis. There was a higher prevalence of non-specific dermatological findings, such as xerosis, hyperpigmentation, nail findings, hair, and mucosal changes in the dialytic group, except pruritus. Any such cutaneous marker in the absence of a primary dermatological problem warrants a thorough search, including blood, urine, and radiological investigations, to rule out kidney disease.

Benefits of a prolonged-release amino acid mixture in four pregnant women with phenylketonuria.

Background: Maternal phenylketonuria (mPKU) is a pathologic condition occurring in the fetus of a mother with PKU that is caused by prolonged elevated intrauterine blood phenylalanine (Phe) levels, which can lead to congenital abnormalities and mental retardation of newborns. Management of PKU during pregnancy can be challenging as protein substitutes may exacerbate nausea, vomiting, and gastrointestinal symptoms. Aim: To report the successful management of four PKU pregnant women. Methods: The patients were administered with prolonged-release amino acid supplementation and were recommended to follow a strict diet. Blood Phe concentration, adherence to diet, and occurrence of adverse events were monitored. Results: All patients achieved safe levels of blood Phe concentration (120-360 µmol/L) since preconception and during pregnancy (mean Phe concentration values of 143.34 ± 137.59, 226.48 ± 194.57, 186.68 ± 133.67, and 187.47 ± 42.59 µmol/L). During the first trimester of pregnancy, all patients manifested gastrointestinal symptoms such as nausea, gastrointestinal reflux, and abdominal bloating, which were managed by either changing protein substitute or extending the time window between different meals and amino acid mixtures administration. The four women continued their pregnancies without experiencing further complications and delivered neonates with normal growth parameters and no malformations. Conclusion: Findings of this case series suggest that the intake of a prolonged-release amino acid mixture in granules is well tolerated by pregnant PKU patients, eventually leading to good metabolic control and fetal growth within normal ranges.

Pregnancy and acromegaly: clinical outcomes of retrospectively analysed data from the German acromegaly registry

ContextAcromegaly is a rare disease caused by excessive growth hormone (GH) secretion, mostly induced by pituitary adenomas. The care of pregnant women with acromegaly is challenging, in part due to existing clinical data being limited and not entirely consistent with regard to potential risks for mother and child.ObjectiveTo retrospectively examine data on pregnancy and maternal as well as neonatal outcomes in patients with acromegaly.Design & methodsRetrospective data analysis from 47 pregnancies of 31 women treated in centers of the German Acromegaly Registry.Results87.1% of the studied women underwent transsphenoidal surgery before pregnancy. In 51.1% a combination of dopamine agonists and somatostatin analogs were used before pregnancy. Three women did not receive any therapy for acromegaly. During pregnancy only 6.4% received either somatostatin analogs or dopamine agonists. In total, 70.2% of all documented pregnancies emerged spontaneously. Gestational diabetes was diagnosed in 10.6% and gravid hypertension in 6.4%. Overall, no preterm birth was detected. Indeed, 87% of acromegalic women experienced a delivery without complications.ConclusionPregnancies in women with acromegaly are possible and the course of pregnancy is in general safe for mother and child both with and without specific treatment for acromegaly. The prevalence of concomitant metabolic diseases such as gestational diabetes is comparable to the prevalence in healthy pregnant women. Nevertheless, larger studies with more data in pregnant patients with acromegaly are needed to provide safe and effective care for pregnant women with this condition.

Risk prediction model based on machine learning for predicting miscarriage among pregnant patients with immune abnormalities.

