Maternal Group B Streptococcus identification study
| ISRCTN | ISRCTN37848792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37848792 |
| IRAS number | 307873 |
| Secondary identifying numbers | IRAS 307873; Funder (Addenbrooke's Charitable Trust) reference number 900336 |
- Submission date
- 13/10/2022
- Registration date
- 02/11/2022
- Last edited
- 10/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
We aim to trial a new diagnostic test which can rapidly detect Group B Streptococcus (GBS). GBS is a bug which is present in the bodies of 1 in 5 pregnant women and, if transmitted to the baby during birth, can cause a dangerous illness. To trial this new diagnostic test, we hope to obtain information about pregnant women, their pregnancies, deliveries and babies, and swab samples from the vagina to test for GBS.
Who can participate?
Pregnant people who are 16 years old and over who attend the Rosie Hospital for antenatal care during their pregnancy and the care they will receive routinely includes obtaining a swab from the vagina
What does the study involve?
Participation in the study will allow the research team to collect the information and samples which are required to trial the new diagnostic test for GBS. This process will only require one meeting with the participants; all other information gathered from the medical notes will be done by the research team remotely and usually the participant won’t be contacted again.
Specifically, participation in the study involves the following:
1. The research team member will work with the clinical team in the clinic to perform the care needed, with the additional research swab tests for GBS taken at the same time as the routine vaginal examination (in order to minimise the additional burden of the study as much as possible). There will be four vaginal swab samples taken all at the same time (one for the clinical requirement and three research samples). Obtaining the research swabs will only require a few seconds.
2. The participant's clinical records will be accessed to obtain information on the outcome of the pregnancy (such as the baby's birth weight, whether there were any complications, for example, infection). The baby's clinical notes will also be accessed to determine what special care (if any) the baby required after birth.
What are the possible benefits and risks of participating?
The benefits are that participation in this study will hopefully help develop a better test for GBS that could benefit pregnant women in the future. It will not benefit the participant directly as they will be having the standard method of assessment for GBS and this result will be used to guide their care. There are no risks to participants. Obtaining the extra swab test samples may be slightly uncomfortable.
Where is the study run from?
Rosie Hospital, Cambridge (UK)
When is the study starting and how long is it expected to run for?
November 2021 to October 2027
Who is funding the study?
Addenbrooke’s Charitable Trust (UK)
Who is the main contact?
Prof Gordon Smith
paoandghod@medschl.cam.ac.uk
Contact information
Principal Investigator
Department of Obstetrics and Gynaecology
University of Cambridge
Box 223
The Rosie Hospital
Robinson Way
Cambridge
CB2 0SW
United Kingdom
| Phone | +44(0)1223 336871 |
|---|---|
| paoandghod@medschl.cam.ac.uk |
Public
Department of Obstetrics and Gynaecology
University of Cambridge
Box 223
The Rosie Hospital
Robinson Way
Cambridge
CB2 0SW
United Kingdom
 ORCID ID |
0000-0003-4131-4535 |
|---|---|
| Phone | +44(0)1223 336871 |
| paoandghod@medschl.cam.ac.uk |
Scientific
Department of Obstetrics and Gynaecology
University of Cambridge
Box 223
The Rosie Hospital
Robinson Way
Cambridge
CB2 0SW
United Kingdom
| Phone | +44(0)1223 336871 |
|---|---|
| paoandghod@medschl.cam.ac.uk |
Study information
| Study design | Single-centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 42599 MAGIC PIS V2.0 23Aug2022.pdf |
| Scientific title | Molecular detection of Group B Streptococcus (GBS, Streptococcus agalactiae) in pregnant women: a study of a novel diagnostic test |
| Study acronym | MAGIC |
| Study objectives | Primary research question: Do we have a diagnostic test that is better able to detect Group B Streptococcus (GBS) from high vaginal swabs in pregnant women than the current NHS standard of care? Secondary research question: Is the presence of GBS detected by existing or novel methods associated with poor neonatal outcomes? |
| Ethics approval(s) | Approved 23/08/2022 by the Proportionate Review sub-committee of the London - Bromley Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, UK, +44 (0)207 104 8118; bromley.rec@hra.nhs.uk), ref: 22/PR/1045 |
| Health condition(s) or problem(s) studied | Group B Streptococcus agalactiae in pregnant women |
