8 research outputs found
Prediction of uncomplicated pregnancies in obese women: A prospective multicentre study
BACKGROUND: All obese pregnant women are considered at equal high risk with respect to complications in pregnancy and birth, and are commonly managed through resource-intensive care pathways. However, the identification of maternal characteristics associated with normal pregnancy outcomes could assist in the management of these pregnancies. The present study aims to identify the factors associated with uncomplicated pregnancy and birth in obese women, and to assess their predictive performance. METHODS: Data form obese women (BMI ≥ 30 kg/m 2 ) with singleton pregnancies included in the UPBEAT trial were used in this analysis. Multivariable logistic regression was used to identify sociodemographic, clinical and biochemical factors at 15 +0 to 18 +6 weeks' gestation associated with uncomplicated pregnancy and birth, defined as delivery of a term live-born infant without antenatal or labour complications. Predictive performance was assessed using area under the receiver operating characteristic curve (AUROC). Internal validation and calibration were also performed. Women were divided into fifths of risk and pregnancy outcomes were compared between groups. Sensitivity, specificity, and positive and negative predictive values were calculated using the upper fifth as the positive screening group. RESULTS: Amongst 1409 participants (BMI 36.4, SD 4.8 kg/m 2 ), the prevalence of uncomplicated pregnancy and birth was 36% (505/1409). Multiparity and increased plasma adiponectin, maternal age, systolic blood pressure and HbA1c were independently associated with uncomplicated pregnancy and birth. These factors achieved an AUROC of 0.72 (0.68-0.76) and the model was well calibrated. Prevalence of gestational diabetes, preeclampsia and other hypertensive disorders, preterm birth, and postpartum haemorrhage decreased whereas spontaneous vaginal delivery increased across the fifths of increasing predicted risk of uncomplicated pregnancy and birth. Sensitivity, specificity, and positive and negative predictive values were 38%, 89%, 63% and 74%, respectively. A simpler model including clinical factors only (no biomarkers) achieved an AUROC of 0.68 (0.65-0.71), with sensitivity, specificity, and positive and negative predictive values of 31%, 86%, 56% and 69%, respectively. CONCLUSION: Clinical factors and biomarkers can be used to help stratify pregnancy and delivery risk amongst obese pregnant women. Further studies are needed to explore alternative pathways of care for obese women demonstrating different risk profiles for uncomplicated pregnancy and birth
Do lower antenatal blood pressure cut-offs in pregnant women with obesity identify those at greater risk of adverse maternal and perinatal outcomes? A secondary analysis of data from the UK Pregnancies Better Eating and Activity Trial (UPBEAT)
\ua9 The Author(s) 2025. Background: Obesity is a major risk-factor for adverse pregnancy outcomes. While the 2017 American College of Cardiology/American Heart Association (ACC/AHA) classification of normal and abnormal blood pressure (BP) outside pregnancy has been suggested for use in pregnancy, the impact on adverse outcomes has not been examined specifically in women with obesity. Methods: The UK Pregnancies Better Eating and Activity Trial (UPBEAT) enroled women with a body mass index (BMI) ≥ 30 kg/m2. In secondary analyses, maximal antenatal BP was categorised by 2017 ACC/AHA criteria: ‘Normal’ BP (systolic [sBP] <120 mmHg and diastolic [dBP] <80 mmHg), ‘Elevated’ BP (sBP 120–129 mmHg and dBP <80 mmHg), ‘Stage 1 hypertension’ (sBP 130–139 mmHg and/or dBP 80-89 mmHg), and ‘Stage 2 hypertension’ (sBP ≥140 mmHg and/or dBP ≥90 mmHg, non-severe [sBP 140-159 mmHg and/or dBP 90–109 mmHg] and severe (sBP ≥160 mmHg and/or dBP ≥110 mmHg). Main outcomes were preterm birth, postpartum haemorrhage (PPH), birthweight <10th centile (small-for-gestational age, SGA), and neonatal intensive care unit (NICU) admission. Associations with adverse outcomes were adjusted for UPBEAT intervention, maternal age, booking BMI, ethnicity, parity, smoking, alcohol, and previous pre-eclampsia or gestational diabetes. Diagnostic test properties (positive and negative likelihood ratios, -LR and +LR) were assessed as individual categories (vs. ‘Normal’ BP), and as threshold values. Results: Severe ‘Stage 2 hypertension’ (vs. BP < 160/110 mmHg) was associated with PPH (RR 2.57 (1.35, 4.86)) and SGA (RR 2.52 (1.05, 6.07)) only in unadjusted analyses. No outcomes were associated with ‘Stage 1 hypertension’ or ‘Elevated BP’. All +LR were <5.0 and -LR ≥ 0.20, indicating that no BP threshold was useful as a diagnostic test to detect preterm birth, PPH, SGA, or NICU admission. Conclusions: Among pregnant women with obesity, we found no evidence that lowering the antenatal BP considered to be abnormal (from 140/90 mmHg) would assist in identifying women and babies at risk
Lifestyle intervention in obese pregnancy and cardiac remodelling in 3-year olds: children of the UPBEAT RCT
