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Evaluating Drug Safety in Pregnancy: A Hospital-Based Study on TGA Classification and Prescription Practices in Indonesia

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Abstract
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Pregnant women are frequently prescribed medications, yet limited data exist on the safety profiles of these drugs in low-resource settings. The Therapeutic Goods Administration (TGA) classification system is a critical tool to evaluate fetal risks, but its application in Indonesian clinical practice remains understudied. This study aimed to analyze prescription patterns and TGA safety categories of drugs prescribed to pregnant women at a tertiary hospital in Indonesia. A cross-sectional study was conducted using medical records of 374 pregnant women at Bunda Arif Hospital (2021-2022). Drugs were classified according to TGA categories (A, B1, B2, B3, C, D, X). Data were analyzed descriptively (frequencies, percentages) and compared across trimesters. Most patients (63%) received one drug, primarily electrolytes/minerals/vitamins (67%). Based on TGA classification, 33% of drugs were Category A (safe), while 27% were Category D (e.g., high-dose Vitamin A). Notably, Category D drugs were increasingly prescribed across trimesters (12% in 1st trimester to 46% in 3rd trimester). No Category X drugs were identified. Conclusion: Despite overall adherence to safe prescribing (Category A), the high prevalence of Category D drugs, particularly Vitamin A, highlights a critical gap in perinatal pharmacovigilance. Clinicians should prioritize evidence-based guidelines to mitigate potential teratogenic risks in pregnancy.

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  • Research Article
  • Cite Count Icon 1
  • 10.33533/jpm.v17i2.5800
Challenges in the Diagnosis and Management of Intracranial Abscess in Developing Countries: A Retrospective Study from a Tertiary Hospital in Indonesia
  • Nov 22, 2023
  • Jurnal Profesi Medika : Jurnal Kedokteran dan Kesehatan
  • Akhmad Imron + 3 more

Despite progressive development of antibiotics and surgical approaches, outcomes in patients with intracranial abscess remained far from ideal. This paper aimed to describe challenges in the diagnosis and treatment of intracranial abscess in developing countries based on study from a tertiary hospital in Indonesia. A retrospective study was performed and included patients who were suspected of intracranial abscess at a tertiary referral hospital in Indonesia between January 1, 2012 and January 1, 2020. Clinical, radiological and laboratory characteristics were analyzed. Two-hundred-and-seventy-seven patients were initially enrolled. Age (p = 0.001), GCS at admission (p = 0.009), comorbidity with hypoalbuminemia (p = 0.003) and hydrocephalus (p = 0.009) are significantly associated with patients’ GCS when discharged. Results from culture and resistance tests could only be retrieved from 66 patients, with 33 (50%) obtained negative results, while the other 33 (50%) results were positive, consisted of 20 (60.6%) were of gram-negative bacteria and 13 (39.4%) were of gram-positive bacteria. Treatments that are directed to hypoalbuminemia and hydrocephalus should also be prioritized when any of these comorbidities exist.

  • Research Article
  • 10.7860/jcdr/2025/75911.21170
Trimester Specific Effect of Pregnancy on Maternal Cognitive Function using Critical Flicker Fusion Frequency: A Cross-sectional Study
  • Jul 1, 2025
  • JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH
  • J Roshni + 2 more

