Fetal Medicine Research Articles

Incidence of neonatal morbidity in small-for-gestational-age twins based on singleton and twin charts.

To compare morbidity, as measured by length of stay in the neonatal intensive care unit (NICU), in twin and singleton gestations classified as small-for-gestational age (SGA) according to estimated fetal weight < 10th percentile on twin or singleton growth charts. NICU length of stay was compared in 1150 twins and 29 035 singletons that underwent ultrasound assessment between 35 + 0 and 36 + 6 weeks' gestation. Estimated fetal weight was obtained from measurements of head circumference, abdominal circumference and femur length using the Hadlock formula. Gestational age was derived from the first-trimester crown-rump length measurement, using the larger of the two twins. Singletons and twins were compared in terms of NICU admission rate and length of stay according to classification as SGA by the Fetal Medicine Foundation singleton and twin reference distributions. The overall proportions of twins and singletons admitted to NICU were similar (7.3% vs 7.4%), but twins tended to have longer lengths of stay in NICU (≥ 7 days: 2.4% vs 0.8%; relative risk (RR), 3.0 (95% CI, 1.6-4.4)). Using the singleton chart, a higher proportion of twins were classified as SGA compared with singletons (37.6% vs 7.0%). However, the proportion of SGA neonates entering NICU was similar (10.2% for twins and 10.1% for singletons) and the proportion of SGA neonates spending ≥ 7 days in NICU was substantially higher for twins compared with singletons (3.7% vs 1.4%; RR, 2.6 (95% CI, 1.4-4.7)). When singleton charts are used to define SGA in twins and in singletons, there is a greater degree of growth-related neonatal morbidity amongst SGA twins compared with SGA singletons. Consequently, singleton charts do not inappropriately overdiagnose fetal growth restriction in twins and they should be used for monitoring fetal growth in both twins and singletons. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

Profile of various congenital anomalies in fetus detected during antenatal period among high risk mothers by Ultrasonography at Tertiary Care Centre, South Gujarat

Background: With the improvement of basic maternal and child health care services, the deaths due to malnutrition and infections are on a descending trend and due to westernization and lifestyle modifications, perinatal deaths due to anomalies are in ascending trend. Aim &amp; Objectives: The purpose of this study was to estimate the antenatal proportion of congenital anomalies, types, pattern of anomalies and factors associated with anomalies in Tertiary Care Centre, South Gujarat. Settings and Design: Cross-sectional study in Department of Fetal Medicine of New Civil Hospital, Surat. Methods and Material: Sample size was 435. First 10 consecutive high-risk ANC patients, who were referred to Fetal Medicine department from Obstetrics and Gynecology department per day were selected. Data was collected during September 2021 to February 2022. Statistical analysis used: Frequencies, proportions and tests of significance was applied for testing the association of socio-demographic variables, clinical variables etc on presence or absence of congenital anomalies. Results: Proportion of different types of congenital anomalies in high risk pregnant mother was 17.2%. There was significant association between presence of congenital anomalies with history of irregular menstruation (p value: 0.001, OR: 5.19, [CI: 1.76-15.27]) and inadequate amniotic fluid (p value: 0.00, OR: 14.5[CI: 7.23-29.06]). Among total detected anomalies in Ultrasonography scanning, most common anomalies were Cardio-vascular system anomalies (36.4%) and Central Nervous System anomalies (24%). Conclusions: Congenital anomalies were present in about 17 % of high risk antenatal mothers.

Patient experiences with prenatal cell-free DNA screening in a safety net setting.

Thirty-five states, including Florida, now cover cell-free DNA (cfDNA) screening of fetuses for all pregnant patients enrolled in state public insurance programs. We interviewed Black and Hispanic obstetric patients at a safety net clinic in Florida shortly after the state rolled out cfDNA as a first-tier screening method for publicly insured patients. Black and Hispanic patients receiving prenatal care from a prenatal or maternal fetal medicine clinic at a federally qualified health center in Jacksonville, FL were invited to participate in a qualitative interview in English or Spanish to explore experiences and perceptions of prenatal cfDNA screening. Participants were recruited following their first prenatal visit when cfDNA is typically introduced. Interview transcripts were qualitatively analyzed for iterative themes based on principles of grounded theory. One hundred Black and Hispanic patients (n=51 non-Hispanic Black, n=43 Hispanic, n=3 Hispanic Black, n=3 Not Reported/Other) completed an interview. Participants described minimal opportunity for pre-screening counseling and limited health literacy about cfDNA or its uses. Some believed that cfDNA could positively impact pregnancy health. Many were unsure if they had received cfDNA even though they were aware of the information provided by it. Most participants expressed an interest in cfDNA as a means for early detection of fetal sex and as an additional indication of general fetal health. Patient experiences indicate limited informed consent and decision-making for cfDNA, discordant with professional guidelines on pre-screen counseling. Our findings suggest that there should be additional investment in implementing cfDNA in safety net settings to ensure that patients and providers receive the support necessary for effective patient counseling and follow-on care for the ethical implementation of cfDNA.

