The effectiveness of maternal pertussis vaccination for protecting Aboriginal and Torres Strait Islander infants against infection, 2012-2017: a retrospective cohort study.

OBJECTIVES: To evaluate the effectiveness of maternal pertussis vaccination for preventing pertussis infections in Aboriginal and Torres Strait Islander infants under seven months of age. STUDY DESIGN: Retrospective cohort study; analysis of linked administrative health data. SETTING, PARTICIPANTS: Mother-infant cohort (Links2HealthierBubs) including all pregnant women who gave birth to live infants (gestational age ≥ 20 weeks, birthweight ≥ 400 g) in the Northern Territory, Queensland, and Western Australia during 1 January 2012 - 31 December 2017. MAIN OUTCOME MEASURES: Proportions of women vaccinated against pertussis during pregnancy, rates of pertussis infections among infants under seven months of age, and estimated effectiveness of maternal vaccination for protecting infants against pertussis infection, each by Indigenous status. RESULTS: Of the 19 892 Aboriginal and Torres Strait Islander women who gave birth to live infants during 2012-2017, 7398 (37.2%) received pertussis vaccine doses during their pregnancy, as had 137 034 of 259 526 non-Indigenous women (52.8%; Indigenous v non-Indigenous: adjusted odds ratio, 0.66; 95% confidence interval [CI], 0.62-0.70). The annual incidence of notified pertussis infections in non-Indigenous infants declined from 16.8 (95% CI, 9.9-29) in 2012 to 1.4 (95% CI, 0.3-8.0) cases per 10 000 births in 2017; among Aboriginal and Torres Strait Islander infants, it declined from 47.6 (95% CI, 16.2-139) to 38.6 (95% CI, 10.6-140) cases per 10 000 births. The effectiveness of maternal vaccination for protecting non-Indigenous infants under seven months of age against pertussis infection during 2014-17 was 68.2% (95% CI, 51.8-79.0%); protection of Aboriginal and Torres Strait Islander infants was not statistically significant (36.1%; 95% CI, -41.3% to 71.1%). CONCLUSIONS: During 2015-17, maternal pertussis vaccination did not protect Aboriginal and Torres Strait Islander infants in the NT, Queensland, and WA against infection. Increasing the pertussis vaccination rate among pregnant Aboriginal and Torres Strait Islander women requires culturally appropriate, innovative strategies co-designed in partnership with Indigenous organisations and communities.

SOMANZ position statement for the investigation and management of sepsis in pregnancy 2023.

BACKGROUND: The Society of Australia and New Zealand (SOMANZ) published its first sepsis in pregnancy and the postpartum period guideline in 2017 (Aust N Z J Obstet Gynaecol, 57, 2017, 540). In the intervening 6 years, maternal mortality from sepsis has remained static. AIMS: To update clinical practice with a review of the subsequent literature. In particular, to review the definition and screening tools for the diagnosis of sepsis. MATERIALS AND METHODS: A multi-disciplinary group of clinicians with experience in all aspects of the care of pregnant women analysed the clinical evidence according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system following searches of Cochrane, Medline and EMBASE. Where there were conflicting views, the authors reviewed the topic and came to a consensus. All authors reviewed the final position statement. RESULTS: This position statement has abandoned the use of the quick Sequential Organ Failure Assessment score (qSOFA) score to diagnose sepsis due to its poor performance in clinical practice. Whilst New Zealand has a national maternity observation chart, in Australia maternity early warning system charts and vital sign cut-offs differ between states. Rapid recognition, early antimicrobials and involvement of senior staff remain essential factors to improving outcomes. CONCLUSION: Ongoing research is required to discover and validate tools to recognize and diagnose sepsis in pregnancy. Australia should follow New Zealand and have a single national maternity early warning system observation chart.

Inequity of antenatal influenza and pertussis vaccine coverage in Australia: the Links2HealthierBubs record linkage cohort study, 2012-2017.

