Association between hospital case volume and maternal adverse events in patients with placental abruption: An analysis using a Japanese national inpatient database.

OBJECTIVE: To clarify the relationship between the prognosis of patients with placental abruption (PA) and the healthcare delivery system using data from a large national inpatient database in Japan. METHODS: Using the Diagnosis Procedure Combination database, we conducted a retrospective cohort study with the data of patients in almost 1000 hospitals with the primary diagnosis of PA who were hospitalized from April 2014 to March 2021. We divided the hospitals into four groups based on the number of deliveries per month. We performed multilevel logistic regression analysis to analyze the relationship between hospital case volume and maternal end-organ injury (MEOI). RESULTS: Altogether, 8222 patients were included for analysis; among whom, 3575 (44%) were transferred by ambulance. MEOI was noted in 977 patients (12%) with no obvious difference by hospital case volume. Ambulance transfer, age, gestational weeks at admission, delivery on the first day of hospitalization, and history of eclampsia were significantly associated with a higher incidence of MEOI, but the hospital case volume was not. CONCLUSION: Using a Japanese administrative database, our study shows that hospital case volume was not significantly associated with the severity of maternal illness among patients with PA.

Antiemetic Effect of Rikkunshito, a Japanese Kampo Herbal Medicine, on Cisplatin-induced Nausea and Vomiting: A Nationwide Database Study in Japan.

Objective The effect of Rikkunshito, a Japanese herbal Kampo medicine, on chemotherapy-induced nausea and vomiting (CINV) has been evaluated in several small prospective studies, with mixed results. We retrospectively evaluated the antiemetic effects of Rikkunshito in patients undergoing cisplatin-based chemotherapy using a large-scale database in Japan. Methods The Diagnosis Procedure Combination inpatient database from July 2010 to March 2019 was used to compare adult patients with malignant tumors who had received Rikkunshito on or before the day of cisplatin administration (Rikkunshito group) and those who had not (control group). Antiemetics on days 2 and 3 and days 4 and beyond following cisplatin administration were used as surrogate outcomes for CINV. Patient backgrounds were adjusted using the stabilized inverse probability of treatment weighting, and outcomes were compared using univariable regression models. Results We identified 669 and 123,378 patients in the Rikkunshito and control groups, respectively. There were significantly fewer patients using intravenous 5-HT3-receptor antagonists in the Rikkunshito group (odds ratio, 0.38; 95% confidence interval, 0.16-0.87; p=0.023) on days 2 and 3 of cisplatin-based chemotherapy. Conclusion The reduced use of antiemetics on day 2 and beyond of cisplatin administration suggested a beneficial effect of Rikkunshito in palliating the symptoms of CINV.

Hospital case volume and maternal adverse events following abnormal deliveries: Analysis using a Japanese national in-patient database.

OBJECTIVE: To clarify the relationship between the number of deliveries and maternal outcomes in Japan, considering the declining birth rate and the evidence that hospitals with few deliveries have medical safety issues. METHODS: Hospitalizations for deliveries were analyzed using the Diagnosis Procedure Combination database from April 2014 to March 2019, after which maternal comorbidities, maternal end-organ injury, medical treatment during hospitalization, and hemorrhage volume during delivery were compared. Hospitals were divided into four groups based on the number of deliveries per month. RESULTS: A total of 792 379 women were included in the analysis, among whom 35 152 (4.4%) received blood transfusions, with a median blood loss of 1450 mL during delivery. Regarding complications, pulmonary embolism was significantly more frequent in hospitals with the lowest number of deliveries. CONCLUSION: Using a Japanese administrative database, this study suggests an association between hospital case volume and the occurrence of preventable complications, such as pulmonary embolisms.

Significance of positive peritoneal cytology for recurrence and survival in patients with endometrial cancer.

