A randomised trial of timed delivery for the compromised preterm fetus: Short term outcomes and bayesian interpretation

B. Van Bulck; G. M. Kalakoutis; P. Sak; K. T.M. Schneider; T. Major; S. E. Karpathios; T. Todros; D. Arduini; A. Tranquilli; A. C. Tenore; N. Roncaglia; T. Frusca; A. Z. Groningen; M. J.N. Weinans; A. Z. Leiden; J. Van Roosmalen; Heel De Heel; Zaandam; J. W. Van der Slikke; H. Van Geijn; P. J.M. Pernet; H. Wolf; A. Z. Utrecht; R. H. Stigter; J. Wilczynski; E. Vasco; M. Rashid; Z. Novak-Antolic; P. Danielian; S. D. Jenkinson; C. R. Welch; C. Griffin; H. Gee; D. Tuffnell; J. Cresswell; T. Tariq; B. Sengupta; G. Tydeman; M. K. Kumarendran; D. Churchill; S. Bewley; L. Fusi; S. W. Lindow; W. Johal; F. M. Fairlie; K. Neales; J. G. Thornton; I. Scudamore; J. Konje; S. A. Walkinshaw; M. Griffiths; A. Dawson; G. Mires; R. Johanson; R. B. Fraser; P. Hendy Ibbs; S. A. Steel; M. Ramsay; J. B. Robins; M. J. Heard; H. M. Tonge; I. T. Manyonda; J. Walker; M. Maresh; A. Yoong; P. Soothill; H. Cameron; D. Byrne; B. Beattie; S. Bober; B. Felber; E. Isaac; L. Liddle; T. McGhee; P. Rowsell; P. Howie; D. Field; M. Levene; R. J. Lilford; A. Grant; P. Steer; G. Breart; D. Torgeson; J. Hornbuckle; A. Vail; D. Spiegelhalter

A randomised trial of timed delivery for the compromised preterm fetus: Short term outcomes and bayesian interpretation

B. Van Bulck
, G. M. Kalakoutis
, P. Sak
, K. T.M. Schneider
, T. Major
, S. E. Karpathios
, T. Todros
, D. Arduini
, A. Tranquilli
, A. C. Tenore
, N. Roncaglia
, T. Frusca
, A. Z. Groningen
, M. J.N. Weinans
, A. Z. Leiden
, J. Van Roosmalen
, Heel De Heel
, Zaandam
, J. W. Van der Slikke
, H. Van Geijn

P. J.M. Pernet, H. Wolf, A. Z. Utrecht, R. H. Stigter, J. Wilczynski, E. Vasco, M. Rashid, Z. Novak-Antolic, P. Danielian, S. D. Jenkinson, C. R. Welch, C. Griffin, H. Gee, D. Tuffnell, J. Cresswell, T. Tariq, B. Sengupta, G. Tydeman, M. K. Kumarendran, D. Churchill, S. Bewley, L. Fusi, S. W. Lindow, W. Johal, F. M. Fairlie, K. Neales, J. G. Thornton^*, I. Scudamore, J. Konje, S. A. Walkinshaw, M. Griffiths, A. Dawson, G. Mires, R. Johanson, R. B. Fraser, P. Hendy Ibbs, S. A. Steel, M. Ramsay, J. B. Robins, M. J. Heard, H. M. Tonge, I. T. Manyonda, J. Walker, M. Maresh, A. Yoong, P. Soothill, H. Cameron, D. Byrne, B. Beattie, S. Bober, B. Felber, E. Isaac, L. Liddle, T. McGhee, P. Rowsell, P. Howie, D. Field, M. Levene, R. J. Lilford, A. Grant, P. Steer, G. Breart, D. Torgeson, J. Hornbuckle, A. Vail, D. Spiegelhalter

