The EQUIPTT Study: Evaluating whether clinicians using the QUIPP app make more appropriate management decisions for women who arrive to hospital thinking they may be in preterm labour
| ISRCTN | ISRCTN17846337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17846337 |
| Secondary identifying numbers | 35947 |
- Submission date
- 08/01/2018
- Registration date
- 16/01/2018
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Scientific
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
 ORCID ID |
0000-0001-5273-3132 |
|---|---|
| Phone | +44 0207 188 3639 |
| andrew.shennan@kcl.ac.uk |
Scientific
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
| Phone | +44 0207 188 3634 |
|---|---|
| naomi.carlisle@kcl.ac.uk |
Scientific
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 |
Study information
| Study design | Non-randomised; Interventional; Design type: Process of Care, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Individual consent is not required for the EQUIPTT study, therefore no participant information sheet is available. |
| Scientific title | Evaluation of the QUIPP App for Triage and Transfer: reducing inappropriate management for threatened preterm labour |
| Study 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(s) | London Bridge Research Ethics Committee, 23/11/2017, ref: 17/LO/1802 |
| 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 |
| 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 study start date | 02/01/2017 |
| Overall study end date | 01/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 580; UK Sample Size: 580 |
| Total final enrolment | 2584 |
| 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 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 | 12/02/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE1 7EH
United Kingdom
London
SW10 9NH
United Kingdom
Thornton Heath
CR7 7YE
United Kingdom
Camberley
GU16 7UJ
United Kingdom
Kingston Upon Thames
KT2 7QB
United Kingdom
London
SE13 6LH
United Kingdom
Northampton
NN1 5BD
United Kingdom
London
NW1 2BU
United Kingdom
Isleworth
TW7 6AF
United Kingdom
London
N19 5NF
United Kingdom
London
SE18 4QH
United Kingdom
London
E1 1BB
United Kingdom
London
E13 8SL
United Kingdom
Sponsor information
Hospital/treatment centre
NIHR GSTFT/KCL Biomedical Research Centre
16th floor, Tower Wing, Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The anonymised datasets generated during the EQUIPTT study will be available for access (e.g. for secondary analysis or IPD meta-analysis), upon request from the Chief Investigator Prof. Andrew Shennan (andrew.shennan@kcl.ac.uk). Access will generally be granted, after a 1 year period of embargo from publication of the main paper; or 2 years after the end of the grant if no paper has appeared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 20/12/2017 | 16/01/2018 | No | No | |
| Protocol article | protocol | 13/02/2019 | Yes | No | |
| Results article | 06/07/2021 | 07/07/2021 | Yes | No | |
| Other publications | Clinicians' experiences of app | 18/11/2021 | 27/02/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN66950576_BasicResults_20Dec2017.pdf
- Uploaded 16/01/2018
Editorial Notes
27/02/2023: Publication reference added.
07/07/2021: Publication reference added.
15/06/2021: The intention to publish date was changed from 01/06/2021 to 01/09/2021.
08/07/2020: IPD sharing statement updated.
15/03/2019: The total final enrolment number has been added.
15/02/2019: Publication reference added.
08/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 12/02/2019.
2. The overall trial end date has been updated from 31/07/2019 to 01/06/2020.
3. The intention to publish date has been updated from 01/12/2019 to 01/06/2021.
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)
