Can a test of preterm labour (quantitative fetal fibronectin) help diagnosis and clinical decision making?
| ISRCTN | ISRCTN41598423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41598423 |
| Secondary identifying numbers | HTA 14/32/01 |
- Submission date
- 15/10/2015
- Registration date
- 27/10/2015
- Last edited
- 10/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
About 11% of all babies born worldwide are preterm (premature) meaning that they are born more than three weeks before their due date. Accurately predicting whether a woman will have a preterm delivery is notoriously challenging. Up to 80% of women who show signs of preterm labour remain pregnant after 7 days. Despite this, many women are given treatments aimed at preventing complications for their babies, should they be premature. This can be very costly and little is known about the effects for mothers and their babies if a preterm delivery does not take place. Fetal fibronectin (fFN) is a “glue-like” protein which attaches the amniotic sac (the fluid sac that contains and protects a fetus) to the lining of the womb. At the end of pregnancy, fFN begins to break down and can be detected in vaginal fluid. By measuring the concentration of fFN, it is possible to predict whether the baby is likely to arrive prematurely (quantitative foetal Fibronectin test). Generally, the result will either be positive (showing the fFN is present and so there is an increased chance of labour) or negative (where it is not present, ruling out the chance of labour). The aim of this study is to find out how accurate the quantitative foetal Fibronectin (qfFN) test is at predicting preterm delivery. The results are compared with two pre-term birth marker tests currently available in the NHS (Actim Partus and Partosure).
Who can participate?
Women who are showing signs of going into labour prematurely.
What does the study involve?
Women have a vaginal swab taken so that levels of quantitative fetal fibronectin can be measured. This will allow the researchers to predict the chance of the women delivering their babies prematurely over the next seven days. Two additional vaginal swabs are also taken for the Actim Partus and Partosure tests. Regular contact is kept with the women in the form of telephone interviews so that the number of women who have had a preterm delivery can be measured.
What are the possible benefits and risks of participating?
There are no direct benefits to women or their babies for participating in this study, although some women gain satisfaction from contributing research studies which will improve future care for women with preterm labour. There are very few risks from participation as qfFN is the most commonly used test for preterm labour, and it is considered to be safe. Knowledge of qfFN results may increase or decrease anxiety levels, and this will be assessed as part of the trial.
Where is the study run from?
Royal Infirmary of Edinburgh (lead centre) and three Scottish, four Welsh and 19 English hospitals (UK)
When is the study starting and how long is it expected to run for?
December 2015 to January 2019 (as of 04/10/2018)
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
1. Ms Lisa Wotherspoon (public)
lisa.wotherspoon@ed.ac.uk
2. Dr Sarah Stock (scientific)
sarah.stock@ed.ac.uk
Contact information
Public
University of Edinburgh MRC Centre for Reproductive Health
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 (0)131 242 6753 |
|---|---|
| lisa.wotherspoon@ed.ac.uk |
Scientific
University of Edinburgh MRC Centre for Reproductive Health
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
 ORCID ID |
0000-0003-4308-856X |
|---|---|
| Phone | +44 (0)131 242 6449 |
| sarah.stock@ed.ac.uk |
Study information
| Study design | Multi-centre prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | QUIDS – Quantitative Fibronectin to help Decision-making in women with Symptoms of Preterm Labour |
| Study acronym | QUIDS |
| Study hypothesis | In women with symptoms suggestive of preterm labour, quantitative fetal fibronectin will help rule out preterm labour and aid decision making. |
| Ethics approval(s) | 1. QUIDS – West of Scotland REC 5, 22/03/2016, ref: 16/WS/0068 2. QUIDS 2 – West of Scotland REC 5, 10/05/2017, ref: 17/WS/0081 |
| Condition | Preterm labour |
| Intervention | Women with symptoms of preterm labour (22-34 weeks gestational age) who are participating in the study will have a vaginal swab sample taken to test levels of quantitative fetal fibronectin in order to predict the likelihood of preterm delivery within the next 7 days. Women will be followed up until delivery to determine the diagnostic accuracy of the test. Added 15/03/2017: QUIDS 2 sub study: The sub study will involve taking two additional cervical swabs from the participants to be used for testing additional pre-term birth marker tests currently available in the NHS (Actim Partus and Partosure). These results will be compared to the results and the model developed in QUIDS. |
