Antibiotic (cefuroxime) levels after caesarean section
| ISRCTN | ISRCTN17527512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17527512 |
| IRAS number | 244803 |
| Secondary identifying numbers | v0.4, IRAS 244803 |
- Submission date
- 03/08/2020
- Registration date
- 26/10/2020
- Last edited
- 29/07/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
A caesarean section, or C-section, is an operation to deliver a baby through a cut made in the tummy and womb. Doctors and pharmacists at Birmingham Women’s Hospital and the University of Birmingham, School of Pharmacy are investigating how the body mass index of the woman affects the concentration of the standard antibiotic (cefuroxime) given to women before having a Caesarean section. They are particularly interested in the concentration of antibiotic in the blood and at the site of incision (tummy).
Who can participate?
Healthy women who are experiencing a normal pregnancy. The researchers are interested in women with a range of body mass index values so that they know as much as possible about cefuroxime concentrations. As this is a pilot study a limited budget prevents them from providing translation services for those participants unable to read and understand English. Participation has no direct benefits to participants thus exclusion on this basis does not affect the standard of care provided.
What does the study involve?
The researchers will need to use information from participants and from their medical records for this research project. This information will include initials, name, contact details, body mass index (related to height and weight), details of the drugs used during caesarean section, and general details about health at the time of caesarean section. People at Birmingham Women’s Hospital will use this information to do the research or to check their records to make sure that the research is being done properly.
People who do not need to know will not be able to see participants' names or contact details. The data will have a code number instead. Some of this information and the blood and fat samples will be transferred to the University of Birmingham, this information and the samples will use a coded number and there will be no identifiable information that is transferred to the University of Birmingham. The researchers will keep all information safe and secure.
The researchers also ask permission from participants to take three blood samples (each one of less than 10 ml (two teaspoons) and two small samples of fat from their tummy during the caesarean section. The first sample of blood will be taken at the time of skin incision. After the operation, they will need to take another blood sample as close to the time of delivery as possible and the final blood sample will be taken in the recovery room. The samples will either be taken from a cannula inserted in hand, the insertion of the cannula will be uncomfortable, or the samples taken by a very small ‘butterfly’ needle from hand or foot. If the samples are taken from foot this will be numb from the anaesthetic and will not hurt.
Just before the baby is delivered, the researchers will ask the doctor to remove a small amount of the fat from under the skin on the participant's tummy. This will be a very small amount (about the size of a 50p coin). During C-section, participants will have an anaesthetic so they should not feel any pain. The doctor will deliver the baby and placenta then stitch the womb. Just before the skin is stitched, the doctor will remove a second 50p sized sample of fat. Taking these small fat samples will take less than a minute each so the overall procedure is only a maximum of 2 minutes longer than without the fat samples. As well as the samples taken on the day of C-section the researchers will ask permission from participants to contact them by telephone between 30-40 days after their C-section to ask a few questions and to find out if they have had an infection.
What are the possible benefits and risks of participating?
There are no direct health benefits to participants. The findings from this study will help to determine the appropriate antibiotic dosing strategy used in future for patients with a high BMI that need a C-section. The researchers do not believe that there are any major disadvantages or risks of taking part in this study. The additional procedures that participants will receive are (i) insertion of an additional cannula for the taking of three additional blood samples and (ii) the removal of two samples of fat. The blood will be taken by a trained healthcare professional using standard methods to take blood; the risks associated with taking blood samples are minimal. The samples of fat will be taken from participants whilst the skin is open for the C-section; they will be anaesthetized so will not feel any pain from this process. The amount of fat taken is small (about the size of a 50p coin) and this will not lead to visible differences to participants’ body following C-section. Participants can stop being part of the study at any time, without giving a reason, but the researchers will keep information about participants that they already have.
Where is the study run from?
University of Birmingham, School of Pharmacy and Birmingham Women’s Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2018 to December 2025
Who is funding the study?