^*Corresponding author for this work

Athena Institute

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

Objectives. To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design. A randomised controlled trial. Setting. 69 hospitals in 13 European countries. Participants. Pregnant women with fetal compromise between 24 and 36 weeks, an umbilical artery Doppler waveform recorded and clinical uncertainty whether immediate delivery was indicated. Methods. The interventions were 'immediate delivery' or 'delay until the obstetrician is no longer uncertain'. The data monitoring and analysis were Bayesian. Main outcome measures. 'Survival to hospital discharge' and 'developmental quotient at two years of age', this latter to be reported later. Results. Of 548 women (588 babies) recruited, outcomes were available on 547 mothers (587 babies). The median time-to-delivery intervals were 0.9 days in the immediate group and 4.9 days in the delay group. Total deaths prior to discharge were 29 (10%) in the immediate group versus 27 (9%) in the delay group (odds ratio 1.1, 95% CI 0.61-1.8). Total caesarean sections were 249 (91%) in the immediate group versus 217 (79%) in the delay group: (OR 2.7; 95% CI 1.6-4.5). These odds ratios were similar for those randomised at gestational ages above or below 30 weeks. Interpretation. The lack of difference in overall mortality suggests that clinicians participating in this trial were on average prepared to randomise at about the correct equivocal threshold between delivery and delay. However, there was insufficient evidence to convince enthusiasts for either immediate or delayed delivery that they were wrong.

Original language	English
Pages (from-to)	27-32
Number of pages	6
Journal	BJOG : An International Journal of Obstetrics and Gynaecology
Volume	110
Issue number	1
Publication status	Published - Jan 2003

Bibliographical note

First Published 'online':22 December 2003

Funding

This work was funded by the United Kingdom Medical Research Council, a European Union Concerted Action and the Dutch Princess Beatrix Foundation. GRIT Study Group Belgium Algemeen Centrum Ziekenhuis Antwerp B Van Bulck. Cyprus Arch. Makarios III Hospital, Nicosia, GM Kalakoutis. Czech Republic Ceske Budejovice, Hradec Kralove, P Sak. Germany Universitat Munchen, KTM Schneider. Hungary Debrecen, T Major; Greece Alexandra, Athens, SE Karpathios; Italy Turin, T Todros; Fatebenefratelli, Rome, D Arduini; Ospedale Salesi, Ancona, A Tranquilli; Ospedale Valduce, Como, AC Tenore; Universita Degli Studi Di Milano—Bicocca, Monza, N Roncaglia; University of Brescia, T Frusca. Netherlands AZ Groningen, MJN Weinans; AZ Leiden, J van Roosmalen; De Heel, Zaandam, JW van der Slikke; Free University, Amsterdam, H van Geijn; Kennemer Gasthius Lokatie Deo, Haarlem, PJM Pernet; Amsterdam Medical Centre, H Wolf; AZ Utrecht, RH Stigter. Poland Polish Mother's Memorial Hospital, Lodz, J Wilczynski. Portugal Hospital Universidad Coimbra, E Vasco; Saudi Arabia Riyadh Security Forces Hospital, M Rashid. Slovenia Ljubljana, Z Novak-Antolic. UK Aberdeen, P Danielian; Redditch, SD Jenkinson; Arrowe Park,Wirral, CR Welch; Birmingham Heartlands, C Griffin; Birmingham Women's, H Gee; Bradford Royal Infirmary, D Tuffnell; Chesterfield, J Cresswell; Dewsbury, T Tariq; Dryburn, B Sengupta; Forth Park, Kirkcaldy, G Tydeman; Northallerton, MK Kumarendran, Good Hope Sutton Coldfield, D Churchill; St Thomas' London, S Bewley; Hammersmith, London, L Fusi; Hull, SW Lindow; Ipswich, W Johal; Jessop, Sheffield, FM, Fairlie; Kent and Canterbury , K Neales; Leeds General, JG Thornton; Leicester General, I Scudamore; Leicester Royal, J Konje; Liverpool Women's, SA Walkinshaw; Luton and Dunstable, M Griffiths; Abergavenny, A Dawson; Ninewells, Dundee, G Mires; North Staffordshire Maternity, R Johanson; Northern General, Sheffield, RB Fraser; Ormskirk, P Hendy Ibbs; Peterborough, SA Steel; Queens Medical Centre, Nottingham, M Ramsay; Inverclyde, JB Robins; Winchester, MJ Heard; Bath, HM Tonge; St Georges, London, IT Manyonda; St James, Leeds, J Walker; St Mary's Manchester, M Maresh; St Mary's Isle of Wight, A Yoong; St Michael's Bristol, P, Soothill; Sunderland, H Cameron; Treliske, Truro, D Byrne; Heath Cardiff, B Beattie; West Cumberland, S Bober. The following trial office staff ran the trial: B Felber, E Isaac, L Liddle (principal trial coordinator), T McGhee and P Rowsell. Data Monitoring Ethics Committee P Howie, D Field, M Levene, RJ Lilford. Steering Committee A Grant, P Steer, G Breart, D Torgeson. Paper Preparation J Hornbuckle, Vail A, Spiegelhalter D, Levene M, Thornton JG.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1046/j.1471-0528.2003.02014.x