| Intervention type | Other |
| Primary outcome measure | Delivery rate is measured within 7 days of enrollment in the study |
| Secondary outcome measures | 1. Acceptability of the qfFN, measured by telephone interviews in a subset of participants (n=30) at 48 hours following test 2. Anxiety, measured using the State Trait Anxiety Index questionnaire pre and 48 hours post test 3. Cost effectiveness of fFN measured by decison analytical modelling until discharge from hospital 4. Delivery within 48 hours of enrollment in the study 5. Rate of spontaneous preterm delivery before 34 weeks 6. Rate of spontaneous preterm delivery before 37 weeks |
| Overall study start date | 01/12/2015 |
| Overall study end date | 30/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | QUIDS – 3000, QUIDS2 – 550 |
| Total final enrolment | 2924 |
| Participant inclusion criteria | 1. Women with signs and symptoms of preterm labour 24-34 weeks (or earlier gestation if the fetus is considered potentially viable) in whom hospital admission, inter-hospital transfer or treatment (antenatal steroids, tocolysis or magnesium sulphate) is being considered 2. Signs and symptoms may include any or all of the following: 2.1. Back pain 2.2. Abdominal cramping 2.3. Abdominal pain 2.4. Light vaginal bleeding 2.5. Vaginal pressure 2.6. Uterine tightenings or contractions 2.7. Cervical effacement or dilatation |
| Participant exclusion criteria | 1. Women who have moderate or severe vaginal bleeding 2. Women who have cervical dilatation greater or equal to 3cm 3. Women with confirmed rupture of membranes 4. Sexual intercourse, vaginal examination or transvaginal ultrasound in the preceding 24 hours factors can invalidate results and so these women will be initially excluded from the study. They can later be included if still symptomatic after 24 hours, when fFN accuracy will be restored |
| Recruitment start date | 01/09/2016 |
| Recruitment end date | 31/10/2018 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Edinburgh
EH16 4TJ
United Kingdom
Birmingham
B15 2TG
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Isleworth
TW7 6AF
United Kingdom
Sponsor information
University/education
Research & Development Management Suite
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3336 |
|---|---|
| R&DOffice@nhslothian.scot.nhs.uk | |
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/04/2018 | Yes | No | |
| Protocol file | version v7.0 | 16/08/2018 | 11/01/2019 | No | No |
| Protocol file | version v5.0 | 23/10/2018 | 11/01/2019 | No | No |
| Results article | Qualitative results | 01/10/2019 | 12/08/2019 | Yes | No |
| Other publications | Development and validation of a risk prediction model | 06/07/2021 | 30/07/2021 | Yes | No |
| Funder report results | 01/09/2021 | 10/09/2021 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN41598423_Protocol for QUIDS_v7.0_16Aug2018.pdf
- Uploaded 11/01/2019
- ISRCTN41598423_Protocol for QUIDS2_v5.0_23Oct2018.pdf
- Uploaded 11/01/2019
Editorial Notes
10/09/2021: Publication reference added.
05/08/2021: Internal review.
30/07/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
12/08/2019: Publication reference added.
11/01/2019: The trial website has been added.
11/01/2019: Uploaded QUIDS2 protocol Version 5.0 23 October 2018 (not peer reviewed)
11/01/2019: Uploaded QUIDS protocol Version 7.0 16 August 2018 (not peer reviewed)
04/10/2018: The following changes have been made to the trial record:
1. The overall trial start date has been changed from 30/09/2018 to 30/01/2019
2. The recruitment end date has been changed from 31/08/2018 to 31/10/2018
3. The plain English summary has been updated
4. The intention to publish date has been changed from 01/10/2018 to 30/01/2020
23/04/2018: Publication reference added.
08/03/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2018 to 31/08/2018.
2. The target number of participants was changed from "QUIDS – 2100, QUIDS2 – 550" to "QUIDS – 3000, QUIDS2 – 550".
31/07/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2017 to 30/04/2018
2. The overall trial end date was changed from 31/05/2018 to 30/09/2018.
3. The target number of participants was changed from "1,600 for QUIDS; 1100 for the QUIDS 2 sub study" to "QUIDS – 2100, QUIDS2 – 550"
15/03/2017: The target number of participants was changed from "1,600" to "1,600; 1100 for the QUIDS 2 sub study".
24/03/2016: Ethics approval information added.