European Association of Perinatal Medicine (EAPM), European Board and College of Obstetricians and Gynaecologists (EBCOG), European Midwives Association (EMA). Joint position statement: Substandard and disrespectful care in labour – because words matter

Substandard or disrespectful care during labour should be of serious concern for healthcare professionals, as it can affect one of the most important events in a woman’s life. Substandard care refers to the use of interventions that are not considered best-practice, to the inadequate execution of interventions, to situations where best-practice interventions are withheld from patients, or there is lack of adequate informed consent. Disrespectful care refers to forms of verbal and non-verbal communication that affect patients’ dignity, individuality, privacy, intimacy, or personal beliefs. There are many possible underlying causes for substandard and disrespectful care in labour, including difficulties in modifying behaviours, judgmental or paternalistic attitudes, personal interests and individualism, and a human tendency to make less arduous, less difficult, or less stressful clinical decisions. The term “obstetric violence” is used in some parts of the world to describe various forms of substandard and disrespectful care in labour, but suggests that it is mainly carried out by obstetricians and is a serious form of aggression, carried out with the intent to cause harm. We believe that this term should not be used, as it does not help to identify the underlying problem, its causes, or its correction. In addition, it is generally seen by obstetricians and other healthcare professionals as an unjust and offensive term, generating a defensive and less collaborative mindset. We reach out to all individuals and institutions sharing the common goal of improving women’s experience during labour, to work together to address the underlying causes of substandard and disrespectful care, and to develop common strategies to deal with this problem, based on mutual comprehension, trust and respect

Maternal and fetal arrhythmia as a sign of hemodynamic deterioration: a case report

The co-existing maternal (MA) and fetal arrythmia (FA) are associated with maternal goiter disease, chorioamnionitis, or Ballantyne’s syndrome. The aim of the study - to determine the involvement of maternal arrhythmia and fetal arrhythmia in the pathogenic scenario of hemodynamic deterioration in Ballantyne’s syndrome. Clinical case. It is presented the case of sustained several weeks of MA and FA. A pregnant woman aged 36 years was admitted to the division of maternal and fetal medicine at 34 weeks of gestation. She was gravida 4 and para 3. She had complaints of rapid heartbeat, left-side chest discomfort, and lower extremities edema. The diagnosis of maternal sinus tachycardia was supported via electrocardiography. The indices of fetal, umbilical, and uteroplacental hemodynamics detected via Doppler ultrasound were appropriate. However, fetal heart rate was 209 beats/min. The transplacental attack of oral sotalol 80 mg thrice daily was prescribed. But maternal and fetal tachycardia persisted to stay. The tricuspid regurgitation was detected via Doppler ultrasound next day. The fetus was hydropic. The male baby of 2400 g, 46 cm length, 31 cm head circumference, and Apgar score 3→5 was delivered via caesarean. The newborn was discharged in 21 days. He was admitted again in one month for rehabilitation. Maternal heart rate reduced to 72 beats/min and edema regressed in three days after birth. Conclusions. MA and FA before fetal hydrops are supposed to be the early signs of mirror syndrome. This speculation needs further investigation. The research was carried out in accordance with the principles of the Helsinki Declaration. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

Society for Maternal-Fetal Medicine Statement: RhD immune globulin after spontaneous or induced abortion at less than 12 weeks of gestation

Guidelines for management of first-trimester spontaneous and induced abortion vary regarding RhD testing and Rho(D) immune globulin administration. These existing guidelines are based on limited data that do not convincingly demonstrate the safety of withholding Rho(D) immune globulin for first-trimester abortions or pregnancy losses. Given the adverse fetal and neonatal outcomes associated with RhD alloimmunization, prevention of maternal sensitization is essential in RhD negative patients who may experience subsequent pregnancies. In care settings where RhD testing and Rho(D) immune globulin administration are logistically and financially feasible and do not hinder access to abortion care, we recommend both RhD testing and RhIg administration for spontaneous and induced abortion at <12 weeks of gestation in unsensitized, RhD-negative individuals.

