Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials

for the GRIT Study Group; the TRUFFLE Study Group

doi:10.1002/uog.20354

Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials

for the GRIT Study Group, the TRUFFLE Study Group

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

Abstract

Objective: To explore the effect on perinatal outcome of different fetal monitoring strategies for early-onset fetal growth restriction (FGR). Methods: This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results: Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P < 0.01). The rate of survival without impairment at 2 years was lowest in pregnancies that underwent immediate delivery (70% (95% CI, 61–78%)) or delayed delivery with monitoring by CTG (69% (95% CI, 57–82%)), increased in those monitored using cCTG only in both GRIT (80% (95% CI, 68–91%)) and TRUFFLE (77% (95% CI, 70–84%)), and was highest in pregnancies monitored using cCTG and DV Doppler (84% (95% CI, 80–89%)) (P < 0.01 for trend). Conclusions: This analysis supports the hypothesis that the optimal method for fetal monitoring in pregnancies complicated by early-onset FGR is a combination of cCTG and DV Doppler assessment. Trial Registration: GRIT ISRCTN41358726 and TRUFFLE ISRCTN56204499.

Original language	English
Pages (from-to)	68-74
Number of pages	7
Journal	Ultrasound in Obstetrics and Gynecology
Volume	55
Issue number	1
Early online date	24 May 2019
DOIs	https://doi.org/10.1002/uog.20354
Publication status	Published - Jan 2020

Funding

We gratefully acknowledge the support of Prof. Andy Vail, Centre for Biostatistics, University of Manchester for the provision of the relevant GRIT study data. This analysis was performed without funding. The original TRUFFLE study was partly funded by Grant Number 94506556, ZonMw, POBox 93245, 2509 AE Den Haag, The Netherlands. The GRIT study was funded by the United Kingdom Medical Research Council, a European Union Concerted Action and the Dutch Princess Beatrix Foundation. We gratefully acknowledge the support of Prof. Andy Vail, Centre for Biostatistics, University of Manchester for the provision of the relevant GRIT study data. This analysis was performed without funding. The original TRUFFLE study was partly funded by Grant Number 94506556, ZonMw, POBox 93245, 2509 AE Den Haag, The Netherlands. The GRIT study was funded by the United Kingdom Medical Research Council, a European Union Concerted Action and the Dutch Princess Beatrix Foundation.

Funders	Funder number
AE Den Haag
Dutch Princess Beatrix Foundation
European Union Concerted Action
United Kingdom Medical Research Council
University of Manchester	94506556
University of Manchester
ZonMw	POBox 93245
ZonMw

Keywords

cardiotocography
ductus venosus
fetal growth restriction
monitoring
short-term variation

UN SDGs

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

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10.1002/uog.20354

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Cite this

@article{5738085fd8e048d6ae201a94cac56bfe,

title = "Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials",

abstract = "Objective: To explore the effect on perinatal outcome of different fetal monitoring strategies for early-onset fetal growth restriction (FGR). Methods: This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results: Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P < 0.01). The rate of survival without impairment at 2 years was lowest in pregnancies that underwent immediate delivery (70% (95% CI, 61–78%)) or delayed delivery with monitoring by CTG (69% (95% CI, 57–82%)), increased in those monitored using cCTG only in both GRIT (80% (95% CI, 68–91%)) and TRUFFLE (77% (95% CI, 70–84%)), and was highest in pregnancies monitored using cCTG and DV Doppler (84% (95% CI, 80–89%)) (P < 0.01 for trend). Conclusions: This analysis supports the hypothesis that the optimal method for fetal monitoring in pregnancies complicated by early-onset FGR is a combination of cCTG and DV Doppler assessment. Trial Registration: GRIT ISRCTN41358726 and TRUFFLE ISRCTN56204499.",

keywords = "cardiotocography, ductus venosus, fetal growth restriction, monitoring, short-term variation",

