Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy.

BACKGROUND: Whether treatment of gestational diabetes before 20 weeks' gestation improves maternal and infant health is unclear. METHODS: We randomly assigned, in a 1:1 ratio, women between 4 weeks' and 19 weeks 6 days' gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes (World Health Organization 2013 criteria) to receive immediate treatment for gestational diabetes or deferred or no treatment, depending on the results of a repeat oral glucose-tolerance test [OGTT] at 24 to 28 weeks' gestation (control). The trial included three primary outcomes: a composite of adverse neonatal outcomes (birth at <37 weeks' gestation, birth trauma, birth weight of ≥4500 g, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia), pregnancy-related hypertension (preeclampsia, eclampsia, or gestational hypertension), and neonatal lean body mass. RESULTS: A total of 802 women underwent randomization; 406 were assigned to the immediate-treatment group and 396 to the control group; follow-up data were available for 793 women (98.9%). An initial OGTT was performed at a mean (±SD) gestation of 15.6±2.5 weeks. An adverse neonatal outcome event occurred in 94 of 378 women (24.9%) in the immediate-treatment group and in 113 of 370 women (30.5%) in the control group (adjusted risk difference, -5.6 percentage points; 95% confidence interval [CI], -10.1 to -1.2). Pregnancy-related hypertension occurred in 40 of 378 women (10.6%) in the immediate-treatment group and in 37 of 372 women (9.9%) in the control group (adjusted risk difference, 0.7 percentage points; 95% CI, -1.6 to 2.9). The mean neonatal lean body mass was 2.86 kg in the immediate-treatment group and 2.91 kg in the control group (adjusted mean difference, -0.04 kg; 95% CI, -0.09 to 0.02). No between-group differences were observed with respect to serious adverse events associated with screening and treatment. CONCLUSIONS: Immediate treatment of gestational diabetes before 20 weeks' gestation led to a modestly lower incidence of a composite of adverse neonatal outcomes than no immediate treatment; no material differences were observed for pregnancy-related hypertension or neonatal lean body mass. (Funded by the National Health and Medical Research Council and others; TOBOGM Australian New Zealand Clinical Trials Registry number, ACTRN12616000924459.).

A summary of the 2023 Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) hypertension in pregnancy guideline.

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) affect up to 10% of all pregnancies annually and are associated with an increased risk of maternal and fetal morbidity and mortality. This guideline represents an update of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines for the management of hypertensive disorders of pregnancy 2014 and has been approved by the National Health and Medical Research Council (NHMRC) under section 14A of the National Health and Medical Research Council Act 1992. In approving the guideline recommendations, NHMRC considers that the guideline meets NHMRC's standard for clinical practice guidelines. MAIN RECOMMENDATIONS: A total of 39 recommendations on screening, preventing, diagnosing and managing HDP, especially preeclampsia, are presented in this guideline. Recommendations are presented as either evidence-based recommendations or practice points. Evidence-based recommendations are presented with the strength of recommendation and quality of evidence. Practice points were generated where there was inadequate evidence to develop specific recommendations and are based on the expertise of the working group. CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINE: This version of the SOMANZ guideline was developed in an academically robust and rigorous manner and includes recommendations on the use of combined first trimester screening to identify women at risk of developing preeclampsia, 14 pharmacological and two non-pharmacological preventive interventions, clinical use of angiogenic biomarkers and the long term care of women who experience HDP. The guideline also includes six multilingual patient infographics which can be accessed through the main website of the guideline. All measures were taken to ensure that this guideline is applicable and relevant to clinicians and multicultural women in regional and metropolitan settings in Australia and New Zealand.

Intrahepatic cholestasis of pregnancy - Diagnosis and management: A consensus statement of the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ): Executive summary.

Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy liver disease, characterised by pruritus and increased total serum bile acids (TSBA), Australian incidence 0.6-0.7%. ICP is diagnosed by non-fasting TSBA ≥19 µmol/L in a pregnant woman with pruritus without rash without a known pre-existing liver disorder. Peak TSBA ≥40 and ≥100 µmol/L identify severe and very severe disease respectively, associated with spontaneous preterm birth when severe, and with stillbirth, when very severe. Benefit-vs-risk for iatrogenic preterm birth in ICP remains uncertain. Ursodeoxycholic acid remains the best pharmacotherapy preterm, improving perinatal outcome and reducing pruritus, although it has not been shown to reduce stillbirth.

