Bioengineering approaches for patient-specific analysis of placenta structure and function.

The leading cause of perinatal mortality is fetal growth restriction (FGR), defined as in utero fetal growth below the 10th percentile. Insufficient exchange of oxygen and nutrients at the maternal-fetal interface is associated with FGR. This transport occurs through the vasculature of the placenta, particularly in the terminal villi, where the vascular membranes have a large surface area and are the thinnest. Altered structure of the placenta villi is thought to contribute to decreased oxygen exchange efficiency, however, understanding how the three-dimensional microstructure and properties decrease this efficiency remains a challenge. Here, a novel, multiscale workflow is presented to quantify patient-specific biophysical properties, 3D structural features, and blood flow of the villous tissue. Namely, nanoindentation, optical coherence tomography, and ultrasound imaging were employed to measure the time-dependent material properties of placenta tissue, the 3D structure of villous tissue, and blood flow through the villi to characterize the microvasculature of the placenta at increasing length scales. Quantifying the biophysical properties, the 3D architecture, and blood flow in the villous tissue can be used to infer changes in maternal-fetal oxygen transport at the villous membrane. Overall, this multiscale understanding will advance knowledge of how microvascular changes in the placenta ultimately lead to FGR, opening opportunities for diagnosis and intervention.

Peripartum Prediction of Fetal Weight in Gravidas With Obesity.

OBJECTIVES: Estimated fetal weight (EFW) is an important metric at delivery as neonates with abnormal birthweight and their mothers are at higher risk of birth complications. Data regarding optimal EFW assessment in gravidas with obesity is inconsistent, and with the increasing incidence of obesity, clarification of this question is crucial. We aimed to compare accuracy of ultrasound (US)-derived EFW and clinical assessments of EFW in predicting neonatal birthweight among gravidas with obesity. METHODS: This prospective cohort study enrolled gravidas with obesity and a singleton pregnancy admitted for delivery at term. EFW was determined using either US biometry or clinical assessment (Leopold's maneuvers, Johnson's formula, and Insler's formula) at time of admission. Our primary outcome was accurate EFW, defined as EFW within 500 g of birthweight. Secondary outcomes included ability to predict small-for-gestational age (SGA) and large-for-gestational age (LGA) birthweights. These outcomes were compared between all EFW methods. RESULTS: A total of 250 gravidas with a median body mass index of 36.4 kg/m2 were enrolled. Admission US outperformed Leopold's maneuvers in obtaining accurate EFW (81.6% versus 74.5%, P = .03). When comparing all methods, Johnson's and Insler's formulae performed the worst, accurately predicting EFW in only 27.4% and 14.3% of cases, respectively. Likewise, US-derived EFW outperformed Leopold's maneuvers and fundal height in the prediction of SGA and LGA neonates. CONCLUSIONS: US is more accurate than clinical assessment of EFW in gravidas with obesity both for estimation of actual birthweight and prediction of abnormal birthweight. Universal late third-trimester or peripartum US for EFW should be considered in gravidas with obesity.

Association between interpregnancy interval and the labor curve.

BACKGROUND: Both short and long interpregnancy intervals are associated with adverse pregnancy outcomes; however, the impact of interpregnancy intervals on labor progression is unknown. OBJECTIVE: We examined the impact of interpregnancy intervals on the labor curve, hypothesizing that those with a longer interpregnancy intervals would have slower labor progression. STUDY DESIGN: This is a retrospective cohort study of patients with a history of one prior vaginal delivery admitted for induction of labor or spontaneous labor with a singleton gestation ≥37 weeks at an academic medical center between 2004 and 2015. Repeated measures regression was used to construct labor curves, which were compared between patients with short interpregnancy intervals, defined as <3 years since the last delivery, and long interpregnancy intervals, defined as >3 years since the last delivery. We chose this interval as it approximates the median birth interval in the United States. Interval-censored regression was used to estimate the median duration of labor after 4 centimeters of dilation, stratified by type of labor (spontaneous vs induced). Multivariate analysis was used to adjust for potential confounders. RESULTS: Of the 1331 patients who were included in the analysis, 544 (41%) had a long interpregnancy interval. Among the entire cohort, there were no significant differences in first or second-stage progression between short and long interpregnancy interval groups. In the stratified analysis, first-stage progression varied between groups on the basis of labor type: long interpregnancy interval was associated with a slower active phase among those being induced and a quicker active phase among those in spontaneous labor. The second-stage duration was similar between cohorts regardless of labor type. CONCLUSION: Multiparas with an interpregnancy interval >3 years may have a slower active phase than those with a shorter interpregnancy interval when undergoing induction of labor. Interpregnancy interval does not demonstrate an effect on the length of the second stage.