Maternal Hemodynamics from Preconception to Delivery: Research and Potential Diagnostic and Therapeutic Implications: Position Statement by Italian Association of Preeclampsia and Italian Society of Perinatal Medicine.

The Italian Association of Preeclampsia (AIPE) and the Italian Society of Perinatal Medicine (SIMP) developed clinical questions on maternal hemodynamics state of the art. AIPE and SIMP experts were divided in small groups and were invited to propose an overview of the existing literature on specific topics related to the clinical questions proposed, developing, wherever possible, clinical and/or research recommendations based on available evidence, expert opinion, and clinical importance. Draft recommendations with a clinical rationale were submitted to 8th AIPE and SIMP Consensus Expert Panel for consideration and approval, with at least 75% agreement required for individual recommendations to be included in the final version. More and more evidence in literature underlines the relationship between maternal and fetal hemodynamics, as well as the relationship between maternal cardiovascular profile and fetal-maternal adverse outcomes such as fetal growth restriction and hypertensive disorders of pregnancy. Experts agreed on proposing a classification of pregnancy hypertension, complications, and cardiovascular states based on three different hemodynamic profiles depending on total peripheral vascular resistance values: hypodynamic (>1,300 dynes·s·cm-5), normo-dynamic, and hyperdynamic (<800 dynes·s·cm-5) circulation. This differentiation implies different therapeutical strategies, based drugs' characteristics, and maternal cardiovascular profile. Finally, the cardiovascular characteristics of the women may be useful for a rational approach to an appropriate follow-up, due to the increased cardiovascular risk later in life. Although the evidence might not be conclusive, given the lack of large randomized trials, maternal hemodynamics might have great importance in helping clinicians in understanding the pathophysiology and chose a rational treatment of patients with or at risk for pregnancy complications. · Altered maternal hemodynamics is associated to fetal growth restriction.. · Altered maternal hemodynamics is associated to complicated hypertensive disorders of pregnancy.. · Maternal hemodynamics might help choosing a rational treatment during hypertensive disorders..

Adverse pregnancy outcome in fetuses with early increased nuchal translucency: prospective cohort study.

An increased nuchal translucency (NT) thickness of ≥ 3.5 mm is a well-established marker for congenital anomalies and adverse pregnancy outcome between 11 and 14 weeks' gestation, but little is known about its performance as a screening tool before 11 weeks. We aimed to investigate, in a prospective setting, whether fetuses with increased NT before 11 weeks are at risk for adverse pregnancy outcome. This was a prospective cohort study including pregnant women with a viable fetus with NT ≥ 2.5 mm and a crown-rump length (CRL) < 45 mm. All included women were referred to our fetal medicine unit (FMU) and scheduled for a follow-up scan where the NT was remeasured after 1 week when the CRL was > 45 mm. Two groups were evaluated: cases with a normalized NT (< 3.5 mm) and cases with persistently increased NT (≥ 3.5 mm). The cases were monitored until 4 weeks after delivery. The main outcome was a composite adverse outcome of aneuploidy, other genetic disorders, structural anomalies and pregnancy loss. We performed subgroup analyses of NT thickness at inclusion and normalized or persistently increased NT at follow-up. The study included 109 cases, of which 39 (35.8%) had an adverse pregnancy outcome. Of these, 64.1% (25/39) were aneuploid, corresponding to 22.9% (25/109) of the total study population. In the subgroups of NT thickness at inclusion of 2.5-3.4 mm, 3.5-4.4 mm and ≥ 4.5 mm, an adverse outcome was reported in 22.0% (9/41), 40.0% (18/45) and 52.2% (12/23), respectively. In fetuses with a normalized NT and without ultrasound abnormalities at the follow-up scan, the incidence of adverse outcome was 8.5% (5/59), of which 5.1% (3/59) cases were aneuploid. Fetuses with an early increased NT thickness are at considerable risk of an adverse pregnancy outcome, even if the NT normalizes after 11 weeks. Not all congenital anomalies can be diagnosed with routine first-trimester screening, such as non-invasive prenatal testing and/or a first-trimester anomaly scan. Therefore, expectant parents should always be referred to a FMU for detailed ultrasonography. Invasive prenatal testing should be offered if an increased NT of ≥ 2.5 mm is observed before 11 weeks' gestation. © 2024 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Optimizing prenatal diagnosis and referral of classic bladder exstrophy: Lessons from a single-institution experience