Effect of asthma management with exhaled nitric oxide versus usual care on perinatal outcomes.

INTRODUCTION: Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide (F ENO)-based asthma management improves perinatal outcomes compared to usual care. METHODS: The Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided by F ENO (adjustment of asthma treatment according to exhaled nitric oxide and symptoms each 6-12 weeks) to usual care (no treatment adjustment as part of the trial). The primary outcome was a composite of adverse perinatal events (preterm birth, small for gestational age (SGA), perinatal mortality or neonatal hospitalisation) assessed using hospital records. Secondary outcomes included maternal asthma exacerbations. Concealed random allocation, stratified by study site and self-reported smoking status was used, with blinded outcome assessment and statistical analysis (intention to treat). RESULTS: Pregnant women with current asthma were recruited; 599 to the control group (608 infants) and 601 to the intervention (615 infants). There were no significant group differences for the primary composite perinatal outcome (152 (25.6%) out of 594 control, 177 (29.4%) out of 603 intervention; OR 1.21, 95% CI 0.94-1.56; p=0.15), preterm birth (OR 1.14, 95% CI 0.78-1.68), SGA (OR 1.06, 95% CI 0.78-1.68), perinatal mortality (OR 3.62, 95% CI 0.80-16.5), neonatal hospitalisation (OR 1.24, 95% CI 0.89-1.72) or maternal asthma exacerbations requiring hospital admission or emergency department presentation (OR 1.19, 95% CI 0.69-2.05). CONCLUSION: F ENO-guided asthma pharmacotherapy delivered by a nurse or midwife in the antenatal clinic setting did not improve perinatal outcomes.

Is there an association between the vaginal microbiome and first trimester miscarriage? A prospective observational study.

AIM: To examine whether there are differences in the vaginal microbiome of women who miscarry compared to those who have normal pregnancy outcomes. METHODS: Prospective observational study conducted at the Canberra Hospital, Australia, with 24 participant women in the first trimester of pregnancy. The vaginal microbiomes of the 24 women were characterized using sequencing analysis of the V4 region of the 16S rRNA gene employing an Illumina MiSeq instrument with QIAGEN reagents. Vaginal microbiome data were correlated with pregnancy clinical metadata. RESULTS: Ordination plots showed differences in the composition of microbiomes of women who miscarried and controls. In nulliparous women, Lactobacillus crispatus was the dominant bacterium in 50% of women. Lactobacillus iners was the dominant bacterium in 50% of women with a history of prior miscarriage and a miscarriage in the study compared to 15% (p = 0.011) in those with no history of miscarriage and no miscarriage in the study. There were significant differences in the number of operational taxonomic units and the richness of the microbiomes of women who miscarried compared to those who delivered at term. Eight taxa were found in different relative abundances in both groups of women. CONCLUSIONS: The study indicated that the composition of the vaginal microbiome varies with pregnancy history. Also, there was a significant difference in the vaginal microbiomes between women who suffered miscarriage and those who continued to term delivery both in the overall microbiome populations and in the abundances of individual taxa.

Aspirin for the prevention of pre-eclampsia in women with pre-existing diabetes: Systematic review.

BACKGROUND: There is a lack of evidence for pre-eclampsia prophylaxis with aspirin in women with pre-existing diabetes mellitus (DM). AIMS: To examine the evidence for aspirin in pre-eclampsia prophylaxis in women with pre-existing DM. MATERIAL AND METHODS: An electronic search using Ovid MEDLINE, Embase, CinicalTrials.gov and the Cochrane CENTRAL register of controlled trials through to February 2021 was performed. Reference lists of identified studies, previous review articles, clinical practice guidelines and government reports were manually searched. Randomised controlled trials (RCTs) of aspirin vs placebo for pre-eclampsia prophylaxis were included. Articles were manually reviewed to determine if cohorts included women with DM. The systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data from included trials were extracted independently by two authors who also independently assessed risk of bias as per the Cochrane Handbook criteria version 5.1.0. Data were analysed using Rev-Man 5.4. RESULTS: Forty RCTs were identified, of which 11 included a confirmed subset of women with DM; however, data were insufficient for meta-analysis. Meta-analysis of 930 women with DM, from individual patient data included in a systematic review and unpublished data from one of the 11 RCTs, showed a non-significant difference in the outcome of pre-eclampsia in participants treated with aspirin compared to placebo (odds ratio 0.58; 95% CI 0.20-1.71; P = 0.33). CONCLUSIONS: Pre-eclampsia risk reduction with aspirin prophylaxis in women with pre-existing DM may be similar to women without pre-existing DM. However, randomised data within this meta-analysis were insufficient, warranting the need for further studies within this high-risk group of women.

