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.

Molecular phylogeny of coronaviruses and host receptors among domestic and close-contact animals reveals subgenome-level conservation, crossover, and divergence.

BACKGROUND: Coronaviruses have the potential to cross species barriers. To learn the molecular intersections among the most common coronaviruses of domestic and close-contact animals, we analyzed representative coronavirus genera infecting mouse, rat, rabbit, dog, cat, cattle, white-tailed deer, swine, ferret, mink, alpaca, Rhinolophus bat, dolphin, whale, chicken, duck and turkey hosts; reference or complete genome sequences were available for most of these coronavirus genera. Protein sequence alignments and phylogenetic trees were built for the spike (S), envelope (E), membrane (M) and nucleocapsid (N) proteins. The host receptors and enzymes aminopeptidase N (APN), angiotensin converting enzyme 2 (ACE2), sialic acid synthase (SAS), transmembrane serine protease 2 (TMPRSS2), dipeptidyl peptidase 4 (DPP4), cathepsin L (and its analogs) and furin were also compared. RESULTS: Overall, the S, E, M, and N proteins segregated according to their viral genera (α, ß, or γ), but the S proteins of alphacoronaviruses lacked conservation of phylogeny. Interestingly, the unique polybasic furin cleavage motif found in severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) but not in severe acute respiratory syndrome coronavirus (SARS-CoV) or Middle East respiratory syndrome coronavirus (MERS-CoV) exists in several ß-coronaviruses and a few α- or γ-coronaviruses. Receptors and enzymes retained host species-dependent relationships with one another. Among the hosts, critical ACE2 residues essential for SARS-CoV-2 spike protein binding were most conserved in white-tailed deer and cattle. CONCLUSION: The polybasic furin cleavage motif found in several ß- and other coronaviruses of animals points to the existence of an intermediate host for SARS-CoV-2, and it also offers a counternarrative to the theory of a laboratory-engineered virus. Generally, the S proteins of coronaviruses show crossovers of phylogenies indicative of recombination events. Additionally, the consistency in the segregation of viral proteins of the MERS-like coronavirus (NC_034440.1) from pipistrelle bat supports its classification as a ß-coronavirus. Finally, similarities in host enzymes and receptors did not always explain natural cross-infections. More studies are therefore needed to identify factors that determine the cross-species infectivity of coronaviruses.

Reducing the Risk for Postpartum Depression in Adolescent Mothers: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effect of an interpersonal therapy-based intervention on reducing the risk of postpartum depression in adolescents. METHODS: A randomized controlled trial enrolled 250 pregnant adolescents who were aged 18 years or younger at conception. The initial sample size calculation estimated 276 participants (324 with attrition) were needed to detect a 50% reduction in risk of the primary outcome, postpartum major depressive episode, with an alpha of 0.05% and 80% power. An interim analysis by the Data Safety and Monitoring Committee informed a revision in the sample size target to 250. Participants were randomized to the intervention (n=129) or a time-matched control group (n=121) who attended sessions about pregnancy topics. Each group received five prenatal sessions and a postpartum booster session. A structured diagnostic interview was administered at baseline and specific time points through 12-months postpartum to assess for major depressive episode onset. RESULTS: Participants were recruited from December 2011 to May 2016 through urban prenatal care sites in the state of Rhode Island. Of the 250 participants, 58% identified as Hispanic and 20% as black or African American. The rate of major depressive episode by 12 months postpartum was 7.0% (95% CI 2.3-11.7%) in the control group and 7.6% (95% CI 2.5-12.7%) in the intervention group, with no significant difference between groups at any time point (P=.88 by log-rank test). CONCLUSION: No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted). Enhanced local community resources available to pregnant and parenting adolescents during the study period may be an explanation for this result. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01482832.

Project ESCUCHE: A Spanish-language Radio-based Intervention to Increase Science Literacy.

Project ESCUCHE was developed to evaluate the potential to increase science literacy among Spanish-language radio listeners. In collaboration with community partners, we developed a 10-week culturally applicable science and health curriculum delivered through Spanish-language radio. Science literacy was assessed before and after the intervention. Among the 51 participants, 70% were female, 76% were > 35 years old, 60% reported some college education, and 90% preferred speaking in Spanish versus English. The majority of participants (>94%) demonstrated adequate baseline functional health literacy, and 70% reported listening to all ten of the radio programs. Participants demonstrated significant increases in science knowledge post intervention (mean score before intervention 68.4% and after intervention 77%). This improvement was consistent across gender, education level, age, and baseline functional health literacy. Radio has the potential to be an effective method of engaging the Spanish-speaking community to improve science literacy. The results from the ESCUCHE program add to the groundwork for further exploration of how radio programming and other media platforms can be used to impact health.