Vasa previa in singleton pregnancies: diagnosis and clinical management based on an international expert consensus.

BACKGROUND: There are limited data to guide the diagnosis and management of vasa previa. Currently, what is known is largely based on case reports or series and cohort studies. OBJECTIVE: This study aimed to systematically collect and classify expert opinions and achieve consensus on the diagnosis and clinical management of vasa previa using focus group discussions and a Delphi technique. STUDY DESIGN: A 4-round focus group discussion and a 3-round Delphi survey of an international panel of experts on vasa previa were conducted. Experts were selected on the basis of their publication record on vasa previa. First, we convened a focus group discussion panel of 20 experts and agreed on which issues were unresolved in the diagnosis and management of vasa previa. A 3-round anonymous electronic survey was then sent to the full expert panel. Survey questions were presented on the diagnosis and management of vasa previa, which the experts were asked to rate on a 5-point Likert scale (from "strongly disagree"=1 to "strongly agree"=5). Consensus was defined as a median score of 5. Following responses to each round, any statements that had median scores of ≤3 were deemed to have had no consensus and were excluded. Statements with a median score of 4 were revised and re-presented to the experts in the next round. Consensus and nonconsensus statements were then aggregated. RESULTS: A total of 68 international experts were invited to participate in the study, of which 57 participated. Experts were from 13 countries on 5 continents and have contributed to >80% of published cohort studies on vasa previa, as well as national and international society guidelines. Completion rates were 84%, 93%, and 91% for the first, second, and third rounds, respectively, and 71% completed all 3 rounds. The panel reached a consensus on 26 statements regarding the diagnosis and key points of management of vasa previa, including the following: (1) although there is no agreement on the distance between the fetal vessels and the cervical internal os to define vasa previa, the definition should not be limited to a 2-cm distance; (2) all pregnancies should be screened for vasa previa with routine examination for placental cord insertion and a color Doppler sweep of the region over the cervix at the second-trimester anatomy scan; (3) when a low-lying placenta or placenta previa is found in the second trimester, a transvaginal ultrasound with Doppler should be performed at approximately 32 weeks to rule out vasa previa; (4) outpatient management of asymptomatic patients without risk factors for preterm birth is reasonable; (5) asymptomatic patients with vasa previa should be delivered by scheduled cesarean delivery between 35 and 37 weeks of gestation; and (6) there was no agreement on routine hospitalization, avoidance of intercourse, or use of 3-dimensional ultrasound for diagnosis of vasa previa. CONCLUSION: Through focus group discussion and a Delphi process, an international expert panel reached consensus on the definition, screening, clinical management, and timing of delivery in vasa previa, which could inform the development of new clinical guidelines.

Predictors and timing of hydrocephalus treatment in patients undergoing prenatal versus postnatal surgery for myelomeningocele.