Classic bladder exstrophy (CBE) is a malformation of the genitourinary system that occurs due to failure of abdominal wall closure. Unlike other malformations of similar incidence, prenatal diagnosis of CBE relies on suggested, rather than formal, diagnostic criteria. This report describes prenatal diagnosis of CBE in the largest single-institutional cohort to date and delineates key sonographic findings and protocols for specialist referral. A single-institutional database was reviewed for CBE patients born since 2000. Data on screening ultrasound use, gestational age at ultrasound, and abnormal findings were extracted. Where possible, time of prenatal diagnosis (pre- or postnatal and gestational age), ultrasound findings and other imaging data, specialist referral, institution of birth and closure, and outcome of primary closure attempt were compared. Of 557 patients born with CBE between 2000 and 2022, 284 met inclusion criteria and complete data were available for 280 (229 born domestically and 51 born internationally) who were included for analysis. Abnormal sonography suggestive of CBE was present for 48% (n=134) of patients, for whom absent bladder was the most common abnormal finding (76% [102/134]). Of domestic patients, 46% (n=106) were diagnosed prenatally at a median gestational age of 22 weeks (inter-quartile range [IQR]: 20-24), and 14% (n=32) underwent confirmatory fetal magnetic resonance imaging. Of domestic patients with abnormal prenatal findings, 75% (n=80/106) consulted with maternal-fetal medicine and 58% (n=62/106) consulted with pediatric urology. On univariate analysis, prenatal diagnosis was positively associated with primary repair at Association for the Bladder Exstrophy Community-recognized centers of excellence (54% vs. 38%, p=0.02) and negatively associated with osteotomy at primary closure (41% vs 59%, p=0.003) but not success of primary closure (74% vs. 82%, p=0.07). Rates of prenatal diagnosis in this cohort were similar to previous reports of smaller cohorts. Diagnosis allows for comprehensive pre- and postnatal follow-up with a pediatric urologist, with implications on birth planning and decisions on termination of pregnancy. Because of the previously-reported association between exstrophy and invitro fertilization, these pregnancies should undergo detailed sonography. Any nonvisualization of the fetal bladder should prompt a detailed exam, and any finding characteristic of bladder exstrophy warrants referral to pediatric urology. Although CBE is a rare disorder, it is underdiagnosed during pregnancy. Sonographers and obstetricians should be aware of characteristic findings and best practices following diagnosis. Early referral to pediatric urology and maternal-fetal medicine is important for counseling and postnatal planning.

Cytomegalovirus infection during pregnancy: cross-sectional survey of knowledge and prevention practices of healthcare professionals in French-speaking Switzerland

BackgroundLack of Cytomegalovirus (CMV) knowledge among healthcare professionals has been proven to be the main threat to pregnant women's awareness, preventing them from reducing the risk of infection. The aims of this study were to assess the knowledge and practices of French-speaking Swiss perinatal professionals in terms of CMV prevention, as well as the sociodemographic-professional factors that influence them.MethodsThis observational study used a cross-sectional design to collect data-via an anonymous electronic questionnaire in French distributed to gynecologists-obstetricians, general practitioners and midwives via various channels: e-mails and social networks of partner centers, professional associations, and conferences. The 41-item questionnaire collected data on sociodemographic and professional characteristics, general CMV knowledge, national recommendation knowledge and prevention practices. Univariable and multivariable analyses were performed.ResultsA total of 110 gynecologist-obstetricians, 5 general practitioners and 226 midwives participated in the study. While more than 80% of practitioners were familiar with protective hygiene measures, significant gaps were highlighted concerning the transmission routes, as well as the signs of short- and long-term congenital CMV infection. Regarding practice, 63.3% of participants provided information on CMV to their patients, mainly during the first antenatal visit. Among those who did not, lack of knowledge and forgetfulness were the two main reasons cited. Concerning systematic screening, 45.7% of participants offered it to their patients, and 37.3% only offered it to “at risk” groups. The existence of national guidelines on CMV was known by 62.0% of participants. Multivariable analysis revealed that working as a gynecologist-obstetrician was independently associated with higher score of preventive practices, while performing ultrasound or preconception consultations was independently associated with a higher score of general CMV knowledge, and working in a university hospital was independently associated with a higher score of Swiss recommendation knowledge. A level of training higher than the basic medical or midwifery diploma and participation in fetal medicine symposia both promote a higher score of CMV knowledge and prevention practices in line with current recommendations.ConclusionThis study confirms the significant gaps in CMV knowledge among French-speaking Swiss caregivers along with the heterogeneity of their prevention practices. To raise awareness among pregnant women and reduce the burden of congenital CMV infections, improving professional knowledge through access to specific training and standardizing practices should be a national priority.