BACKGROUND: Pregnancy and early infancy are increased risk periods for severe adverse effects of respiratory infections. Aboriginal and/or Torres Strait Islander (respectfully referred to as First Nations) women and children in Australia bear a disproportionately higher burden of respiratory diseases compared to non-Indigenous women and infants. Influenza vaccines and whooping cough (pertussis) vaccines are recommended and free in every Australian pregnancy to combat these infections. We aimed to assess the equity of influenza and/or pertussis vaccination in pregnancy for three priority groups in Australia: First Nations women; women from culturally and linguistically diverse (CALD) backgrounds; and women living in remote areas or socio-economic disadvantage. METHODS: We conducted individual record linkage of Perinatal Data Collections with immunisation registers/databases between 2012 and 2017. Analysis included generalised linear mixed model, log-binomial regression with a random intercept for the unique maternal identifier to account for clustering, presented as prevalence ratios (PR) and 95% compatibility intervals (95%CI). RESULTS: There were 445,590 individual women in the final cohort. Compared with other Australian women (n = 322,848), First Nations women (n = 29,181) were less likely to have received both recommended antenatal vaccines (PR 0.69, 95% CI 0.67-0.71) whereas women from CALD backgrounds (n = 93,561) were more likely to have (PR 1.16, 95% CI 1.10-1.13). Women living in remote areas were less likely to have received both vaccines (PR 0.75, 95% CI 0.72-0.78), and women living in the highest areas of advantage were more likely to have received both vaccines (PR 1.44, 95% CI 1.40-1.48). CONCLUSIONS: Compared to other groups, First Nations Australian families, those living in remote areas and/or families from lower socio-economic backgrounds did not receive recommended vaccinations during pregnancy that are the benchmark of equitable healthcare. Addressing these barriers must remain a core priority for Australian health care systems and vaccine providers. An extension of this cohort is necessary to reassess these study findings.

Timing and temporal trends of influenza and pertussis vaccinations during pregnancy in three Australian jurisdictions: The Links2HealthierBubs population-based linked cohort study, 2012-2017.

BACKGROUND: Antenatal inactivated influenza (IIV) and pertussis-containing vaccines (dTpa) offer protection against severe respiratory infections for pregnant women and infants <6 months of age. Both vaccines are recommended in pregnancy; however, little is known about temporal or jurisdictional trends and predictors of uptake. AIMS: To identify gaps and predictors of IIV and/or dTpa vaccinations in Australian pregnancies from 2012 to 2017. MATERIALS AND METHODS: We conducted a probabilistically linked, multi-jurisdictional population-based cohort study, drawing from perinatal data collections and immunisation databases. We used a generalised linear mixed model with a random effect term to account for clustering of multiple pregnancies within mothers, to calculate vaccination uptake, and identify predictors of uptake by maternal demographic, pregnancy, and health characteristics. RESULTS: Of 591 868 unique pregnancies, IIV uptake was 15%, dTpa 27% and 12% received both vaccines. Pertussis vaccinations in First Nations pregnancies were 20% lower than non-Indigenous pregnancies; dTpa was strongly associated with IIV uptake (risk ratio (RR): 8.60, 95% CI 8.48-8.73). This trend was temporally and jurisdictionally consistent. First Nations women were more likely to have had IIV in pregnancy before the introduction of dTpa in the pregnancy program: (RR: 1.48, 95% CI 1.40-1.57), but less likely after dTpa implementation (RR: 0.78, 95% CI 0.76-0.80). CONCLUSIONS: Inequity in vaccine uptake between First Nations and non-Indigenous pregnancies, and dismal rates of vaccination in pregnancy overall need urgent review, particularly before the next influenza pandemic or pertussis outbreak. If antenatal dTpa is driving IIV uptake, changes in antenatal healthcare practices are needed to ensure vaccines are offered equitably and optimally to protect against infection.

Late termination of pregnancy at a major Queensland tertiary hospital, 2010-2020.