Persistent URL (handle)

Persistent link

Cite this

Van Bulck, B., Kalakoutis, G. M., Sak, P., Schneider, K. T. M., Major, T., Karpathios, S. E., Todros, T., Arduini, D., Tranquilli, A., Tenore, A. C., Roncaglia, N., Frusca, T., Groningen, A. Z., Weinans, M. J. N., Leiden, A. Z., Van Roosmalen, J., De Heel, H., Zaandam, Van der Slikke, J. W., ... Spiegelhalter, D. (2003). A randomised trial of timed delivery for the compromised preterm fetus: Short term outcomes and bayesian interpretation. BJOG : An International Journal of Obstetrics and Gynaecology, 110(1), 27-32. https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1046/j.1471-0528.2003.02014.x

@article{8db5add3a0fd4c03905cbdb4562cd0b1,

title = "A randomised trial of timed delivery for the compromised preterm fetus: Short term outcomes and bayesian interpretation",

abstract = "Objectives. To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design. A randomised controlled trial. Setting. 69 hospitals in 13 European countries. Participants. Pregnant women with fetal compromise between 24 and 36 weeks, an umbilical artery Doppler waveform recorded and clinical uncertainty whether immediate delivery was indicated. Methods. The interventions were 'immediate delivery' or 'delay until the obstetrician is no longer uncertain'. The data monitoring and analysis were Bayesian. Main outcome measures. 'Survival to hospital discharge' and 'developmental quotient at two years of age', this latter to be reported later. Results. Of 548 women (588 babies) recruited, outcomes were available on 547 mothers (587 babies). The median time-to-delivery intervals were 0.9 days in the immediate group and 4.9 days in the delay group. Total deaths prior to discharge were 29 (10\%) in the immediate group versus 27 (9\%) in the delay group (odds ratio 1.1, 95\% CI 0.61-1.8). Total caesarean sections were 249 (91\%) in the immediate group versus 217 (79\%) in the delay group: (OR 2.7; 95\% CI 1.6-4.5). These odds ratios were similar for those randomised at gestational ages above or below 30 weeks. Interpretation. The lack of difference in overall mortality suggests that clinicians participating in this trial were on average prepared to randomise at about the correct equivocal threshold between delivery and delay. However, there was insufficient evidence to convince enthusiasts for either immediate or delayed delivery that they were wrong.",

author = "\{Van Bulck\}, B. and Kalakoutis, \{G. M.\} and P. Sak and Schneider, \{K. T.M.\} and T. Major and Karpathios, \{S. E.\} and T. Todros and D. Arduini and A. Tranquilli and Tenore, \{A. C.\} and N. Roncaglia and T. Frusca and Groningen, \{A. Z.\} and Weinans, \{M. J.N.\} and Leiden, \{A. Z.\} and \{Van Roosmalen\}, J. and \{De Heel\}, Heel and Zaandam and \{Van der Slikke\}, \{J. W.\} and \{Van Geijn\}, H. and Pernet, \{P. J.M.\} and H. Wolf and Utrecht, \{A. Z.\} and Stigter, \{R. H.\} and J. Wilczynski and E. Vasco and M. Rashid and Z. Novak-Antolic and P. Danielian and Jenkinson, \{S. D.\} and Welch, \{C. R.\} and C. Griffin and H. Gee and D. Tuffnell and J. Cresswell and T. Tariq and B. Sengupta and G. Tydeman and Kumarendran, \{M. K.\} and D. Churchill and S. Bewley and L. Fusi and Lindow, \{S. W.\} and W. Johal and Fairlie, \{F. M.\} and K. Neales and Thornton, \{J. G.\} and I. Scudamore and J. Konje and Walkinshaw, \{S. A.\} and M. Griffiths and A. Dawson and G. Mires and R. Johanson and Fraser, \{R. B.\} and \{Hendy Ibbs\}, P. and Steel, \{S. A.\} and M. Ramsay and Robins, \{J. B.\} and Heard, \{M. J.\} and Tonge, \{H. M.\} and Manyonda, \{I. T.\} and J. Walker and M. Maresh and A. Yoong and P. Soothill and H. Cameron and D. Byrne and B. Beattie and S. Bober and B. Felber and E. Isaac and L. Liddle and T. McGhee and P. Rowsell and P. Howie and D. Field and M. Levene and Lilford, \{R. J.\} and A. Grant and P. Steer and G. Breart and D. Torgeson and J. Hornbuckle and A. Vail and D. Spiegelhalter",