Introduction: Critical Flicker Fusion Frequency (CFFF) measures cognitive function by detecting the threshold at which flickering light appears steady. This threshold reflects neural processing and cortical arousal, making it useful for diagnosing conditions like Alzheimer’s and schizophrenia. During pregnancy, hormonal fluctuations can cause cognitive symptoms (“pregnancy brain”). Monitoring cognition ensures safety, productivity, and early detection of complications like pre-eclampsia. Despite importance, CFFF research during pregnancy is limited, especially across trimesters. Aim: To find out objective cognitive changes in various trimesters of pregnancy using CFFF in primigravid women and compare with non pregnant women. Materials and Methods: The present observational crosssectional study was conducted from October 2023 to March 2024 in the Department of Physiology of Velammal Medical College Hospital and Research Institute, Madurai, Tamil Nadu, India. The study involved 155 primigravid women in various trimesters and 50 non pregnant women in the age group of 21-25 years. The subjects were categorised into three groups. Group A- 1st trimester group with Gestational Age (GA) between 0-13 weeks, Group B - 2nd trimester group with GA between 14- 27 weeks, Group C- 3rd trimester with GA between 28-40 weeks. CFFF was measured in all these groups and the association was analysed. CFFF was measured with CFF M1 model instrument (Mavom Labs, Bangalore) using Netra software. Data were statistically analysed by using Chi-square test. Results: The study included 53 pregnant primigravid women in the 1st trimester, 51 in the 2nd trimester, 51 in the 3rd trimester, and 50 non pregnant samples of similar age, marital status and with the average husband’s income of 42,261.29 with significant variability (SD= 28,048.74). A significant decrease in CFFF values were observed in 1st (p-value <0.001) and 3rd (p-value <0.001) trimesters in pregnant women when compared to non pregnant individuals. The 2nd trimester showed a significant increase in CFFF (p-value <0.001). Conclusion: The CFFF measurements could provide a useful tool for identifying individuals at risk of more severe cognitive decline or sensory processing difficulties during pregancy and take appropriate measures. Introduction: Critical Flicker Fusion Frequency (CFFF) measures cognitive function by detecting the threshold at which flickering light appears steady. This threshold reflects neural processing and cortical arousal, making it useful for diagnosing conditions like Alzheimer’s and schizophrenia. During pregnancy, hormonal fluctuations can cause cognitive symptoms (“pregnancy brain”). Monitoring cognition ensures safety, productivity, and early detection of complications like pre-eclampsia. Despite importance, CFFF research during pregnancy is limited, especially across trimesters. Aim: To find out objective cognitive changes in various trimesters of pregnancy using CFFF in primigravid women and compare with non pregnant women. Materials and Methods: The present observational crosssectional study was conducted from October 2023 to March 2024 in the Department of Physiology of Velammal Medical College Hospital and Research Institute, Madurai, Tamil Nadu, India. The study involved 155 primigravid women in various trimesters and 50 non pregnant women in the age group of 21-25 years. The subjects were categorised into three groups. Group A- 1st trimester group with Gestational Age (GA) between 0-13 weeks, Group B - 2nd trimester group with GA between 14- 27 weeks, Group C- 3rd trimester with GA between 28-40 weeks. CFFF was measured in all these groups and the association was analysed. CFFF was measured with CFF M1 model instrument (Mavom Labs, Bangalore) using Netra software. Data were statistically analysed by using Chi-square test. Results: The study included 53 pregnant primigravid women in the 1st trimester, 51 in the 2nd trimester, 51 in the 3rd trimester, and 50 non pregnant samples of similar age, marital status and with the average husband’s income of 42,261.29 with significant variability (SD= 28,048.74). A significant decrease in CFFF values were observed in 1st (p-value <0.001) and 3rd (p-value <0.001) trimesters in pregnant women when compared to non pregnant individuals. The 2nd trimester showed a significant increase in CFFF (p-value <0.001). Conclusion: The CFFF measurements could provide a useful tool for identifying individuals at risk of more severe cognitive decline or sensory processing difficulties during pregancy and take appropriate measures.

  • Research Article
  • 10.35975/apic.v29i1.2658
Anesthesia ready time for emergency surgery at the 24-hour operating room of the central surgical installation in a tertiary hospital in Indonesia
  • Feb 3, 2025
  • Anaesthesia, Pain & Intensive Care
  • Erwin Pradian + 2 more