OBJECTIVE: Although hydrocephalus rates have decreased with intrauterine surgery for myelomeningocele (MMC), 40%-85% of children with MMC still go on to develop hydrocephalus. Prenatal ventricle size is known to be associated with later development of hydrocephalus; however, it is not known how prediction measures or timing of hydrocephalus treatment differ between pre- and postnatal surgery for MMC. The goal of this study was to determine anatomical, clinical, and radiological characteristics that are associated with the need for and timing of hydrocephalus treatment in patients with MMC. METHODS: The authors retrospectively identified patients from Barnes Jewish Hospital or St. Louis Children's Hospital between 2016 and 2021 who were diagnosed with MMC prenatally and underwent either pre- or postnatal repair. Imaging, clinical, and demographic data were examined longitudinally between treatment groups and hydrocephalus outcomes. RESULTS: Fifty-eight patients were included (27 females, 46.6%), with a mean gestational age at birth of 36.8 weeks. Twenty-three patients (39.7%) underwent prenatal surgery. For the overall cohort, the ventricle size at prenatal ultrasound (HR 1.175, 95% CI 1.071-1.290), frontal-occipital horn ratio (FOHR) at birth > 0.50 (HR 3.603, 95% CI 1.488-8.720), and mean rate of change in head circumference (HC) in the first 90 days after birth (> 0.10 cm/day: HR 12.973, 95% CI 4.262-39.486) were identified as predictors of hydrocephalus treatment. The factors associated with hydrocephalus in the prenatal cohort were FOHR at birth > 0.50 (HR 27.828, 95% CI 2.980-259.846) and the rate of change in HC (> 0.10 cm/day: HR 39.414, 95% CI 2.035-763.262). The factors associated with hydrocephalus in the postnatal cohort were prenatal ventricle size (HR 1.126, 95% CI 1.017-1.246) and the mean rate of change in HC (> 0.10 cm/day: HR 24.202, 95% CI 5.119-114.431). FOHR (r = -0.499, p = 0.008) and birth HC (-0.409, p = 0.028) were correlated with time to hydrocephalus across both cohorts. For patients who underwent treatment for hydrocephalus, those in the prenatal surgery group were significantly more likely to develop hydrocephalus after 3 months than those treated with postnatal surgery, although the overall rate of hydrocephalus was significantly higher in the postnatal surgery group (p = 0.018). CONCLUSIONS: Clinical and imaging factors associated with hydrocephalus treatment differ between those receiving pre- versus postnatal MMC repair, and while the overall rate of hydrocephalus is lower, those undergoing prenatal repair are more likely to develop hydrocephalus after 3 months of age. This has implications for clinical follow-up timing for patients treated prenatally, who may live at a distance from the treatment site.

Hepatitis C and obstetrical morbidity in a substance use disorder clinic: a role for telemedicine?

BACKGROUND: Hepatitis C infection often co-occurs with substance use disorders in pregnancy. Accessing hepatitis C treatment is challenging because of loss to follow-up in the postpartum period, attributable to social and financial barriers to care. Telemedicine has been explored as a means of increasing routine postpartum care, but the potential impact on retention in and completion of care for postpartum hepatitis C has not been assessed. OBJECTIVE: This study aimed to evaluate the impact of hepatitis C on obstetrical morbidity in a substance use disorder-specific prenatal clinic, and the effect of Infectious Disease telemedicine consultation on subsequent treatment delivery. STUDY DESIGN: We performed a retrospective cohort study of all patients in our substance use disorder prenatal clinic from June 2018 to February 2023. Telemedicine consults for hepatitis C diagnoses began in March 2020 and included electronic chart review by Infectious Disease when patients were unable to be seen. Our primary outcome was composite obstetrical morbidity (preterm birth, preeclampsia, fetal growth restriction, fetal anomaly, abruption, postpartum hemorrhage, or chorioamnionitis) compared between patients with and without active hepatitis C. We additionally evaluated rates of completed referral and initiation of hepatitis C treatment before and after implementation of telemedicine consult. RESULTS: A total of 224 patients were included. Of the 222 patients who underwent screening, 71 (32%) were positive for active hepatitis C. Compared with patients without hepatitis C, a higher proportion of patients with hepatitis C were White (80% vs 58%; P=.02), had a history of amphetamine use (61% vs 32%; P<.01), injection drug use (72% vs 38%; P<.01), or overdose (56% vs 29%; P<.01), and were on methadone (37% vs 18%; P<.01). There was no difference in the primary outcome of composite obstetrical morbidity. The rate of hepatitis C diagnosis was not statistically significantly different between the pre- and posttelemedicine cohorts (N=29 [41%], N=42 [27%]), and demographics of hepatitis C virus-positive patients were similar, with most being unemployed, single, and publicly insured. A lower proportion of patients in the posttelemedicine group reported heroin use compared with the pretelemedicine cohort (62% vs 90%; P=.013). After implementation of telemedicine, patients were more likely to attend the visit (19% vs 44%; P=.03), and positive patients were much more likely to receive treatment (14% vs 57%; P<.01); 100% of visits in the posttelemedicine group occurred via telemedicine. There were 7 patients who were prescribed treatment by their obstetrician after chart review by Infectious Disease. CONCLUSION: Patients with and without hepatitis C had similar maternal and neonatal outcomes, with multiple indicators of social and financial vulnerability. Telemedicine Infectious Disease consult was associated with increased follow-up and hepatitis C treatment, and obstetricians were able to directly prescribe. Because patients with substance use disorders and hepatitis C may have increased barriers to care, telemedicine may represent an opportunity for intervention.

