Evidence map›Paper›PMID 31912780›Full record

Trial reportHealth technology assessment (Winchester, England)2019

Glyceryl trinitrate to reduce the need for manual removal of retained placenta following vaginal delivery: the GOT-IT RCT.

Fiona C Denison, Kathryn F Carruthers, Jemma Hudson, Gladys McPherson, Graham Scotland, Sheonagh Brook-Smith, Cynthia Clarkson, Mathilde Peace, Jane Brewin, Gin Nie Chua and 4 more

Open access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Health technology assessment (Winchester, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
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

14 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.
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.
Jemma HudsonCentre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Gladys McPhersonCentre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Graham ScotlandHealth Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Sheonagh Brook-SmithSimpson's Centre for Reproductive Health, Royal Infirmary 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.
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.
Jane BrewinTommy's, Nicholas House, London, UK.
Gin Nie ChuaHealth Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Nina HallowellEthox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, 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.
Julia LawtonUsher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
John NorrieEdinburgh Clinical Trials Unit/Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
MRC Centre for Reproductive Health · GBUniversity of Aberdeen · GBEdinburgh Royal Infirmary · GBUniversity of Edinburgh · GBTommy's · GBUniversity of Oxford · GB

Funding

Chief Scientist Office HSRU1Department of Health 12/29/01
6 · The paper itself

Abstract

backgroundRetained placenta is associated with postpartum haemorrhage and can lead to significant maternal morbidity if untreated. The only effective treatment is the surgical procedure of manual removal of placenta, which is costly, requires skilled staff, requires an operative environment and is unpleasant for women. Small studies suggest that glyceryl trinitrate may be an effective medical alternative.

objectiveTo determine the clinical effectiveness and cost-effectiveness of sublingual glyceryl trinitrate spray compared with placebo in reducing the need for manual removal of placenta in women with retained placenta after vaginal delivery following the failure of current management.

designA group-sequential randomised double-blind placebo-controlled trial with a cost-effectiveness analysis.

settingThere were 29 obstetric units in the UK involved in the study.

participantsThere were 1107 women (glyceryl trinitrate group,

interventionsGlyceryl trinitrate spray was administered to 541 women in the intervention group, and a placebo was administered to 563 women in the control group.

main outcome measuresFour primary outcomes were defined: (1) clinical - the need for manual removal of placenta, (2) safety - measured blood loss, (3) patient sided - satisfaction with treatment and side effects and (4) economic - cost-effectiveness of both treatments using the UK NHS perspective. Secondary clinical outcomes included a > 15% decrease in haemoglobin level, time from randomisation to delivery of placenta in theatre, the need for earlier manual removal of placenta than planned, increase in heart rate or decrease in blood pressure, requirement for blood transfusion, requirement for general anaesthesia, maternal pyrexia, and sustained uterine relaxation requiring additional uterotonics.

resultsNo difference was observed between the glyceryl trinitrate group and the control group for the placenta remaining undelivered within 15 minutes of study treatment (93.3% vs. 92%; odds ratio 1.01, 95% confidence interval 0.98 to 1.04;

conclusionsGlyceryl trinitrate spray did not increase the delivery of retained placenta within 15 minutes of administration when compared with the placebo, and was not cost-effective for medical management of retained placenta. More participants reported palpitations and required a blood transfusion in the glyceryl trinitrate group. Further research into alternative methods of medical management of retained placenta is required.

trial registrationCurrent Controlled Trials ISRCTN88609453.

fundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in

Indexed as

Cost-Benefit AnalysisAdministration, SublingualAdolescentAdultBlood TransfusionDouble-Blind MethodFemaleHumansNitroglycerinObstetric Surgical ProceduresPlacenta, RetainedPostpartum HemorrhagePregnancyTechnology Assessment, BiomedicalVasodilator AgentsYoung AdultNitroglycerinVasodilator AgentsGLYCERYL TRINITRATERETAINED PLACENTA

Identifiers

PMID31912780
PMCPMC6970217
OpenAlexW2999078556

What OpenQuestion holds

Textmetadata
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.