OBJECTIVE: To review rates of and indications for late pregnancy feticide at a major Queensland tertiary perinatal centre over the past decade. DESIGN: Retrospective cohort study. SETTING, PARTICIPANTS: The Centre for Advanced Prenatal Care at the Royal Brisbane and Women's Hospital, a tertiary perinatal centre; feticides of singleton pregnancies of at least 22 weeks' gestation, 1 January 2010 - 31 December 2020. MAIN OUTCOME MEASURES: Indications for feticide; median gestational age at feticide; referral source; time between referral, maternal-fetal medicine review, and feticide. RESULTS: During 2010-2020, 305 feticides were undertaken at 22 weeks' gestation or later. The annual number of feticides increased from 20 in 2010 to 54 in 2020. The median gestational age at feticide was consistent across the decade (24+6 weeks; range, 17+0 to 37+1 weeks). The most frequent fetal indications for feticide were neurological abnormalities (110 of 305, 36%), aneuploidy or genetic syndromes (67, 22%), and cardiac malformations (59, 19%). Most women were seen for review within seven days of referral for feticide (154 of 197 for whom this information was available, 78%; median, five days; range, 0-34 days), and 136 of 197 feticides (69%) were undertaken within seven days of the initial maternal-fetal medicine review. CONCLUSIONS: Most late pregnancy feticides were performed because of fetal indications, primarily structural malformations or genetic abnormalities. Despite advances in prenatal imaging and diagnosis, late termination of pregnancy remains a necessary option in some pregnancies with maternal or fetal indications, and equitable access to late termination of pregnancy services is a vital component of reproductive health care.

Characteristics and in-hospital outcomes of patients requiring aeromedical retrieval for pregnancy, compared to non-retrieved metropolitan cohorts.

BACKGROUND: Limited access to obstetrics and gynaecology (O&G) services in rural and remote Australia is believed to contribute to suboptimal birth outcomes. AIMS: To describe the characteristics of pregnancy aeromedical transfers, in-hospital outcomes, and patient access to O&G services, as compared to whole of Australia data. MATERIALS AND METHODS: We conducted a cohort study of women who required aeromedical retrieval for pregnancy-related issues between the 1 January 2015 and 31 December 2017. RESULTS: Hospital outcome data were collected on 2171 (65.2%) mothers and 2438 (100.0%) babies. The leading retrieval reason was threatened preterm labour and delivery (n = 883; 40.7%). Most patients were retrieved from rural and remote areas (n = 2224; 93.0%). Retrieved patients were significantly younger (28.0 vs 30.0 years, 95% CI 27.7-28.3), more likely to be overweight or obese (52.2% vs 45.1%, 95% CI 47.5-56.9) and to have smoked during their pregnancy (14.0% vs 9.9%, 95% CI 12.5-15.5) compared to Australian pregnant women overall. Over one-third of transferred women gave birth by Caesarean section (n = 812; 37.4%); the median gestational age at birth was 33.0 (95% CI 32.7-33.3) weeks. Early gestation is associated with low birth weights (median = 2579.5 g; 95% CI 2536.1-2622.9), neonatal resuscitation (35.4%, 95% CI 33.5-37.3), and special care nursery admission (41.2%, 95% CI 39.3-43.2). There were 42 (1.7%, 95% CI 1.2-2.2) stillbirths, which was significantly higher than seen Australia-wide (n = 6441; 0.7%). CONCLUSION: This study found that pregnant women retrieved by the Royal Flying Doctor Service were younger, with higher rates of obesity and smoking.

Pregnancy Following Heart Transplantation: A Single Centre Case Series and Review of the Literature.

