Objective To test equivalence of two doses of intravenous iron (ferric carboxymaltose) in pregnancy. Design Parallel, two-arm equivalence randomised controlled trial with an equivalence margin of 5%. Setting Single centre in Australia. Population 278 pregnant women with iron deficiency. Methods Participants received either 500 mg (n=152) or 1000mg (n=126) of intravenous ferric carboxymaltose in the second or third trimester. Main outcome measures The proportion of participants requiring additional intravenous iron (500mg) to achieve and maintain ferritin >30ug/L (diagnostic threshold for iron deficiency) at 4 weeks post-infusion, and at 6 weeks, and 3-, 6- and 12-months postpartum. Secondary endpoints included repeat infusion rate, iron status, birth, and safety outcomes. Results The two doses were not equivalent within a 5% margin at any timepoint. At 4 weeks post infusion, 26/73 (36%) participants required a repeat infusion in the 500 mg group compared with 5/67 (8%) in the 1000 mg group (difference in proportions, 0.283 95% confidence interval (0.177, 0.389)). Overall, participants in the 500 mg arm received twice the repeat infusion rate (0.81 (SD= 0.824 vs 0.40 (SD= 0.69), rate ratio 2.05, 95% CI (1.45, 2.91)). Conclusions Administration of 1000mg ferric carboxymaltose in pregnancy maintains iron stores and reduces the need for repeat infusions. A 500 mg dose requires ongoing monitoring to ensure adequate iron stores are reached and sustained.

Background: Offspring size at birth is known to be associated with maternal cardiovascular disease (CVD) risk. Low birthweight (LBW), small for gestational age (SGA) and intrauterine growth restriction (IUGR) are all used to define infants considered small at birth. Objectives: To determine whether women who give birth to SGA/LBW/IUGR infants have higher levels of cardio-metabolic risk factors compared to women who give birth to average for gestational age infants or women. Search strategy: We performed a systematic literature search using PubMed, Embase and CINAHL. Selection criteria: Studies that compared cardio-metabolic risk factors in women who gave birth to SGA/LBW/IUGR infants compared to a control group. Data collection and analysis: Two independent authors screened and extracted data. Meta-analysis was performed on Review Manager 5.3. Main results: The meta-analysis showed a significantly increased CVD mortality among women who gave birth to SGA infants compared to AGA infants (relative risk 1.45, 95% confidence interval (CI) 1.40 to 1.52; 2,584,533 participants, three studies; heterogeneity: Chi2 P=0.48; I2=0%). Women who gave birth to growth restricted infants had significantly higher mean BMI (1.72kg/m2, 95% CI 0.97 to 2.47; 77 participants, two studies; heterogeneity: Chi2 P=0.35; I2=0%), and higher total mean cholesterol levels (0.32mmol/l, 95% CI 0.13 to 0.50; 77 participants, two studies; heterogeneity: Chi2 P=0.69; I2=0%) compared to women who had uncomplicated pregnancies. Conclusions: Women who give birth to small infants are at increased risk of CVD. Postpartum screening for CVD risk factors will help identify those at risk.

Abstract Objective To evaluate the safety of maternal pertussis vaccination on pregnancy and birth outcomes. Design Prospective, multicentre cohort study. Setting Two major materiality hospitals in South Australia. Population A total of 1364 low-risk nulliparous women with a singleton pregnancy recruited at 9–16 weeks’ gestation between 2015 to 2018. Methods Participants were followed prospectively, with vaccination (confirmed by medical records), extensive amounts of pregnancy and birth outcome data collected by research midwives. Adjusted relative risks (aRRs) and hazard ratios (aHRs) were estimated accounting for time-varying vaccine exposure and the temporal nature of each outcome. Main Outcome Measures Pregnancy and birth outcomes. Results Of the 1272 women included in this study, 80.1% (n=1019) received maternal pertussis vaccination. Vaccinated women had an average 0.22 weeks (95% CI 0.001, 0.44) longer gestation at delivery compared to unvaccinated women. Maternal pertussis vaccination was not associated with chorioamnionitis (aRR 0.71, 95% CI 0.27,1.82), gestational hypertension (aHR 1.24, 95% CI, 0.66, 2.30), preeclampsia (aHR 0.75, 95% CI 0.47, 1.18) nor preterm birth (aHR 0.99, 95% CI 0.47, 2.07). Neither risk of low birth weight (aHR 0.72, 95% CI 0.41, 1.27) nor small for gestational age infants (aHR 0.67,95% CI 0.29, 1.55) were increased following maternal pertussis vaccination. No associations between pertussis vaccination during pregnancy and adverse birth outcomes including admission to the neonatal care unit, low Apgar scores, and mechanical ventilation were observed. Conclusions Our study provides reassuring evidence of the safety of maternal pertussis vaccination with no increased risk of adverse pregnancy and birth outcomes.