The Spectrum, Severity and Outcomes of Rheumatic Mitral Valve Disease in Pregnant Women in Australia and New Zealand.

BACKGROUND: Rheumatic heart disease (RHD) poses significant perinatal risks. We aimed to describe the spectrum, severity and outcomes of rheumatic mitral valve disease in pregnancy in Australia and New Zealand. METHODS: A prospective, population-based cohort study of pregnant women with RHD recruited 2013-14 through the hospital-based Australasian Maternity Outcomes Surveillance System. Outcome measures included maternal and perinatal morbidity and mortality. Univariable and multivariable logistic regression analyses were undertaken to test for predictors of adverse maternal and perinatal outcomes. RESULTS: Of 274 pregnant women identified with RHD, 124 (45.3%) had mitral stenosis (MS) and 150 (54.7%) had isolated mitral regurgitation (MR). One woman with mild MS/moderate MR died. There were six (2.2%) stillbirths and two (0.7%) neonatal deaths. Babies born to women with MS were twice as likely to be small-for-gestational-age (22.7% vs 11.4%, p=0.013). In women with MS, use of cardiac medication (AOR 7.42) and having severe stenosis (AOR 16.35) were independently associated with adverse cardiac outcomes, while New York Heart Association (NYHA) class >1 (AOR 3.94) was an independent predictor of adverse perinatal events. In women with isolated MR, use of cardiac medications (AOR 7.03) and use of anticoagulants (AOR 6.05) were independently associated with adverse cardiac outcomes. CONCLUSIONS: Careful monitoring and specialist care for women with RHD in pregnancy is required, particularly for women with severe MS, those on cardiac medication, and those on anticoagulation, as these are associated with increased risk of adverse maternal cardiac outcomes. In the context of pregnancy, contraception and preconception planning are important for young women diagnosed with RHD.

Place of birth and outcomes associated with large volume transfusion: an observational study.

BACKGROUND: Guidelines recommend that women at high risk of postpartum haemorrhage deliver at facilities able to handle heavy bleeding. However postpartum haemorrhage is often unexpected. This study aims to compare outcomes and health service use related to transfusion of ≥4 units of red blood cells between women delivering in tertiary and lower level hospitals. METHODS: The study population was women giving birth in public hospitals in New South Wales, Australia, between July 2006 and December 2010. Data were obtained from linked hospital, birth and blood bank databases. The exposure of interest was transfusion of four or more units of red cells during admission for delivery. Outcomes included maternal morbidity, length of stay, neonatal morbidity and need for other blood products or transfer to higher care. Multivariable regression models were developed to predict need of transfusion of ≥4 units of red cells using variables known early in pregnancy and those known by the birth admission. RESULTS: Data were available for 231,603 births, of which 4309 involved a blood transfusion, with 1011 (0.4%) receiving 4 or more units. Women giving birth in lower level and/or smaller hospitals were more likely to receive ≥4 units of red cells. Women receiving ≥4 units in tertiary settings were more likely to receive other blood products and have longer hospital stays, but morbidity, readmission and hysterectomy rates were similar. Although 46% of women had no identifiable risk factors early in pregnancy, 20% of transfusions of ≥4 units occurred within this group. By the birth admission 70% of women had at least one risk factor for requiring ≥4 units of red cells. CONCLUSIONS: Overall outcomes for women receiving ≥4 units of red cells were comparable between tertiary and non-tertiary facilities. This is important given the inability of known risk factors to predict many instances of postpartum haemorrhage.