Change in Prevalence of Hepatitis B Virus Infection in Pregnant Women in the Last Two Decades in Thailand.

Objectives: In Thailand, there has been a strategy to prevent the mother-to-child transmission of HBV for over 30 years. However, there is still a lack of empirical evidence regarding the effectiveness of this strategy. This study aims to investigate the trends in the prevalence of HBV infection in pregnant women and to identify factors that may be associated with the prevalence of HBV infection in pregnant women. Patients and Methods: A maternal-fetal medicine database was accessed to retrieve the consecutive obstetric records of women giving birth at Chiang Mai University Hospital, Thailand, from January 2003 to December 2022. All women undergoing HBV tests with available results were included for an analysis of the trends and changes in the prevalence of maternal HBV infection. Also, the rates of infection in different age cohorts were compared. Results: During the study period, a total of 36,958 women were eligible for analysis. Overall, the prevalence of HBV infection in pregnant women was found to be 5.3% (1970 cases). Overall, HBV prevalence fell from 6.11% in 2003 to 3.15% in 2022. There was a significant reduction, especially in the adolescent group, decreasing from 8.26% in 2003 to 0% in 2022. In the reproductive age group, the prevalence significantly decreased from 6.41% to 2.01%. However, the prevalence in the elderly group was unchanged. The only significant risk factor was the years in the early timeline of the study period, presumably associated with previous HBV vaccination. Other factors, such as socioeconomic status, residential area, and being a private case, were not correlated with the prevalence of HBV. Conclusion: The prevalence of HBV infection in pregnant women has significantly decreased in the past two decades from 6.11% in 2003 to 3.15% in 2022. The percentage of reduction was very striking in the adolescent group, dropping from 8.6% in 2003 to 0.0% in 2022 or being nearly eradicated in the most recent years. Our results suggest that the overall prevalence of HBV infection among our pregnant women will probably be less than 1.0% in the near future.

First-trimester preterm preeclampsia prediction model for prevention with low-dose aspirin.

Preeclampsia (PE) is a major maternal and fetal threat. Previous risk-scoring methods in guidelines lacked precision. The Fetal Medicine Foundation (FMF) proposed a first-trimester PE screening model using Bayes' theorem. FMF prediction model combines maternal characteristics and medical/obstetrical history to determine prior risk and further incorporate maternal blood pressure, maternal serum biomarkers, and uterine Doppler pulsatility index expressed as multiples of the median (MoM) to estimate posterior risk. Low-dose aspirin is one ofthe potential PE prevention strategies. Initiating it before 16 weeks is crucial. Aspirin's antiplatelet and anti-inflammatory properties align with PE's pathophysiology. Dosing and resistance warrant further study, but a standard regimen of 150 mg nightly, starting before 16 weeks, is widely supported. Clinical trials, including ASPRE, affirm aspirin's role in PE prevention. Starting aspirin based on FMF screening significantly reduces preterm PE and associated complications. Emerging research explores predictors like maternal ophthalmic arterial waveform. Regional variations, especially in Asian populations, are considered. Machine learning and AI show promise, but examiner expertise remains essential for accurate prediction. In conclusion, integrating FMF's first-trimester PE screening with low-dose aspirin offers a promising strategy. Further advancements may enhance precision and broaden prevention efforts.

Abortion care at 20 weeks and over in Victoria: a thematic analysis of healthcare providers' experiences.

In many countries, abortions at 20 weeks and over for indications other than fetal or maternal medicine are difficult to access due to legal restrictions and limited availability of services. The Abortion and Contraception Service at the Royal Women's Hospital in Victoria, Australia is the only service in the state that provides this service. The views and experiences of these abortion providers can give insight into the experiences of staff and women and the abortion system accessibility. The aim of this study was to examine health providers' perceptions and experiences of providing abortion care at 20 weeks and over for indications other than fetal or maternal medicine, as well as enablers and barriers to this care and how quality of care could be improved in one hospital in Victoria, Australia. A qualitative study was conducted at the Abortion and Contraception Service at the Royal Women's Hospital. Participants were recruited by convenience and purposive sampling. Semi-structured interviews were conducted one-on-one with participants either online or in-person. A reflexive thematic analysis was performed. In total, 17 healthcare providers from medicine, nursing, midwifery, social work and Aboriginal clinical health backgrounds participated in the study. Ultimately, three themes were identified: 'Being committed to quality care: taking a holistic approach', 'Surmounting challenges: being an abortion provider is difficult', and 'Meeting external roadblocks: deficiencies in the wider healthcare system'. Participants felt well-supported by their team to provide person-centred and holistic care, while facing the emotional and ethical challenges of their role. The limited abortion workforce capacity in the wider healthcare system was perceived to compromise equitable access to care. Providers of abortion at 20 weeks and over for non-medicalised indications encounter systemic enablers and barriers to delivering care at personal, service delivery and healthcare levels. There is an urgent need for supportive policies and frameworks to strengthen and support the abortion provider workforce and expand provision of affordable, acceptable and accessible abortions at 20 weeks and over in Victoria and in Australia more broadly.