| Intervention | Women will be recruited from clinical areas which often require speculum examinations and swabs taken as part of the routine assessment in the Rosie Hospital, Cambridge (e.g. the Maternity Assessment Unit and the Preterm Birth Prevention Clinic). 200 women will be recruited, in accordance with the sample size calculation. Four swabs will be obtained from each participant, one swab for the clinical requirement and three research swabs for: 1. Enriched culture, specific for Group B Streptococcus (GBS) (gold standard) 2. DNA extraction for multiplex PCR (sip qPCR, 16S rRNA PCR-PCR, and a human DNA control, RNASEH) and sequencing 3. Optimised DNA extraction for Nanopore sequencing (for future testing) All DNA extraction and analysis will be of non-human (i.e. bacterial) DNA. Data on maternal characteristics and maternal and neonatal outcomes will be collected from the electronic medical record. |
| Intervention type | Other |
| Primary outcome measure | Presence of Group B Streptococcus (GBS) in the maternal genital tract (positive/ negative) at the time of a clinically-indicated vaginal swab at any point in pregnancy, measured with the following methodologies: 1. Routine microbiological culture and sensitivity without enriched media 2. Enriched microbiological culture specific for GBS 3. DNA extraction for multiplex PCR, with two approaches: 3.1. qPCR for sip, a GBS-specific gene of which GBS has only one copy 3.2. Nested PCR-qPCR for a GBS-specific sequence of the 16S RNA gene, of which the genome has seven copies |
| Secondary outcome measures | Maternal and neonatal outcomes measured by examination of electronic medical records at the time of hospital discharge following delivery: 1. Mode of delivery 2. Complications with labour/delivery (e.g. fever, chorioamnionitis, intensive care admission) 3. Gestation at delivery (days) 4. Birthweight (kg) 5. Admission to the NICU (and indication for admission) 6. Stillbirth/neonatal death |
| Overall study start date | 01/11/2021 |
| Completion date | 31/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 250 |
| Key inclusion criteria | 1. Attending the Rosie Hospital, Cambridge, pregnant at any gestation, for an assessment which includes a vaginal examination and swabs taken 2. Aged 16 years old and over, and have the capacity to provide informed consent for themselves |
| Key exclusion criteria | Not meeting the inclusion criteria |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 31/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development Department
Cambridge University Hospitals NHS Foundation Trust
Box 277, Block S, Level 4
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)1223 348490 |
|---|---|
| research@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
University/education
Cambridge Biomedical Campus
Clifford Allbutt Building, Bay 13
Hills Road
Cambridge
CB2 0AH
England
United Kingdom
| Phone | +44 (0)1223 333543 |
|---|---|
| croenquiries@admin.cam.ac.uk | |
| Website | http://www.cam.ac.uk/ |
|
"ROR" |
https://ror.org/013meh722 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Addenbrooke's Charitable Trust, Cambridge University Hospitals NHS Foundation Trust, ACT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Dissemination of the final study report will be via the research team’s website (https://www.obgyn.cam.ac.uk/, which will be provided to participants), an appropriate academic conference, and publication in a peer-reviewed journal. Authorship of the final study report will be in accordance with the International Committee of Medical Journal Editors guidelines on authorship criteria for manuscripts submitted for publication. |
| IPD sharing plan | Data will be available in relation to the studies described above (i.e. demographic, clinical and laboratory). Data will be available for sharing during the 5 years of data storage. Requests should be sent to Prof GCS Smith (paoandghod@medschl.cam.ac.uk) and reasonable requests with an acceptable scientific case will be considered. Transfer of data will require a Data Transfer Agreement (DTA), with the signature of the requester and a legal representative of the institution. The DTA will specify all conditions of the agreement and the scope of the work and will be negotiated by the Research Operations Office of the University of Cambridge. Participant identifiers will not be included in the data sent and researchers will be required to provide a commitment to refrain from using the data to try and identify participants. All participants have provided their written informed consent for their data to be used in this way. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 23/08/2022 | 31/10/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
10/01/2025: Total final enrolment added.
09/01/2025: The following changes were made to the study record:
1. The recruitment start date was changed from 01/11/2022 to 01/02/2023.
2. The recruitment end date was changed from 30/04/2027 to 31/07/2023.
31/10/2022: Trial's existence confirmed by NHS HRA.