Introduction: It is known that patients with immune-abnormal co-pregnancies are at a higher risk of adverse pregnancy outcomes. Traditional pregnancy risk management systems have poor prediction abilities for adverse pregnancy outcomes in such patients, with many limitations in clinical application. In this study, we will use machine learning to screen high-risk factors for miscarriage and develop a miscarriage risk prediction model for patients with immune-abnormal pregnancies. This model aims to provide an adjunctive tool for the clinical identification of patients at high risk of miscarriage and to allow for active intervention to reduce adverse pregnancy outcomes. Methods: Patients with immune-abnormal pregnancies attending Sichuan Provincial People's Hospital were collected through electronic medical records (EMR). The data were divided into a training set and a test set in an 8:2 ratio. Comparisons were made to evaluate the performance of traditional pregnancy risk assessment tools for clinical applications. This analysis involved assessing the cost-benefit of clinical treatment, evaluating the model's performance, and determining its economic value. Data sampling methods, feature screening, and machine learning algorithms were utilized to develop predictive models. These models were internally validated using 10-fold cross-validation for the training set and externally validated using bootstrapping for the test set. Model performance was assessed by the area under the characteristic curve (AUC). Based on the best parameters, a predictive model for miscarriage risk was developed, and the SHapley additive expansion (SHAP) method was used to assess the best model feature contribution. Results: A total of 565 patients were included in this study on machine learning-based models for predicting the risk of miscarriage in patients with immune-abnormal pregnancies. Twenty-eight risk warning models were developed, and the predictive model constructed using XGBoost demonstrated the best performance with an AUC of 0.9209. The SHAP analysis of the best model highlighted the total number of medications, as well as the use of aspirin and low molecular weight heparin, as significant influencing factors. The implementation of the pregnancy risk scoring rules resulted in accuracy, precision, and F1 scores of 0.3009, 0.1663, and 0.2852, respectively. The economic evaluation showed a saving of ¥7,485,865.7 due to the model. Conclusion: The predictive model developed in this study performed well in estimating the risk of miscarriage in patients with immune-abnormal pregnancies. The findings of the model interpretation identified the total number of medications and the use of other medications during pregnancy as key factors in the early warning model for miscarriage risk. This provides an important basis for early risk assessment and intervention in immune-abnormal pregnancies. The predictive model developed in this study demonstrated better risk prediction performance than the Pregnancy Risk Management System (PRMS) and also demonstrated economic value. Therefore, miscarriage risk prediction in patients with immune-abnormal pregnancies may be the most cost-effective management method.

Effects on ondansetron of post-dural puncture headache after cesarean section under spinal anesthesia

Background: Spinal anesthesia is commonly performed for cesarean section, however, post-dural puncture headache (PDPH) is one of its most common adverse effects. Ondansetron is an antiemetic for cancer treatment and analgesia-induced nausea and vomiting. In this study, we aim to evaluate the effect of postoperative ondansetron on PDPH. Methods: In this randomized controlled clinical trial study, 120 Pregnant patients are ASA ll, undergoing elective cesarean section, were randomized into two groups (placebo or study). The patients in the study group , immediately after the birth of a baby and 24 hours after the operation, received ondansetron 4 mg IV while the placebo group received a placebo. The severity and incidence of headache, postoperative nausea and vomiting, dizziness, neck and lower back pain and the use of analgesia was assessed in the two groups. Results: The significant meaning of the time effect (P&lt;0.001) indicated that regardless of the group, for each unit increase in time, the chance of developing a headache increased by 23%, which was statistically significant. Also, the significant meaning of the group effect indicated that regardless of time, patients who did not take indomethacin had approximately 4.11 times higher chances of developing a headache compared to those who received the medication, which was statistically significant (P=0.004). Conclusion: The administration of ondansetron significantly reduces the occurrence of post-spinal anesthesia headaches and neck pain. There was no significant difference in headache severity between the two study groups.

A validated method for simultaneous quantification of four antiretrovirals in dried blood spot and plasma using LC-MS/MS: Application to efavirenz therapeutic drug monitoring in pregnant patients

