Evidence map›Paper›PMID 28928192›Full record

Trial reportBMJ open2017

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 and 7 more

Open access · goldAbstract readPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 6 institutions in 1 country.

Fiona C DenisonTommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.ORCID 0000-0003-0371-2014
John NorrieThe Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Julia LawtonCentre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
Jane E NormanTommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Graham ScotlandHealth Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Gladys C McPhersonThe Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Alison McDonaldThe Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Mark ForrestThe Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jemma HudsonThe Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Jane BrewinTommy's, Nicholas House, London, UK.
Mathilde PeaceTommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Cynthia ClarksonTommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Sheonagh Brook-SmithSimpson's Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.
Susan MorrowUsher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
Nina HallowellCentre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
Laura HodgesTommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Kathryn F CarruthersTommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
MRC Centre for Reproductive Health · GBUniversity of Aberdeen · GBUniversity of Edinburgh · GBEdinburgh Royal Infirmary · GBTommy's · GBUniversity of Oxford · GB

Funding

Chief Scientist Office HSRU1Department of Health 12/29/01Medical Research Council G1002033Medical Research Council MR/N022556/1
6 · The paper itself

Abstract

introductionA 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.

Indexed as

Administration, SublingualBlood VolumeCost-Benefit AnalysisCost SavingsDouble-Blind MethodFemaleHealth Care CostsHumansNitroglycerinObstetric Surgical ProceduresPatient SatisfactionPlacenta, RetainedPostpartum HemorrhagePregnancyResearch DesignUnited KingdomNitroglycerinVasodilator Agentsglyceryl trinitraterandomised controlled trialretained placenta

Identifiers

PMID28928192
PMCPMC5623532
OpenAlexW2757201186

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.