Ethnic Differences in Characteristics of Women Diagnosed with Early Gestational Diabetes: Findings from the TOBOGM Study.

Objective: To compare the prevalence and clinical characteristics of early gestational diabetes (eGDM) and associated birth outcomes amongst women of different ethnic groups.

Research Design And Methods: This is a secondary analysis of an international, multicentre randomized controlled trial of treating eGDM among pregnant women with GDM risk factors enrolled <20 weeks' gestation. The diagnosis of GDM was made using WHO-2013 criteria.

Association Between Glycemia, Glycemic Variability, and Pregnancy Complications in Early GDM.

Objective: To investigate the association of timing of commencing glucose management with glycemia, glycemic variability, and pregnancy outcomes among women with early gestational diabetes mellitus (GDM).

Research Design And Methods: In this substudy among participants of a trial of immediate vs. delayed treatment of early GDM diagnosed by 2013 World Health Organization criteria, all women treated immediately and those with delayed diagnosis at 24-28 weeks' gestation (treated as if late GDM) were instructed to monitor capillary blood glucose (BG) four times a day (fasting and 2-h postprandial) until delivery.

Postpartum dysglycaemia after early gestational diabetes: Follow-up of women in the TOBOGM randomised controlled trial.

Aim: To evaluate the incidence and predictors of postpartum dysglycaemia among high-risk women who develop early gestational diabetes (eGDM) prior to 20 weeks' gestation.

Methods: This is a sub-study of the Treatment of Booking Gestational Diabetes (TOBOGM) Study, a randomised controlled trial of early or deferred treatment for women with risk factors for gestational diabetes diagnosed with eGDM, using current WHO criteria. Overt diabetes in pregnancy was excluded.

Significant kidney disease in pregnancy: Feasibility and outcomes of a national population-based study using the Australasian Maternity Outcomes Surveillance System.

Background: Current understanding of clinical practice and care for maternal kidney disease in pregnancy in Australia is hampered by limitations in available renal-specific datasets.

Aims: To capture the epidemiology, management, and outcomes of women with significant kidney disease in pregnancy and demonstrate feasibility of a national cohort study approach.

Materials And Methods: An Australian prospective study (2017-2018) using a new kidney disease-specific survey within the Australasian Maternity Outcomes Surveillance System (AMOSS).

Measuring bile acids: Are we all talking the same language?

In this paper, we discuss the Bile Acid Comparison and Harmonisation project, a sub-study of the Trial of URsodeoxycholic acid vs RIFampicin in early-onset severe Intrahepatic Cholestasis of pregnancy, giving an overview of the current state of affairs for total bile acid measurements.

Intrahepatic cholestasis of pregnancy: Introduction and overview 2024.

Considerable progress has been made to explain the aetiology of intrahepatic cholestasis of pregnancy (ICP) and of the adverse pregnancy outcomes associated with high maternal total serum bile acids (TSBAs). The reported thresholds for non-fasting TSBA associated with the risk of stillbirth and spontaneous preterm birth can be used to identify pregnancies at risk of these adverse outcomes to decide on appropriate interventions and to give reassurance to women with lower concentrations of TSBA. Data also support the use of ursodeoxycholic acid to protect against the risk of spontaneous preterm birth.

ICP - could there be a virus in the works?

Intrahepatic cholestasis of pregnancy (ICP) is the most common liver-specific disorder affecting pregnant women, with an Australian incidence of 0.6% pa and recurring in 70% of those affected. ICP causes mild to severe pruritus, often resulting in considerable skin excoriations, profound sleep disturbances, and severe anxiety, and yet the aetiology and optimal treatment or management of this condition remains unknown.

Effect of treatment for early gestational diabetes mellitus on neonatal respiratory distress: A secondary analysis of the TOBOGM study.

Objective: To identify factors associated with neonatal respiratory distress (NRD) in early Gestational diabetes mellitus (eGDM).

Design: Nested case-control analysis of the TOBOGM trial.

Setting: Seventeen hospitals: Australia, Sweden, Austria and India.

Relationship Between Early-Pregnancy Glycemia and Adverse Outcomes: Findings From the TOBOGM Study.

Objective: We evaluated associations between early-pregnancy oral glucose tolerance test (OGTT) glucose and complications in the Treatment of Booking Gestational Diabetes Mellitus (TOBOGM) cohort to inform prognostic OGTT thresholds.

Research Design And Methods: Individuals with risk factors for hyperglycemia were recruited for an international, multicenter, randomized controlled gestational diabetes mellitus (GDM) (World Health Organization 2013 criteria) treatment trial. A 2-h 75-g OGTT was performed at <20 weeks' gestation.

Cost-effectiveness of diagnosis and treatment of early gestational diabetes mellitus: economic evaluation of the TOBOGM study, an international multicenter randomized controlled trial.