BACKGROUND: Maternal and fetal outcomes of pregnancy amongst cardiac transplant recipients are limited in the current literature. METHODS: We describe five pregnancies in three cardiac transplant recipients managed between a tertiary centre for obstetric medicine and an associated state-wide transplant centre between 2014-2018, and provide a narrative review of the literature. RESULTS: Pre-conception counselling was undertaken. There were no recent rejection episodes and all women demonstrated good baseline cardiac function. Median maternal age was 27 years (range 23-38 yrs.). Median time from transplantation to pregnancy was 5 years (range 2-14 yrs.). All women were managed with modified immunosuppressant regimens and multidisciplinary care. Cardiac function, tacrolimus levels and renal function were closely monitored with frequent monitoring for common complications of pregnancy. There were no maternal or fetal deaths. There was no evidence of graft rejection and no deterioration in cardiac function. Tacrolimus doses were increased to maintain therapeutic targets. Gestational diabetes occurred in three women and cholestasis of pregnancy occurred in one. Each infant was delivered by vaginal delivery. One mother had postpartum haemorrhage in both pregnancies. Pre-eclampsia did not occur. Median gestation at delivery was 37 weeks (range 35+4-40+5 days) with two preterm deliveries. One (1) infant was born with low birth weight. One (1) infant had jaundice requiring phototherapy. All infants were breastfed. CONCLUSION: Pregnancy in transplant recipients confers risk to the mother and fetus. Pre-conception counselling, immunosuppressant tailoring and regular monitoring are paramount to avoid rejection and possible teratogenic complications. Favourable pregnancy outcomes are achievable with specialist multidisciplinary care.

Heart Disease and Pregnancy: The Need for a Twenty-First Century Approach to Care .

Pregnancy and childbirth present a specific challenge to the maternal cardiovascular system. Pre-existing cardiac diseases, or cardiac diseases that occur during pregnancy, are associated with a significant risk of morbidity and mortality for both mother and baby. In recent decades, cardiac disease has emerged as a leading cause of maternal death in most high income countries, including Australia and New Zealand. The burden of cardiac disease in pregnancy is likely to be growing due to an increase in adult survivors with congenital heart disease embarking on pregnancy coupled with demographic shifts in the age and cardiovascular risk factors of women giving birth and the persisting high incidence of acute rheumatic fever in First Nations women. There is widespread consensus that the best obstetric and neonatal outcomes in women with cardiac disease are delivered by a strategy of carefully coordinated multidisciplinary care. Australia and New Zealand currently lack nationally agreed strategies for clinical practice and service delivery for women with heart disease in pregnancy. This state-of-the-art review summarises some of the key issues faced in relation to prevention, diagnosis, treatment and health service delivery in this patient group and concludes with suggested priorities for policy and research.

SOMANZ guidelines for the investigation and management sepsis in pregnancy.

SOMANZ (Society of Obstetric Medicine Australia and New Zealand) has written a guideline to provide evidence-based guidance for the investigation and care of women with sepsis in pregnancy or the postpartum period. The guideline is evidence-based and incorporates recent changes in the definition of sepsis. The etiology, investigation and treatment of bacterial, viral and non-infective causes of sepsis are discussed. Obstetric considerations relevant to anaesthetic and intensive care treatment in sepsis are also addressed. A multi-disciplinary group of clinicians with experience in all aspects of the care of pregnant women have contributed to the development of the guidelines. This is an executive summary of the guidelines.

SOMANZ guidelines for the management of hypertensive disorders of pregnancy 2014.

This guideline is an evidence based, practical clinical approach to the management of Hypertensive Disorders of Pregnancy. Since the previous SOMANZ guideline published in 2008, there has been significant international progress towards harmonisation of definitions in relation to both the diagnosis and management of preeclampsia and gestational hypertension. This reflects increasing knowledge of the pathophysiology of these conditions, as well as their clinical manifestations. In addition, the guideline includes the management of chronic hypertension in pregnancy, an approach to screening, advice regarding prevention of hypertensive disorders of pregnancy, and discussion of recurrence risks and long term risk to maternal health. The literature reviewed included the previous SOMANZ Hypertensive Disorders of Pregnancy guideline from 2008 and its reference list, plus all other published National and International Guidelines on this subject. Medline, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Registry of Controlled Trials (CCRCT), National Institute for Health and Care Excellence (NICE) Evidence Search, and Database of Abstracts and Reviews of Effects (DARE) were searched for literature published between January 2007 and March, 2014.

The conundrum of eclampsia and fitness to drive.