The Impact of Cervical Effacement at Time of Amniotomy in Patients Undergoing Induction of Labor.

OBJECTIVE: There is evidence to suggest that early amniotomy during induction of labor is advantageous. However, following cervical ripening balloon removal, the cervix remains less effaced and the utility of amniotomy in this setting is less clear. We investigated whether cervical effacement at the time of amniotomy impacts outcomes among nulliparas undergoing induction of labor. STUDY DESIGN: This was a secondary analysis of a prospective cohort of singleton, term, nulliparous patients at a tertiary care center undergoing induction of labor and amniotomy. The primary outcome was completion of the first stage of labor. Secondary outcomes were vaginal delivery and postpartum hemorrhage. Outcomes were compared between patients with cervical effacement ≤50% (low effacement) and >50% (high effacement) at time of amniotomy. Multivariable logistic regression was used calculate risk ratios (RR) to adjust for confounders including cervical dilation. Stratified analysis was performed in patients with cervical ripening balloon use. A post hoc sensitivity analysis was performed to further control for cervical dilation. RESULTS: Of 1,256 patients, 365 (29%) underwent amniotomy at low effacement. Amniotomy at low effacement was associated with reduced likelihood of completing the first stage (aRR: 0.87 [95% confidence interval, CI: 0.78-0.95]) and vaginal delivery (aRR: 0.87 [95% CI: 0.77-0.96]). Although amniotomy at low effacement was associated with lower likelihood of completing the first stage in all-comers, those who had amniotomy performed at low effacement following cervical ripening balloon expulsion were at the highest risk (aRR: 0.84 [95% CI: 0.69-0.98], p for interaction = 0.04) In the post hoc sensitivity analysis, including patients who underwent amniotomy at 3- or 4-cm dilation, low cervical effacement remained associated with a lower likelihood of completing the first stage of labor. CONCLUSION: Low cervical effacement at time of amniotomy, particularly following cervical ripening balloon expulsion, is associated with a lower likelihood of successful induction. KEY POINTS: · Low cervical effacement at amniotomy was associated with lower rates of complete dilation.. · Effacement at amniotomy is especially important for patients who had a cervical ripening balloon.. · Providers should consider cervical effacement when timing amniotomy for nulliparous term patients..

Risks of stillbirth, neonatal mortality, and severe neonatal morbidity by birthweight centiles associated with expectant management at term.

