Introduction. Antibiotics are the most commonly prescribed prenatal medications worldwide, accounting for approximately 80% of all prescription medications for pregnant women. Previous studies have shown that exposure to antibiotics in early life or prenatally is associated with neuropsychiatric disorders, including autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), sleep disorder, conduct disorder, and mood and anxiety disorders. However, some previous studies showed that antibiotic exposure during pregnancy does not appear to affect early childhood socio-emotional development.
Aims. We aimed to investigate the potential association between prenatal antibiotics and the risk of neuropsychiatric disorders in children.
Methods. A nationwide, population-based, birth cohort study (infants, n=3,163,206; paired mothers, n=2,322,735) was conducted in South Korea, with four designs (unmatched, propensity matched, sibling-comparison, and health-screening cohorts). Follow-up continued until the first diagnosis of neuropsychiatric disorder, 31 December 2020 (end of the study period), or the date of death, whichever occurred first.
Results. Antibiotic exposure in both fetal life and infant age was associated with an increased risk of overall neuropsychiatric disorders in childhood (prenatal [HR=1.07, 95%CI {1.05 to 1.08}]; postnatal [HR=1.05, 95% CI {1.03 to 1.07]). There was a synergistic effect of antibiotic exposures occurring both prenatally and postnatally (HR=1.12, 95% CI {1.09 to 1.15}). The association was significant in both common and severe neuropsychiatric disorders, while it was more pronounced in severe outcomes such as anxiety and stress-related disorders, autism spectrum disorders, and mood disorders (excluding those with psychotic symptoms).
Discussion. Prenatal and postnatal exposure to antibiotics can lead to the development of neuropsychiatric disorders, suggesting clinicians take into account the potential for adverse consequences that might not be diagnosed until childhood when assessing the risk-benefit of early-life antibiotic prescription. Our study suggests that antibiotic exposure may influence the risk of neuropsychiatric disorders, but further research is needed to confirm these findings.

- Introduction/Aims
We aimed at estimating the association of COVID-19 vaccination during pregnancy with preterm birth from a national population cohort investigation.
-Methods
Individual-level data of women who gave births between January 1, 2021, and December 31, 2022, along with their infants, were obtained from the National Health Insurance System database. Preterm births were identified based on the ICD-10 codes of preterm birth in neonates and pregnant women. We 1:4 matched mothers who received COVID-19 vaccination during pregnancy to those who did not receive any COVID-19 vaccination during pregnancy based on propensity score (PS) for COVID-19 vaccination during pregnancy. Odds ratios (ORs) for preterm birth per any COVID-19 vaccination during pregnancy were calculated, adjusting for age, residential area, employment status, level of income, presence of disability, season of delivery, and the baby gender. We further compared the OR of preterm birth between the type of vaccines among the vaccinated mothers.
-Result:
Among a total of 106,692 mother and neonate pairs, 8,966 (8.4%) mothers received a COVID-19 vaccination during pregnancy. Of these vaccinated mothers, 78.0% received the Pfizer-BioNTech vaccine, 16.8% received the Moderna vaccine, and 5.1% received the Novavax vaccine. Overall, 7,039 (6.6%) neonates were born preterm. Preterm birth occurred in 5.5% (496/8,966) of vaccinated mothers and 6.6% (2,379/35,848) of their matched controls. The association between COVID-19 vaccination during pregnancy and preterm birth was not evident (OR=0.79, 95% confidence interval [CI]: 0.71, 0.89). The odds ratio of preterm birth was not different between the Pfizer-BioNTech and Moderna vaccines (OR=1.00, 95% CI: 0.76, 1.32) or between the Pfizer-BioNTech and Novavax vaccines (OR=1.17, 95% CI: 0.72, 1.91).
-Conclusion
We observed no increase in the risk of preterm birth among mothers who received a COVID-19 vaccination during pregnancy. Our findings add to the evidence supporting the safety profile of COVID-19 vaccination during pregnancy.

Introduction:
Although pregnant women, who are vulnerable to infections, should be administered vaccines promptly during global disease outbreaks, potential concerns about harmful effects on fetuses disturb their timely vaccination.
Aims:
To evaluate preterm birth, stillbirth, and miscarriage outcomes in pregnant women who were vaccinated COVID-19 vaccine during pregnancy.
Methods:
A retrospective cohort study was conducted on pregnancy episodes of women aged 18-49 occurring between February 27, 2021, and December 31, 2022, using a linked database of the Korea Disease Control and Prevention Agency-COVID-19-National Health Insurance Service cohort (K-COV-N cohort). Each episode was defined using an algorithm validated in previous studies, which distinguishes pregnancy outcomes with both surgical and ICD-10 codes. All episodes were classified into two groups depending on whether they received the COVID-19 vaccination during pregnancy. After 1:3 propensity score (PS) matching for maternal age, residence, insurance type, parity, hypertension status, diabetes status, and last menstrual month, we calculated the relative risk (RR) and 95% confidence intervals (CI) of pregnancy outcomes using a conditional logistic regression model.
Results:
A total of 581,740 pregnancy episodes were identified among 544,649 women, consisting of 440,645 (75.8%) full-term, 15,512 (2.7%) preterm, 3,050 (0.5%) stillbirth, and 122,533 (21.1%) miscarriage episodes. During the pregnancy, 63,394 (10.9%) episodes received at least one dose, with 1,238 for preterm, 510 for stillbirth, and 10,060 for miscarriage episodes. After PS matching, the RRs of the COVID-19 vaccination were 0.61 (95% CI: 0.58-0.65), 1.89 (95% CI: 1.69-2.11), 0.66 (95% CI: 0.65-0.68) for preterm, stillbirth and miscarriage, respectively.
Discussion/Conclusion:
In our study, COVID-19 vaccination reduced the risks of preterm birth and miscarriage. However, unlike previous studies, it increased the risk of stillbirth. Further analysis based on the gestational age at vaccination and the number of doses is needed.