Background: Anesthesia Ready Time (ART) is the time required by an anesthesiologist, calculated from the time the monitor is placed on the patient until the patient is declared by the anesthesiologist to be ready for the surgery. ART varies based on the patient's ASA classification, equipment availability, preoperative invasive procedures, drug preparation, and waiting for the surgical team. The aim of this study was to determine the ART of patients undergoing emergency surgery and identify the affecting factors at a tertiary hospital in Indonesia. Methodology: Samples were collected from patients consulted for emergency surgery at the 24-hour Central Operating Room of a tertiary hospital in Indonesia from August 2023 until February 2024, that included 116 patients. We used consecutive sampling and non-probability data collection methods. Results: Overall, in 91.4% of cases, ART complied with the standards, with an average of 14.22 min. All regional spinal procedures met the standard, while general anesthesia procedures achieved the standard by 98.46%. The lowest ART rate was for regional epidural procedures, at 30.76%. Based on ASA status, only samples with ASA status 3 achieved a 100% compliance rate. While samples with ASA status 1 achieved 88%, and ASA status 2 achieved 89.7%. Several causes influenced prolonged ART in 8.6% of cases. Difficulty with the anesthesia procedure was the most common (60%), followed by waiting for the surgical team (30%), and monitor malfunction at 10%. Conclusion: Anesthesia ready time in our tertiary hospital in Indonesia is satisfactory. Factors found to influence prolonged anesthesia ready time were mostly correctable ones. Keywords: Anesthesia; Anesthesia Ready Time; ART; Emergency Surgery Citation: Pradian E, Kestriani ND, Putra GA. Anesthesia ready time for emergency surgery at the 24-hour operating room of the central surgical installation in a tertiary hospital in Indonesia. Anaesth. pain intensive care 2025;29(1):32-39. DOI: 10.35975/apic.v29i1.2658 Received: May 09, 2024; Reviewed: October 26, 2024; Accepted: January 01, 2025

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  • Cite Count Icon 7
  • 10.15562/bmj.v11i1.3376
Dealing with tests and treatments for HIV, syphilis, and hepatitis B infection to prevent mother-to-child transmission (MTCT) from a tertiary hospital in Indonesia
  • Apr 22, 2022
  • Bali Medical Journal
  • Maya Wardiana + 7 more

Background: Mother-to-child transmission (MTCT) of Human Immunodeficiency Virus (HIV), syphilis, and Hepatitis B can cause a health burden and lead to morbidity and mortality in children. An attempt to eliminate the transmission has been made worldwide. This study aimed to evaluate the triple elimination of MTCT for HIV, syphilis, and hepatitis B in a tertiary hospital in Indonesia. Methods: We evaluated 690 medical records of new pregnant women seeking antenatal care (ANC) in a tertiary hospital in the east part of Indonesia from January to December 2018. Results: HIV, syphilis, and hepatitis B testing were performed on 97 patients (14.1%). HIV and hepatitis B, HIV and syphilis, and syphilis and hepatitis B testing were performed on 149 (21.6%), 6 (0.9%), and 6 (0.9%) patients, respectively. The prevalence of HIV, syphilis and hepatitis B was 4.2%, 0.4%, and 3.8%, respectively. HIV treatment by administering antiretroviral therapy (ART) was done in 86.2% of patients. Injection of benzathine penicillin G as the treatment of syphilis was done in 66.7% of syphilis patients. HBV DNA examination followed by tenofovir administration was done in 3.8% of hepatitis B patients. Conclusion: The testing rate of HIV, syphilis, and hepatitis B in pregnant women in a tertiary hospital in the east part of Indonesia in 2018 (14.1%) was below the target set by World Health Organization (≥ 95%). Increasing access to antenatal screening as early detection is the key to preventing mother-to-child transmission (MTCT).

  • Research Article
  • 10.20473/joints.v13i2.2024.61-68
Characteristics and Management of Neck and Trochanteric Femur Fractures at a Tertiary Hospital in Indonesia: A Retrospective, Single-Center Study
  • Oct 31, 2024
  • (JOINTS) Journal Orthopaedi and Traumatology Surabaya
  • Ndilalah Pulungan + 4 more