BACKGROUND: Determining the optimal time of birth at term is challenging given the ongoing risks of stillbirth with increasing gestation vs the risks of significant neonatal morbidity at early-term gestations. These risks are more pronounced in small infants. OBJECTIVE: This study aimed to evaluate the risks of stillbirth, neonatal mortality, and severe neonatal morbidity by comparing expectant management with delivery from 37+0 weeks of gestation. STUDY DESIGN: This was a retrospective cohort study evaluating women with singleton, nonanomalous pregnancies at 37+0 to 40+6 weeks' gestation in Queensland, Australia, delivered from 2000 to 2018. Rates of stillbirth, neonatal death, and severe neonatal morbidity were calculated for <3rd, 3rd to <10th, 10th to <25th, 25th to <90th, and ≥90th birthweight centiles. The composite risk of mortality with expectant management for an additional week in utero was compared with rates of neonatal mortality and severe neonatal morbidity. RESULTS: Of 948,895 singleton, term nonanomalous births, 813,077 occurred at 37+0 to 40+6 weeks' gestation. Rates of stillbirth increased with gestational age, with the highest rate observed in infants with birthweight below the third centile: 10.0 per 10,000 (95% confidence interval, 6.2-15.3) at 37+0 to 37+6 weeks, rising to 106.4 per 10,000 (95% confidence interval, 74.6-146.9) at 40+0 to 40+6 weeks' gestation. The rate of neonatal mortality was highest at 37+0 to 37+6 weeks for all birthweight centiles. The composite risk of expectant management rose sharply after 39+0 to 39+6 weeks, and was highest in infants with birthweight below the third centile (125.2/10,000; 95% confidence interval, 118.4-132.3) at 40+0 to 40+6 weeks' gestation. Balancing the risk of expectant management and delivery (neonatal mortality), the optimal timing of delivery for each birthweight centile was evaluated on the basis of relative risk differences. The rate of severe neonatal morbidity sharply decreased in the period between 37+0 to 37+6 and 38+0 to 38+6 weeks, particularly for infants with birthweight below the third centile. CONCLUSION: Our data suggest that the optimal time of birth is 37+0 to 37+6 weeks for infants with birthweight <3rd centile and 38+0 to 38+6 weeks' gestation for those with birthweight between the 3rd and 10th centile and >90th centile. For all other birthweight centiles, birth from 39+0 weeks is associated with the best outcomes. However, large numbers of planned births are required to prevent a single excess death. The healthcare costs and acceptability to women of potential universal policies of planned birth need to be carefully considered.

Heterogeneity in management of category II fetal tracings: data from a multihospital healthcare system.

BACKGROUND: Electronic fetal monitoring is widely used to identify and intervene in suspected fetal hypoxia and/or acidemia. Category II fetal heart rate tracings are the most common class of fetal monitoring in labor, and intrauterine resuscitation is recommended given the association of category II fetal heart rate tracings with fetal acidemia. However, limited published data are available to guide intrauterine resuscitation technique selection, leading to heterogeneity in the response to category II fetal heart rate tracings. OBJECTIVE: This study aimed to characterize approaches to intrauterine resuscitation in response to category II fetal heart rate tracings. STUDY DESIGN: This was a survey study administered to labor unit nurses and delivering clinicians (physicians and midwives) across 7 hospitals in a Midwestern healthcare system spanning 2 states. The survey posed 3 category II fetal heart rate tracing scenarios (recurrent late decelerations, minimal variability, and recurrent variable decelerations) and asked participants to select first- and second-line intrauterine resuscitation management strategies. The participants were asked to quantify the level of influence certain factors have on their choice using a scale from 1 to 5. Intrauterine resuscitation strategy selection was compared by clinical role and hospital type (nurses vs delivering clinicians and university-affiliated hospital vs non-university-affiliated hospital). RESULTS: Of 610 providers invited to take the survey, 163 participated (response rate of 27%): 37% of participants from university-affiliated hospitals, 62% of nurses, and 37% of physicians. Maternal repositioning was the most selected first-line strategy, regardless of the type of category II fetal heart rate tracing. First-line management varied by clinical role and hospital affiliation for each fetal heart rate tracing scenario, particularly for minimal variability, which was associated with the most heterogeneity in the first-line approach. Previous experience and recommendations from professional societies were the most influential factors in intrauterine resuscitation selection overall. Of note, 16.5% of participants reported that published evidence did not influence their choice at all. Participants from a university-affiliated hospital were more likely than participants from a non-university-affiliated hospital to consider patient preference when selecting an intrauterine resuscitation technique. Nurses and delivering clinicians differed significantly in the rationale for management choices: nurses were more often influenced by advice from other healthcare providers on the team (P<.001), whereas delivering clinicians were more influenced by literature (P=.02) and ease of technique (P=.02). CONCLUSION: There was significant heterogeneity in the management of category II fetal heart rate tracing. In addition, motivations for choice in intrauterine resuscitation technique varied by hospital type and clinical role. These factors should be considered when creating fetal monitoring and intrauterine resuscitation protocols.

