BACKGROUND: The rate of recurrent spontaneous preterm delivery (sPTD) ranges between 27% and 34% and is 22.3% in Japan. Although it currently remains unclear whether probiotics prevent sPTD, retrospective studies recently reported a reduction in the rate of recurrent sPTD with the administration of probiotics including Clostridium spp., which induce regulatory T cells that play an important role in maintaining pregnancy.
OBJECTIVE: The objective of this trial is to evaluate the preventative effects of available oral probiotics, including Clostridium butyricum, on recurrent sPTD.
METHODS: This is a prospective, single-arm, nonblinded, multicenter trial in Japan. The sample size required for this trial is 345 pregnant women with a history of sPTD, considering a clinically significant reduction in the relative risk of 30% (risk ratio=0.7). The primary endpoint is the rate of recurrent sPTD at <37 weeks of gestation. The secondary endpoints are the rate of sPTD at <34 weeks of gestation, the rate of recurrent sPTD at <28 weeks of gestation, the ratio of intestinal Clostridium spp. (detected by next-generation sequencing), and bacterial vaginosis (using the Nugent score).
RESULTS: The trial procedures were approved by the Clinical Research Review Board of Toyama University Hospital (SCR2020008) on March 31, 2021. The trial was registered on the Japan Registry of Clinical Trial website on April 28, 2021. Recruitment began on May 1, 2021, and the trial is estimated to finish on March 31, 2025.
CONCLUSIONS: The findings will clarify the rate of recurrent sPTD following probiotic administration including Clostridium butyricum. Outcomes from this trial will inform clinical practice and guide future randomized controlled trials.
BACKGROUND: Japan Registry of Clinical Trials jRCTs041210014; https://jrct.niph.go.jp/latest-detail/jRCTs041210014.
UNASSIGNED: DERR1-10.2196/59928.

Numerous traditional practices are both beneficial and harmful. Traditional harmful practices, such as female genital mutilation and traditional cervical cauterization, are carried out for a number of reasons but can have negative health and social effects. In addition to deeply held beliefs, a lack of knowledge and awareness of the consequences of these practices contributes to the persistence of these issues. The objective of this study is to examine whether traditional cervical cauterizations were associated with preterm births in Somalia. This prospective cohort study was conducted at our hospital over a one-year period. Seven hundred and two patients were included in this study; these patients were divided into two groups, cauterized and non-cauterized groups, and the two groups were compared on pregnancy outcomes. We examined whether traditional cervical cauterizations were associated with adverse pregnancy outcomes, including preterm births. According to the findings of this study, traditional cervical cauterization was prevalent among patients visiting MSTREH (n = 328, 46.7%). Infections of the uterine cervix and infertility were the two main indications for cauterization, 44.8%, and 34.8%, respectively.Being older, uneducated, and poverty were significantly associated with traditional cauterization (P < 0.001). There was a significant correlation between prior traditional cervical cauterization and the risk of preterm births. Women with prior cauterization were two and half times more likely to deliver a preterm fetus (OR: 2.64, 95% CI 2.15-3.33) compared to non-cauterized mothers. Our findings show that women who have previously undergone traditional cervical cauterization have a significantly higher risk of preterm birth and negative pregnancy outcomes than non-cauterized women. Health professionals, particularly those who are close to the community, are crucial in developing and putting into practice plans to end harmful traditions in Somalia.

BACKGROUND: Maternal depression during pregnancy is prevalent and has been associated with increased risk of preterm delivery (PTD). However, comparative effectiveness of two commonly used treatment options, mental health counseling and use of antidepressants, in mitigating the risk of PTD associated with maternal depression remains uncertain. Although antidepressant use has been associated with increased risk of PTD in many previous studies, a direct head-to-head comparison between these two treatment options has not been investigated. Thus, the comparative risk-benefit profiles of those two treatment options remain unclear.
OBJECTIVE: To determine the comparative effectiveness of two commonly used options for treating prenatal depression in limiting the risk of PTD associated with maternal depression.
METHODS: A large prospective cohort study was conducted among 82,170 pregnant women at Kaiser Permanente Northern California (KPNC), an integrated health delivery system. Clinically diagnosed depression and its treatments (use of antidepressants and mental health counseling) were identified from the KPNC electronic health record system (EHR). Gestational age was also recorded for all deliveries and captured by EHRs for determining PTD.
RESULTS: Using Cox proportional hazards regression incorporating propensity score methodology to ensure comparability between comparison cohorts, relative to those without depression, pregnant women with untreated depression had 41% increased risk of PTD: adjusted hazard ratio (aHR)=1.41, 95% confidence interval (CI)=1.24-1.60, confirming increased risk of PTD associated underlying maternal depression. Relative to untreated depression, any mental health counseling was associated with a 18% of reduced risk of PTD: aHR=0.82 (0.71-0.96). The inverse association showed a dose-response pattern: increased number of counseling visits was associated with greater reduction in PTD risk with 43% reduction in PTD risk associated with 4 or more visits (aHR=0.57, 95% CI=0.45-0.73). In contrast, use of antidepressants during pregnancy was associated with an additional 31% increased risk of PTD independent of underlying depression: aHR=1.31, 95% CI=1.06-1.61. This positive association also showed a dose-response relationship: a longer duration of use was associated with an even higher risk.
CONCLUSIONS: This study provides much needed evidence regarding the comparative effectiveness of two common treatment options for prenatal depression in the context of PTD risk. The results indicate that, to reduce PTD risk due to maternal depression, mental health counseling is more effective. Use of antidepressants may add additional risk of PTD, independent of the underlying depression. The findings provide data for clinicians and pregnant women to make informed and evidence-based treatment decisions that take into account the risks and benefits to both maternal and fetal health.