Background: Although hip fractures are common among the elderly population, there are still limited studies on neck-trochanteric fractures, one of the less common types of hip fractures. This study aims to describe the characteristics of patients and their management in patients with neck trochanteric fractures. Methods: This retrospective cross-sectional study analyzed medical records of patients aged >18 years with trochanteric fractures from a tertiary hospital in Central Java, Indonesia, between January and December 2021. Fracture types were identified and classified using the Garden, Pauwels, and AO/OTA classifications. Demographic data, risk factors, fracture locations, and treatment types were also collected. Statistical analysis was performed using SPSS 21.0 to describe patient characteristics. Results: The total sample was 77 patients, most were female (n = 55 (71.4%)) and aged > 60 years. More than a third of diagnosed fractures were neck of the femur fractures in 33 patients (42.9%). Among the most common classification types of fractures were Garden Type 3, Pauwels Type 3, and AO/OTA type A1.1. A total of 33 patients (42.9%) underwent open reduction of the fracture with internal fixation. Conclusions: Our findings show that the prevalence of neck-trochanteric fractures mostly occurs in patients > 60 years of age and in females. Although open reduction with internal fixation is generally performed, there are several cases of fractures that are not classifiable due to limited imaging examinations. Further research on a wider population is needed to confirm the findings of this study.

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  • Cite Count Icon 4
  • 10.1071/ah22008
Use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration in approving new medicines: a cross-sectional study.
  • May 5, 2022
  • Australian Health Review
  • Joel Lexchin

Objective Examine the use of priority and provisional approval pathways by the Australian Therapeutic Goods Administration (TGA) for evaluating new medicines. Methods This observational study assessed all new medicines approved by the TGA between 1 January 2018 and 18 October 2021. It examined how frequently priority and provisional approval pathways are being used, the conditions which the medicines are being approved to treat, how long medicines are spending in the approval pathways, the additional therapeutic value of the medicines being approved through these pathways and how the use of the pathways compares with similar regulatory pathways used by Health Canada. Results The TGA approved 138 new medicines in the time period under study, of which 33 were approved through either the priority or provisional approval pathways. Sixteen were approved to treat cancer. It took the TGA a mean of 130 (95% CI 118, 143) and 144 (95% 101, 188) working days for priority and provisional pathways, respectively. Therapeutic evaluations were available for 16 of these medicines and 11 offered little to no therapeutic gain over existing medicines. There was moderate agreement between the TGA and Health Canada in their use of these pathways (Kappa = 0.5458, 95% CI 0.3900, 0.7016). Conclusions The priority and provisional approval pathways are now being used by the TGA for about one-third of all new medicine approvals. Although the medicines approved in these ways are moving through the review process more quickly than those approved through the standard approval pathway, the majority of these medicines, for which an evaluation of therapeutic value is available, do not offer any substantial additional therapeutic value over existing medicines.

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  • Research Article
  • Cite Count Icon 9
  • 10.1038/s41598-023-43459-2
Risk factors of severe hypoglycemia among patients with type 2 diabetes mellitus in outpatient clinic of tertiary hospital in Indonesia
  • Sep 27, 2023
  • Scientific Reports
  • Em Yunir + 7 more

This study aimed to describe risk factors of severe hypoglycemia in type 2 diabetes mellitus (T2DM) patients in a tertiary care hospital in Indonesia. This study was a retrospective cohort study in the Endocrinology Outpatient Clinic of Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia. All subjects more than 18 years old who had been visiting the clinic for at least a year were included. Subjects were interviewed whether they had any severe hypoglycemia events within the past year, while data on risk factor variables of severe hypoglycemia was taken from medical records one year before data collection. We recruited 291 subjects, among whom 25.4% suffered at least one episode of severe hypoglycemia within one year. History of severe hypoglycemia (OR 5.864, p ≤ 0.001), eGFR less than 60 mL/min/1.73m2 (OR 1.976, p = 0.028), and insulin use (OR 2.257, p = 0.021) were associated with increased risk of severe hypoglycemia. In conclusion, history of previous severe hypoglycemia, eGFR less than 60 mL/min/1.73m2, and insulin use were associated with severe hypoglycemia.

