Got-it-trial: A pragmatic, adaptive, sequential, placebo controlled randomised trial to determine the effectiveness of glycerine triturate for retained placenta
Retained placenta (RP) affects 2% of vaginal deliveries, which equates to nearly 11,000 women in the UK per annum, and is a major cause of post-partum haemorrhage with major obstetric haemorrhage itself affecting nearly 1 in 180 women and being the commonest cause of significant maternal morbidity. It was hypothesised that sublingual glyceryl trinitrate (GTN) spray could reduce the need for manual removal of the placenta (MROP) following failure of the current approach to management (oxytocin and controlled cord traction). GTN was compared with placebo on outcomes measured over four interrelated domains – clinical, safety, patient-sided and economic. The economic evaluation took the form of a cost–consequence analysis, relating differences in costs to the health service out to six weeks post-delivery with differences on the clinical, safety, and patient-sided outcomes.
Outcome and translation
The results that have now been published showed GTN to be ineffective for the management of retained placenta. There was no significant impact on health service costs.
International Standard Randomised Controlled Trial Number Register: ISRCTN88609453
HERU researchers involved in this research project: Graham Scotland
External collaborators: F Denison, J Lawton (University of Edinburgh); J Norrie, G McPherson (HSRU, University of Aberdeen) and S Brook-Smith (NHS Lothian)
Denison, F.C., Norrie, J., Lawton, J., Norman, J.E., Scotland, G., Mcpherson, G.C., Mcdonald, A., Forrest, M., Hudson, J., Brewin, J., Peace, M., Clarkson, C., Brook-Smith, S., Morrow, S., Hallowell, N., Hodges, L. and Carruthers, K.F. (2017) 'A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol', BMJ Open, 7(9).
Denison, F.C., McPherson, G., Scotland, G., Brook-Smith, S., Clarkson, C., Peace, M., Brewin, J., Norman, J.E., Norrie, J. and Lawton, J. (2018) A pragmatic adaptive sequential placebo controlled randomised trial to determine the effectiveness of Glyceryl trinitrate for retained placenta (Got-it trial). Final report submitted to the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Project Number 12/29/01).
Denison, F.C., Carruthers, K.F., Hudson, J., McPherson, G., Chua, G.N., Peace, M., Brewin, J., Hallowell, N., Scotland, G., Lawton, J., Norrie, J. and Norman, J.E. (2019) 'Nitroglycerin for treatment of retained placenta: a randomised, placebo-controlled, multicentre, double-blind trial in the UK', PLoS Medicine, 16(12), e1003001.
Denison, F.C., Carruthers, K.F., Hudson, J., McPherson, G., Scotland, G., Brook-Smith, S., Clarkson, C., Peace, M., Brewin, J., Chua, G.N., Hallowell, N., Norman, J.E., Lawton, J. and Norrie, J. (2020) 'Glyceryl trinitrate to reduce the need for manual removal of retained placenta following vaginal delivery: the GOT-IT RCT', Health Technology Assessment, 23(70).