AIM: This study aims to examine the association between malignant peritoneal cytology and prognosis in women with endometrial cancer. METHODS: We retrospectively analyzed the records of patients with endometrial cancer who underwent surgery with intraoperative peritoneal cytology at our hospital between January 1988 and December 2012. All results were reclassified according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) system, and the relation between intraoperative peritoneal cytology results and recurrence and prognosis was examined. RESULTS: Of the 908 patients analyzed, 205 (22.6%) had positive peritoneal cytology. Patients with positive peritoneal cytology had significantly lower rates of recurrence-free survival (RFS) and overall survival (OS) than those in the negative cytology group (both p < 0.001). Subgroup analysis of patients with FIGO stage I/II showed significantly lower RFS in the positive-cytology group (p = 0.005), but there was no significant difference in OS (p = 0.637). In the patients with FIGO stage III/IV or patients classified as "high risk," the RFS and OS were significantly lower in the positive-cytology group (both p < 0.001). Cox regression analysis identified positive peritoneal cytology as a significant predictor of recurrence in patients with FIGO stage I/II disease. CONCLUSIONS: Patients with positive peritoneal cytology for endometrial cancer have a high risk of recurrence, regardless of histopathologic type or FIGO stage. Peritoneal cytology has already been removed from the 2009 FIGO classification of endometrial cancer, but it may deserve reconsideration.

Postoperative adverse events and re-treatment among patients who have undergone laparoscopic and robotic sacrocolpopexy for pelvic organ prolapse in Japan.

OBJECTIVE: To describe and compare the postoperative adverse events and re-treatment for recurrence after laparoscopic and robotic-assisted sacrocolpopexy in Japanese patients with pelvic organ prolapse (POP). METHODS: This was a retrospective cohort study using the DeSC database, which contains claims and medical check-up data provided by DeSC Healthcare Inc., Tokyo, Japan. We identified all patients who had undergone either laparoscopic or robotic-assisted sacrocolpopexy from April 2014 to May 2021. Patient backgrounds and postoperative outcomes were compared between the laparoscopic and robotic-assisted sacrocolpopexy groups. Moreover, the composite adverse event comprising vaginal erosion, postoperative urinary incontinence, postoperative dysuria, urinary tract injury, and abdominal incisional hernia was evaluated. Re-treatment for POP recurrence included pessary use and surgery for POP was also evaluated. RESULTS: Among 28 748 patients diagnosed with POP, 409 (1.4%) had undergone laparoscopic sacrocolpopexy and 52 (0.2%) had undergone robotic-assisted sacrocolpopexy. The prevalence of postoperative adverse events was 20.8% and 13.5% in the laparoscopic and robotic-assisted sacrocolpopexy groups, respectively (P = 0.270). One patient (1.9%) underwent surgery after robotic-assisted sacrocolpopexy, and none of the patients was administered pessaries postoperatively in both groups. CONCLUSION: In Japan, postoperative outcomes after laparoscopic and robotic-assisted sacrocolpopexy are similar and comparable to those reported in western countries.

Association of white blood cell count after operative vaginal delivery with maternal adverse outcome: A retrospective cohort study.

BACKGROUND: The white blood cell count is often used to assess the maternal condition after an operative vaginal delivery. However, it remains unknown whether the maternal white blood cell count on the day after delivery is associated with sequential maternal adverse outcomes, especially infectious complications. The aim of this study was to investigate the association between maternal white blood cell count on the day after operative vaginal delivery and sequential maternal adverse events. METHODS: The study was a retrospective cohort study using the Medical Data Vision claims database containing administrative claims data, discharge abstracts, and laboratory values in Japan. We identified all patients who underwent operative vaginal delivery with data on maternal white blood cell count from December 2011 to November 2020. The main composite outcome was maternal adverse outcomes, comprising additional treatment for maternal injuries, postpartum intravenous antibiotic use, and intensive care unit use during hospitalization. We conducted a restricted cubic spline analysis to investigate the nonlinear association between white blood cell count and the primary outcome. RESULTS: There were 485 eligible patients including 73 patients with occurrence of the primary outcome. The median (interquartile range) white blood cell count on the day after delivery in all eligible women was 15,170 (12,610-18,300)/mL. In the restricted cubic spline analysis, there was no significant association of white blood cell count with the primary outcome. CONCLUSION: White blood cell count on the day after operative vaginal delivery was not significantly associated with maternal adverse outcomes during hospitalization.