OBJECTIVE: To examine the relation between maternal pre-delivery body mass index (BMI) and the accuracy of sonographic estimated foetal weight (EFW) in very preterm infants (<32 weeks gestation).
METHODS: This retrospective study included singleton infants born between January 2010 and March 2023, at gestational ages 23+0 to 31+6 weeks, at a tertiary university-affiliated hospital. Absolute weight, percentage error, absolute percentage error, and overestimation and underestimation of EFW were compared between women with pre-delivery normal weight (BMI 18.5-24.99 kg/m2), overweight (BMI 25.0-29.99 kg/m2), and obesity (BMI >35.0 kg/m2). Multivariate linear regression analyses adjusted for potential confounders were performed to assess relations of maternal pre-conception and of pre-delivery BMI, with EFW accuracy.
RESULTS: Included were 286 pregnancies. Absolute difference, percentage error, absolute percentage error, error within 10% range, and underestimation or overestimation of EFW were similar between the groups. The multivariate linear regression analyses did not show significant associations of pre-conceptional BMI or of pre-delivery BMI with the percentage error. However, for small for gestational age compared to appropriate for gestational age foetuses, the percentage error was greater (8.9% vs. -0.6%, beta = 0.35, P < 0.001) and the absolute percentage error was greater (11.0% vs. 6.7%, P < 0.001). Small for gestational age foetuses were at risk of foetal weight overestimation (percentage error exceeding 15%); odds ratio 7.20 (95% CI 2.91-17.80).
CONCLUSIONS: Maternal pre-delivery BMI was not found to be related to EFW accuracy in very preterm infants. Nevertheless, EFW should be interpreted carefully, as it may underdiagnose poor foetal growth in this population.

OBJECTIVE: Our study aimed to explore the impact of COVID-19 infection on pregnancy outcomes, accounting for the progression of variants, vaccines, and treatment modalities.
METHODS: We performed a prospective longitudinal cohort study at two urban tertiary centers enrolling patients with a confirmed intrauterine singleton pregnancy from December 23, 2020 to July 18, 2022. Patients were evaluated for SARS-CoV-2 infection at enrollment and every trimester using serum antibody testing. The primary outcome was preterm birth. Symptom and treatment data were collected from pregnant patients with COVID-19 infections. Variant strain infection status was determined from local wastewater analysis.
RESULTS: 448 patients were enrolled, and 390 patients were retained through delivery with 159 unexposed and 231 exposed patients, of whom 56 patients (26.0 %) crossed over after enrollment to the exposed cohorts during pregnancy. There was no difference in rates of preterm birth between exposed and unexposed cohorts (14.6 % vs 11.3 %), in deliveries < 34 weeks (1.5 % vs 2.7 %), PPROM, (0.4 % vs 1.3 %), or gestational age at delivery (38.1 vs 38.2). Exposed patients were significantly more likely to be diagnosed with a hypertensive disorder (aOR 2.3, 95 % CI 1.2-4.1), specifically gestational hypertension (aOR 2.8, 95 % CI 1.3--6.0), but not preeclampsia/eclampsia. There were no differences in individual or composite neonatal outcomes.
CONCLUSIONS: Our study contributed to the understanding of the effects of SARS-CoV-2 infection on pregnancy outcomes, with increased risk of hypertensive disorders of pregnancy but overall, no differences in adverse neonatal outcomes. Regular antenatal PCR and antibody screening allowed for higher detection and inclusion of patients with asymptomatic SARS-CoV-2 infection and effects on maternal and neonatal outcomes.

OBJECTIVE: This study aimed to establish criteria for defining \"large\" subchorionic hematoma (SCH) and assess its association with pregnancy complications.
METHODS: This was a retrospective cohort study conducted at our institution between 2019 and 2020. We compared the size of SCH between the pregnancy-related complication and non-complication groups, using two measurement methods. Receiver operating characteristic (ROC) curve analysis determined cutoff values. Additionally, we compared the occurrence of pregnancy complications among three groups: large SCH group (above the cutoff value), non-large SCH group (below the cutoff value), and non-SCH group.
RESULTS: Of 1305 singleton pregnancies managed during the study, 80 cases were diagnosed with SCH. Pregnancy complications occurred in 15 patients. The patients with pregnancy complications had significantly larger SCH sizes with both measurement methods. For each method, the cutoff values calculated from the ROC curve analysis were as follows: Method 1, 25% (area under the ROC curve [AUC], 0.662); Method 2, 30% (AUC, 0.624). In Method 1, we found a significantly higher occurrence of preterm delivery in the large SCH group (24.1%) than in the non-large SCH (4.2%) and non-SCH groups (5.3%; all p < 0.01). In Method 2, there was a significantly higher occurrence of preterm delivery in the large SCH group (33.3%) than in the non-large SCH (6.5%) and non-SCH groups (5.3%; all p < 0.01).
CONCLUSIONS: Large SCHs may indicate a high risk of pregnancy-related complications. Among these, recognizing and managing cases that exceed the aforementioned cutoff value as high-risk cases may be beneficial for reducing pregnancy complications.

