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Coomarasamy A, Harb HM, Devall AJ, et al. Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT. Southampton (UK): NIHR Journals Library; 2020 Jun. (Health Technology Assessment, No. 24.33.)

Cover of Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT

Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.

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List of abbreviations

AE

adverse event

BCa

bias-corrected and accelerated

BMI

body mass index

BNF

British National Formulary

CEA

cost-effectiveness analysis

CEAC

cost-effectiveness acceptability curve

CHARM

Charity for Research into Miscarriage

CHEERS

Consolidated Health Economic Evaluation Reporting Standards

CI

confidence interval

CRF

case report form

C-section

caesarean section

DAU

day assessment unit

DMEC

Data Monitoring and Ethics Committee

FIGO

International Federation of Gynaecology and Obstetrics

GP

general practitioner

HCHS

Hospital and Community Health Services

HDU

high-dependency unit

HRG

Healthcare Resource Group

HTA

Health Technology Assessment

ICER

incremental cost-effectiveness ratio

IMP

investigational medicinal product

IQR

interquartile range

ITMS

integrated trial management system

ITU

intensive therapy unit

LLETZ

large loop excision of the cervical transformation zone

MID

minimally important difference

NICE

National Institute for Health and Care Excellence

NIHR

National Institute for Health Research

PBAC

pictorial bleeding assessment chart

PI

principal investigator

PRIME

Public and Researchers Involvement in Maternity and Early Pregnancy

PRISM

Progesterone in Spontaneous Miscarriage

PROMISE

Progesterone in Recurrent Miscarriage

PSS

Personal Social Services

PSSRU

Personal Social Services Research Unit

PUL

pregnancy of unknown location

QALY

quality-adjusted life-year

RCT

randomised controlled trial

RR

relative rate

SAE

serious adverse event

SAP

statistical analysis plan

SAR

serious adverse reaction

SD

standard deviation

SUSAR

suspected unexpected serious adverse reaction

TCC

trial co-ordinating centre

TSC

Trial Steering Committee

WTP

willingness to pay

Copyright © Queen’s Printer and Controller of HMSO 2020. This work was produced by Coomarasamy et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK558711

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