Trends in antihypertensive prescription for pregnant women with hypertension and their peripartum outcomes before and after label and guideline revisions in Japan.

We investigated the trends in the proportion of antihypertensive prescriptions listed in the guidelines for pregnant patients and their pregnancy outcomes before and after regulatory actions in Japan. This retrospective cohort study used the Japan Medical Data Center claims data from January 2005 to April 2020. We identified women who had delivered and had hypertensive disorders before childbirth. To evaluate the influence of regulatory actions (label revision in 2011 and guideline updates in 2014), we divided the study period into three terms based on the year of the last menstrual period. We assessed the time trend of the prescription proportion of antihypertensives and conducted multivariable logistic regression analyses to assess the impact of the investigation terms on pregnancy outcomes (preterm birth, cesarean section, emergency cesarean section, and Hemolysis, Elevated Liver enzymes, and Low Platelets syndrome). Among the 13,797 eligible patients, 1739 (12.6%) were treated with oral antihypertensives during pregnancy. Before the policy revisions, the most frequently prescribed antihypertensive medication was methyldopa, but after the label and guideline revisions, nifedipine was the most frequently prescribed. The trend in the prescription proportion of nifedipine increased (P < 0.001) and that of hydralazine decreased (P < 0.001), while those of methyldopa and labetalol showed no significant trend. The adjusted odds ratios for all four pregnancy outcomes showed no significant differences according to the investigation terms. By investigating the three terms before and after the label and guideline revisions, significant changes were identified in the trend of the prescription proportion for pregnant women-an increase in nifedipine and a decrease in hydralazine-but not in pregnancy outcomes.

Emergency Visits and Hospitalization After Chat Message, Voice Call, or Video Call for Telehealth in Obstetrics and Gynecology Using Telehealth Service User Data in Japan: Cross-sectional Study.

BACKGROUND: In obstetric and gynecologic practices, synchronous telehealth services via chat message, voice calls, and video calls have been increasingly equipped to improve patients' health care accessibility and clinical outcomes. Nevertheless, differences in clinical outcomes between communication tools remain unknown, especially in terms of safety. OBJECTIVE: This study compared the occurrence of emergency visits and hospitalization after telehealth services through different communication tools, including chat messages, voice calls, and video calls. METHODS: We collected data on obstetric and gynecologic concerns of women who consulted specialized doctors and midwives through a telehealth consulting service in Japan (Sanfujin-ka Online) between January 1, 2019, and December 31, 2020. The outcomes were emergency visits or hospitalizations at night after the consultation. Chi-square test and multivariate logistic regression analysis were performed to compare the clinical outcomes between the groups who received telehealth services via chat message, voice calls, and video calls. RESULTS: This study included 3635 participants. The mean age of the participants was 31.4 (SD 5.7) years, and the largest age group (n=2154, 59.3%) was 30-39 years. The numbers (or proportions) of those who received telehealth services via chat message, voice calls, and video calls were 1584 (43.5%), 1947 (53.6%), and 104 (2.9%), respectively. The overall incidence of the outcome was 0.7% (26/3635), including 10 (0.3%) cases of chat message, 16 (0.5%) cases of voice calls, and no video calls. There were no emergency visits that happened due to inappropriate advice. No significant difference in the proportions of the outcomes was observed between the communication tools (P=.55). The multivariate logistic regression analysis showed no significant differences in the outcome between those who used chat message and those who used voice calls (odds ratio 1.63, 95% CI 0.73-3.65). CONCLUSIONS: The communication tools of telehealth services in obstetrics and gynecology did not show a significant difference in terms of emergency visits or hospitalizations after using the service.

Risk Factors for Postoperative Bleeding Following Breast Cancer Surgery: A Nationwide Database Study of 477,108 Cases in Japan.