A multi-centre, open label, randomised, parallel-group, superiority Trial to compare the efficacy of URsodeoxycholic acid with RIFampicin in the management of women with severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC randomised trial.

BACKGROUND: Severe early onset (less than 34 weeks gestation) intrahepatic cholestasis of pregnancy (ICP) affects 0.1% of pregnant women in Australia and is associated with a 3-fold increased risk of stillbirth, fetal hypoxia and compromise, spontaneous preterm birth, as well as increased frequencies of pre-eclampsia and gestational diabetes. ICP is often familial and overlaps with other cholestatic disorders. Treatment options for ICP are not well established, although there are limited data to support the use of ursodeoxycholic acid (UDCA) to relieve pruritus, the main symptom. Rifampicin, a widely used antibiotic including in pregnant women, is effective in reducing pruritus in non-pregnancy cholestasis and has been used as a supplement to UDCA in severe ICP. Many women with ICP are electively delivered preterm, although there are no randomised data to support this approach. METHODS: We have initiated an international multicentre randomised clinical trial to compare the clinical efficacy of rifampicin tablets (300 mg bd) with that of UDCA tablets (up to 2000 mg daily) in reducing pruritus in women with ICP, using visual pruritus scores as a measuring tool. DISCUSSION: Our study will be the first to examine the outcomes of treatment specifically in the severe early onset form of ICP, comparing "standard" UDCA therapy with rifampicin, and so be able to provide for the first-time high-quality evidence for use of rifampicin in severe ICP. It will also allow an assessment of feasibility of a future trial to test whether elective early delivery in severe ICP is beneficial. TRIAL IDENTIFIERS: Australian New Zealand Clinical Trials Registration Number (ANZCTR): 12618000332224p (29/08/2018). HREC No: HREC/18/WCHN/36. EudraCT number: 2018-004011-44. IRAS: 272398. NHMRC registration: APP1152418 and APP117853.

Vitamin B3 levels in women who experience first-trimester miscarriage.

Miscarriage is the most common complication in early pregnancy. It was recently reported in mice that miscarriage can be prevented through the administration of niacin. We conducted a prospective, exploratory pilot study involving 24 women who were less than 14 weeks pregnant. Neither niacin intake (P = 0.24) nor urinary vitamin B3 measured as the 1-methyl-5-carboxylamide-2-pyridone/N-1-methylnicotinamide (2-pyr/MNA) ratio (P = 1.00) predicted miscarriage. However, the difference in mean 2-pyr/MNA ratios between women who miscarried and controls suggests there may be a threshold niacin level protective in miscarriage prevention warranting further investigation.

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.

Eclampsia in Australia and New Zealand: A prospective population-based study.

BACKGROUND: Eclampsia is a serious consequence of pre-eclampsia. There are limited data from Australia and New Zealand (ANZ) on eclampsia. AIM: To determine the incidence, management and perinatal outcomes of women with eclampsia in ANZ. MATERIALS AND METHODS: A two-year population-based descriptive study, using the Australasian Maternity Outcomes Surveillance System (AMOSS), carried out in 263 sites in Australia, and all 24 New Zealand maternity units, during a staggered implementation over 2010-2011. Eclampsia was defined as one or more seizures during pregnancy or postpartum (up to 14 days) in any woman with clinical evidence of pre-eclampsia. RESULTS: Of 136 women with eclampsia, 111 (83%) were in Australia and 25 (17%) in New Zealand. The estimated incidence of eclampsia was 2.2 (95% confidence interval (CI) 1.9-2.7) per 10 000 women giving birth. Aboriginal and Torres Strait Islander women were over-represented in Australia (n = 9; 8.1%). Women with antepartum eclampsia (n = 58, 42.6%) were more likely to have a preterm birth (P = 0.04). Sixty-three (47.4%) women had pre-eclampsia diagnosed prior to their first eclamptic seizure of whom 19 (30.2%) received magnesium sulphate prior to the first seizure. Nearly all women (n = 128; 95.5%) received magnesium sulphate post-seizure. No woman received prophylactic aspirin during pregnancy. Five women had a cerebrovascular haemorrhage, and there were five known perinatal deaths. CONCLUSIONS: Eclampsia is an uncommon consequence of pre-eclampsia in ANZ. There is scope to reduce the incidence of this condition, associated with often catastrophic morbidity, through the use of low-dose aspirin and magnesium sulphate in women at higher risk.