Pre-Medications for Non-Emergency Tracheal Intubation in the United States Neonatal Intensive Care Units.

Premedication in neonates undergoing elective intubation effectively minimizes the negative physiological events of bradycardia, systemic hypertension, intracranial hypertension, and hypoxia. Premedication decreases procedure-related pain and discomfort. This study aimed to evaluate the current practice of pre-intubation medications for non-emergent intubations in preterm and term neonates in the United States. A cross-sectional survey (Appendix) was sent via e-mail to all level 3 and 4 Neonatal Intensive Care Units (NICUs) of the Organization of Neonatal Perinatal Medicine Training Program Directors (ONTPD), NICU directors with pediatric residency only, and Baylor Scott and White Health, Mednax, and Envision health services systems. Of 170 responses, 41% (69/168) routinely premedicate, 38% (64/168) premedicate under specific circumstances, and 21% (35/168) do not administer any routine pre-intubation medications. Only 46% (77/168) of units had a written policy. The most frequently used drugs were fentanyl (68%, 116/170), atropine (39%, 66/170), midazolam (38%, 64/170), and morphine (26%, 45/170). 21% (36/170) used a two-drug combination, and 38% (64/170) used a three-drug combination. The most commonly used two-drug combination was atropine and fentanyl, and the most common three-drug combination was atropine, fentanyl, and a paralytic agent. Despite the well-documented benefits of premedication for NICU intubations, as aligned with AAP recommendations, the US lags behind other nations, with stagnant rates since 2006. This disparity persists despite a rise in written policies, which exhibit significant content variations. The authors advocate for the adoption of standardized, AAP-aligned policies across all NICUs in the US. Continued research is vital to monitor the progress of this crucial practice and address any underlying barriers to implementation.

Prevention of Preeclampsia in Saudi Arabia: Knowledge about Risk Factors and Aspirin Use among Obstetrical Care Physicians - A National Survey

Objectives: To assess the level of awareness among obstetrical care providers about preeclampsia prevention including risk factors, good practice in aspirin prophylaxis, and to analyze the associated factors. Methods: A cross-sectional study conducted among gynecologists and obstetricians, maternal and fetal medicine specialists, and internal or family medicine physicians working in public or private care centers whom involved in obstetric care in Saudi Arabia. An online-administered questionnaire was designed to assess familiarity of aspirin role in prevention of preeclampsia and fetal growth restriction including proper dose, timing of intake, gestational age to start and discontinuation of treatment as well as the risk factors of PE among set of 13 conditions. An awareness score was calculated and divided into two levels: adequate and inadequate familiarity and knowledge. Practice in PE prevention and attitude towards aspirin use, in addition to participants’ demographic and professional factors, were investigated and analyzed as profound factors. Results: Hundred sixty physicians were participated, 85% were obstetrician/gynecologists and 13.1 were maternal fetal medicine Specialists. Less than half of participants have adequate knowledge and awareness in aspirin role and a minority provided correct answers regarding the recommended aspiring dose, timing of intake, gestational age to start and discontinuation of treatment. However, knowledge about preeclampsia risk factors was relatively acceptable. Maternal fetal medicine specialist and physicians working in teaching hospitals were remarkably with better knowledge compared to their respective counterparts in primary and secondary centers. The existence of institutional guidelines about ASA use in pregnancy did not improve the knowledge level. Conclusion: The overall familiarity and knowledge in that regard was relatively poor, associating misconceptions about the risk factors and substantial gaps regarding the optimal timing and prescribing practice. Formal and continuous medical education curricula should be reviewed to promote good clinical practice in preeclampsia prevention as an essential dimension of maternal and fetal care.

Pharmacokinetics and pharmacodynamics across infusion rates of intravenously administered nipocalimab: results of a phase 1, placebo-controlled study.