Video Instruction for Pushing in the Second Stage: a randomized controlled trial.

BACKGROUND: The second stage of labor requires active patient engagement. Previous studies suggest that coaching can influence the second stage of labor duration. However, a standardized education tool has not been established, and patients face many barriers to accessing childbirth education before delivery. OBJECTIVE: This study aimed to investigate the effect of an intrapartum video pushing education tool on the second stage of labor duration. STUDY DESIGN: This was a randomized controlled trial of nulliparous patients with singleton pregnancies ≥37 weeks of gestation admitted for induction of labor or spontaneous labor with neuraxial anesthesia. Patients were consented on admission and block randomized in active labor to 1 of 2 arms in a 1:1 ratio. The study arm viewed a 4-minute video before the second stage of labor on what to anticipate in the second stage of labor and pushing techniques. The control arm received the standard of care: bedside coaching at 10 cm dilation from a nurse or physician. The primary outcome was second stage of labor duration. The secondary outcomes were birth satisfaction (using the Modified Mackey Childbirth Satisfaction Rating Scale), mode of delivery, postpartum hemorrhage, clinical chorioamnionitis, neonatal intensive care unit admission, and umbilical artery gases. Of note, 156 patients were needed to detect a 20% decrease in the second stage of labor duration with 80% power, 2-sided alpha level of .05, and 10% loss after randomization. Funding was provided by the Lucy Anarcha Betsy award from the division of clinical research at Washington University. RESULTS: Of 161 patients, 81 were randomized to standard of care, and 80 were randomized to intrapartum video education. Among these patients, 149 progressed to the second stage of labor and were included in the intention-to-treat analysis: 69 in the video group and 78 in the control group. Maternal demographics and labor characteristics were similar between groups. The second stage of labor duration was statistically similar between the video arm (61 minutes [interquartile range, 20-140]) and the control arm (49 minutes [interquartile range, 27-131]) (P=.77). There was no difference in mode of delivery, postpartum hemorrhage, clinical chorioamnionitis, neonatal intensive care unit admission, or umbilical artery gases between groups. Although the overall birth satisfaction score on the Modified Mackey Childbirth Satisfaction Rating Scale was similar between groups, patients in the video group rated their "level of comfort during birth" and "attitude of the doctors in birth" significantly higher or more positively than patients in the control group (P<.05 for both). CONCLUSION: Intrapartum video education was not associated with a shorter second stage of labor duration. However, patients who received video education reported a higher level of comfort and a more favorable perception of their physician, suggesting that video education may be a helpful tool to improve the birth experience.

A systematic review and critical evaluation of quality of clinical practice guidelines on fetal growth restriction.