Trends in asthma self-management skills and inhaled corticosteroid use during pregnancy and postpartum from 2004 to 2017.

OBJECTIVE: Asthma exacerbations and medication non-adherence are significant clinical problems during pregnancy. While asthma self-management education is effective, the number of education sessions required to maximise asthma management knowledge and inhaler technique and whether improvements persist postpartum, are unknown. This paper describes how asthma knowledge, skills, and inhaled corticosteroid (ICS) use have changed over time. METHODS: Data were obtained from 3 cohorts of pregnant women with asthma recruited in Newcastle, Australia between 2004 and 2017 (N = 895). Medication use, adherence, knowledge, and inhaler technique were compared between cohorts. Changes in self-management knowledge/skills and women's perception of medication risk to the fetus were assessed in 685 women with 5 assessments during pregnancy, and 95 women who had a postpartum assessment. RESULTS: At study entry, 41%, 29%, and 38% of participants used ICS in the 2004, 2007, and 2013 cohorts, respectively (p = 0.017), with 40% non-adherence in each cohort. Self-management skills of pregnant women with asthma did not improve between 2004 and 2017 and possession of a written action plan remained low. Maximum improvements were reached by 3 sessions for medications knowledge and one session for inhaler technique, and were maintained postpartum. ICS adherence was maximally improved after one session, but not maintained postpartum. Perceived risk of asthma medications on the fetus was highest for corticosteroid-containing medication; and was significantly reduced following education. CONCLUSIONS: There was a high prevalence of non-adherence and poor self-management skills in all cohorts. More awareness of the importance of optimal asthma management during pregnancy is warranted, since no improvements were observed over the past decade.

Standardizing clinical care measures of rheumatic heart disease in pregnancy: A qualitative synthesis.

BACKGROUND: Rheumatic heart disease (RHD) is a preventable cardiac condition that escalates risk in pregnancy. Models of care informed by evidence-based clinical guidelines are essential to optimal health outcomes. There are no published reviews that systematically explore approaches to care provision for pregnant women with RHD and examine reported measures. The review objective was to improve understanding of how attributes of care for these women are reported and how they align with guidelines. METHODS: A search of 13 databases was supported by hand-searching. Papers that met inclusion criteria were appraised using CASP/JBI checklists. A content analysis of extracted data from the findings sections of included papers was undertaken, informed by attributes of quality care identified previously from existing guidelines. RESULTS: The 43 included studies were predominantly conducted in tertiary care centers of low-income and middle-income countries. Cardiac guidelines were referred to in 25 of 43 studies. Poorer outcomes were associated with higher risk scores (detailed in 36 of 41 quantitative studies). Indicators associated with increased risk include anticoagulation during pregnancy (28 of 41 reported) and late booking (gestation documented in 15 of 41 studies). Limited access to cardiac interventions was discussed (19 of 43) in the context of poorer outcomes. Conversely, early assessment and access to regular multidisciplinary care were emphasized in promoting optimal outcomes for women and their babies. CONCLUSIONS: Despite often complex care requirements in challenging environments, pregnancy provides an opportunity to strengthen health system responses and address whole-of-life health for women with RHD. A standard set of core indicators is proposed to more accurately benchmark care pathways, outcomes, and burden.

Serious kidney disease in pregnancy: an Australian national cohort study protocol.