BACKGROUND: Australian Fitness to Drive guidelines suggest that anyone who has had a seizure of any kind in the context of a 'metabolic' disorder should avoid driving for a period of 6 months. The special case of eclampsia is not mentioned. AIMS: In this study, we aimed to assess what advice healthcare professionals involved in the peripartum care of women provide to women who have an eclamptic seizure, what investigations they would conduct to exclude other causes of seizures and their level of awareness of whether eclampsia was addressed in the Australian Fitness to Drive guidelines. MATERIALS AND METHODS: A survey of 165 healthcare professionals attending the 2012 Society of Obstetric Medicine of Australia and New Zealand annual scientific meeting. Participants included registered nurses, midwives, consultant obstetricians, consultant physicians, doctors in training and others, interested in medical disorders of pregnancy. RESULTS: One hundred and nine conference attendees completed the survey (response rate 66.1%). 58 respondents (53.2%) had cared for 5 or more women with peripartum seizures, and 23 respondents (21.1%) had cared for 10 or more women with peripartum seizures. 46 respondents (42.2%) had never considered the issue of driving after an eclamptic seizure. For those who had considered the issue, advice ranged from no restriction (n = 5, 4.6%), no driving for 1-2 weeks (n = 14, 12.8%), no driving for 3 months (n = 20, 18.4%) or no driving for 6 months (n = 6, 5.5%). CONCLUSIONS: Many healthcare professionals caring for women with peripartum seizures have not considered issues relating to fitness to drive after an eclamptic seizure. There is a wide range of advice provided. Better prospective data are required regarding the risk of subsequent seizure after eclampsia, to inform clear fitness to drive guidelines.

Pregnancy in women with cystic fibrosis and diabetes: An audit of outcomes at two tertiary obstetric hospitals in Australia in the pre-cystic fibrosis transmembrane conductance regulator modulator era.

Background: Pregnancy in women with cystic fibrosis (CF) is becoming more common. Long-term metabolic issues such as diabetes are also becoming more common and have potentially important impacts on pregnancy outcomes. This study aimed to assess the impact of diabetes on pregnancy outcomes for women with CF. Methods: We undertook a retrospective chart audit of pregnancies to women with CF at the two tertiary obstetric hospitals in Southeast Queensland associated with CF and transplant management clinics between 2006 and 2016. Results: A total of 38 pregnancies among 26 women were identified. Four women (five pregnancies) had cystic fibrosis-related diabetes (CFRD) diagnosed prior to pregnancy, and 12 women (15 pregnancies) developed gestational diabetes (GDM) complicating pregnancy. CFRD and GDM were associated with higher rates of delivery complications, prematurity, and the need for neonatal intensive care unit admission. Conclusion: Diabetes is common during pregnancy in women with CF and impacts pregnancy outcomes.

Maternal Pertussis Vaccination, Infant Immunization, and Risk of Pertussis.

OBJECTIVES: Following the introduction of jurisdictional maternal pertussis vaccination programs in Australia, we estimated maternal vaccine effectiveness (VE) and whether maternal pertussis vaccination modified the effectiveness of the first 3 primary doses of pertussis-containing vaccines. METHODS: We conducted a population-based cohort study of 279 418 mother-infant pairs using probabilistic linkage of administrative health records in 3 Australian jurisdictions. Infants were maternally vaccinated if their mother had a documented pertussis vaccination ≥14 days before birth. Jurisdictional immunization records were used to identify receipt of the first 3 infant doses of pertussis-containing vaccines. Infant pertussis infections were identified using notifiable disease records. VE was estimated using Cox proportional hazard models. RESULTS: Pertussis was administered during 51.7% (n = 144 429/279 418) of pregnancies, predominantly at 28-31 weeks' gestation. VE of maternal pertussis vaccination declined from 70.4% (95% confidence interval [CI], 50.5-82.3) among infants <2 months old to 43.3% (95% CI, 6.8-65.6) among infants 7-8 months old and was not significant after 8 months of age. Although we observed slightly lower VE point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs 92.9%, P = .002), we did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% CI, 0.61-3.39). CONCLUSIONS: Pertussis vaccination near 28 weeks' gestation was associated with lower risk of infection among infants through 8 months of age. Although there was some evidence of lower effectiveness of infant vaccination among maternally vaccinated infants, this did not appear to translate to greater risk of disease.