BACKGROUND: Although postoperative bleeding is a common and serious complication in breast cancer surgery, the risk factors remain unclear. Therefore, we examined the risk factors using a Japanese nationwide database. METHODS: Patients who underwent breast cancer surgery between July 2010 and March 2020 were identified from a Japanese nationwide database. Multivariable analyses for 47 candidate risk factors (4 patient characteristics, 32 comorbidities, 5 tumor characteristics, 3 preoperative drug uses, and 3 surgical procedures) were conducted to investigate risk factors associated with postoperative bleeding requiring reoperation. Two sensitivity analyses were conducted: an analysis for postoperative bleeding with or without reoperation and an analysis for patients who underwent total mastectomy without breast reconstruction. RESULTS: Among the 477,108 patients included, 7048 (1.5%) developed postoperative bleeding and 2357 (0.5%) underwent reoperation for postoperative bleeding. Male sex, old age, body mass index ≥ 25.0 kg/m2, several comorbidities (deficiency anemia, cardiac arrhythmias, hypertension, liver disease, psychoses, and valvular disease), preoperative heparin use, and several procedures were identified as risk factors. Deficiency anemia showed the highest odds ratio among the risk factors (4.41 [95% confidence interval, 3.63-5.36]). High odds ratios were also observed in total mastectomy (2.32 [2.10-2.56]), flap reconstruction (1.93 [1.55-2.40]), and preoperative heparin use (1.64 [1.26-2.14]). The results corresponded with the sensitivity analyses. CONCLUSIONS: This study identified several risk factors for postoperative bleeding in breast cancer surgery, such as high body mass index, anemia, cardiovascular diseases, liver diseases, psychoses, preoperative heparin use, and surgical procedures.

Surgical and obstetric outcomes of breast cancer surgery during pregnancy: a nationwide database study in Japan.

PURPOSE: Although the incidence of breast cancer during pregnancy is increasing, little is known about short-term outcomes following breast cancer surgery during pregnancy. We aimed to compare the characteristics and outcomes of breast cancer surgery with and without pregnancy, and describe the obstetric outcomes following surgery. METHODS: The data of 249,257 female patients aged < 60 years who underwent breast cancer surgery between July 2010 and March 2020 were analyzed using a nationwide Japanese database; we generated a 1:10 matched-pair cohort (260 and 2597 patients with and without pregnancy, respectively) matched according to age and treatment year. We conducted multivariable analyses to compare surgical procedures and outcomes, adjusting for potential confounders in the matched-pair cohort. Additionally, we described the obstetric outcomes of patients with pregnancy. RESULTS: Patients with pregnancy were more likely to undergo total mastectomy [odds ratio: 1.48 (95% confidence interval: 1.13-1.94)] and axillary dissection [1.62 (1.17-2.24)], but less likely to undergo reconstruction [0.14 (0.07-0.31)], than patients without; however, postoperative complications, postoperative length of stay, and total hospitalization costs did not differ significantly with pregnancy. Additionally, some pregnant patients experienced premature delivery [n = 18 (6.9%)] and miscarriage [n = 4 (1.5%)], and 31 of 101 patients in the third trimester at breast cancer surgery underwent a cesarean section. CONCLUSION: This study demonstrated significant differences regarding surgical procedures; however, there were no significant differences regarding surgical outcomes between patients who underwent breast cancer surgery with and without pregnancy. Obstetric outcomes following breast cancer surgery were also reported.

Importance of human papillomavirus vaccination leaflets focusing on the safety profile targeted pediatricians in Japan.

OBJECTIVES: To investigate the association between providing leaflets to support pediatricians in explaining the safety of the human papillomavirus (HPV) vaccine and mother's decision to vaccinate their daughters in Japan. METHODS: In this cross-sectional study, we conducted a survey of mothers to evaluate the effect of leaflets that were created to support pediatricians in explaining the safety profile of the HPV vaccine. Mothers who provided consent for vaccination before receiving an explanation were excluded from the study. The primary outcome was the mother's decision to vaccinatetheir daughters with the HPV vaccine after receiving an explanation from pediatricians using our leaflets. RESULTS: Among 161 eligible mothers, 101 decided on HPV vaccination (decided group) and 60 did not (decided against group). There was no difference in the maternal background between the 2 groups. The decided group had a significantly more positive impression of the leaflets than the undecided group. In multivariable logistic regression analysis, a detailed explanation for possible adverse events and specific solutions to them was associated with the mother's decision to have their daughters vaccinated (odds ratio 2.35, 95% confidence interval 1.02-5.44), but not the pathology of cervical cancer and the HPV vaccination process. CONCLUSION: Leaflets emphasizing an explanation of adverse events may contribute to mothers' decision making for HPV vaccination.