BACKGROUND: Maternal kidney disease (acute kidney injury (AKI), advanced chronic kidney disease (CKD), dependence on dialysis or a kidney transplant) has a substantial impact on pregnancy, with risks of significant perinatal morbidity. These pregnancies require integrated multidisciplinary care to manage a complex and often challenging clinical situation. The ability to deliver optimal care is currently hindered by a lack of understanding around prevalence, management and outcomes in Australia. This study aims to expand an evidence base to improve clinical care of women with serious kidney impairment in pregnancy. METHODS/DESIGN: The "Kidney Disease in Pregnancy Study" is a national prospective cohort study of women with stage 3b-5 CKD (including dialysis and transplant) and severe AKI in pregnancy, using the Australasian Maternity Outcomes Surveillance System (AMOSS). AMOSS incorporates Australian maternity units with > 50 births/year (n = 260), capturing approximately 96% of Australian births. We will identify women meeting the inclusion criteria who give birth in Australia between 1st August 2017 and 31st July 2018. Case identification will occur via monthly review of all births in Australian AMOSS sites and prospective notification to AMOSS via renal or obstetric clinics. AMOSS data collectors will capture key clinical data via a web-based data collection tool. The data collected will focus on the prevalence, medical and obstetric clinical care, and maternal and fetal outcomes of these high-risk pregnancies. DISCUSSION: This study will increase awareness of the issue of serious renal impairment in pregnancy through engagement of 260 maternity units and obstetric and renal healthcare providers across the country. The study results will provide an evidence base for pre-pregnancy counselling and development of models of optimal clinical care, clinical guideline and policy development in Australia. Understanding current practices, gaps in care and areas for intervention will improve the care of women with serious renal impairment, women with high-risk pregnancies, their babies and their families.

Obesity, gestational diabetes and macrosomia are associated with increasing rates of early-term induction of labour at The Canberra Hospital.

BACKGROUND: Early-term delivery is an important cause of short-term neonatal morbidity and associated high healthcare costs, with possible additional long-term developmental ramifications. As a form of 'iatrogenic' delivery, induction of labour (IOL) is a potentially modifiable contributor to this burden. AIMS: To determine patterns of, and primary indication for, early-term IOL, as well as temporal trends in this primary indication and differences from other modes of delivery with respect to maternal factors and maternal/neonatal outcomes. MATERIALS AND METHODS: The Canberra Hospital births database (2012-2016) was queried; patients who underwent IOL were included in the analysis. RESULTS: Total deliveries and the proportion of early-term IOL procedures rose markedly over the time period. Gestational diabetes mellitus (GDM) was the most frequent and an increasing main indication for IOL. GDM was associated with significantly higher body mass index, an increased proportion of obesity, and a greater incidence of labour complications related to macrosomia. Birthweight of neonates of diabetic mothers was significantly higher, which was associated with decreased rates of admission to the special care nursery/neonatal intensive care unit (SCN/NICU) compared to all other babies. GDM increased relative risk of early-term IOL in obese women by 1.8 times. CONCLUSIONS: The burden of GDM and early-term IOL have increased at The Canberra Hospital although adverse short-term neonatal outcomes have not, possibly suggesting appropriate management of these patients. Nonetheless, effort should be made to identify patients who can safely continue pregnancy to full term, given the higher proportion of SCN/NICU admissions among early-term neonates.

Hyperglycaemia in early pregnancy: the Treatment of Booking Gestational diabetes Mellitus (TOBOGM) study. A randomised controlled trial.

BACKGROUND: Gestational diabetes mellitus (GDM) causes adverse pregnancy outcomes that can be averted by treatment from 24-28 weeks' gestation. Assessing and treating women for overt diabetes in pregnancy (ODIP) at the first antenatal clinic booking is now recommended in international guidelines. As a consequence, women with milder hyperglycaemia are being diagnosed and treated for early GDM, but randomised controlled trial (RCTs) assessing the benefits and harms of such treatment have not been undertaken. The Treatment Of Booking Gestational diabetes Mellitus (TOBOGM) study is a multi-centre RCT examining whether diagnosing and treating GDM diagnosed at booking improves pregnancy outcomes. Methods and analysis: 4000 adult pregnant women (< 20 weeks' gestation) at risk of ODIP will be recruited from 12 hospital antenatal booking clinics and referred for an oral glucose tolerance test (OGTT). 800 women with hyperglycaemia (ie, booking GDM) according to the 2014 Australasian Diabetes-in-Pregnancy Society criteria for pregnant women at 24-28 weeks' gestation will be randomised to immediate treatment for GDM (intervention) or to no treatment (control), pending the results of a second OGTT at 24-28 weeks' gestation. Antenatal and GDM care will otherwise follow local guidelines. Randomisation will be stratified by site and OGTT glycaemic risk strata. The primary pregnancy outcome is a composite of respiratory distress, phototherapy, birth trauma, birth before 37 weeks' gestation, stillbirth or death, shoulder dystocia, and birthweight ≥ 4.5 kg. The primary neonatal outcome is neonatal lean body mass. The primary maternal outcome is pre-eclampsia. Ethics approval: South Western Sydney Local Health District Research and Ethics Office (reference, 15/LPOOL/551). Dissemination of results: Peer-reviewed publications, scientific meetings, collaboration with research groups undertaking comparable studies, discussions with guideline groups and policy makers. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000924459.