note = "First Published 'online':22 December 2003",

year = "2003",

month = jan,

language = "English",

volume = "110",

pages = "27--32",

journal = "BJOG : An International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

publisher = "John Wiley and Sons Inc.",

number = "1",

}

Van Bulck, B, Kalakoutis, GM, Sak, P, Schneider, KTM, Major, T, Karpathios, SE, Todros, T, Arduini, D, Tranquilli, A, Tenore, AC, Roncaglia, N, Frusca, T, Groningen, AZ, Weinans, MJN, Leiden, AZ, Van Roosmalen, J, De Heel, H, Zaandam, Van der Slikke, JW, Van Geijn, H, Pernet, PJM, Wolf, H, Utrecht, AZ, Stigter, RH, Wilczynski, J, Vasco, E, Rashid, M, Novak-Antolic, Z, Danielian, P, Jenkinson, SD, Welch, CR, Griffin, C, Gee, H, Tuffnell, D, Cresswell, J, Tariq, T, Sengupta, B, Tydeman, G, Kumarendran, MK, Churchill, D, Bewley, S, Fusi, L, Lindow, SW, Johal, W, Fairlie, FM, Neales, K, Thornton, JG, Scudamore, I, Konje, J, Walkinshaw, SA, Griffiths, M, Dawson, A, Mires, G, Johanson, R, Fraser, RB, Hendy Ibbs, P, Steel, SA, Ramsay, M, Robins, JB, Heard, MJ, Tonge, HM, Manyonda, IT, Walker, J, Maresh, M, Yoong, A, Soothill, P, Cameron, H, Byrne, D, Beattie, B, Bober, S, Felber, B, Isaac, E, Liddle, L, McGhee, T, Rowsell, P, Howie, P, Field, D, Levene, M, Lilford, RJ, Grant, A, Steer, P, Breart, G, Torgeson, D, Hornbuckle, J, Vail, A & Spiegelhalter, D 2003, 'A randomised trial of timed delivery for the compromised preterm fetus: Short term outcomes and bayesian interpretation', BJOG : An International Journal of Obstetrics and Gynaecology, vol. 110, no. 1, pp. 27-32. <https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1046/j.1471-0528.2003.02014.x>

TY - JOUR

T1 - A randomised trial of timed delivery for the compromised preterm fetus

T2 - Short term outcomes and bayesian interpretation

AU - Van Bulck, B.

AU - Kalakoutis, G. M.

AU - Sak, P.

AU - Schneider, K. T.M.

AU - Major, T.

AU - Karpathios, S. E.

AU - Todros, T.

AU - Arduini, D.

AU - Tranquilli, A.

AU - Tenore, A. C.

AU - Roncaglia, N.

AU - Frusca, T.

AU - Groningen, A. Z.

AU - Weinans, M. J.N.

AU - Leiden, A. Z.

AU - Van Roosmalen, J.

AU - De Heel, Heel

AU - Zaandam,

AU - Van der Slikke, J. W.

AU - Van Geijn, H.

AU - Pernet, P. J.M.

AU - Wolf, H.

AU - Utrecht, A. Z.

AU - Stigter, R. H.

AU - Wilczynski, J.

AU - Vasco, E.

AU - Rashid, M.

AU - Novak-Antolic, Z.

AU - Danielian, P.

AU - Jenkinson, S. D.

AU - Welch, C. R.

AU - Griffin, C.

AU - Gee, H.

AU - Tuffnell, D.

AU - Cresswell, J.

AU - Tariq, T.

AU - Sengupta, B.

AU - Tydeman, G.

AU - Kumarendran, M. K.

AU - Churchill, D.

AU - Bewley, S.

AU - Fusi, L.

AU - Lindow, S. W.

AU - Johal, W.

AU - Fairlie, F. M.

AU - Neales, K.

AU - Thornton, J. G.

AU - Scudamore, I.

AU - Konje, J.

AU - Walkinshaw, S. A.

AU - Griffiths, M.

AU - Dawson, A.

AU - Mires, G.

AU - Johanson, R.

AU - Fraser, R. B.

AU - Hendy Ibbs, P.

AU - Steel, S. A.

AU - Ramsay, M.

AU - Robins, J. B.