  • Research Article
  • Cite Count Icon 5
  • 10.15562/bmj.v11i2.3498
Trends of ischemic stroke admission during two years of COVID-19 pandemic: A retrospective cross-sectional study at a tertiary hospital in Indonesia
  • Aug 16, 2022
  • Bali Medical Journal
  • Pipit Mei Sari + 2 more

Introduction: There is no much information on how admission rates of non-coronavirus disease 2019 (COVID-19) diseases altered after two years of COVID-19 pandemic. The aim of this study was to determine the pattern of ischemic stroke admission rates within the two years of the COVID-19 pandemic in Indonesia. Method: A cross-sectional retrospective study investigated the admissions data of ischemic stroke was conducted at a tertiary hospital in Indonesia between January 2019 and December 2021. Ischemic stroke patients aged over 18 years old were identified using the ICD-10 I63 code. The data was accumulated every month and analyzed descriptively. We also analyzed the admissions data of ischemic stroke patients with COVID-19 and in-hospital mortality was calculated. Results: There were 2,710 ischemic stroke patients treated between 2019 and 2021 of which the number decreased from 1535 patients in 2019 to 730 in 2020 and only 445 cases in 2021. During 2019-2021, a total of 777 patients (28.67%) died during hospitalization; the most was in 2021 (33.3%). There is a consistent downward trend in ischemic stroke admissions during the COVID-19 pandemic with the monthly average admissions decreased 52.4% in 2020 compared to 2019 and 38.9% in 2021. Despite that, the mortality rate of ischemic stroke patients in the hospital increased from 26.5% in 2019 to 30.4% in 2020, and 33.3% in 2021. The number of ischemic stroke patients coinfected with COVID-19 was 3.5% (26/730) in 2020 and 8.1% (36/445) in 2021. Of all 62 ischemic stroke cases with COVID-19 in 2020-2021, 36 died yielded 58.1% in-hospital mortality rate. Conclusion: The decreased admissions and the increased mortality rate of ischemic stroke patients in particular those coinfected with COVID-19 during the first two years of pandemic should draw government attention to the necessity of improving stroke managements in Indonesia.

  • Research Article
  • Cite Count Icon 2
  • 10.13181/mji.oa.237092
Characteristics of pressure injuries among geriatric patients at an Indonesian tertiary hospital: a cross-sectional study
  • Nov 14, 2023
  • Medical Journal of Indonesia
  • Shannaz Nadia Yusharyahya + 4 more

BACKGROUND Pressure injury develops due to sustained pressure at the bony prominence of the skin and tissues. Geriatric patients often have multiple comorbidities, predisposing them to pressure injury. Data on the characteristics of the geriatric with pressure injuries are still limited. This study aimed to report the characteristics of geriatric patients with pressure injuries admitted at a tertiary hospital in Indonesia. METHODS This cross-sectional study used medical records of geriatric patients admitted with all stages of pressure injuries consulted to the Department of Dermatology and Venereology at a tertiary hospital in Indonesia between January 2017 and April 2021. Pressure injuries were classified based on the 2019 National Pressure Injury Advisory Panel guideline. RESULTS 39 patients presented with varied pressure injury characteristics. The sacral region was the most reported site (36%), with stage 2 pressure injury being the most commonly found stage in the patients (74%). Interestingly, 22% of the patients had pressure injuries found on the atypical sites due to prolonged surgery or the pressure of medical devices. More than half of the patients used conventional dressings (51.3%). Immobility was found in 35.9% of the patients due to being bedridden. CONCLUSIONS No characteristics were found as a significant risk factor for pressure injury formation during or outside the admission period. However, a history of surgery might be related to pressure injury formation during admission.

