A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

Fiona C Denison; John Norrie; Julia Lawton; Jane E Norman; Graham Scotland; Gladys C McPherson; Alison McDonald; Mark Forrest; Jemma Hudson; Jane Brewin; Mathilde Peace; Cynthia Clarkson; Sheonagh Brook-Smith; Susan Morrow; Nina Hallowell; Laura Hodges; Kathryn F Carruthers

doi:10.1136/bmjopen-2017-017134

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

Fiona C Denison, John Norrie, Julia Lawton, Jane E Norman, Graham Scotland, Gladys C McPherson, Alison McDonald, Mark Forrest, Jemma Hudson, Jane Brewin, Mathilde Peace, Cynthia Clarkson, Sheonagh Brook-Smith, Susan Morrow, Nina Hallowell, Laura Hodges, Kathryn F Carruthers

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Abstract

INTRODUCTION: A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP).

METHODS AND ANALYSIS: The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice.

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ISCRTN88609453; Pre-results.

Original language	English
Article number	e017134
Journal	BMJ Open
Volume	7
DOIs	https://doi.org/10.1136/bmjopen-2017-017134
Publication status	Published - Sept 2017

Bibliographical note

The GOT-IT Trial (trial registration number: ISCRTN 88609453) is funded
by the National Institute for Health Research Health Technology Assessment (HTA)
programme (Project number 12/29/01). The views and opinions expressed therein
are those of the authors and do not necessarily reflect those of the HTA, the
National Institute for Health Research, the NHS or the Department of Health. This
work was undertaken in the MRC Centre for Reproductive Health which is funded
by MRC Centre grant (MRC G1002033)

Keywords

Journal Article

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10.1136/bmjopen-2017-017134Licence: CC BY

A pragmatic group sequential, placebocontrolled
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Final published version, 340 KBLicence: CC BY

Cite this

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., & 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, Article e017134. https://doi.org/10.1136/bmjopen-2017-017134

Denison, FC, Norrie, J, Lawton, J, Norman, JE, Scotland, G, McPherson, GC, McDonald, A, Forrest, M , Hudson, J, Brewin, J, Peace, M, Clarkson, C, Brook-Smith, S, Morrow, S, Hallowell, N, Hodges, L & Carruthers, KF 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, vol. 7, e017134. https://doi.org/10.1136/bmjopen-2017-017134

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abstract = "INTRODUCTION: A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP).METHODS AND ANALYSIS: The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice.ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISCRTN88609453; Pre-results.",

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T1 - A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT)

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AU - Denison, Fiona C

AU - Norrie, John

AU - Lawton, Julia

AU - Norman, Jane E

AU - Scotland, Graham

AU - McPherson, Gladys C

AU - McDonald, Alison

AU - Forrest, Mark

AU - Hudson, Jemma

AU - Brewin, Jane

AU - Peace, Mathilde

AU - Clarkson, Cynthia

AU - Brook-Smith, Sheonagh

AU - Morrow, Susan

AU - Hallowell, Nina

AU - Hodges, Laura

AU - Carruthers, Kathryn F

N1 - The GOT-IT Trial (trial registration number: ISCRTN 88609453) is funded by the National Institute for Health Research Health Technology Assessment (HTA) programme (Project number 12/29/01). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, the National Institute for Health Research, the NHS or the Department of Health. This work was undertaken in the MRC Centre for Reproductive Health which is funded by MRC Centre grant (MRC G1002033)

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N2 - INTRODUCTION: A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP).METHODS AND ANALYSIS: The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice.ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISCRTN88609453; Pre-results.

AB - INTRODUCTION: A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP).METHODS AND ANALYSIS: The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice.ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISCRTN88609453; Pre-results.

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DO - 10.1136/bmjopen-2017-017134

M3 - Article

C2 - 28928192

SN - 2044-6055

VL - 7

JO - BMJ Open

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M1 - e017134

ER -

A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol

Abstract

Bibliographical note

Keywords

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Cite this