Condition category
Pregnancy and Childbirth
Date applied
08/01/2018
Date assigned
16/01/2018
Last edited
07/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Accurate diagnosis of preterm labour is desirable in order ensure the best management of those most at risk of preterm birth and to prevent the maternal and fetal risks incurred by unnecessary interventions to the majority of women who do not deliver within a week of presentation. Current over-intervention results in many women being transferred unnecessarily out of their local hospital and most women receiving unnecessary drugs, such as steroids. It also prevents appropriate transfers as neonatal cots are blocked unnecessarily, resulting in more dangerous ex-utero transfers. Our group has developed the QUIPP App which is a clinical decision-making aid based on quantitative fetal fibronectin (fFN) values (a fibronectin protein produced by fetal cells that binds the fetal sac to the uterus), cervical length and previous outcomes of women with threatened preterm labour. The aim of this study is to introduce the App and a management algorithm in 13 sites with the aim of reducing inappropriate management for threatened preterm labour. This study also performs a health economics evaluation of the QUIPP app and explores women's views of its implementation via a qualitative sub-study.

Who can participate?
Woman aged 18 and older who are between 23 to 34+6 weeks gestation and have symptoms of threatened preterm labour.

What does the study involve?
Participating hospitals are randomly allocated to one of two groups. Those in the first group do not use the app and those in the second group use the app. The different hospital sites start the study at the same time. Participants who arrive to a hospital in threatened preterm labour are either treated as per normal hospital guidelines if they are in the first group. Those in the second group receive the normal treatment as well as their doctors and midwives use the app (if they are in the second group). Anonymous data is collected on the participants to see if using the app affects how doctors and midwives make decisions about their care.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants in the study. They will still be treated by a clinician at their hospital unit who will manage them in the way that they think is best. The anonymous information that is collected about them will help us evaluate if the app is successful, and therefore may help women in threatened preterm labour in the future.

Where is the study run from?
This study is being run by King’s College London and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
January 2017 to July 2019

Who is funding the study?
1. Guy's and St Thomas' Charity (UK)
2. Tommy's The Baby Charity (UK)

Who is the main contact?
1. Professor Andrew Shennan (Scientific)
andrew.shennan@kcl.ac.uk
2. Miss Naomi Carlisle (Scientific)
naomi.carlisle@kcl.ac.uk
3. Dr Ellie Watson (Scientific)
helenawatson85@googlemail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Shennan

ORCID ID

http://orcid.org/0000-0001-5273-3132

Contact details

Department of Women and Children's Health
School of Life Course Sciences
King's College London
10th Floor
North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 0207 188 3639
andrew.shennan@kcl.ac.uk

Type

Scientific

Additional contact

Miss Naomi Carlisle

ORCID ID

Contact details

Department of Women and Children's Health
School of Life Course Sciences
King's College London
10th Floor
North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 0207 188 3634
naomi.carlisle@kcl.ac.uk

Type

Scientific

Additional contact

Dr Ellie Watson

ORCID ID

Contact details

Department of Women and Children's Health
School of Life Course Sciences
King's College London
10th Floor
North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
-
helenawatson85@googlemail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35947

Study information

Scientific title

Evaluation of the QUIPP App for Triage and Transfer: reducing inappropriate management for threatened preterm labour

Acronym

EQUIPTT (Evaluation of QUIPP app for Triage and Transfer)

Study hypothesis

The implementation of the QUIPP App and management algorithm will decrease inappropriate management for threatened preterm labour.

Ethics approval

London Bridge Research Ethics Committee, 23/11/2017, ref: 17/LO/1802

Study design

Non-randomised; Interventional; Design type: Process of Care, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Individual consent is not required for the EQUIPTT study, therefore no participant information sheet is available.

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery; UKCRC code/ Disease: Reproductive Health and Childbirth/ Maternal care related to the fetus and amniotic cavity and possible delivery problems

Intervention

This is a parallel cluster randomised control trial across 13 hospital sites. For the first 6 weeks all sites are continuing with their normal hospital routine management. For a nine month period, seven sites are randomised to using the QUIPP App to aid clinical decision making while the remaining six sites continue with normal routine management. For the final six weeks of the study, all 13 hospital sites will use the QUIPP App to aid clinical decision making. Data is collected on participants pregnancy details, their visit to hospital when they thought they may be in threatened preterm labour, and postnatal details (up until discharge or 28 days – whichever is sooner).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Inappropriate management for threatened preterm labour is measured by number of inappropriate admission and in-utero transfer decisions: admitted to hospital/ transferred and delivery interval >7 days, or not admitted to hospital/ transferred and delivery interval <7 days.

Secondary outcome measures

1. Maternal clinical outcomes (e.g. new onset gestational diabetes) measured from the post-delivery outcome data
2. Neonatal clinical outcomes (e.g. gestational age at delivery) measured from the post-delivery outcome data
3. Process measures (e.g. days of maternal hospitalisation) measured from the post-delivery outcome data
4. Compliance to management recommendations measured from their visit to hospital data and post-delivery outcome data

Overall trial start date

02/01/2017

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women who are pregnant
2. Any age range
3. With symptoms of threatened preterm labour (contractions or abdominal pain)
4. Between 23+0 and 34+6 weeks gestation

If they are having the QUIPP App used in their care management:
5. Participants must have a quantitative fetal fibronectin assessment and/or a transvaginal ultrasound scan as part of their clinical care

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 580; UK Sample Size: 580

Participant exclusion criteria

1. Definitive diagnosis of labour (i.e. regular painful contractions with cervical change > 3cm on speculum or digital examination)
2. Confirmed ruptured membranes (on speculum examination)
3. Significant vaginal bleeding

Exclusion Criteria for Qualitative study
1. Unable or unwilling to give informed consent
2. Under 16 years of age
3. Unable to understand English language sufficiently to complete the questionnaire booklet

Recruitment start date

12/02/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas’ Hospital (lead centre)
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Trial participating centre

Croydon University Hospital
530 London Road
Thornton Heath
CR7 7YE
United Kingdom

Trial participating centre

Frimley Hospital
Portsmouth Road
Camberley
GU16 7UJ
United Kingdom

Trial participating centre

Kingston Hospital
Galsworthy Road
Kingston Upon Thames
KT2 7QB
United Kingdom

Trial participating centre

Lewisham University Hospital
Lewisham High Street
London
SE13 6LH
United Kingdom

Trial participating centre

Northampton General Hospital
Cliftonville
Northampton
NN1 5BD
United Kingdom

Trial participating centre

University College London Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Trial participating centre

West Middlesex Hospital
Twickenham Road
Isleworth
TW7 6AF
United Kingdom

Trial participating centre

Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom

Trial participating centre

Queen Elizabeth Hospital Woolwich
Stadium Road
London
SE18 4QH
United Kingdom

Trial participating centre

Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Trial participating centre

Newham Hospital
Glen Road
London
E13 8SL
United Kingdom

Sponsor information

Organisation

Kings College London/ Guys and St Thomas’ Trust co-sponsorship

Sponsor details

NIHR GSTFT/KCL Biomedical Research Centre
16th floor
Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Guy's and St Thomas' Charity

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Tommy's The Baby Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2019

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/02/2018: Internal review. 17/01/2018: The ethics board name has been added. 16/01/2018: Uploaded protocol ISRCTN66950576_BasicResults_20Dec2017 (not peer reviewed)