IntroductionThe specific physiological background induced by pregnancy leads to significant changes in maternal pharmacokinetics, suggesting potential variability in plasma concentrations of antiretrovirals. Pregnant HIV patients exposed to subtherapeutic doses, particularly in the last trimester of the pregnancy, have higher chances to transmit the infection to their children. Therefore, the therapeutic drug monitoring of antiretrovirals in HIV pregnant patients would be of great value. ObjectivesThis study aimed to develop and validate a sensitive liquid chromatograph tandem mass spectrometry (LC-MS/MS) method for simultaneous quantification of efavirenz, raltegravir, atazanavir, and ritonavir in dried blood spots (DBS) and plasma. Design and MethodsThe analytes were extracted from the DBS punch and plasma with a mixture of methanol:zinc sulfate 200 mM (50:50, v/v) and 100 % methanol, respectively. For the chromatographic separation a Shim-pack® C18, 4.6 mm × 150 mm, 5 μm column was used. Detection was performed in a 3200-QTRAP® mass spectrometer, with a run time of 6 min. ResultsThe assay was linear in the range of 15–1,000 ng/mL for raltegravir, 50–10,000 ng/mL for both atazanavir and ritonavir, 50–5,000 ng/mL for efavirenz. Precision and accuracy at these concentrations were less than 15 % for all analytes. Raltegravir, atazanavir, and ritonavir were stable for seven days at 23 °C and 40 °C, whereas efavirenz was stable for twenty-four hours at the same conditions. ConclusionsThe method was successfully applied to quantify efavirenz in DBS samples obtained from HIV-1 infected pregnant volunteers under antiretroviral therapy. The concentrations of efavirenz in DBS and plasma were comparable according to Passing-Bablok regression and Bland-Altman analysis.

Retrospective Cohort Study Comparing the Clinical Profile and Outcomes of Critically Ill Pregnant Patients in Kuwait During the COVID-19 Pandemic Waves.

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 virus). This virus evolved into several variants, each with different severity. There are surges in the numbers of infected patients, commonly described as "waves". In Kuwait, three waves occurred. Our study describes and compares the clinical presentation and outcomes of critically ill pregnant patients infected with different variants. This was a retrospective cohort study in two intensive care units (ICU) dedicated to patients with COVID-19. The wave periods were retrieved from the Kuwait Ministry of Health. The total number of ICU admissions during the study period was 74 patients. Most cases occurred during the third wave (n = 47/74, 63.5%). Most patients did not have comorbidities. The most common presenting symptoms were fever 62.2%, dyspnea 71.6%, and dry cough 74.3%. Low oxygen saturation 35.1% and maternal tachycardia 75.7% were observed in most patients. Cesarean section was the most common route of delivery, with maternal indication accounting for most cases 78.84.%. Eight patients (13.69%) underwent dialysis, and thirty-one (41.9%) needed extracorporeal membrane oxygenation (ECMO). Most patients required ventilatory support 66.21%. Almost all patients were unvaccinated 97.01%. Maternal mortality was mainly noted in the third wave (13.23%). In Kuwait, the number of admissions and the rate of maternal complications, morbidity, and mortality increased with successive waves.

A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS

A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patients posted for elective LSCS

Identifying Pregnant Patients With Suspected Intimate Partner Violence.

Intimate partner violence (IPV) is the leading cause of death in pregnant women. Although it can be difficult to identify patients experiencing IPV, injuries to the head, neck, or face due to an assault are known to correlate with intentional injury. The objective of this study is to assess the contemporary burden of IPV in pregnancy and describe the patient characteristics. The National Inpatient Sample was queried for all pregnant women between January 2016 and December 2019. Patients were divided into two groups: suspected IPV (SIPV) and no-SIPV groups. We defined SIPV as any pregnant patient with an identified head, neck, or face injuries categorized as intentional assault. Multivariable logistic regression analysis was performed to assess the association between SIPV and variables of interest. A total of 28,540 pregnant patients presented with traumatic injuries with 530 (.02%) identified as SIPV. Suspected IPV patients were younger (25 vs 27 years, P = .012), more likely to be of Black race (46% vs 28%, P = .002), more likely to be in the lowest income quartile (51% vs 38%, P = .031), less likely to have private insurance (12% vs 34%, P < .001), and have higher rates of substance use disorder (35% vs 18%, P < .001). Black race and history of substance use disorder were associated with increased odds of SIPV-related injuries (odds ratio [OR]: 2.01, interquartile range [IQR]: 1.27-3.16, P = .003 and OR: 2.30, IQR 1.54-3.43, P < .001, respectively). Our results suggest that there are significant racial and socioeconomic disparities in potential risk for IPV during pregnancy.

An unfavorable and a successful pregnancy outcome during and after treatment of gamma heavy chain disease.