AU - Heard, M. J.

AU - Tonge, H. M.

AU - Manyonda, I. T.

AU - Walker, J.

AU - Maresh, M.

AU - Yoong, A.

AU - Soothill, P.

AU - Cameron, H.

AU - Byrne, D.

AU - Beattie, B.

AU - Bober, S.

AU - Felber, B.

AU - Isaac, E.

AU - Liddle, L.

AU - McGhee, T.

AU - Rowsell, P.

AU - Howie, P.

AU - Field, D.

AU - Levene, M.

AU - Lilford, R. J.

AU - Grant, A.

AU - Steer, P.

AU - Breart, G.

AU - Torgeson, D.

AU - Hornbuckle, J.

AU - Vail, A.

AU - Spiegelhalter, D.

N1 - First Published 'online':22 December 2003

PY - 2003/1

Y1 - 2003/1

N2 - Objectives. To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design. A randomised controlled trial. Setting. 69 hospitals in 13 European countries. Participants. Pregnant women with fetal compromise between 24 and 36 weeks, an umbilical artery Doppler waveform recorded and clinical uncertainty whether immediate delivery was indicated. Methods. The interventions were 'immediate delivery' or 'delay until the obstetrician is no longer uncertain'. The data monitoring and analysis were Bayesian. Main outcome measures. 'Survival to hospital discharge' and 'developmental quotient at two years of age', this latter to be reported later. Results. Of 548 women (588 babies) recruited, outcomes were available on 547 mothers (587 babies). The median time-to-delivery intervals were 0.9 days in the immediate group and 4.9 days in the delay group. Total deaths prior to discharge were 29 (10%) in the immediate group versus 27 (9%) in the delay group (odds ratio 1.1, 95% CI 0.61-1.8). Total caesarean sections were 249 (91%) in the immediate group versus 217 (79%) in the delay group: (OR 2.7; 95% CI 1.6-4.5). These odds ratios were similar for those randomised at gestational ages above or below 30 weeks. Interpretation. The lack of difference in overall mortality suggests that clinicians participating in this trial were on average prepared to randomise at about the correct equivocal threshold between delivery and delay. However, there was insufficient evidence to convince enthusiasts for either immediate or delayed delivery that they were wrong.

AB - Objectives. To compare the effect of delivering early to pre-empt terminal hypoxaemia with delaying for as long as possible to increase maturity. Design. A randomised controlled trial. Setting. 69 hospitals in 13 European countries. Participants. Pregnant women with fetal compromise between 24 and 36 weeks, an umbilical artery Doppler waveform recorded and clinical uncertainty whether immediate delivery was indicated. Methods. The interventions were 'immediate delivery' or 'delay until the obstetrician is no longer uncertain'. The data monitoring and analysis were Bayesian. Main outcome measures. 'Survival to hospital discharge' and 'developmental quotient at two years of age', this latter to be reported later. Results. Of 548 women (588 babies) recruited, outcomes were available on 547 mothers (587 babies). The median time-to-delivery intervals were 0.9 days in the immediate group and 4.9 days in the delay group. Total deaths prior to discharge were 29 (10%) in the immediate group versus 27 (9%) in the delay group (odds ratio 1.1, 95% CI 0.61-1.8). Total caesarean sections were 249 (91%) in the immediate group versus 217 (79%) in the delay group: (OR 2.7; 95% CI 1.6-4.5). These odds ratios were similar for those randomised at gestational ages above or below 30 weeks. Interpretation. The lack of difference in overall mortality suggests that clinicians participating in this trial were on average prepared to randomise at about the correct equivocal threshold between delivery and delay. However, there was insufficient evidence to convince enthusiasts for either immediate or delayed delivery that they were wrong.

UR - https://www.scopus.com/pages/publications/0037222196

UR - https://www.scopus.com/pages/publications/0037222196#tab=citedBy

M3 - Article

C2 - 12504932

AN - SCOPUS:0037222196

SN - 1470-0328

VL - 110

SP - 27

EP - 32

JO - BJOG : An International Journal of Obstetrics and Gynaecology

JF - BJOG : An International Journal of Obstetrics and Gynaecology

IS - 1

ER -

A randomised trial of timed delivery for the compromised preterm fetus: Short term outcomes and bayesian interpretation

Abstract

Bibliographical note

Funding

UN SDGs

Access to Document

Persistent URL (handle)

Other files and links

Fingerprint

Cite this