The Saudi Arabian Government (Royal Embassy of Saudi Arabia, Cultural Bureau in London)
Who is the main contact?
Dr Victoria Hodgetts Morton
v.a.h.morton@bham.ac.uk
Contact information
Scientific
Department of Fetal and Maternal Medicine
Birmingham Women’s and Children’s NHS Foundation Trust
Edgbaston
Birmingham
B15 2TG
United Kingdom
| Phone | +44 (0)121 472 1377 |
|---|---|
| v.a.h.morton@bham.ac.uk |
Public
School of Pharmacy
Institute of Clinical Sciences
Robert Aitken Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| hrammaal@uqu.edu.sa |
Study information
| Study design | Single-centre experimental prospective pilot study with non-probability sampling |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17527512_PIS_V0.4_26Dec19.docx |
| Scientific title | Prophylactic perioperative cefuroxime levels in plasma and adipose tissue at the time of caesarean section (C-LACE): a pilot experimental, prospective study with non-probability sampling to determine interpatient variability |
| Study acronym | C-LACE |
| Study objectives | This study will analyse cefuroxime concentration in plasma and adipose tissue samples to accurately measure levels achieved in non-obese and obese pregnant women undergoing caesarean section to confirm if therapeutical cefuroxime levels are reached in plasma and adipose tissue. |
| Ethics approval(s) | Approved 22/01/2020, Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (East Midlands - Leicester Central Research Ethics Committee, The Old Chapel Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 972 2568; HRA.Approval@nhs.net), ref:19/EM/0356 |
| Health condition(s) or problem(s) studied | Cefuroxime concentration in plasma and adipose tissue (within the incision) at time of skin incision and skin closure in obese and non-obese pregnant patients requiring caesarean section |
| Intervention | This study will measure the concentration of cefuroxime in adipose tissue (two samples from site of incision) and blood (three samples) from pregnant women undergoing scheduled caesarean section. Analysis will explore the impact of BMI (body mass index) on cefuroxime concentration. The study participants will be followed up between 30 and 40 days post caesarean section to record details of any post-caesarean infection to explore correlations in BMI:measured cefuroxime concentrations and post caesarean infection rates. |
| Intervention type | Other |
| Primary outcome measure | Time above the Minimum Inhibitory Concentrations (T>MIC): the MIC is not harmonised between guidelines, thus the time above the T>MIC will be reported for MIC values of 1, 4 and 8 mg/l as these values correlate to the most common bacteria involves in post-CS surgical infections. The analytical method used to measure cefuroxime is LC-MS/MS (Liquid Chromatography with tandem mass spectrometry). At time of caesarean section, five samples will be collected: one blood sample at time of skin incision, one blood sample at time of skin closure, one blood sample at recovery room (<3 hours following CS), one adipose tissue sample (approximately 1 cm from the skin in the middle of the Pfannenstiel or vertical midline incision) at skin incision and one adipose tissue sample (from a similar location to sample 1) just prior to skin closure. |
| Secondary outcome measures | The rate of surgical site infection as per the definitions set out by the US Centers for Disease Control and Prevention (2019). The participants will be contacted at 30-40 days post-CS to record any incidence of infection occurred from day 1 of CS until the time of the contact. |
| Overall study start date | 08/01/2018 |
| Completion date | 01/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Pregnant women 18 years to 50 years old, with a singleton pregnancy undergoing elective CS at 37 weeks or over 2. Participant is able to give consent and agree to sample storage 3. Participant agrees to be contacted for follow-up 4. Participant contributing to the study needs to be able to read and/or understand English |
