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JAMA Pediatrics Jul 2024COVID-19 vaccination is recommended throughout pregnancy to prevent pregnancy complications and adverse birth outcomes associated with COVID-19 disease. To date, data on...
IMPORTANCE
COVID-19 vaccination is recommended throughout pregnancy to prevent pregnancy complications and adverse birth outcomes associated with COVID-19 disease. To date, data on birth defects after first-trimester vaccination are limited.
OBJECTIVE
To evaluate the associated risks for selected major structural birth defects among live-born infants after first-trimester receipt of a messenger RNA (mRNA) COVID-19 vaccine.
DESIGN, SETTING, AND PARTICIPANTS
This was a retrospective cohort study of singleton pregnancies with estimated last menstrual period (LMP) between September 13, 2020, and April 3, 2021, and ending in live birth from March 5, 2021, to January 25, 2022. Included were data from 8 health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin in the Vaccine Safety Datalink.
EXPOSURES
Receipt of 1 or 2 mRNA COVID-19 vaccine doses in the first trimester, as part of the primary series.
MAIN OUTCOMES AND MEASURES
Selected major structural birth defects among live-born infants, identified from electronic health data using validated algorithms, with neural tube defects confirmed via medical record review.
RESULTS
Among 42 156 eligible pregnancies (mean [SD] maternal age, 30.9 [5.0] years) 7632 (18.1%) received an mRNA COVID-19 vaccine in the first trimester. Of 34 524 pregnancies without a first-trimester COVID-19 vaccination, 2045 (5.9%) were vaccinated before pregnancy, 13 494 (39.1%) during the second or third trimester, and 18 985 (55.0%) were unvaccinated before or during pregnancy. Compared with pregnant people unvaccinated in the first trimester, those vaccinated in the first trimester were older (mean [SD] age, 32.3 [4.5] years vs 30.6 [5.1] years) and differed by LMP date. After applying stabilized inverse probability weighting, differences in baseline characteristics between vaccinated and unvaccinated pregnant persons in the first trimester were negligible (standardized mean difference <0.20). Selected major structural birth defects occurred in 113 infants (1.48%) after first-trimester mRNA COVID-19 vaccination and in 488 infants (1.41%) without first-trimester vaccine exposure; the adjusted prevalence ratio was 1.02 (95% CI, 0.78-1.33). In secondary analyses, with major structural birth defect outcomes grouped by organ system, no significant differences between infants vaccinated or unvaccinated in the first trimester were identified.
CONCLUSIONS AND RELEVANCE
In this multisite cohort study, among live-born infants, first-trimester mRNA COVID-19 vaccine exposure was not associated with an increased risk for selected major structural birth defects.
PubMed: 38949821
DOI: 10.1001/jamapediatrics.2024.1917 -
JAMA Network Open Jul 2024Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known.
OBJECTIVE
To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial.
DESIGN, SETTING, AND PARTICIPANTS
A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years.
INTERVENTION
UCM and ECC.
MAIN OUTCOMES AND MEASURES
Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used.
RESULTS
Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86).
CONCLUSIONS AND RELEVANCE
In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03631940.
Topics: Humans; Female; Infant, Newborn; Male; Infant; Umbilical Cord Clamping; Cross-Over Studies; Umbilical Cord; Hypoxia-Ischemia, Brain; Child, Preschool
PubMed: 38949814
DOI: 10.1001/jamanetworkopen.2024.16870 -
Ultrasound in Obstetrics & Gynecology :... Jul 2024
Topics: Humans; Female; Pregnancy; Ultrasonography, Prenatal; Artificial Intelligence; Heart Defects, Congenital; Fetal Heart
PubMed: 38949769
DOI: 10.1002/uog.27703 -
Law and Human Behavior Jun 2024The presence of callous-unemotional (CU) traits in adolescence predisposes youth to negative behavioral and social outcomes and may be particularly damaging to youth...