Association between health literacy and COVID-19 prevention behaviors among pregnant and postpartum women.

OBJECTIVE: To investigate the association between health literacy and COVID-19 prevention behaviors among pregnant and postpartum women in Japan. METHODS: In this cross-sectional, web-based, self-reported questionnaire survey, we investigated the association between health literacy and COVID-19 prevention behaviors among pregnant and postpartum women in Japan. A multivariable logistic regression analysis was performed to evaluate the association with adjustment for socioeconomic characteristics. RESULTS: There were 926 respondents, comprising 368 pregnant and 558 postpartum women. Women with high health literacy scores accounted for 42% of the respondents. This group had a significantly higher proportion of actively adopting preventive behaviors than the low health literacy group (33.5 vs. 25.4%, p = .008). The multivariable logistic regression analysis showed high health literacy was significantly associated with high preventive behaviors scores compared to low health literacy (adjusted odds ratio, 1.66; 95% confidence interval, 1.22-2.27). CONCLUSION: Higher health literacy was significantly associated with a higher proportion of COVID-19 prevention behaviors among women who are pregnant or postpartum.

Association between psoriasis and short-term outcomes of acute myocardial infarction: A matched-pair cohort study using a nationwide inpatient database in Japan.

Background: Psoriasis is a known risk factor for acute myocardial infarction (AMI). However, the associations between psoriasis and short-term outcomes of AMI remain controversial. Objective: To compare the short-term outcomes of AMI patients with and without psoriasis accounting for patient background characteristics and site-specific effects. Methods: We identified patients with AMI between July 2010 and March 2020, using a Japanese national inpatient database. We matched patients with and without psoriasis to generate a 1:10 matched-pair cohort matched for sex, hospital, and fiscal year at admission. Multivariable regression analyses with adjustment for background characteristics including age and Killip class at admission were conducted to compare short-term outcomes of AMI. Results: In this study of AMI patients with psoriasis (n = 455) and without psoriasis (n = 438,534), 30-day in-hospital mortality was 5.6%. Patients with psoriasis had higher proportions of comorbidities than patients without psoriasis. Multivariable regression analyses in the matched-pair cohort revealed that psoriasis was significantly associated with decreased 30-day in-hospital mortality (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.08-0.85). Limitations: Retrospective study design without data on psoriasis severity. Conclusion: The matched-pair cohort analyses with adjustment for patient background characteristics and site-specific effects revealed decreased in-hospital mortality in AMI patients with psoriasis.

Association between placental location and neonatal outcomes in manual fundal pressure-assisted vaginal deliveries: A retrospective single-center study in Japan.

AIM: Manual fundal pressure (MFP) is still used to assist vaginal deliveries during the second stage of labor in predominantly lower-middle income countries; however, there is insufficient evidence on the risk factors in MFP-assisted vaginal deliveries for adverse neonatal outcomes. The aim of the present study was to investigate the association between placental location and neonatal outcomes in MFP-assisted vaginal deliveries. METHODS: The present study was a single-center retrospective cohort study in patients with all MFP-assisted vaginal singleton deliveries from January 2016 to December 2020. Placental location was divided into two categories: posterior-lateral and anterior-fundal. The primary outcome was a neonatal adverse composite including umbilical artery blood pH <7.2, Apgar score <7 at 5 min, neonatal intensive care unit admission and neonatal resuscitation. We used multivariable logistic regression models to investigate the association between placental location and neonatal outcomes. RESULTS: We extracted 522 MFP-assisted deliveries among 5053 vaginal deliveries. The proportion of posterior-lateral and anterior-fundal placentation was 239 (45.8%) and 283 (54.2%), respectively. The crude prevalence of neonatal composite outcome in the anterior-fundal group was significantly higher than that in the posterior-lateral group (39.6% vs. 28.9%; p = 0.013). Multivariable logistic regression analysis found that the prevalence of neonatal adverse outcome in the anterior-fundal group was significantly higher compared with the posterior-lateral group (adjusted odds ratio, 1.52; 95% confidence interval, 1.04-2.23). CONCLUSION: Anterior-fundal placentation was significantly associated with an increased risk of neonatal adverse outcomes compared to posterior-lateral placentation in MFP-assisted vaginal deliveries.

