scholarly journals Antenatal telephone support intervention with and without uterine artery Doppler screening for low risk nulliparous women: a randomised controlled trial

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Vikki J Snaith ◽  
Jenny Hewison ◽  
Ian N Steen ◽  
Stephen C Robson
BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022056 ◽  
Author(s):  
Fionnuala Mone ◽  
Cecilia Mulcahy ◽  
Peter McParland ◽  
Fionnuala Breathnach ◽  
Paul Downey ◽  
...  

ObjectiveEvaluate the feasibility and acceptability of routine aspirin in low-risk women, compared with screening-test indicated aspirin for the prevention of pre-eclampsia and fetal growth restriction.DesignMulticentre open-label feasibility randomised controlled trial.SettingTwo tertiary maternity hospitals in Dublin, Ireland.Participants546 low-risk nulliparous women completed the study.InterventionsWomen underwent computerised randomisation to: Group 1—routine aspirin 75 mg from 11 until 36 weeks; Group 2—no aspirin and; Group 3—aspirin based on the Fetal Medicine Foundation screening test.Primary and secondary outcome measures(1) Proportion agreeing to participate; (2) compliance with protocol; (3) proportion where first trimester uterine artery Doppler was obtainable and; (4) time taken to issue a screening result. Secondary outcomes included rates of pre-eclampsia and small-for-gestational-age fetuses.Results546 were included in the routine aspirin (n=179), no aspirin (n=183) and screen and treat (n=184) groups. 546 of 1054 were approached (51.8%) and enrolled. Average aspirin adherence was 90%. The uterine artery Doppler was obtained in 98.4% (181/184) and the average time to obtain a screening result was 7.6 (0–26) days. Of those taking aspirin, vaginal spotting was greater; n=29 (15.1%), non-aspirin n=28 (7.9%), OR 2.1 (95% CI 1.2 to 3.6). Postpartum haemorrhage >500 mL was also greater; aspirin n=26 (13.5%), no aspirin n=20 (5.6%), OR 2.6 (95% CI 1.4 to 4.8).ConclusionLow-risk nulliparous women are open to taking aspirin in pregnancy and had high levels of adherence. Aspirin use was associated with greater rates of vaginal bleeding. An appropriately powered randomised controlled trial is now required to address the efficacy and safety of universal low-dose aspirin in low-risk pregnancy compared with a screening approach.Trial registration numberISRCTN (15191778); Post-results.


2011 ◽  
Vol 3 (1) ◽  
pp. 44-65 ◽  
Author(s):  
Paul R. Martin ◽  
John Reece ◽  
Sue Lauder ◽  
Andrew McClelland

PLoS ONE ◽  
2013 ◽  
Vol 8 (5) ◽  
pp. e63271 ◽  
Author(s):  
Sietske J. Tamminga ◽  
Jos H. A. M. Verbeek ◽  
Monique M. E. M. Bos ◽  
Guus Fons ◽  
Jos J. E. M. Kitzen ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e040543
Author(s):  
Adam W A Geraghty ◽  
Lisa Roberts ◽  
Jonathan Hill ◽  
Nadine E Foster ◽  
Lucy Yardley ◽  
...  

IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.


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