Background: A recently undertaken multicenter randomized controlled trial (RCT) " (TOBOGM: 2017-2022) found that the diagnosis and treatment of pregnant women with early gestational diabetes mellitus (GDM) improved pregnancy outcomes. Based on data from the trial, this study aimed to assess the cost-effectiveness of diagnosis and treatment of early GDM (from <20 weeks') among women with risk factors for hyperglycemia in pregnancy compared with usual care (no treatment until 24-28 weeks') from a healthcare perspective.

Methods: Participants' healthcare resource utilization data were collected from their self-reported questionnaires and hospital records, and valued using the unit costs obtained from standard Australian national sources.

Regression From Early GDM to Normal Glucose Tolerance and Adverse Pregnancy Outcomes in the Treatment of Booking Gestational Diabetes Mellitus Study.

Objective: To compare pregnancy outcomes among women with a normal oral glucose tolerance test (OGTT) before 20 weeks' gestation (early) and at 24-28 weeks' gestation (late) (no gestational diabetes mellitus, or No-GDM), those with early GDM randomized to observation with a subsequent normal OGTT (GDM-Regression), and those with GDM on both occasions (GDM-Maintained).

Research Design And Methods: Women at <20 weeks' gestation with GDM risk factors who were recruited for a randomized controlled early GDM treatment trial were included. Women with treated early GDM and late GDM (according to the World Health Organization's 2013 criteria) were excluded from this analysis.

Perinatal Outcomes in Early and Late Gestational Diabetes Mellitus After Treatment From 24-28 Weeks' Gestation: A TOBOGM Secondary Analysis.

Objective: In most gestational diabetes mellitus (GDM) studies, cohorts have included women combined into study populations without regard to whether hyperglycemia was present earlier in pregnancy. In this study we sought to compare perinatal outcomes between groups: women with early GDM (EGDM group: diagnosis before 20 weeks' gestation but no treatment until 24-28 weeks' gestation if GDM still present), with late GDM (LGDM group: present only at 24-28 weeks' gestation), and with normoglycemia at 24-28 weeks' gestation (control participants).

Research Design And Methods: This is a secondary analysis of a randomized controlled treatment trial where we studied, among women with risk factors, early (<20 weeks' gestation) GDM defined according to World Health Organization 2013 criteria.

The relationship between body mass index and sleep in women with risk factors for gestational diabetes mellitus.

Background: Both obesity and sleep disorders are common among women during pregnancy. Although prior research has identified a relationship between obesity and sleep disorders, those findings are from women later in pregnancy.

Objective: To explore the relationships between self-reported sleep duration, insufficient sleep and snoring with body mass index (BMI) among multiethnic women at risk of gestational diabetes mellitus (GDM)in early pregnancy.

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%.

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.

Real-world experience of adding placental histopathology studies into perinatal clinical trials.

Addition of placental histopathology studies to obstetric trials is likely to be cost-effective and may reveal structural changes suggestive of functional dysfunction to explain the success or failure of a clinical intervention. We share our recent experience in adding placental pathological examination to two clinical trials, retrospectively in one and at the outset in the other, so that other clinical trial investigators may benefit from it. The practical issues can be summarised as being regulatory and ethical, operational and reporting.

INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG).

Background: Advanced gastro-oesophageal cancer (AGOC) carries a poor prognosis. No standard of care treatment options are available after first and second-line therapies. Regorafenib is an oral multi-targeted tyrosine kinase inhibitor targeting angiogenic, stromal, and oncogenic receptor tyrosine kinases.

Infant Exposure to Armodafinil Through Human Milk Following Maternal Use of Modafinil.

Introduction: Narcolepsy, a condition adversely affecting psychological, social, and cognitive function, is more prevalent in females of childbearing age than the general population. Modafinil and armodafinil are central nervous system stimulants approved for treatment of narcolepsy. Infant exposure to these agents through human milk has not been investigated.

Value of central review of RECIST v1.1 outcomes in the AGITG INTEGRATE randomised phase 2 international trial for advanced oesophago-gastric cancer.

Purpose: Activity estimates should be accurately evaluated in phase 2 clinical trials to ensure appropriate decisions about proceeding to phase 3 trials. RECIST v1.1.

GWAS meta-analysis of intrahepatic cholestasis of pregnancy implicates multiple hepatic genes and regulatory elements.

Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disorder affecting 0.5-2% of pregnancies. The majority of cases present in the third trimester with pruritus, elevated serum bile acids and abnormal serum liver tests.

Performance of four regression frameworks with varying precision profiles in simulated reference material commutability assessment.

Objectives: One approach to assessing reference material (RM) commutability and agreement with clinical samples (CS) is to use ordinary least squares or Deming regression with prediction intervals. This approach assumes constant variance that may not be fulfilled by the measurement procedures. Flexible regression frameworks which relax this assumption, such as quantile regression or generalized additive models for location, scale, and shape (GAMLSS), have recently been implemented, which can model the changing variance with measurand concentration.