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  • Cite Count Icon 10
  • 10.1016/j.amsu.2021.01.012
Management of post-cholecystectomy bile duct injuries without operative mortality at Jakarta tertiary hospital in Indonesia – A cross-sectional study
  • Jan 19, 2021
  • Annals of Medicine and Surgery
  • Toar Jean Maurice Lalisang + 4 more

Management of post-cholecystectomy bile duct injuries without operative mortality at Jakarta tertiary hospital in Indonesia – A cross-sectional study

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  • Research Article
  • Cite Count Icon 24
  • 10.3390/ijerph16183440
Adequacy of Nutrients Intake among Jordanian Pregnant Women in Comparison to Dietary Reference Intakes
  • Sep 1, 2019
  • International Journal of Environmental Research and Public Health
  • Reema F Tayyem + 4 more

Objective: Maternal nutrition is considered an important pillar in the pregnancy outcomes for both mother and infant. A mother’s malnutrition and inadequate nutrient intake is associated with many undesirable pregnancy outcomes. Hence, assessing the nutritional status of the mother in the early stages of the pregnancy and preventing any inadequacy can preclude many health problems for both mother and infant. Therefore, this study aimed to assess the adequacy of nutrient intakes among Jordanian pregnant women as compared to their corresponding dietary reference intakes (DRIs). Methods: This cross-sectional study was conducted at a major University Hospital in Jordan. Three hundred pregnant women were invited to participate in the study and 286 agreed to participate. Fifty pregnant women were enrolled at week 9, then 96 pregnant women were at week 20 and 137 pregnant women were at week 30 of pregnancy. The participants completed the interview-based demographic questionnaire, pregnancy physical activity questionnaire, and quantitative food frequency questionnaire (FFQ). Results: The mean energy intake was 2768.9 ± 767.8 kcal/day and it was significantly higher in the 3rd trimester (p < 0.05). Women in the 3rd trimester consumed significantly more protein, carbohydrates, and sugar than women in the 1st and 2nd trimesters (p < 0.05). The pregnant women in the 3rd trimester consumed more sodium than women in the 1st and 2nd trimesters (p < 0.05). The vitamin K intake was significantly (p = 0.045) lower in the 2nd trimester than the 1st and 3rd trimesters. The calcium intake was significantly higher in the 3rd trimester than the 1st and 2nd trimesters (p = 0.021). The total micronutrient (vitamins B1, B2, B3, B6, B12, and D, calcium, and iron) intakes derived from dietary supplements and food sources throughout the 3 trimesters was significantly higher in the 3rd trimester than the 1st and 2nd trimesters (p < 0.05). The vitamin D, calcium, and iron intakes had the most significant increases between the 1st and 3rd trimesters (p < 0.001), while folic acid intake was significantly higher in the 1st trimester than the 2nd and 3rd trimester (p < 0.001). Most women exceeded the tolerable upper intake level (UL) for sodium in all trimesters, while 82% of women exceeded the UL of folic acid in the 1st trimester and from the supplement, not the diet. Conclusion: While the intake of some nutrients from food alone remains below the DRIs in the diets of pregnant women, the intake of other nutrients is above the UL. Raising the awareness of pregnant women about their diet and how a supplement intake can reduce the risk of inadequate intake for many micronutrients and improve their pregnancy outcomes is of great importance.

  • Research Article
  • 10.1055/s-0046-1817789
Febrile Seizures in Children in a Low-Resource Setting: A Hospital-Based Cross-Sectional Study from Eastern Libya.
  • Jan 1, 2026
  • Avicenna journal of medicine
  • Zinelabedin Mohamed + 9 more

Febrile seizures (FSs) are the most common seizure disorder in early childhood, affecting approximately 2 to 5% of children under 5 years of age. Although generally benign, FSs cause significant parental distress and health care utilization and are commonly triggered by childhood infections. Data from low-resource health care settings remain limited. This study aimed to assess the hospital-based prevalence, clinical characteristics, and factors associated with FSs among children in eastern Libya. This retrospective cross-sectional study was conducted from August 1, 2022, to August 31, 2023, at Tobruk Medical Center, a tertiary referral hospital in eastern Libya. A total of 2,604 pediatric admissions of children aged 6 to 60 months were screened, and 140 children admitted with FSs were included. Demographic, clinical, and laboratory data were extracted from medical records and caregiver interviews. Statistical analyses were performed using SPSS version 27. The hospital-based prevalence of FSs was 5.7%, with equal sex distribution. Simple FSs accounted for 87.9% of cases, while complex FSs comprised 12.1%. The median age at seizure onset was 18 months. A family history of epilepsy was significantly more common among children with complex FSs than among those with simple FSs (29.4% vs. 6.5%, p = 0.009). Upper respiratory tract infections were the most frequent precipitating cause of fever (72.8%). Children with complex FSs experienced more frequent seizures during a single febrile illness and had higher white blood cell counts. In this hospital-based study from a resource-limited setting, FSs, predominantly simple FSs, were common among young children. A family history of epilepsy and elevated white blood cell counts were associated with complex FSs, highlighting the importance of risk stratification and context-appropriate management in low-resource health care environments.