Safety of Japanese herbal Kampo medicines for the treatment of depression during pregnancy.

OBJECTIVE: To clarify the fetal safety of herbal Kampo medicines, including Hange-koboku-to, Koso-san, Nyoshin-san, Yokukansan, Yokukansan-kachinpi-hange, Saiko-keishikankyo-to, Keishi-karyukotu-borei-to, and Kanbaku-taisou-to, when administered to pregnant women with depression using a large healthcare administrative database. METHODS: We extracted data from the JMDC Claims Database (2005-2018) for this retrospective cohort study of pregnant women aged 19 years or older admitted to obstetric clinics or hospitals for delivery. Participants were classified into four groups: those without depression, those diagnosed with depression without medication, those given Kampo medicines for depression, and those given western medicines for depression. Neonatal outcomes (congenital anomalies, low birth weight, and preterm birth) were considered as the safety outcome measures. RESULTS: We identified 179 707 eligible mothers. The adverse outcomes did not differ significantly between participants receiving Kampo medicine and those not diagnosed with depression during pregnancy. The proportion of low-birth-weight neonates did not differ significantly between the Kampo medicine and non-depression groups (adjusted odds ratio [aOR] 1.28; 95% confidence interval [CI] 0.86-1.91), but was significantly higher in the unmedicated depression group (aOR 1.31; 95% CI 1.07-1.61) and western medicine group (aOR 1.47; 95% CI 1.18-1.83). CONCLUSION: Kampo medicines are safe for treating depression during pregnancy without increasing the incidence of congenital anomalies, low birth weight, or preterm birth.

Resuscitative endovascular balloon occlusion of the aorta for life-threatening postpartum hemorrhage: A nationwide observational study in Japan.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used for postpartum hemorrhage (PPH), which is one of the leading causes of maternal mortality worldwide; however, its utility in the obstetrics setting remains unclear. Thus, this study aimed to describe the characteristics, demographics, and mortality of patients with PPH who underwent REBOA. METHODS: We used the Japanese Diagnosis Procedure Combination inpatient database to identify patients with PPH who underwent REBOA from April 2012 to March 2020. We examined the patients' characteristics, interventions administered, and in-hospital mortality. RESULTS: We identified 143 patients with PPH who underwent REBOA. The most common cause of PPH was atonic postpartum hemorrhage (52.4%), followed by disseminated intravascular coagulation (29.4%) and amniotic fluid embolism documented (11.2%). Among patients who delivered at hospitals in which REBOA was performed (n = 55), 38.2% of patients experienced preterm births, and 70.9% delivered via cesarean delivery. The proportion of patients who underwent transcatheter arterial embolization and hysterectomy was 53.8% and 16.1%, respectively. In-hospital mortality was 7.0%. CONCLUSION: The results of the present study could be helpful in clinical decision making and providing patients and families with additional treatment options for PPH. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Eye drops for dry eye disease during pregnancy and adverse neonatal outcomes: high-dimensional propensity score analyses.

