Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial

被引：117

作者：

Brocklehurst, Peter ^{[1
]}

Johns, Nina ^{[2
]}

Johnston, Tracey ^{[2
]}

Barnfield, Gemma ^{[2
]}

Davies, Karen ^{[2
]}

Johnson, Mark ^{[3
]}

Patterson, Holly ^{[3
]}

Montague, Imogen ^{[4
]}

Watmore, Sally ^{[4
]}

Stolton, Alison ^{[4
]}

Parisaei, Maryam ^{[5
]}

McGhee, Natasha ^{[5
]}

Segovia, Silvia ^{[5
]}

Martindale, Elizabeth ^{[6
,15
]}

Jackson, Hilary ^{[6
,15
]}

Holleran, Josephine ^{[6
]}

Roberts, Devender ^{[7
]}

Holt, Siobhan ^{[7
]}

Dragovic, Bosko ^{[8
]}

Willmott-Powell, Miriam ^{[8
]}

Hutchinson, Laura ^{[8
]}

Toth, Benedek ^{[8
]}

Chandler, Gemma ^{[8
]}

Ridley, Suzanne ^{[8
]}

Bugg, George ^{[9
,13
]}

Molnar, Anna ^{[9
]}

Lochrie, Denise ^{[9
]}

Connor, Jillian ^{[10
]}

Howe, David ^{[10
]}

Head, Katie ^{[10
]}

Wellstead, Sue ^{[10
]}

Mathers, Alan ^{[11
,18
]}

Walker, Laura ^{[11
]}

Crawford, Isobel ^{[11
]}

Davies, David ^{[12
]}

Garner, Zoe ^{[12
]}

Galloway, Lucy ^{[12
]}

Bugg, George ^{[9
,13
]}

Davies, Yvette ^{[13
]}

Smith, Carys ^{[13
]}

Perkins, Gill ^{[13
]}

Geary, Mike ^{[14
]}

Walsh, Fiona ^{[14
]}

Nagle, Ursula ^{[14
]}

Martindale, Elizabeth ^{[6
,15
]}

Jackson, Hilary ^{[6
,15
]}

O'Malley, Louise ^{[15
]}

Katakam, Narmada ^{[16
]}

White, Heather ^{[16
]}

Tanton, Emma ^{[16
]}

机构：

[1] Univ Birmingham, Coll Med & Dent Sci, Inst Appl Hlth Res, Birmingham Clin Trials Unit, Birmingham B15 2TT, W Midlands, England

[2] Birmingham Womens Hosp, Birmingham, W Midlands, England

[3] Chelsea & Westminster Hosp, London, England

[4] Derriford Hosp, Plymouth, Devon, England

[5] Homerton Univ Hosp, London, England

[6] Lancashire Women & Newborn Ctr, Burnley, Lancs, England

[7] Liverpool Womens Hosp, Liverpool, Merseyside, England

[8] Northwick Pk Hosp & Clin Res Ctr, Harrow, Middx, England

[9] City Hosp Nottingham, Nottingham, England

[10] Princess Anne Hosp, Southampton, Hants, England

[11] Princess Royal Hosp, Orpington, England

[12] Queen Alexandra Hosp, London, England

[13] Queens Med Ctr, London, England

[14] Rotunda Hosp, Dublin, Ireland

[15] Royal Blackburn Hosp, Blackburn, Lancs, England

[16] Royal Bolton Hosp, Farnworth, England

[17] Royal Derby Hosp, Derby, England

[18] Southern Gen Hosp, Glasgow, Lanark, Scotland

[19] St Marys Hosp, London, England

[20] Stoke Mandeville Hosp, Aylesbury, Bucks, England

[21] Univ Coll London Hosp, London, England

[22] Univ Hosp Coventry & Warwickshire, Coventry, W Midlands, England

[23] Univ Hosp North Staffordshire, Stoke On Trent, Staffs, England

[24] Warrington Hosp, Warrington, Cheshire, England

[25] Warwick Hosp, Warwick, England

来源：

LANCET | 2017年 / 389卷 / 10080期

关键词：

ASPHYXIA; DELIVERY; SYSTEM;

D O I：

10.1016/S0140-6736(17)30568-8

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes. Methods In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for >= 48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152. Findings Between Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups-172 (0.7%) babies in the decision-support group compared with 171 (0.7%) babies in the no-decision-support group (adjusted risk ratio 1.01, 95% CI 0.82-1.25). At 2 years, no significant differences were noted in terms of developmental assessment. Interpretation Use of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies.

引用

页码：1719 / 1729

页数：11

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