INTRODUCTION: To systematically identify and critically assess the quality of clinical practice guidelines (CPGs) on management fetal growth restriction (FGR). CONTENT: Medline, Embase, Google Scholar, Scopus and ISI Web of Science databases were searched to identify all relevant CPGs on FGR. SUMMARY: Diagnostic criteria of FGR, recommended growth charts, recommendation for detailed anatomical assessment and invasive testing, frequency of fetal growth scans, fetal monitoring, hospital admission, drugs administrations, timing at delivery, induction of labor, postnatal assessment and placental histopathological were assessed. Quality assessment was evaluated by AGREE II tool. Twelve CPGs were included. Twenty-five percent (3/12) of CPS adopted the recently published Delphi consensus, 58.3% (7/12) an estimated fetal weight (EFW)/abdominal circumference (AC) EFW/AC <10th percentile, 8.3% (1/12) an EFW/AC <5th percentile while one CPG defined FGR as an arrest of growth or a shift in its rate measured longitudinally. Fifty percent (6/12) of CPGs recommended the use of customized growth charts to assess fetal growth. Regarding the frequency of Doppler assessment, in case of absent or reversed end-diastolic flow in the umbilical artery 8.3% (1/12) CPGs recommended assessment every 24-48, 16.7% (2/12) every 48-72 h, 1 CPG generically recommended assessment 1-2 times per week, while 25 (3/12) did not specifically report the frequency of assessment. Only 3 CPGs reported recommendation on the type of Induction of Labor to adopt. The AGREE II standardized domain scores for the first overall assessment (OA1) had a mean of 50%. OUTLOOK: There is significant heterogeneity in the management of pregnancies complicated by FGR in published CPGs.

Protocol for a multicenter, double-blinded placebo-controlled randomized controlled trial comparing intravenous ferric derisomaltose to oral ferrous sulfate for the treatment of iron deficiency anemia in pregnancy: The IVIDA2 trial.

BACKGROUND: Iron deficiency anemia (IDA) is common during pregnancy and associated with adverse maternal and neonatal outcomes. Treatment with iron supplementation is recommended during pregnancy, but the optimal delivery route is unclear. Oral iron risks has high risk of gastrointestinal side effects and low absorption. Intravenous iron is infused directly but is expensive. The American College of Obstetricians and Gynecologists currently recommends oral iron to treat IDA in pregnancy with intravenous iron reserved as second-line therapy, if needed. This approach is associated with persistent anemia, increasing the risk of peripartum blood transfusion. We aim to provide data on optimal route of iron repletion for IDA in pregnancy. METHODS: In IVIDA2, a double-blind, placebo controlled, multicenter randomized trial in the United States, 746 pregnant people with moderate-to-severe IDA (hemoglobin <10 g/dL and ferritin <30 ng/mL) at 24-28 weeks' gestation will be randomized 1:1 to either a single 1000 mg dose of intravenous ferric derisomaltose and oral placebo (1-3 times daily) or a single placebo infusion with 1-3 times daily 325 mg ferrous sulfate (65 mg elemental iron) tablet. The primary outcome is peripartum blood transfusion (blood transfusion from delivery to 7 days postpartum). Secondary outcomes include adverse medication reactions, maternal and neonatal hematologic indices, and offspring neurodevelopment. ETHICS AND DISSEMINATION: A central ethical review board-Advarra-granted ethical approval (Pro00060930). Participating centers-Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of Ethics and dissemination: A central ethical review board-Advarra-granted ethical approval (Pro00060930). Participating centers-Women & Infants Hospital of Rhode Island, University of Michigan Medical Center, Washington University School of.

One-Step Compared With Two-Step Gestational Diabetes Screening and Pregnancy Outcomes: A Systematic Review and Meta-analysis.