We investigated the association between exposure to eye drops prescribed for dry eye disease (DED) during pregnancy and adverse neonatal outcomes. Pregnant women with DED in the JMDC Claims Database (JMDC Inc., Tokyo, Japan) between 2005 and 2020 were included. According to their prescriptions during the first trimester, the women were classified into three exposed groups (hyaluronate 0.1% alone, hyaluronate 0.3% alone, and diquafosol alone) and an unexposed group (no eye drops for DED). We compared adverse neonatal outcomes (congenital anomalies, preterm birth, low birthweight, and composite outcome of these three) between the exposed and unexposed groups. We conducted a high-dimensional propensity score analysis using many variables in the database together with known potential confounders such as chronic comorbidities. We identified 4,808 eligible women, of whom 936 (19.5%) received eye drops for DED. Congenital anomalies occurred in 7.2% and 6.0%, preterm birth in 3.1% and 4.0%, low birthweight in 7.9% and 6.0%, and composite outcome in 14.9% and 12.3% of women in the hyaluronate 0.1% alone and unexposed groups, respectively. The high-dimensional propensity score analysis showed that hyaluronate 0.1% alone was not significantly associated with increases in congenital anomalies (risk difference, 0.4% [95% confidence interval, -1.9% to 2.7%]), preterm birth (-0.6% [-2.2% to 0.9%]), low birthweight (1.8% [-0.6% to 4.1%]), or composite outcome (1.9% [-1.3% to 5.1%]). Similar results were obtained in the hyaluronate 0.3% alone and diquafosol alone groups. Use of eye drops for DED in pregnant women was not associated with adverse neonatal outcomes.

Safety of topical ophthalmic antibiotics in pregnant women with hordeola, chalazia, blepharitis, or bacterial conjunctivitis: propensity score analyses.

OBJECTIVE: To investigate the association between exposure to topical ophthalmic antibiotics during pregnancy and adverse neonatal outcomes. METHODS: In this retrospective cohort study, we identified pregnant women with hordeola, chalazia, blepharitis, or bacterial conjunctivitis from 2005 to 2018 using the Japanese Medical Data Centre Claims Database. From the eligible women, we extracted women who were dispensed no topical antibiotics during the first trimester (non-antibiotic group), women who were dispensed topical fluoroquinolones alone at least once (fluoroquinolone alone group), and women who were dispensed any single type of antibiotic (single-antibiotic group). We compared the frequency of congenital anomalies (CA), preterm birth (PB), low birth weight (LBW), and the composite outcome of these three between the fluoroquinolone and non-antibiotic groups and between the single-antibiotic and non-antibiotic groups, using propensity score adjustment. RESULTS: A total of 891 eligible women were identified. In the fluoroquinolone (n = 409) and non-antibiotic (n = 309) groups, CA occurred in 6.8% and 6.8%, PB in 2.4% and 3.2%, LBW in 2.9% and 3.2%, and the composite outcome in 10.5% and 11.3%, respectively. Analysis using propensity score adjustment showed no significant difference between the groups in the frequency of CA (adjusted odds ratio, 1.15; 95% confidence interval, 0.61-2.18), PB (0.80; 0.30-2.17), LBW (1.08; 0.45-2.63), or the composite outcome (1.12; 0.67-1.87). Comparison of the single-antibiotic and non-antibiotic groups showed similar results. CONCLUSIONS: Topical ophthalmic antibiotics for hordeola, chalazia, blepharitis, or bacterial conjunctivitis during the first trimester were not associated with increased adverse neonatal outcomes.

Impact of maternal depression and anxiety-related disorders on live birth rate in women with recurrent pregnancy loss.

It is unknown whether depression and anxiety-related conditions associate with poor perinatal outcomes, especially live birth rates, among women diagnosed with recurrent pregnancy loss. We performed a retrospective cohort study using the Japanese Medical Data Centre Claims Database and identified women diagnosed with recurrent pregnancy loss. Live birth rates were compared as the primary outcome between patients with and without depression and/or anxiety-related disorders. A stabilised inverse probability of treatment weight analysis using propensity scores was also performed to assess the association. Among 5,517 eligible patients, there were 804 (14.6%) women who had depression and/or anxiety-related disorders during treatment for recurrent pregnancy loss during pregnancy. The overall live birth rates differed significantly between the groups according to the Kaplan-Meier method and log-rank test (p = 0.011). However, Cox proportional-hazards regression model and stabilised inverse probability of treatment weight analysis showed no statistically significant association between depressive disorders and live birth rates. The current study showed that approximately 15% of patients diagnosed with recurrent pregnancy loss develop depressive disorders. After accounting for variables, we found no independent association between depressive disorders after recurrent pregnancy losses and low live birth rates.