OBJECTIVE
The presence of callous-unemotional (CU) traits in adolescence predisposes youth to negative behavioral and social outcomes and may be particularly damaging to youth involved in the justice system. Whereas research has shown that CU traits predict later arrest, it remains unknown whether rearrest predicts changes in CU traits and whether these associations may be modified by maternal relationship quality. The present study assessed whether being rearrested predicted changes in CU traits and whether these associations varied by maternal warmth and maternal hostility.
HYPOTHESES
We hypothesized that self-reported CU traits would increase at data collection time points following rearrest. Further, we hypothesized that maternal warmth would buffer the negative effects of rearrest, whereas maternal hostility would not have a significant moderating effect on the associations.
METHOD
Hypotheses were tested using a large, multisite longitudinal data set of 1,216 justice-involved male youth (Mage = 15.82 years at baseline; 47% Latino, 38% Black/African American, 15% White). Data from a series of nine interviews (across a 7-year period) were used to determine associations between rearrest at one-time point and CU traits at the subsequent time point.
RESULTS
Rearrest is associated with a significant increase in CU traits. However, these associations are not moderated by either maternal warmth or maternal hostility.
CONCLUSIONS
Rearrest predicts increases in a known risk factor for healthy socioemotional development among justice-involved youths (CU traits). Moreover, the way rearrest is associated with CU traits does not change depending on maternal warmth; rearrest is associated with increases in CU traits irrespective of the quality of a youth's relationship with their mother. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
Topics: Humans; Male; Adolescent; Mother-Child Relations; Female; Juvenile Delinquency; Longitudinal Studies; Hostility; Emotions; Antisocial Personality Disorder
PubMed: 38949766
DOI: 10.1037/lhb0000567 -
The Journal of Nervous and Mental... Jul 2024Wolfram syndrome 1 (WS1) is a rare, autosomal recessive neurodegenerative disorder characterized by diabetes insipidus, insulin-dependent diabetes mellitus, optic...
Wolfram syndrome 1 (WS1) is a rare, autosomal recessive neurodegenerative disorder characterized by diabetes insipidus, insulin-dependent diabetes mellitus, optic atrophy, and deafness resulting from loss-of-function genetic variants in the WFS1 gene. Individuals with WS1 manifest a spectrum of neuropsychiatric disorders. Here, we report a pediatric case of WS1, which stemmed from a novel biallelic WFS1 loss-of-function genetic variant. The individual initially presented with obsessive-compulsive disorder, which was successfully managed by fluvoxamine. After 2 months, the child manifested excessive daytime sleepiness. Clinical evaluation and sleep recordings revealed a diagnosis of narcolepsy type 2. Excessive daytime sleepiness was improved with methylphenidate. To the best of our knowledge, this is the first report of narcolepsy in WS1, which possibly arose during a progressive neurodegenerative process. We emphasize the need for in-depth screening for neuropsychiatric phenotypes and sleep-related disorders in WS1, for clinical management, which significantly improves the quality of life.
Topics: Humans; Female; Wolfram Syndrome; Narcolepsy; Obsessive-Compulsive Disorder; Child; Membrane Proteins
PubMed: 38949661
DOI: 10.1097/NMD.0000000000001784 -
Obstetrics and Gynecology Jul 2024
Topics: Humans; Female; Pregnancy
PubMed: 38949552
DOI: 10.1097/AOG.0000000000005627 -
Obstetrics and Gynecology Jul 2024
Topics: Humans; Pre-Eclampsia; Female; Pregnancy; Biomarkers
PubMed: 38949551
DOI: 10.1097/AOG.0000000000005626 -
Obstetrics and Gynecology Jul 2024To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
OBJECTIVE
To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial.
METHODS
We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding.
RESULTS
Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine.
CONCLUSION
No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT02299414.