OBJECTIVE: We aimed to determine whether the effect of antenatal corticosteroids (ANS) differs in male and female fetuses without anomalies born before 32 weeks in terms of mortality and short-term morbidity.
METHODS: This single-center retrospective study included infants born before 32 weeks\' gestation and admitted to the neonatal intensive care unit between January 1, 2018, and December 31, 2020.
RESULTS: The study included 210 infants with a median gestational age of 28.6 weeks (24-31.6), a birth weight of 1065 g (445-2165), and an ANS use rate of 80%. Compared to female fetuses exposed to ANS, male fetuses exposed to ANS had a lower mortality rate (23% and 11%, respectively, p = 0.038), but there were no differences in intraventricular hemorrhage, retinopathy of prematurity, necrotizing enterocolitis, respiratory distress syndrome, and APGAR scores of 1st and 5th but an increased rate of bronchopulmonary dysplasia (moderate/severe) (p = 0.008). In addition, the mortality rate was similar in exposed and unexposed female fetuses (p = 0.850). Enzyme activities and steroid levels in the placenta might be different in male and female fetuses, which could explain the results of ANS administration.
CONCLUSIONS: In our study, we have shown that ANS has no effect on mortality in female fetuses younger than 32 weeks. Future studies may focus on adjusting the administration of ANS based on fetal sex, altering the dose or taking fetal sex into account when performing ANS.

OBJECTIVE: To assess whether procedural-induced abortion or provider-initiated preterm delivery are associated with improved survival in pregnant people with cancer.
METHODS: Retrospective population-based cohort study.
METHODS: Provinces of Alberta and Ontario, Canada, 2003-2016.
METHODS: Females aged 18-50 years diagnosed with cancer at <20 weeks\' (for the assessment of procedural-induced abortion) or <37 weeks\' gestation (for the assessment of provider-initiated delivery).
METHODS: Cox proportional hazard models assessed all-cause mortality in relation to procedural-induced abortion and provider-initiated preterm delivery, adjusting for cancer site, stage at diagnosis and age. Meta-analysis pooled the results across both provinces.
METHODS: All cause mortality.
RESULTS: There were 512 pregnant people diagnosed with cancer at <20 weeks\' gestation and 782 diagnosed with cancer at <37 weeks\' gestation. Neither procedural-induced abortion (adjusted hazard ratio [aHR] = 1.39, 95% CI: 0.32-6.17) nor provider-initiated preterm delivery (aHR = 1.17, 95% CI: 0.76-1.81) were associated with improved survival following adjustment for age, stage at diagnosis and cancer site.
CONCLUSIONS: Neither procedural-induced abortion nor provider-initiated preterm birth was associated with improved survival in pregnant people diagnosed with cancer; however, these obstetric interventions are highly personal decisions best decided by the pregnant person in consultation with their care providers.

UNASSIGNED: Pregnant women are more vulnerable to the severe effects of COVID-19 compared to their non-pregnant peers. Early in the pandemic, there was a rise in cesarean deliveries and preterm births among infected pregnant women. This study aims to evaluate whether there were any changes in obstetric interventions during the first two waves of the pandemic in Belgium.
UNASSIGNED: Between March 2020 and February 2021, the Belgian Obstetric Surveillance System (B.OSS) conducted an extensive, nationwide population-based registry study, that included nearly all births to women with a confirmed SARS-CoV-2 infection within six weeks before hospitalization in Belgium. The perinatal outcomes of these women were analyzed and compared with pre-pandemic regional perinatal data.
UNASSIGNED: A total of 923 SARS-CoV-2 infected pregnant women were admitted to the hospital; 9.3 % were hospitalized for severe COVID-19, while the remaining were hospitalized for obstetric reasons. Infected women had a higher median BMI, a higher incidence of diabetes, and a greater proportion were overweight or obese compared to the reference group (p < 0.001). While the majority of women gave birth vaginally, symptomatic women and those with a severe infection had slightly higher rates of cesarean delivery, though not statistically significant after adjusting for confounders. Only severely ill women had an increased risk of preterm delivery (aOR 2.3; 95 %CI [1.2-2.5]; p = 0.02) and of induced labor (OR 1.8; 95 %CI [1.1-2.8]; p = 0.01). The use of general anesthesia for cesarean delivery was more common in the infected group (OR 2.6; 95 %CI [1.6-4.1]; p < 0.001).
UNASSIGNED: Obstetric interventions, such as cesarean delivery and induction, remained at pre-pandemic levels. However, a SARS-CoV-2 infection appears to have increased medically induced preterm delivery and the use of general anesthesia for cesarean delivery.

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