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 languageEnglish
Article numbere017134
JournalBMJ Open
Volume7
DOIs
Publication statusPublished - Sep 2017

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Retained Placenta
Nitroglycerin
Placenta
Randomized Controlled Trials
Placebos
Costs and Cost Analysis
Economics
Safety
Postpartum Hemorrhage
Biomedical Technology Assessment
Cost Savings
Qualitative Research
Research Ethics Committees
Operative Surgical Procedures
National Health Programs
Therapeutics
Health Care Costs
Health Services
Publications
Linear Models

Keywords

  • Journal Article

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A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT) : a study protocol. / Denison, Fiona C; Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F.

In: BMJ Open, Vol. 7, e017134, 09.2017.

Research output: Contribution to journalArticle

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
Denison, Fiona C ; Norrie, John ; Lawton, Julia ; Norman, Jane E ; Scotland, Graham ; McPherson, Gladys C ; McDonald, Alison ; Forrest, Mark ; Hudson, Jemma ; Brewin, Jane ; Peace, Mathilde ; Clarkson, Cynthia ; Brook-Smith, Sheonagh ; Morrow, Susan ; Hallowell, Nina ; Hodges, Laura ; Carruthers, Kathryn F. / A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT) : a study protocol. In: BMJ Open. 2017 ; Vol. 7.
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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)

PY - 2017/9

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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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JO - BMJ Open

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