  • Research Article
  • 10.15850/amj.v7n3.1924
Hemoglobin Level Decrease after Open Heart Surgery in a Tertiary Hospital in Indonesia
  • Sep 1, 2020
  • Althea Medical Journal
  • Anabella Nifulea + 2 more

Background: Open heart surgery is usually performed by connecting the heart to a cardiopulmonary bypass (CPB) machine. The use of the CPB machine may decrease the hemoglobin level and a very low hemoglobin levelcould cause seriouscomplications.This study aimed to explore the decrease in hemoglobin level after open heart surgery. Methods: A cross-sectional retrospective descriptive study was conducted on medical records of patients underwent coronary artery bypass graft (CABG) surgery and heart valve surgery in a tertiary hospital in Indonesia in 2018. The total sampling method was deployed to all medical records of patients underwent CABG surgery (n=25) and patients underwent heart valve surgery (n=3). Results: The decrease in hemoglobin level among young-adult female patients after heart valve surgery was 6.8 g/dl. The average decrease in mid-adult male and female patients after CABG surgery were 6 g/dl and 5.8 g/dl, respectively, and, after the heart valve surgery, the levels were 8.5 g/dl and 5.4 g/dl, respectively. The average decrease in Hb level among late-adult male and female patients after CABG surgery was 6.1 g/dl and 5.4 g/dl, respectively. Conclusion: Hemoglobin level decreases after an open heart surgery. Therefore, observation on the hemoglobin level to prevent complications and to facilitate early treatment is necessary.

  • Research Article
  • Cite Count Icon 1
  • 10.22494/cot.v11i2.158
Sleep disorders and changes in melatonin concentrations in pregnant women with preeclampsia
  • Nov 30, 2023
  • Cell and Organ Transplantology
  • Ruslan Savka + 1 more

Melatonin plays a significant role in the development of normal pregnancy, in particular, it contributes to the successful implantation of the fertilized egg, affects the act of childbirth, is actively produced by the trophoblast and placenta, reduces oxidative stress, in particular, with preeclampsia. In addition, melatonin is one of the essential hormones in the protection of the endothelium and stem cells from the oxidant stress. Objective – to study the mechanisms of development, terms of manifestation, and types of sleep disorders, as well as changes in the concentrations of melatonin in the blood of pregnant women with preeclampsia. Material and methods. 50 pregnant women at a mean age of 29.1±3.4 years who had preeclampsia in the 3rd pregnancy trimester were examined (experimental group). All women in the research group had a gestation term of 30-32 weeks of pregnancy. The control group consisted of 33 women with a mean age of 31.2±6.6 years who had an uncomplicated pregnancy. The presence of sleep disorders was established using a questionnaire: pregnant women were asked about the term of pregnancy in which complaints of sleep disorders appeared, the nature of sleep disorders, the frequency of episodes of sleep disorders (how many times a week such a condition was noted), etc. The concentration of melatonin in the venous blood of the examined pregnant women was also determined, for which IBL melatonin ELISA diagnostic kits manufactured by IBL, Germany were used. Blood was taken at 9:00 a.m., on an empty stomach, and all patients were analyzed at the same time of a day. Results and their discussion. The study showed that sleep disorders in pregnant women with pre-eclampsia, which complicates the pregnancy in the 3rd trimester, occurred earlier, compared to women with an uncomplicated course of pregnancy: pregnant women with pre-eclampsia were more likely to notice worsening of sleep, starting from 22-30 weeks of pregnancy (in 26.0 % of cases), while in pregnant women with a physiological course of gestation, similar complaints appeared mainly after 30 weeks. In the third trimester of pregnancy women with preeclampsia were more likely to wake up 2 or more times per night (in 68.0 % of cases) compared to controls (in 23.3 % of cases, p &lt; 0.001) and 3 or more times per night per week (in 54.0 % of cases, in controls – in 16.7 % of cases, p &lt; 0.001), which may be a consequence of a disorder of the function of the pineal gland. Women with preeclampsia were more likely (56.0 % vs. 13.3 % in the control group, p &lt; 0.01) to use gadgets (electronic devices, mainly smartphones) for more than 2 hours after 9:00 p.m., which also negatively affects the function of the pineal gland. In pregnant women whose pregnancy was complicated by preeclampsia in the 3rd trimester, a significant (1.78-fold) decrease in the level of melatonin in venous blood taken at 9 a.m. was observed, compared to women with an uncomplicated pregnancy (p = 0.029). Conclusions. Sleep disorders in pregnant women with preeclampsia occur earlier and are more expressed compared to women with an uncomplicated course of pregnancy. The appearance of complaints of insomnia in the second trimester of pregnancy, in our opinion, can be considered a diagnostic sign of pineal gland dysfunction in preeclampsia. A decrease in the level of melatonin in pregnant women with preeclampsia, established against the background of minimal daily activity of the pineal gland (at 9 a.m.), indicates a decrease in the melatonin-producing function of the placenta which might have an impact on the condition of stem cells of fetus and placenta.

