Urinary tract infection diagnosis in pregnancy by volatile organic compound analysis
| ISRCTN | ISRCTN13032419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13032419 |
| Secondary identifying numbers | Version 0.9 |
- Submission date
- 31/03/2021
- Registration date
- 22/04/2021
- Last edited
- 04/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Urinary tract infections (UTIs) are common in pregnancy, affecting up to one in ten women. Some of these women have symptoms to warn them but others do not. UTIs can lead to complications in pregnancy which can affect both the mother and the baby and therefore diagnosis in a timely fashion is important. The current rapid tests used in clinics are not very accurate to diagnose UTIs. Consequently, it is currently recommended that all women provide a urine sample when they book their pregnancy with their community midwife which is sent to the laboratory to be cultured. If bacteria grow additional tests are done to determine which antibiotics will be effective at treating that bacteria. This process can be repeated several times throughout pregnancy. This is a time consuming and expensive process which can lead to delays in starting treatment. A new technology that mimics the human nose has been recently shown to accurately diagnose several human diseases including various infections. The aim of this study is to find out whether this technology, which could be available as a bedside test, can diagnose UTIs in pregnancy.
Who can participate?
Pregnant women aged 18 and over presenting to the hospital for clinical care
What does the study involve?
Participants will be asked to give a sample of urine from the middle of the stream (midstream urine sample) for routine laboratory analysis (this is part of routine antenatal care). Urine left over after this analysis will be used for this study. The researchers will also use information from participants' medical records. They will only use information that they need for this study.
What are the possible benefits and risks of participating?
There is no direct benefit to the patient taking part but knowledge gained will help patients in the future. The study could lead to commercial gain for the University of Warwick and/or collaborators. There are no known risks to taking part in this study.
Where is the study run from?
University Hospitals Coventry & Warwickshire NHS Trust (UK)
When is the study starting and how long is it expected to run for?
November 2019 to December 2023
Who is funding the study?
The Warwick-Wellcome Translational Partnership (UK)
Who is the main contact?
Dr Lauren Lacey
l.lacey.1@warwick.ac.uk
Contact information
Scientific
Clinical Sciences Research Laboratories (CSRL)
c/o University Hospitals Coventry & Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
 ORCID ID |
0000-0002-3000-928X |
|---|---|
| Phone | +44 (0)2476967528 |
| l.lacey.1@warwick.ac.uk |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN13032419_PIS_V1.0_01Apr21.docx |
| Scientific title | Point of care diagnosis of urinary tract infections in pregnancy by volatile organic compound analysis |
| Study objectives | To optimise volatile organic compound (VOC) detection technology for urinary tract infections (UTIs) and then be able to screen for and diagnose culture-positive UTIs in pregnancy including asymptomatic bacteriuria, symptomatic cystitis and pyelonephritis. |
| Ethics approval(s) | Approved 30/03/2021, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, M1 3DZ, UK; +44 (0)207 104 8221, +44 (0)207 104 8063; gmsouth.rec@hra.nhs.uk), REC ref: 20/NW/0450 |
| Health condition(s) or problem(s) studied | Urinary tract infections in pregnancy |
| Intervention | Volatile organic compound analysis of a midstream urine sample, compared to microscopy culture and sensitivity testing of midstream urine sample and chemical dipstick test results. The researchers will use a volatile organic compound (VOC) analysis (gas chromatography - ion mobility spectrometer [GC-IMS]) machine to identify specific VOC patterns/chemical associated with UTIs from urine samples of pregnant women. These women will be followed up until they have the results of the comparator test (the midstream urine microscopy, culture and sensitivity test). This takes approximately 5-7 days from when the sample is sent to the laboratory. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | VOC detection technology, either GC-IMS or the Electronic Nose |
| Primary outcome measure | The diagnostic accuracy of VOC analysis of midstream urine sample compared to the “Gold Standard” of microscopy, culture and sensitivity testing and compared to the chemical dipstick test, measured at a single timepoint |
| Secondary outcome measures | The causative organism of the urinary tract infection detected by VOC analysis at a single timepoint |
| Overall study start date | 01/11/2019 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 360 |
| Key inclusion criteria | Pregnant women, either confirmed by urinary pregnancy test in the first trimester or with other clinical signs of pregnancy |
| Key exclusion criteria | Women who are not able to give informed consent |
| Date of first enrolment | 12/04/2021 |
| Date of final enrolment | 31/07/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Coventry
CV2 2DX
United Kingdom
Sponsor information
University/education
University of Warwick
Coventry
CV4 7AL
England
United Kingdom
| Phone | +44 (0)2476575386 |
|---|---|
| sponsorship@warwick.ac.uk | |
| Website | http://www2.warwick.ac.uk/ |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| 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 in Obstetrics & Gynaecology field |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Lauren Lacey (l.lacey.1@warwick.ac.uk). Any data provided will be anonymised and discussed with the University of Warwick sponsorship team. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.0 | 01/04/2021 | 04/05/2021 | No | Yes |
| Protocol file | version V1.0 | 01/04/2021 | 04/05/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13032419_PIS_V1.0_01Apr21.docx
- uploaded 04/05/2021
- ISRCTN13032419_PROTOCOL_V1.0_01Apr21.docx
- uploaded 04/05/2021
Editorial Notes
04/05/2021: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file. Version 1.0 1 April 2021.
2. The participant information sheet was uploaded as an additional file.
01/04/2021: Trial's existence confirmed by the North West - Greater Manchester South Research Ethics Committee.