Gamma heavy chain disease (gHCD) is a rare B-cell lymphoproliferative disorder that mostly occurs after childbearing age. Here we report the first case of gHCD in a pregnant patient that was diagnosed in the second trimester, and another pregnancy in the same patient after initial treatment for gHCD. The former pregnancy ended in intrauterine fetal death, believed to be caused by insufficient maternal blood flow due to multiple placental infarcts. The latter pregnancy course was uneventful. Although we cannot rule out the possibility that the poor outcome of the former pregnancy was due to an unfortunate complication independent of gHCD, the courses of these pregnancies suggest that non-lymphomatous gamma heavy chain may have a significant impact on pregnancy and that its removal by treatment may improve outcomes.

Masqueraded sebaceous gland carcinoma of the lower eyelid in ayoung pregnant patient.

The purpose of this case report is to present misdiagnosed sebaceous gland carcinoma of the lower eyelid with rapid growth in ayoung woman during pregnancy. Eyelid sebaceous gland carcinoma is arelatively rare tumor and adisease primarily of older patients. It occurs more commonly in oriental populations and with apredilection for the upper eyelid. Early diagnosis and appropriate treatment may help improve disease control and patient survival.

Equitable Representation of Pregnant and Lactating Women in Clinical Research: A Historical Review and Critical Analysis of Proposed Legislation.

A long history of policymaking and regulation constructed for the purpose of ensuring adequate fetal and infant protections has inadvertently sanctioned the widespread exclusion of pregnant and lactating patients from biomedical research, leaving a paucity of high quality data necessary for clinical decision-making. Although well-intended, the regulatory classification of pregnant women as "vulnerable", in conjunction with burdensome enrollment criteria and other factors weighing against broad inclusion, have ultimately placed the health and safety of these women and their babies in jeopardy. Robust measures are urgently needed to overcome patient and physician reluctance, address substantial evidence gaps and rectify longstanding disparities which precipitate disproportionately poor health outcomes among this population. In February 2023, the Advancing Safe Medications for Moms and Babies Act of 2023 (the Act) was introduced in the United States House of Representatives with the overarching goal of enabling pregnant and lactating women to achieve equitable participation in clinical research and contribute to developing important biomedical knowledge to guide and improve healthcare delivered to these patients. This review discusses the historical influence of federal human subject protection regulations on the health and clinical treatment of pregnant and lactating women, outlines and critically analyzes the provisions incorporated into the Act, and reflects on the potential long-term impact the Act would have should it be successful in becoming law.

Defining an Evaluation Protocol for the Infant with Fetal Echogenic Bowel.

This study aimed to develop an algorithm for pediatricians to use for infants diagnosed with fetal echogenic bowel (FEB) to ensure that each patient is fully evaluated for possible complications while avoiding unnecessary morbidity and mortality and healthcare associated costs. This was a prospective cohort of neonates for which a diagnosis of FEB was made during a Level 2 anatomy ultrasound between February 2016 and January 2017. Women diagnosed with FEB were offered perinatal genetic counseling and testing. These women also received increased third trimester fetal surveillance, including daily fetal kick counts, fetal growth scans every 3-4 weeks beginning at 28 weeks, and weekly fetal NST and/or BPP beginning at 32 weeks. After delivery, neonates received a postnatal evaluation including birth weight, gestational age at birth, presence of other abnormalities, and associated perinatal morbidity and mortality. Comparison between findings was performed using Chi-square test. All statistical evaluation was performed using SPSS. Among 919 pregnant patients who received Level 2 anatomy ultrasounds at a Regional Perinatal Center during the study period, 70 received a diagnosis of FEB. Of those diagnosed with FEB, 52 (74.3%) delivered at the same Regional Medical Center. Of those 52 delivered infants, 3 (5.8%) were IUFDs and 4 (7.6%) had unaffected twins. Only 1 multifetal gestation had the diagnosis of FEB in both twins. Only 19 of the infants delivered had a KUB performed secondary to prematurity or abnormal exams. This study showed that the majority of infants diagnosed with FEB have a normal exam following delivery, and that most of the neonatal outcomes of NICU admissions and other neonatal complications are a result of prematurity rather than FEB. Although the algorithm did not have significant results, it is easy to follow and implement in larger studies.