Keywords: COVID-19 vaccine, pregnancy, pregnancy outcome

Introduction
Benzodiazepines and z-drugs readily cross the placenta and fetal blood-brain barrier and may disrupt fetal central nervous system development. Yet, studies on the potential impact of benzodiazepines or z-drugs use during pregnancy on the onset of psychiatric disorders in children remain scarce.
Aims
To investigate the association between prenatal use of benzodiazepines or z-drugs and a spectrum of psychiatric disorders in children.
Methods
Using Korea’s nationwide healthcare database, we identified all pregnancies resulting in live births between 2009 and 2020. Exposure was defined as ≥1 benzodiazepines or z-drugs prescription during pregnancy and unexposed (the referent group) was those without benzodiazepines and z-drugs prescriptions from 1 month before pregnancy to the delivery. The outcome of interest was psychiatric disorders in children, which were further categorized into 13 groups. Children were followed up from birth until diagnoses of psychiatric disorders, death, or end of the study period (2021). Hazard ratio (HR) with a 95% confidence interval (CI) was estimated using the Cox proportional hazard model and propensity score (PS) fine stratification was used to adjust for numerous potential confounders. We additionally conducted sibling comparison analysis and comparison with those exposed to benzodiazepines or z-drugs before pregnancy to account for unmeasured confounders.
Results
Among 3,902,522 children, 86,392 (2.2%) were prenatally exposed to benzodiazepines or z-drugs. The unadjusted estimate was elevated for psychiatric disorders (HR 1.47, 95% CI 1.44-1.50); however, after adjustment, there was no substantial association (1.08, 1.06-1.10). The weighted cumulative incidence of psychiatric disorders at age 13 years was 15.3% for the unexposed group and 16.9% for the exposed group. The results from the sibling comparison analysis (0.98, 0.93-1.03) and the comparison with the past-exposed group (1.02, 1.00-1.04) further supported no association.
Conclusions
This study suggests that benzodiazepines or z-drugs use during pregnancy is not associated with psychiatric disorders in children.

Introduction:
Ensuring medication safety during pregnancy is crucial for pregnancy pharmacovigilance (PregPV). The current adverse event reporting system tends to collect more information on cases with abnormal outcomes while underreporting cases without abnormalities. The Japan Drug Information Institute in Pregnancy (JDIIP) database, which contains data from drug treatment counseling for pregnant women, is expected to address this gap in comprehensive PregPV databases.

Aims:
To evaluate the utility of the JDIIP database by exploring the real-world implications of PregPV.

Methods:
This study included pregnant women who sought consultation with JDIIP between October 2005 and December 2017. We focused on the 2023 Clinical Guidelines for Obstetrical Practice, which serves as Japan’s basic framework for obstetrical care. The guideline includes clinical questions (CQs) and their corresponding answers. To investigate the potential for capturing data on contraindicated drugs not easily collected in spontaneous reports, we selected drugs listed in CQ104-3 (“Which contraindicated drugs, if used only in early pregnancy, can be considered to have no clinically significant fetal effects?”). Using the JDIIP database, we examined the number of patients exposed to these specified drugs to assess real-world drug exposure.

Results:
Among 7,329 women consented to participate, 5,840 had confirmed pregnancy outcomes (80% follow-up rate). We visualized patient background information and drug exposure status for drugs listed in CQ104-3. Drugs such as female hormones (n = 381), fluoroquinolones (n = 353), and antiemetics (n = 313) were used in pregnant women. We confirmed that exposures to these drugs occurred before pregnancy or during the first trimester, highlighting the JDIIP database’s strength in collecting and visualizing drug exposure patterns.

Discussion:
Our findings underscore the significant potential of the JDIIP database as a resource for understanding real-world drug exposure during pregnancy. The JDIIP database is a promising source for advancing PregPV initiatives.

Introduction: Maintaining a balanced and nutritious diet during pregnancy is vital for maternal and fetal health. This study examines maternal dietary patterns and their effect on biochemical parameters in early gestation.
Aim: To understand the impact of diet on maternal health outcomes, particularly regarding iron status and biochemical profiles.
Methodology: A structured questionnaire was employed to collect detailed dietary intake data from pregnant women during their early trimesters. Nutrient intake was analyzed and compared to established dietary guidelines for pregnant women in India. Blood samples were collected and analyzed for various biochemical parameters, including lipid, renal, and hepatic profile parameters. A cross-sectional study design with a sample size of 85 pregnant women in their early trimesters was included. Statistical analysis was done using SPSS software.
Results: Most participants had normal fruit, milk, and salt intake as per the RDA, but low intake of non-vegetarian food in the first trimester and low salt intake and vegetable intake in the second trimester. Lipid parameter (Total cholesterol, HDL, LDL, and triglycerides) dysfunction was persistent in the second trimester when compared to the first (P<0.001). Significant correlations were found between certain dietary factors and biochemical parameters in both trimesters. Iron levels were found significantly lower in patients not taking iron supplements in both trimesters (P=0.003 and <0.001 respectively). Furthermore, a positive correlation was found between milk intake and iron levels (r=0.634,P=0.004) along with salt intake and iron levels (r=0.728, P=0.027). In addition, higher fruit intake was associated with increased HDL levels (r=0.490, P=0.008) and lower milk intake was associated with higher urea levels (r=-0.712, P=0.02).
Conclusions: In conclusion, this study provides valuable insights into early pregnant women's dietary patterns and biochemical parameters during early gestation. The findings underscore the importance of assessing dietary intake and preparation of standard dietary guideline for Indian pregnant women.