| Key exclusion criteria | 1. Multiple pregnancy 2. Previous CS that resulted in a surgical site infection 3. Emergency CS 4. Any non-elective CS including those requiring early delivery without threat to maternal or foetal health that were not previously planned 5. Body Mass Index (BMI) less than 18 kg/m2 or greater than or equal to 45 kg/m2 (at time of first pregnancy appointment and at time of delivery) 6. Participant contributing to the study is unable to read and/or understand English 7. Currently enrolled in a randomized controlled trial for an intervention to reduce postoperative surgical site infection 8. Diabetes (type 1, type 2 or gestational) 9. Hypertension 10. Renal disease 11. Cardiovascular disease (e.g. maternal structural cardiac disease) 12. Liver disease 13. Inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis) 14. Cephalosporin or penicillin allergy 15. Administration of antibiotic within 1 week prior to delivery 16. Suspected pre-existing infection (including chorioamnionitis) 17. Autoimmune disease (e.g. systemic lupus erythematosus, rheumatoid arthritis) 18. Chronic use of corticosteroid 19. History of wound breakdown in an abdominal surgery 20. Prior laparotomy for any indication (e.g. Previous ovarian cystectomy or previous bowel surgery) |
| Date of first enrolment | 01/12/2024 |
| Date of final enrolment | 01/09/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham
B15 2TG
United Kingdom
Sponsor information
University/education
-
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| studentfees@bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | 1. The protocol will be submitted for publication. 2. Planned publication of the study results in a high-impact peer-reviewed journal. |
| IPD sharing plan | Individual de-identified participant data (IPD) will be stored in a non-publically available repository (Bear Share: https://intranet.birmingham.ac.uk/it/teams/infrastructure/research/bear/BEARDataShare/BEARDataShare.aspx). Direct access will be granted to authorised representatives from the Sponsor and host institution for monitoring and/or audit of the study to ensure compliance with regulations. Data will be stored at this site for 10 years in accordance with the regulations of the University of Birmingham. This anonymised data will be shared in publications that result from this study, most likely as supplementary information to the manuscript. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V0.4 | 26/12/2019 | 26/10/2020 | No | Yes |
| Protocol article | protocol | 18/02/2021 | 22/02/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN17527512_PIS_V0.4_26Dec19.docx
- Uploaded 26/10/2020
Editorial Notes
29/07/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2024 to 01/12/2024.
2. The recruitment end date was changed from 01/09/2025 to 01/09/2026.
3. The overall end date was changed from 01/12/2025 to 01/12/2026.
4. The intention to publish date was changed from 01/12/2023 to 01/12/2026.
22/01/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2023 to 01/06/2024.
2. The recruitment end date was changed from 01/09/2023 to 01/09/2025.
3. The overall end date was changed from 01/12/2024 to 01/12/2025.
4. The plain English summary was updated to reflect these changes.
14/07/2022: The following changes were made to the trial record:
1. The intention to publish date was changed from 01/12/2022 to 01/12/2023.
2. The public contact email was updated.
12/07/2022: The following changes have been made:
1. The overall trial end date has been updated from 01/12/2022 to 01/12/2024.
2. The recruitment start date was changed from 01/06/2022 to 01/06/2023.
3. The recruitment end date was changed from 01/09/2022 to 01/09/2023.
19/01/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2022 to 01/06/2022.
2. The recruitment end date was changed from 01/03/2022 to 01/09/2022.
3. The intention to publish date was changed from 01/12/2021 to 01/12/2022.
27/08/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/08/2021 to 01/01/2022.
2. The recruitment end date was changed from 01/11/2021 to 01/03/2022.
3. The overall trial end date was changed from 01/12/2021 to 01/12/2022.
24/05/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/05/2021 to 01/08/2021.
2. The recruitment end date has been changed from 01/08/2021 to 01/11/2021.
22/02/2021: Publication reference added.
16/02/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/02/2021 to 01/05/2021.
2. The recruitment end date was changed from 01/05/2021 to 01/08/2021.
10/12/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/12/2020 to 01/02/2021.
2. The recruitment end date was changed from 01/03/2021 to 01/05/2021.
13/08/2020: Trial's existence confirmed by East Midlands - Leicester Central Research Ethics Committee.