Nipocalimab is a high-affinity, fully human, aglycosylated, effectorless, immunoglobulin G (IgG) 1 monoclonal antibody that targets the neonatal Fc receptor (FcRn), decreases systemic IgG including autoantibodies, and is under development in several IgG autoantibody- and alloantibody-mediated diseases, including generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, maternal-fetal medicine, and multiple other therapeutic areas. An initial phase 1 study with single and multiple ascending doses of nipocalimab infused intravenously (IV) over 2 h demonstrated dose-dependent serum pharmacokinetics and IgG reductions, with an adverse event (AE) profile comparable to placebo. The current investigation evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of nipocalimab across various IV infusion rates in a randomized, double-blind, placebo-controlled, sequential-dose study. Forty participants were randomized to receive nipocalimab 30 mg/kg over 60, 30, 15 or 7.5 min (0.5, 1, 2, or 4 mg/kg/min); nipocalimab 60 mg/kg over 15 min (4 mg/kg/min); or matching placebo. At doses up to 60 mg/kg and infusion rates up to 4 mg/kg/min (maximum clinically feasible rate), single doses of nipocalimab were tolerable, with 12 (40%) participants experiencing AEs across nipocalimab cohorts compared with 1 (10%) participant in the placebo cohort. AEs deemed treatment related occurred in 6 (20%) participants receiving nipocalimab and 1 (10%) participant receiving placebo. None of the AEs were severe, and no participants discontinued treatment due to AEs. Nipocalimab provided consistent, dose-dependent serum pharmacokinetics and IgG reductions, regardless of infusion rate. This study supports the use of shortened durations of nipocalimab infusion for future studies.

Capabilities of perinatal healthcare institutions in primary and tertiary care of low birth weight infants in the Federation of Bosnia and Herzegovina: a cross-sectional multicentric study

Introduction: Providing adequate healthcare for premature infants is an important issue in perinatal medicine. The aim of this study is to assess the level of the perinatal healthcare institution (PHI) where the newborns were delivered and the possibilities of transporting them to the cantons of the Federation of Bosnia and Herzegovina. The authors also aimed to examine the overall survival of low birth-weight infants (LBWI) in the Federation of Bosnia and Herzegovina and to compare the survival of newborns according to the PHI where they were born and the PHI where they were treated. Materials and methods: This cross-sectional study included newborns of both sexes that were born in the maternity wards in 10 cantons of the Federation of Bosnia and Herzegovina with a gestational age between 22 and 42 weeks, and a birth weight less than 2500 g. Result: From the PHI of the first and second level, 159 newborns were referred to the third level. A total of 159/669 (23.7%) were referred from a second level PHI to a third level PHI, and 127/669 (l8.9%) LBWI were definitely taken care of. A total of 513/669 (76.8%) LBWI were definitely taken care of in the third level PHI. Out of a total of 159 LBWI referred from other PHI, only 31 (19.5%) LBWI were transported in less than 4 h, and 128 (80.5%) newborns were admitted to the third level PHI within 4 h of birth (P&lt;0.0001). In second level PHI, most LBWI died in the first 12 h after birth, while in third level PHI, 69.2% of LBWI died after 1 week of life. Conclusion: Based on world experience and assessment of the situation in Federation of Bosnia and Herzegovina, it is necessary to take measures to improve perinatal care and its regional organization.

Assessment of fetal cardiac function in early fetal life: feasibility, reproducibility, and early fetal nomograms

BackgroundFetal cardiology has shown a rapid development in the last decades. Fetal echocardiography is not only used for the detection of structural anomalies but also to assess fetal cardiac function. Assessment of the fetal cardiac function is performed mostly at second and third trimester. The study of fetal cardiac function at the end of first timester has not been properly investigated and there is a lack of reference values at early gestational weeks. ObjectiveTo assess whether the measurement of time related parameters of cardiac function in the left ventricle of the fetal heart is feasible and reproducible at the end of the first trimester. If possible, we provide nomograms of these parameters from 11 to 13.6 gestational weeks. Study designWe conducted a prospective observational study from March to September 2022. The study was carried out in two hospitals (Hospital Universitari Dexeus, Barcelona and Hospital VITAHS 9 Octubre, Valencia). The scans were performed by 3 specialists in fetal medicine. Exclusion criteria were: fetal cardiac rhythm abnormalities, abnormal nuchal translucency, abnormal ductus venosus, fetal malformations, stillbirth, estimated fetal weight< 10 centile, diabetes and gestational hypertensive disorders. The cardiac function parameters studied in the left ventricle were: isovolumetric contraction time, isovolumetric relaxation time, ejection time, filling time, cycle time, myocardial performance index, ejection time fraction and filling time fraction. We study the feasibility and intra- and inter-observer reproducibility of this parameters using the interclass correlation coefficient (ICC). Nomograms were made and the percentiles of the values of the different parameters were calculated. Results409 cases were recruited but only 296 could be included in the statistical analysis once exclusion criteria were applied. The intra-observer reproducibility study was excellent (ICC>0.900) and the inter-observer reproducibility study was good (ICC>0.700). Data regression analysis showed that cycle time, filling time, isovolumetric contraction time and filling time fraction increased with gestational age, whereas ejection time fraction decreased with gestational age and myocardial performance index (mean 0.43±0.08), isovolumetric relaxation time (mean 0.04±0.01) and ejection time (mean 0.16±0.01) remained constant from 11 to 13 weeks. ConclusionsThe study of fetal cardiac function is feasible and reproducible at 11 to 13+6 gestational weeks. Nomograms of the studied parameters are provided.