Rheumatic heart disease in pregnancy: How can health services adapt to the needs of Indigenous women? A qualitative study.

OBJECTIVES: To study rheumatic heart disease health literacy and its impact on pregnancy, and to identify how health services could more effectively meet the needs of pregnant women with rheumatic heart disease. MATERIALS AND METHODS: Researchers observed and interviewed a small number of Aboriginal women and their families during pregnancy, childbirth and postpartum as they interacted with the health system. An Aboriginal Yarning method of relationship building over time, participant observations and interviews with Aboriginal women were used in the study. The settings were urban, island and remote communities across the Northern Territory. Women were followed interstate if they were transferred during pregnancy. The participants were pregnant women and their families. We relied on participants' abilities to tell their own experiences so that researchers could interpret their understanding and perspective of rheumatic heart disease. RESULTS: Aboriginal women and their families rarely had rheumatic heart disease explained appropriately by health staff and therefore lacked understanding of the severity of their illness and its implications for childbearing. Health directives in written and spoken English with assumed biomedical knowledge were confusing and of limited use when delivered without interpreters or culturally appropriate health supports. CONCLUSIONS: Despite previous studies documenting poor communication and culturally inadequate care, health systems did not meet the needs of pregnant Aboriginal women with rheumatic heart disease. Language-appropriate health education that promotes a shared understanding should be relevant to the gender, life-stage and social context of women with rheumatic heart disease.

The Breathing for Life Trial: a randomised controlled trial of fractional exhaled nitric oxide (FENO)-based management of asthma during pregnancy and its impact on perinatal outcomes and infant and childhood respiratory health.

BACKGROUND: Asthma exacerbations are common during pregnancy and associated with an increased risk of adverse perinatal outcomes. Adjusting asthma treatment based on airway inflammation rather than symptoms reduces the exacerbation rate by 50 %. The Breathing for Life Trial (BLT) will test whether this approach also improves perinatal outcomes. METHODS/DESIGN: BLT is a multicentre, parallel group, randomised controlled trial of asthma management guided by fractional exhaled nitric oxide (FENO, a marker of eosinophilic airway inflammation) compared to usual care, with prospective infant follow-up. Women with physician-diagnosed asthma, asthma symptoms and/or medication use in the previous 12 months, who are 12-22 weeks gestation, will be eligible for inclusion. Women randomised to the control group will have one clinical assessment of their asthma, including self-management education. Any treatment changes will be made by their general practitioner. Women randomised to the intervention group will have clinical assessments every 3-6 weeks during pregnancy, and asthma treatments will be adjusted every second visit based on an algorithm which uses FENO to adjust inhaled corticosteroid (ICS) dose (increase in dose when FENO >29 parts per billion (ppb), decrease in dose when FENO <19 ppb, and no change when FENO is between 19 and 29 ppb). A long acting beta agonist (LABA) will be added when symptoms remain uncontrolled. Both the control and intervention groups will report on exacerbations at a postpartum phone interview. The primary outcome is adverse perinatal outcome (a composite measure including preterm birth, intrauterine growth restriction, neonatal hospitalisation at birth or perinatal mortality), assessed from hospital records. Secondary outcomes will be each component of the primary outcome, maternal exacerbations requiring medical intervention during pregnancy (both smokers and non-smokers), and hospitalisation and emergency department presentation for wheeze, bronchiolitis or croup in the first 12 months of infancy. Outcome assessment and statistical analysis of the primary outcome will be blinded. To detect a reduction in adverse perinatal outcomes from 35 % to 26 %, 600 pregnant women with asthma per group are required. DISCUSSION: This trial will provide evidence for the effectiveness of a FENO-based management strategy in improving perinatal outcomes in pregnant women with asthma. If successful, this would improve the management of pregnant women with asthma worldwide. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000202763 .