Management of idiopathic intracranial hypertension in pregnancy.

Idiopathic intracranial hypertension is more common among women of reproductive age and is often encountered in pregnancy, either pre-existing and exacerbated by pregnancy-associated weight gain and hormonal changes or arising de novo. We report the case of a 33-year-old woman with progressive visual loss and intractable headache from 20 weeks' gestation requiring ventriculoperitoneal shunting during pregnancy. The risk of permanent maternal vision loss raises complex management dilemmas, when this must be balanced with the fetal and neonatal risks of treatment and possible premature delivery.

Overweight and obesity knowledge prior to pregnancy: a survey study.

BACKGROUND: Overweight and obesity are associated with increased risk for pregnancy complications. Knowledge about increased risks in overweight and obese women could contribute to successful prevention strategies and the aim of this study is to assess current levels of knowledge in a pregnant population. METHODS: Cross sectional survey of 412 consecutive unselected women in early pregnancy in Brisbane, Australia: 255 public women attending their first antenatal clinic visit and 157 women at private maternal fetal medicine clinics undergoing a routine ultrasound evaluation prior to 20 weeks gestation. The cohort was stratified according to pre pregnancy BMI (< 25.0 or ≥ 25.0). The main outcome measure was knowledge regarding the risks of overweight and obesity in pregnancy. RESULTS: Over 75% of respondents identified that obese women have an increased risk of overall complications, including gestational diabetes and hypertensive disorders of pregnancy compared to women of normal weight. More than 60% of women asserted that obesity would increase the risk of caesarean section and less than half identified an increased risk of adverse neonatal outcomes. Women were less likely to know about neonatal complications (19.7% did not know about the effect of obesity on these) than maternal complications (7.4%). Knowledge was similar amongst women recruited at the public hospital and those recruited whilst attending for an ultrasound scan at a private clinic. For most areas they were also similar between women of lower and higher BMI, but women with BMI < 25.0 were less likely to know that obesity was associated with increased rate of Caesarean section than those with higher BMI (16.8% versus 4.5%, P < 0.001). Higher educational status was associated with more knowledge of the risks of overweight and obesity in pregnancy. CONCLUSIONS: Many women correctly identify that overweight and obesity increases the overall risk of complications of pregnancy and childbirth. The increased risks of maternal complications associated with being obese are better known than the increased risk of neonatal complications. Maternal education status is a main determinant of the extent of knowledge and this should be considered when designing education campaigns.

Adherence to evidence-based guidelines for the management of pyelonephritis in pregnancy.

BACKGROUND: Pyelonephritis occurs in approximately two per cent of pregnancies and can cause significant maternal and fetal morbidity and mortality. Evidence-based guidelines recommend appropriate antibiotic therapy, urine culture for test of cure after treatment and monthly follow-up cultures until delivery. AIMS: To evaluate adherence to guidelines for the management of antepartum pyelonephritis within an Australian obstetric population and to assess associations with noncompliance. METHODS: A retrospective study was performed for the 103 pregnant women admitted with pyelonephritis between January 2001 and December 2009 at the Royal Brisbane and Women's Hospital, a tertiary referral obstetric hospital. We assessed baseline characteristics, the frequency of appropriate treatment and follow-up, and any associations among these. RESULTS: The guideline recommended antibiotic treatment was prescribed in 90.3% of women. Of the women with antibiotic-resistant organisms, 31.6% had their antibiotics changed appropriately. The test of cure urine culture was performed in only 35.0% of women after treatment completion. Inadequate long-term follow-up occurred in 60.2% of the cohort studied. Inappropriate follow-up was associated with low socioeconomic status (P=0.04), unemployment (P=0.04) and the absence of a test of cure urine culture (P=0.001). CONCLUSION: The empiric treatment of antepartum pyelonephritis is generally appropriate; however, antibiotic changes for bacterial resistance are inadequate. Test of cure and monthly follow-up urine cultures are infrequently performed despite their recommendation in published treatment guidelines.