Counseling in fetal medicine: update on mild and moderate fetal ventriculomegaly.

Ultrasound in Obstetrics & GynecologyAccepted Articles Opinion Counseling in fetal medicine: update on mild and moderate fetal ventriculomegaly D. Di Mascio, D. Di Mascio orcid.org/0000-0002-6560-3393 Department of Maternal and Child Health and Urological Sciences, Sapienza University of Rome, Rome, ItalySearch for more papers by this authorF. D'Antonio, Corresponding Author F. D'Antonio [email protected] orcid.org/0000-0002-7546-8025 Center for Fetal Care and High-Risk Pregnancy, Department of Obstetrics and Gynecology, University of Chieti, Chieti, ItalyCorrespondence to: Prof. F. D'Antonio, Center for Fetal Care and High-Risk Pregnancy, Department of Obstetrics and Gynecology, University of Chieti, Chieti, Italy, E-mail: [email protected]Search for more papers by this authorG. Rizzo, G. Rizzo orcid.org/0000-0002-5525-4353 Department of Obstetrics and Gynecology, Fondazione Policlinico Tor Vergata, University of Rome Tor Vergata, Rome, ItalySearch for more papers by this authorG. Pilu, G. Pilu Obstetric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalySearch for more papers by this authorA. Khalil, A. Khalil orcid.org/0000-0003-2802-7670 Fetal Medicine Unit, St George's Hospital, London, UK Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK Fetal Medicine Unit, Liverpool Women's Hospital, University of Liverpool, Liverpool, UKSearch for more papers by this authorA. Papageorghiou, A. Papageorghiou Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UKSearch for more papers by this author D. Di Mascio, D. Di Mascio orcid.org/0000-0002-6560-3393 Department of Maternal and Child Health and Urological Sciences, Sapienza University of Rome, Rome, ItalySearch for more papers by this authorF. D'Antonio, Corresponding Author F. D'Antonio [email protected] orcid.org/0000-0002-7546-8025 Center for Fetal Care and High-Risk Pregnancy, Department of Obstetrics and Gynecology, University of Chieti, Chieti, ItalyCorrespondence to: Prof. F. D'Antonio, Center for Fetal Care and High-Risk Pregnancy, Department of Obstetrics and Gynecology, University of Chieti, Chieti, Italy, E-mail: [email protected]Search for more papers by this authorG. Rizzo, G. Rizzo orcid.org/0000-0002-5525-4353 Department of Obstetrics and Gynecology, Fondazione Policlinico Tor Vergata, University of Rome Tor Vergata, Rome, ItalySearch for more papers by this authorG. Pilu, G. Pilu Obstetric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalySearch for more papers by this authorA. Khalil, A. Khalil orcid.org/0000-0003-2802-7670 Fetal Medicine Unit, St George's Hospital, London, UK Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK Fetal Medicine Unit, Liverpool Women's Hospital, University of Liverpool, Liverpool, UKSearch for more papers by this authorA. Papageorghiou, A. Papageorghiou Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UKSearch for more papers by this author First published: 19 May 2023 https://doi.org/10.1002/uog.26251 This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/uog.26251. AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Accepted ArticlesAccepted, unedited articles published online and citable. The final edited and typeset version of record will appear in the future. RelatedInformation

Safety and efficacy of a class II medical device based on highly purified and standardized plant extracts in the management of post-menopausal patients with vulvar and vaginal atrophy: a single-center prospective observational study.

Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica. Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity. The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days. In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.