Topics: Humans; Pregnancy; Female; Labetalol; Nifedipine; Antihypertensive Agents; Adult; Pregnancy Outcome; Hypertension; Infant, Newborn; Pregnancy Complications, Cardiovascular; Hypertension, Pregnancy-Induced; Administration, Oral; Infant, Small for Gestational Age; Pre-Eclampsia; Chronic Disease
PubMed: 38949541
DOI: 10.1097/AOG.0000000000005613 -
Paediatric and Perinatal Epidemiology Jul 2024Past research on the safety of prenatal exposure to medications has focused on maternal use during gestation, with limited research into the potential effects of...
BACKGROUND
Past research on the safety of prenatal exposure to medications has focused on maternal use during gestation, with limited research into the potential effects of paternal use during the spermatogenic period preceding conception. Knowing the most common medications used by fathers around the time of conception can inform research priorities in this field.
OBJECTIVES
To identify the most common medications dispensed to fathers in the preconception period.
METHODS
Within the MarketScan research database of commercially insured individuals in the United States from 2011 to 2020, we identified pregnancies, estimated the date of conception, linked each pregnancy to the father using family enrolment information and required minimum enrolment period and prescription benefits. Then, we described the use of prescription medications by the father during the 90 days before conception based on pharmacy dispensation claims.
RESULTS
Of 4,437,550 pregnancies, 51.6% were linked with a father. Among the 1,413,762 pregnancies connected with a father that also met the inclusion criteria, the most common classes of medications dispensed were psychotropics (8.66%), antibiotics (7.21%), and analgesics (6.82%). The most frequently dispensed medications were amoxicillin (3.75%), azithromycin (3.15%), fluticasone (2.70%) and acetaminophen/hydrocodone (2.70%). Some fathers filled prescriptions for medications associated with foetal embryopathy when used by the mother, including mycophenolate (0.04%), methotrexate (0.03%) and isotretinoin (0.02%).
CONCLUSIONS
More than a third of fathers filled at least one prescription medication in the preconception period, and several of them are known to be embryotoxic, emphasizing the necessity for further investigation into the potential teratogenicity of paternal exposure.
PubMed: 38949455
DOI: 10.1111/ppe.13098 -
African Journal of Primary Health Care... Jun 2024Antenatal care remains critical for identifying and managing complications contributing to maternal and infant mortality, yet attendance among women in South Africa...
BACKGROUND
Antenatal care remains critical for identifying and managing complications contributing to maternal and infant mortality, yet attendance among women in South Africa persists as a challenge.
AIM
This study aimed to understand the challenges faced by women attending antenatal care in Soweto, Johannesburg, using the three-delay model.
SETTING
This study was conducted in Soweto, Johannesburg.
METHODS
An exploratory, descriptive and qualitative research design was used, and in-depth interviews were conducted with 10 pregnant women and four women who had recently given birth.
RESULTS
Findings indicate delays in seeking care due to factors such as pregnancy unawareness, waiting for visible signs, and fear of human immunodeficiency virus (HIV) testing. Challenges such as transportation difficulties, distance to clinics, and facility conditions further impeded the initiation of antenatal care. Late initiation often occurred to avoid long waits, inadequate facilities, language barriers and nurse mistreatment.
CONCLUSION
From this study, we learn that challenges such as unawareness of pregnancy, cultural notions of keeping pregnancy a secret, fear of HIV testing, long waiting lines, high cost of transportation fees, clinic demarcation, shortage of essential medicines, broken toilets and verbal abuse from nurses have delayed women from initiating antenatal care early in Soweto, Johannesburg.Contribution: Challenges of women with antenatal care attendance in South Africa must be addressed by implementing community-based health education interventions, institutionalising HIV psycho-social support services and improving quality of antenatal care services in public health facilities.
Topics: Humans; South Africa; Female; Pregnancy; Prenatal Care; Adult; Qualitative Research; Patient Acceptance of Health Care; HIV Infections; Health Services Accessibility; Young Adult; Health Knowledge, Attitudes, Practice; Time Factors; Interviews as Topic
PubMed: 38949438
DOI: 10.4102/phcfm.v16i1.4333