OBJECTIVE: To estimate short-term maternal and neonatal outcomes with one-compared with two-step testing for gestational diabetes mellitus (GDM). DATA SOURCES: A systematic review of randomized controlled trials (RCTs) and observational studies comparing one-step and two-step GDM testing strategies before September 2021 was conducted. We searched Ovid Medline (1946-), EMBASE (1947-), Scopus (1960-), Cochrane Central, and ClinicalTrials.gov . The primary outcome was rate of large-for-gestational age (LGA) neonates. Secondary outcomes were clinically relevant outcomes for GDM that were selected a priori. METHODS OF STUDY SELECTION: Titles, abstracts, and manuscripts were screened, selected, and reviewed by the first two authors. Four RCTs (24,966 patients) and 13 observational studies (710,677 patients) were analyzed. TABULATION, INTEGRATION, AND RESULTS: Pooled relative risks (RRs) were calculated with 95% CIs using random-effects models and were plotted graphically with forest plots. Study heterogeneity was evaluated using Cochran Q and Higgins I 2 tests. The quality of studies that met the inclusion criteria was evaluated with the Downs and Black checklist. Publication bias was assessed by using asymmetry of funnel plots and Harbord's test. There was no difference in the rate of LGA neonates (pooled RR 0.95; 95% CI 0.88-1.04) by testing strategy among RCTs, but patients who underwent one-step testing were more likely to be diagnosed with GDM (pooled RR 2.13; 95% CI 1.61-2.82) and treated with diabetes medications (pooled RR 2.24; 95% CI 1.21-4.15). One-step testing was associated with higher rates of neonatal intensive care unit (NICU) admission (pooled RR 1.12; 95% CI 1.00-1.26) and neonatal hypoglycemia (pooled RR 1.23; 95% CI 1.13-1.34). In analysis of high-quality RCTs and observational studies, one-step testing was associated with a lower rate of LGA neonates (pooled RR 0.97; 95% CI 0.95-0.98), but higher rates of GDM diagnosis, treatment, NICU admission, and neonatal hypoglycemia. CONCLUSION: Despite a significant increase in GDM diagnosis and treatment with one-step testing, there is no difference in rate of LGA neonates compared with two-step testing among RCTs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021252703.

COVID Vaccine Information Sources Utilized by Female Healthcare Workers.

BACKGROUND: Clinical trials of the messenger RNA COVID-19 vaccines excluded individuals with active reproductive needs (attempting to conceive, currently pregnant, and/or lactating). Women comprise three-quarters of healthcare workers in the United States-an occupational field among the first to receive the vaccine. Professional medical and government organizations have encouraged shared decision-making and access to vaccination among those with active reproductive needs. OBJECTIVE: This study aimed to characterize the information sources used by pregnancy-capable healthcare workers for information about the COVID-19 vaccines and to compare the self-reported "most important" source by the respondents' active reproductive needs, if any. STUDY DESIGN: This was a web-based national survey of female, US-based healthcare workers in January 2021. Recruitment was done using social media and subsequent sharing via word of mouth. We classified the respondents into 6 groups on the basis of self-reported reproductive needs as follows: (1) preventing pregnancy, (2) attempting pregnancy, (3) currently pregnant, (4) lactating, (5) attempting pregnancy and lactating, and (6) currently pregnant and lactating. We provided respondents with a list of information sources (friends, family, obstetrician-gynecologists, pediatrician, news, social media, government organizations, their employer, and "other") and asked respondents which source(s) they used when looking for information about the vaccine and their most important source. We used descriptive statistics to characterize the information sources and compared the endorsement of government organizations and obstetrician-gynecologists, which were the most important information source between reproductive groups, using the chi-square test. The effect size was calculated using Cramér V. RESULTS: Our survey had 11,405 unique respondents: 5846 (51.3%) were preventing pregnancy, 955 (8.4%) were attempting pregnancy, 2196 (19.3%) were currently pregnant, 2250 (19.7%) were lactating, 67 (0.6%) were attempting pregnancy and lactating, and 91 (0.8%) were currently pregnant and lactating. The most endorsed information sources were government organizations (88.7%), employers (48.5%), obstetrician-gynecologists (44.9%), and social media (39.6%). Considering the most important information source, the distribution of respondents endorsing government organizations was different between reproductive groups (P<.001); it was most common among respondents preventing pregnancy (62.6%) and least common among those currently pregnant (31.5%). We observed an inverse pattern among the respondents endorsing an obstetrician-gynecologist as the most important source; the source was most common among currently pregnant respondents (51.4%) and least common among those preventing pregnancy (5.8%), P<.001. The differences in the endorsement of social media as an information source between groups were significant but had a small effect size. CONCLUSION: Healthcare workers use government and professional medical organizations for information. Respondents attempting pregnancy and those pregnant and/or lactating are more likely to use social media and an obstetrician-gynecologist as information sources for vaccine decision-making. These data can inform public health messaging and counseling for clinicians.