author = "Wessel Ganzevoort and Thornton, {J. G.} and N. Marlow and B. Thilaganathan and B. Arabin and F. Prefumo and C. Lees and H. Wolf and {Van Bulck}, B. and Kalakoutis, {G. M.} and P. Sak and Schneider, {K. T.M.} and Karpathios, {S. E.} and T. Major and Tullia Todros and D. Arduini and C. Flumini and Tenore, {A. C.} and N. Roncaglia and Tiziana Frusca and G. Ferretti and Weinans, {M. J.N.} and {van Roosmalen}, J. and {van der Slikke}, {J. W.} and {van Geijn}, H. and Pernet, {P. J.M.} and H. Wolf and Stigter, {R. H.} and J. Wilczynski and E. Vasco and M. Abdullah 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 D. Churchill and S. Bewley and L. Fusi and Lindow, {S. W.} and W. Johal and Fairlie, {F. M.} and K. Neales and G. Mason 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 Ibbs, {P. Hendy} 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 {Van Damme}, M. and S. Kyriakides and P. Pokorna and A. Zimmerman and H. Tsitsikas and E. Mani and P. Bosisio and E. Mastritta and M. Nicocia and C. Fabris and P. Eken and {De Vries}, L. and Z. Kubicka and R. Ramalho and M. Rashid and L. Cerar-Kornhauser and S. Thomas and A. Elliman and T. Sim and S. Swaminathan and L. Walker and D. McCormick and Z. Sibanda and J. Hughes and J. Kilding and A. O'Hara and V. Harpin and N. Porter and S. Pandey and K. Murtagh and K. Burton and R. MacGregor and B. Stewart and H. Klenke and P. Hallam and N. Kai and M. Graham and A. Harrison and E. Saharia and T. McGhee and P. Rowsell and P. Howie and Max Parmar and D. Field and A. Grant and P. Steer and G. Breart and M. Levene and D. Torgeson and S. Kitzinger and M. Levene and N. Marlowe and D. Wolke and {De Vries}, L. and A. Johnson and G. Ferretti and Birgit Arabin and Bilardo, {Caterina M.} and Christoph Brezinka and Cornette, {Jerome M.J.} and Derks, {Jan B.} and Anke Diemert and Duvekot, {Johannes J.} and Enrico Ferrazzi and Nicola Fratelli and Wessel Ganzevoort and Kurt Hecher and {van Leemhuis}, Aleid and Lees, {Christoph C.} and Silvia Lobmaier and Neil Marlow and Pasquale Martinelli and Gianpaolo Maso and Hannah Missfelder-Lobos and Raffaele Napolitano and Eva Ostermayer and Papageorghiou, {Aris T.} and Federico Prefumo and Dietmar Schlembach and Schneider, {K. T.M.} and Baskaran Thilaganathan and Tullia Todros and Adriana Valcamonico and Visser, {Gerard H.A.} and Hans Wolf and John Kingdom and Karel Marsal and Jim Thornton and Herbert Valensise and {for the GRIT Study Group} and {the TRUFFLE Study Group}",

year = "2020",

month = jan,

doi = "10.1002/uog.20354",

language = "English",

volume = "55",

pages = "68--74",

journal = "Ultrasound in Obstetrics and Gynecology",

issn = "0960-7692",

publisher = "John Wiley and Sons Ltd",

number = "1",

}

TY - JOUR

T1 - Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials

AU - Ganzevoort, Wessel

AU - Thornton, J. G.

AU - Marlow, N.

AU - Thilaganathan, B.

AU - Arabin, B.

AU - Prefumo, F.

AU - Lees, C.

AU - Wolf, H.

AU - Van Bulck, B.

AU - Kalakoutis, G. M.

AU - Sak, P.

AU - Schneider, K. T.M.

AU - Karpathios, S. E.

AU - Major, T.

AU - Todros, Tullia

AU - Arduini, D.

AU - Flumini, C.

AU - Tenore, A. C.

AU - Roncaglia, N.

AU - Frusca, Tiziana

AU - Ferretti, G.

AU - Weinans, M. J.N.

AU - van Roosmalen, J.

AU - van der Slikke, J. W.

AU - van Geijn, H.

AU - Pernet, P. J.M.

AU - Wolf, H.

AU - Stigter, R. H.

AU - Wilczynski, J.

AU - Vasco, E.

AU - Abdullah, 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 - Churchill, D.

AU - Bewley, S.

AU - Fusi, L.

AU - Lindow, S. W.

AU - Johal, W.

AU - Fairlie, F. M.

AU - Neales, K.

AU - Mason, 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 - Ibbs, P. Hendy

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 - Van Damme, M.

AU - Kyriakides, S.

AU - Pokorna, P.

AU - Zimmerman, A.

AU - Tsitsikas, H.

AU - Mani, E.

AU - Bosisio, P.

AU - Mastritta, E.

AU - Nicocia, M.

AU - Fabris, C.

AU - Eken, P.

AU - De Vries, L.

AU - Kubicka, Z.

AU - Ramalho, R.

AU - Rashid, M.

AU - Cerar-Kornhauser, L.

AU - Thomas, S.

AU - Elliman, A.

AU - Sim, T.

AU - Swaminathan, S.

AU - Walker, L.

AU - McCormick, D.

AU - Sibanda, Z.

AU - Hughes, J.

AU - Kilding, J.

AU - O'Hara, A.

AU - Harpin, V.

AU - Porter, N.

AU - Pandey, S.

AU - Murtagh, K.

AU - Burton, K.

AU - MacGregor, R.

AU - Stewart, B.

AU - Klenke, H.

AU - Hallam, P.

AU - Kai, N.

AU - Graham, M.

AU - Harrison, A.

AU - Saharia, E.

AU - McGhee, T.

AU - Rowsell, P.

AU - Howie, P.

AU - Parmar, Max

AU - Field, D.

AU - Grant, A.

AU - Steer, P.

AU - Breart, G.

AU - Levene, M.

AU - Torgeson, D.

AU - Kitzinger, S.

AU - Levene, M.