Characterizing Social Determinants of Health for Adolescent Mothers during the Prenatal and Postpartum Periods.

PURPOSE: Significant racial disparities and continuing poor birth outcomes make adolescent pregnancy a significant public health concern in the United States despite declining pregnancy rates. Social determinants of health are associated with increased likelihood of pregnancy and poor maternal and child health outcomes. This study aims to characterize specific elements of social determinants of health in a cohort of predominantly Latina adolescent mothers. METHODS: Between February 2007 and August 2008, 106 pregnant adolescents participated in a study with assessments at 20 to 24 weeks of gestation, and at 3 and 6 months postpartum. Survey questions addressed residential mobility, financial support and childcare, and perceived need for and use of community resources. Comparative analysis assessed differences between adolescents by age (<16 vs. ≥16 years old) and ethnicity (Latina vs. non-Latina). FINDINGS: Adolescent mothers experienced high rates of residential mobility, with 59.4% moving at least once in the year before their prenatal survey. Participants relied primarily on public aid (94-96%) and their parents (81-85%) for financial support. Latina participants were more likely than non-Latinas to rely on public aid. Although many participants reported needing financial support and housing, few used available services. Younger adolescents relied less often on the father of the baby for support than older adolescents. CONCLUSIONS: Adolescent mothers' high rates of residential mobility and increasing reliance on public assistance highlight resource gaps that potentially put them and their children at risk for poor outcomes. Targeted efforts to augment systemic support in these domains are a critical component of addressing health disparities for this population.

Accuracy of brief screening tools for identifying postpartum depression among adolescent mothers.

OBJECTIVE: To evaluate the accuracy of the Edinburgh Postnatal Depression Scale (EPDS) and 3 subscales for identifying postpartum depression among primiparous adolescent mothers. METHODS: Mothers enrolled in a randomized controlled trial to prevent postpartum depression completed a psychiatric diagnostic interview and the 10-item EPDS at 6 weeks, 3 months, and 6 months postpartum. Three subscales of the EPDS were assessed as brief screening tools: 3-item anxiety subscale (EPDS-3), 7-item depressive symptoms subscale (EPDS-7), and 2-item subscale (EPDS-2) that resemble the Patient Health Questionnaire-2. Receiver operating characteristic curves and the areas under the curves for each tool were compared to assess accuracy. The sensitivities and specificities of each screening tool were calculated in comparison with diagnostic criteria for a major depressive disorder. Repeated-measures longitudinal analytical techniques were used. RESULTS: A total of 106 women contributed 289 postpartum visits; 18% of the women met criteria for incident postpartum depression by psychiatric diagnostic interview. When used as continuous measures, the full EPDS, EPDS-7, and EPDS-2 performed equally well (area under the curve >0.9). Optimal cutoff scores for a positive depression screen for the EPDS and EPDS-7 were lower (≥ 9 and ≥ 7, respectively) than currently recommended cutoff scores (≥ 10). At optimal cutoff scores, the EPDS and EPDS-7 both had sensitivities of 90% and specificities of >85%. CONCLUSIONS: The EPDS, EPDS-7, and EPDS-2 are highly accurate at identifying postpartum depression among adolescent mothers. In primary care pediatric settings, the EPDS and its shorter subscales have potential for use as effective depression screening tools.

Randomized controlled trial to prevent postpartum depression in adolescent mothers.

OBJECTIVE: The purpose of this study was to estimate the effect of an interpersonally oriented intervention on the reduction of the risk of postpartum depression in primiparous adolescents. STUDY DESIGN: We conducted a randomized controlled trial of 106 pregnant primiparous adolescents who were ≤17 years old at their first prenatal visit. Participants were assigned randomly to the intervention program (n = 54) or the attention and dose-matched control program (n = 52). Each program included 5 sessions that were delivered during the prenatal period. A structured diagnostic interview was administered to assess for the primary outcome and depression at 6 weeks, 3 months, and 6 months after delivery. RESULTS: Participants included Hispanic (53%), non-Hispanic black (17%), and non-Hispanic white (16%) adolescents. The overall rate of depression in the intervention group (12.5%) was lower than the control group (25%) with a hazard rate ratio of 0.44 (95% confidence interval, 0.17-1.15) at 6 months after delivery. CONCLUSION: An intervention that is delivered during the prenatal period has the potential to reduce the risk for postpartum depression in primiparous adolescent mothers.