Termination of pregnancy for maternal medical indications: failings in delivery of contraceptive advice?

BACKGROUND: The majority of therapeutic terminations of pregnancy occur for maternal psychological, social or fetal reasons. Available data on maternal medical indications, rather than social, are sparse. AIMS: To examine the maternal medical indications for the termination of pregnancy and use of contraception over a ten-year period. METHODS: A retrospective review of cases of termination of pregnancy performed for maternal indications in an Australian tertiary obstetric referral hospital. Cases from January 2000 to July 2010 inclusive were selected by examination of a termination of pregnancy database at our hospital. RESULTS: From 893 terminations, 104 were performed for maternal indications and had notes available for review: mean maternal age, 28.2 years (SD, 6.6; range, 14-44); median gravidity, 2; and parity, 1; and mean gestational age, 11.5 weeks (SD, 4.6; range, 5-23). Terminations were primarily surgical (n=81 (78.6%)) rather than by induction of labour (n=22 (21.4%)). Frequent maternal indications included psychiatric (n=24 (23.1%)), malignancy (n=17 (16.3%)) and cardiac (n=13 (12.5%)). Information on contraceptive use prior to termination was available in 40 (53%) women known to have disease prior to conception. Contraception was recorded as being in use prior to conception in 19 (47.5%) of these. Following termination, 75 (75.7%) were recorded as using contraception. CONCLUSIONS: Contraceptive rates in this at risk group appear to be poor and require attention.

Study Protocol for Preventing Early-Onset Pneumonia in Young Children Through Maternal Immunisation: A Multi-Centre Randomised Controlled Trial (PneuMatters).

Background: Preventing and/or reducing acute lower respiratory infections (ALRIs) in young children will lead to substantial short and long-term clinical benefits. While immunisation with pneumococcal conjugate vaccines (PCV) reduces paediatric ALRIs, its efficacy for reducing infant ALRIs following maternal immunisation has not been studied. Compared to other PCVs, the 10-valent pneumococcal-Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) is unique as it includes target antigens from two common lower airway pathogens, pneumococcal capsular polysaccharides and protein D, which is a conserved H. influenzae outer membrane lipoprotein. Aims: The primary aim of this randomised controlled trial (RCT) is to determine whether vaccinating pregnant women with PHiD-CV (compared to controls) reduces ALRIs in their infants' first year of life. Our secondary aims are to evaluate the impact of maternal PHiD-CV vaccination on different ALRI definitions and, in a subgroup, the infants' nasopharyngeal carriage of pneumococci and H. influenzae, and their immune responses to pneumococcal vaccine type serotypes and protein D. Methods: We are undertaking a parallel, multicentre, superiority RCT (1:1 allocation) at four sites across two countries (Australia, Malaysia). Healthy pregnant Australian First Nation or Malaysian women aged 17-40 years with singleton pregnancies between 27+6 and 34+6 weeks gestation are randomly assigned to receive either a single dose of PHiD-CV or usual care. Treatment allocation is concealed. Study outcome assessors are blinded to treatment arms. Our primary outcome is the rate of medically attended ALRIs by 12-months of age. Blood and nasopharyngeal swabs are collected from infants at birth, and at ages 6- and 12-months (in a subset). Our planned sample size (n = 292) provides 88% power (includes 10% anticipated loss to follow-up). Discussion: Results from this RCT potentially leads to prevention of early and recurrent ALRIs and thus preservation of lung health during the infant's vulnerable period when lung growth is maximum. The multicentre nature of our study increases the generalisability of its future findings and is complemented by assessing the microbiological and immunological outcomes in a subset of infants. Clinical Trial Registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374381, identifier: ACTRN12618000150246.