AU - Marlowe, N.

AU - Wolke, D.

AU - De Vries, L.

AU - Johnson, A.

AU - Ferretti, G.

AU - Arabin, Birgit

AU - Bilardo, Caterina M.

AU - Brezinka, Christoph

AU - Cornette, Jerome M.J.

AU - Derks, Jan B.

AU - Diemert, Anke

AU - Duvekot, Johannes J.

AU - Ferrazzi, Enrico

AU - Fratelli, Nicola

AU - Ganzevoort, Wessel

AU - Hecher, Kurt

AU - van Leemhuis, Aleid

AU - Lees, Christoph C.

AU - Lobmaier, Silvia

AU - Marlow, Neil

AU - Martinelli, Pasquale

AU - Maso, Gianpaolo

AU - Missfelder-Lobos, Hannah

AU - Napolitano, Raffaele

AU - Ostermayer, Eva

AU - Papageorghiou, Aris T.

AU - Prefumo, Federico

AU - Schlembach, Dietmar

AU - Schneider, K. T.M.

AU - Thilaganathan, Baskaran

AU - Todros, Tullia

AU - Valcamonico, Adriana

AU - Visser, Gerard H.A.

AU - Wolf, Hans

AU - Kingdom, John

AU - Marsal, Karel

AU - Thornton, Jim

AU - Valensise, Herbert

AU - for the GRIT Study Group

AU - the TRUFFLE Study Group

PY - 2020/1

Y1 - 2020/1

N2 - Objective: To explore the effect on perinatal outcome of different fetal monitoring strategies for early-onset fetal growth restriction (FGR). Methods: This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results: Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P < 0.01). The rate of survival without impairment at 2 years was lowest in pregnancies that underwent immediate delivery (70% (95% CI, 61–78%)) or delayed delivery with monitoring by CTG (69% (95% CI, 57–82%)), increased in those monitored using cCTG only in both GRIT (80% (95% CI, 68–91%)) and TRUFFLE (77% (95% CI, 70–84%)), and was highest in pregnancies monitored using cCTG and DV Doppler (84% (95% CI, 80–89%)) (P < 0.01 for trend). Conclusions: This analysis supports the hypothesis that the optimal method for fetal monitoring in pregnancies complicated by early-onset FGR is a combination of cCTG and DV Doppler assessment. Trial Registration: GRIT ISRCTN41358726 and TRUFFLE ISRCTN56204499.

AB - Objective: To explore the effect on perinatal outcome of different fetal monitoring strategies for early-onset fetal growth restriction (FGR). Methods: This was a cohort analysis of individual participant data from two European multicenter trials of fetal monitoring methods for FGR: the Growth Restriction Intervention Study (GRIT) and the Trial of Umbilical and Fetal Flow in Europe (TRUFFLE). All women from GRIT (n = 238) and TRUFFLE (n = 503) who were randomized between 26 and 32 weeks' gestation were included. The women were grouped according to intervention and monitoring method: immediate delivery (GRIT) or delayed delivery with monitoring by conventional cardiotocography (CTG) (GRIT), computerized CTG (cCTG) only (GRIT and TRUFFLE) or cCTG and ductus venosus (DV) Doppler (TRUFFLE). The primary outcome was survival without neurodevelopmental impairment at 2 years of age. Results: Gestational age at delivery and birth weight were similar in both studies. Fetal death rate was similar between the GRIT and TRUFFLE groups, but neonatal and late death were more frequent in GRIT (18% vs 6%; P < 0.01). The rate of survival without impairment at 2 years was lowest in pregnancies that underwent immediate delivery (70% (95% CI, 61–78%)) or delayed delivery with monitoring by CTG (69% (95% CI, 57–82%)), increased in those monitored using cCTG only in both GRIT (80% (95% CI, 68–91%)) and TRUFFLE (77% (95% CI, 70–84%)), and was highest in pregnancies monitored using cCTG and DV Doppler (84% (95% CI, 80–89%)) (P < 0.01 for trend). Conclusions: This analysis supports the hypothesis that the optimal method for fetal monitoring in pregnancies complicated by early-onset FGR is a combination of cCTG and DV Doppler assessment. Trial Registration: GRIT ISRCTN41358726 and TRUFFLE ISRCTN56204499.

KW - cardiotocography

KW - ductus venosus

KW - fetal growth restriction

KW - monitoring

KW - short-term variation

UR - http://www.scopus.com/inward/record.url?scp=85076925546&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85076925546&partnerID=8YFLogxK

U2 - 10.1002/uog.20354

DO - 10.1002/uog.20354

M3 - Article

C2 - 31125465

AN - SCOPUS:85076925546

SN - 0960-7692

VL - 55

SP - 68

EP - 74

JO - Ultrasound in Obstetrics and Gynecology

JF - Ultrasound in Obstetrics and Gynecology

IS - 1

ER -

Comparative analysis of 2-year outcomes in GRIT and TRUFFLE trials

Abstract

Funding

Keywords

UN SDGs

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