Background/Objectives: Obesity in pregnancy has been associated with increased childhood cardiometabolic risk and reduced life expectancy. The UK UPBEAT multicentre randomised control trial was a lifestyle intervention of diet and physical activity in pregnant women with obesity. We hypothesised that the 3-year-old children of women with obesity would have heightened cardiovascular risk compared to children of normal BMI women, and that the UPBEAT intervention would mitigate this risk. Subjects/Methods: Children were recruited from one UPBEAT trial centre. Cardiovascular measures included blood pressure, echocardiographic assessment of cardiac function and dimensions, carotid intima-media thickness and heart rate variability (HRV) by electrocardiogram. Results: Compared to offspring of normal BMI women (n = 51), children of women with obesity from the trial standard care arm (n = 39) had evidence of cardiac remodelling including increased interventricular septum (IVS; mean difference 0.04 cm; 95% CI: 0.018 to 0.067), posterior wall (PW; 0.03 cm; 0.006 to 0.062) and relative wall thicknesses (RWT; 0.03 cm; 0.01 to 0.05) following adjustment. Randomisation of women with obesity to the intervention arm (n = 31) prevented this cardiac remodelling (intervention effect; mean difference IVS −0.03 cm (−0.05 to −0.008); PW −0.03 cm (−0.05 to −0.01); RWT −0.02 cm (−0.04 to −0.005)). Children of women with obesity (standard care arm) compared to women of normal BMI also had elevated minimum heart rate (7 bpm; 1.41 to 13.34) evidence of early diastolic dysfunction (e prime) and increased sympathetic nerve activity index by HRV analysis. Conclusions: Maternal obesity was associated with left ventricular concentric remodelling in 3-year-old offspring. Absence of remodelling following the maternal intervention infers in utero origins of cardiac remodelling. Clinical trial registry name and registration number: The UPBEAT trial is registered with Current Controlled Trials, ISRCTN89971375
Patient-Centered Methods for Designing and Developing Health Information Communication Technologies: A Systematic Review
Lifestyle intervention in obese pregnancy and cardiac remodelling in 3-year olds: children of the UPBEAT RCT
Tranexamic acid versus placebo to prevent bleeding in patients with haematological malignancies and severe thrombocytopenia (TREATT): a randomised, double-blind, parallel, phase 3 superiority trial
Background:
Bleeding is common in patients with haematological malignancies undergoing intensive therapy. We aimed to assess the effect of tranexamic acid on preventing bleeding and the need for platelet transfusions.
Methods:
TREATT was an international, randomised, double-blind, parallel, phase 3 superiority trial conducted at 27 haematology centres in Australia and the UK. We enrolled adults (aged ≥18 years) receiving intensive chemotherapy or haematopoietic stem-cell transplantation for a haematological malignancy, with a platelet count of 10 × 109 platelets per L or less for 5 days or longer. Patients were randomly assigned (1:1) using block randomisation, stratified by site, to tranexamic acid (1 g every 8 h intravenously or 1·5g every 8 h orally) or placebo when their platelet count was less than 30 × 109 platelets per L. Treatment was continued until platelet recovery or day 30. Prophylactic platelet transfusions were maintained as standard of care. The primary endpoint was the proportion of patients who died or had WHO grade 2 or higher bleeding up to day 30. A modified intention-to-treat population including randomly assigned patients whose platelet count decreased to 30 × 109 platelets per L or less was used for analysis. This trial is registered with ClinicalTrials.gov (NCT03136445), ISRCTN (ISRCTN73545489), and the European Clinical Trials Register (EudraCT 2014-001513-35).
Findings:
Between June 23, 2015, and Feb 17, 2022, 1736 patients were screened for eligibility, 616 of whom were enrolled and randomly assigned (310 to tranexamic acid and 306 to placebo). 19 participants were excluded from the modified intention-to-treat analysis, leaving 300 participants in the tranexamic acid group and 297 in the placebo group. Participant median age was 58 years (IQR 49–65), 380 (62%) of 616 participants were male, and 235 (38%) were female. The proportion of participants who died or had WHO grade 2 or higher bleeding was 31·7% (90/298 [95% CI 26·6–37·4]) in the tranexamic acid group and 34·2% (98/295 [29·0–40·0]) in the placebo group (hazard ratio 0·92 [95% CI 0·67–1·27]; p=0·62). There were no differences in thrombotic events or veno-occlusive disease. 94 serious adverse events in 77 participants were reported up to day 60 in the tranexamic acid group and 103 events in 82 participants in the placebo group.
Interpretation:
There is insufficient evidence to support routine use of tranexamic acid to reduce bleeding in patients with haematological malignancies undergoing intensive chemotherapy.
Funding:
UK National Health Service Blood and Transplant and Australian National Health and Medical Research Council