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  • Research Article
  • Cite Count Icon 5
  • 10.3389/fimmu.2023.1176898
Panoramic snapshot of serum soluble mediator interplay in pregnant women with convalescent COVID-19: an exploratory study.
  • Apr 12, 2023
  • Frontiers in Immunology
  • Geraldo Magela Fernandes + 38 more

SARS-CoV-2 infection during pregnancy can induce changes in the maternal immune response, with effects on pregnancy outcome and offspring. This is a cross-sectional observational study designed to characterize the immunological status of pregnant women with convalescent COVID-19 at distinct pregnancy trimesters. The study focused on providing a clear snapshot of the interplay among serum soluble mediators. A sample of 141 pregnant women from all prenatal periods (1st, 2nd and 3rd trimesters) comprised patients with convalescent SARS-CoV-2 infection at 3-20 weeks after symptoms onset (COVID, n=89) and a control group of pre-pandemic non-infected pregnant women (HC, n=52). Chemokine, pro-inflammatory/regulatory cytokine and growth factor levels were quantified by a high-throughput microbeads array. In the HC group, most serum soluble mediators progressively decreased towards the 2nd and 3rd trimesters of pregnancy, while higher chemokine, cytokine and growth factor levels were observed in the COVID patient group. Serum soluble mediator signatures and heatmap analysis pointed out that the major increase observed in the COVID group related to pro-inflammatory cytokines (IL-6, TNF-α, IL-12, IFN-γ and IL-17). A larger set of biomarkers displayed an increased COVID/HC ratio towards the 2nd (3x increase) and the 3rd (3x to 15x increase) trimesters. Integrative network analysis demonstrated that HC pregnancy evolves with decreasing connectivity between pairs of serum soluble mediators towards the 3rd trimester. Although the COVID group exhibited a similar profile, the number of connections was remarkably lower throughout the pregnancy. Meanwhile, IL-1Ra, IL-10 and GM-CSF presented a preserved number of correlations (≥5 strong correlations in HC and COVID), IL-17, FGF-basic and VEGF lost connectivity throughout the pregnancy. IL-6 and CXCL8 were included in a set of acquired attributes, named COVID-selective (≥5 strong correlations in COVID and <5 in HC) observed at the 3rd pregnancy trimester. From an overall perspective, a pronounced increase in serum levels of soluble mediators with decreased network interplay between them demonstrated an imbalanced immune response in convalescent COVID-19 infection during pregnancy that may contribute to the management of, or indeed recovery from, late complications in the post-symptomatic phase of the SARS-CoV-2 infection in pregnant women.

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