Prenatal iodine supplementation and early childhood neurodevelopment: the PoppiE trial - study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Observational studies suggest both low and high iodine intakes in pregnancy are associated with poorer neurodevelopmental outcomes in children. This raises concern that current universal iodine supplement recommendations for pregnant women in populations considered to be iodine sufficient may negatively impact child neurodevelopment. We aim to determine the effect of reducing iodine intake from supplements for women who have adequate iodine intake from food on the cognitive development of children at 24 months of age. METHODS AND ANALYSIS: A multicentre, randomised, controlled, clinician, researcher and participant blinded trial with two parallel groups. Using a hybrid decentralised clinical trial model, 754 women (377 per group) less than 13 weeks' gestation with an iodine intake of ≥165 µg/day from food will be randomised to receive either a low iodine (20 µg/day) multivitamin and mineral supplement or an identical supplement containing 200) µg/day (amount commonly used in prenatal supplements in Australia), from enrolment until delivery. The primary outcome is the developmental quotient of infants at 24 months of age assessed with the Cognitive Scale of the Bayley Scales of Infant Development, fourth edition. Secondary outcomes include infant language and motor development; behavioural and emotional development; maternal and infant clinical outcomes and health service utilisation of children. Cognitive scores will be compared between groups using linear regression, with adjustment for location of enrolment and the treatment effect described as a mean difference with 95% CI. ETHICS AND DISSEMINATION: Ethical approval has been granted from the Women's and Children's Health Network Research Ethics Committee (HREC/17/WCHN/187). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04586348.

Addressing the crisis of congenital syphilis: Key findings from an evaluation of the management of syphilis in pregnancy and the newborn in South-East Queensland.

BACKGROUND: Syphilis in pregnancy and congenital syphilis (CS) are increasing in Australia. Prevention of adverse outcomes requires adherence to management guidelines. AIMS: The aim is to evaluate the management of syphilis in pregnant women and their newborns. MATERIALS AND METHODS: A retrospective study of public health notifications, clinical records and testing results of women with positive syphilis serology in pregnancy requiring treatment from 2016 to 2018 inclusive across South-East Queensland was conducted. Management was described and compared with contemporary guidelines from the Australasian Society of Infectious Diseases, the Communicable Diseases Network Australia and the United States Centers for Disease Control and Prevention. RESULTS: Of 30 women identified, 22 (73%) had management consistent with the guidelines (stage-appropriate penicillin regimen, appropriate dosing interval and treatment completed greater than 30 days before delivery). Only 14 (47%) women had documentation of partner testing and/or treatment. Of 26 mother-infant pairs with complete data, 16 (62%) had investigations at delivery consistent with recommendations (parallel maternal-infant rapid plasma reagin, infant syphilis immunoglobulin M, placental histopathology +/- syphilis polymerase chain reaction and infant clinical examination). One infant met the criteria for confirmed CS. Five infants received penicillin therapy. Only seven (27%) infants had serological monitoring after discharge. CONCLUSIONS: Management can be optimised with timely maternal testing and treatment, comprehensive partner screening and treatment, strict adherence to seven-day penicillin dosing for late latent syphilis and thorough maternal and infant testing after treatment and delivery. If maternal treatment was inadequate in pregnancy, consideration needs to be given to close evaluation and empiric treatment of the infant.

A Randomized Trial of Prenatal n-3 Fatty Acid Supplementation and Preterm Delivery.

BACKGROUND: Previous studies have suggested that maternal supplementation with n-3 long-chain polyunsaturated fatty acids may reduce the incidence of preterm delivery but may also prolong gestation beyond term; however, more data are needed regarding the role of n-3 long-chain polyunsaturated fatty acids in pregnancy. METHODS: We performed a multicenter, double-blind, randomized trial in which women who were pregnant with single or multiple fetuses were assigned to receive either fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids (control group) daily, beginning before 20 weeks of gestation and continuing to 34 weeks of gestation or delivery, whichever occurred first. The primary outcome was early preterm delivery, defined as delivery before 34 completed weeks of gestation. Other pregnancy and neonatal outcomes were also assessed. RESULTS: A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis. Early preterm delivery occurred in the case of 61 of 2734 pregnancies (2.2%) in the n-3 group and 55 of 2752 pregnancies (2.0%) in the control group; the between-group difference was not significant (adjusted relative risk, 1.13; 95% confidence interval [CI], 0.79 to 1.63; P = 0.50). There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65). Percentages of serious adverse events did not differ between the groups. Minor gastrointestinal disturbances were more commonly reported in the n-3 group than in the control group. CONCLUSIONS: Supplementation with n-3 long-chain polyunsaturated fatty acids from early pregnancy (<20 weeks of gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control. (Funded by the Australian National Health and Medical Research Council and the Thyne Reid Foundation; ORIP Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729.).

Ectopic Intralaryngo-Tracheal Thyroid Tissue Causing Neonatal Death.

INTRODUCTION: Ectopic thyroid tissue can be found anywhere along the embryologic path of thyroid descent. Intralaryngo-tracheal thyroid tissue is the least common site of ectopia and can present with upper airways obstruction. Its presentation in the neonate is exceptional. CASE REPORT: We describe a term female neonate with subglottic thyroid tissue causing near-total occlusion of the larynx, which led to upper airways obstruction and neonatal death. CONCLUSION: This emphasizes the importance of considering intralaryngo-tracheal tumors as a cause of acute and otherwise unexplainable respiratory distress immediately after birth. The cause of this neonatal death would not have been elucidated without careful autopsy examination.

Comparison of maternal and neonatal outcomes from full-dilatation cesarean deliveries using the Fetal Pillow or hand-push method.

OBJECTIVE: To compare maternal and neonatal outcomes of full-dilatation cesarean deliveries using the Fetal Pillow or hand- push method. METHODS: A retrospective cohort study included data from all women who underwent full-dilatation cesarean deliveries at term that involved the use of the Fetal Pillow or the hand-push method at Mater Mothers' Hospital, Brisbane, Australia between May 1, 2013 and March 31, 2015. Maternal (estimated blood loss, need for blood transfusion, uterine angle extension, and duration of stay in hospital following delivery) and neonatal outcomes (5-minute Apgar score below 7, cord arterial pH, admission to neonatal intensive care unit, and need for endotracheal intubation) were compared between the two treatment methods. RESULTS: Of 361 cesarean deliveries performed at full dilation during the study period, clinicians documented the use of a Fetal Pillow in 91 deliveries and use of the hand-push method in 69. Lower mean intra-operative blood loss (P=0.026), a shorter duration of postpartum hospital admission (P=0.002), and higher mean cord arterial pH (P=0.003) were observed in the Fetal Pillow group. CONCLUSION: The Fetal Pillow appears to be a safe and effective aid for the delivery of the fetal head during cesarean deliveries at full dilatation.