Investigating skin-to-thigh muscle depth in pregnant patients for medication injections
| ISRCTN | ISRCTN56917791 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56917791 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 356744 |
- Submission date
- 27/06/2025
- Registration date
- 24/07/2025
- Last edited
- 24/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
During caesarian section or vaginal birth medications are occasionally required to be given to the patient. Some of these medications are required to be given via a small needle into the side of the leg. The muscle that the medication is aiming to reach is called the 'vastus lateralis' muscle. This study aims to measure the distance between the skin and this muscle using a simple ultrasound scan. By knowing this measurement, it will help to ensure that these medications are reaching the muscle appropriately for our patients. This is a non-invasive scan and will not impact individual patient care.
Who can participate?
Participants can be any patient aged between 18 and 55 years of age who are attending either Queen Elizabeth Hospital or University Hospital Lewisham, which are both hospitals that are part of Lewisham and Greenwich NHS Trust, for a caesarian section or who are in labour.
What does the study involve?
The study involves a simple ultrasound scan of the side of the leg. This will take approximately 5 minutes to perform by one of the research team members who is trained to perform the scan. The scans will be performed for women who would like to be involved in the study who are either in the labour process, any pregnant patient on the day of their c-section, before the procedure or within 2 hours after the baby has been delivered. The study team will also collect some information about the patient, including demographics such as ethnicity, weight and how many weeks pregnant the patient is.
What are the possible benefits and risks of participating?
This study may not benefit the patient directly during their current pregnancy; however, the aim is to improve the delivery of intramuscular injections for all pregnant patients giving birth to ensure they will be most effective. This could have a positive benefit for the individual patient in future pregnancies.
The study team do not think that there are any risks in taking part in this study. There is a small chance that if the patient has a bruise on the thigh that it may feel sensitive to have pressure applied with the ultrasound. However, we can use either leg to try and avoid this. Ultrasound imaging is safe and does not have any side effects. The main disadvantage to the patient is the time it requires to be involved in the study. Both the consent and scanning process are anticipated to take no more than 15 minutes and will not impact patient care on the day.
Where is the study run from?
The study will run at both Queen Elizabeth Hospital and University Hospital Lewisham, which are both part of Lewisham and Greenwich NHS Trust.
When is the study starting and how long is it expected to run for?
June 2025 to October 2025
Who is funding the study?
The Lewisham and Greenwich NHS Trust, UK
Who is the main contact?
Dr Richard Crowson (MBChB FRCA BSc), richard.crowson2@nhs.net
Contact information
Principal Investigator
Queen Elizabeth Hospital
Stadium Road
Woolwich
London
SE18 4QH
United Kingdom
| Phone | +44 (0)7812988613 |
|---|---|
| richard.crowson2@nhs.net |
Public, Scientific
Queen Elizabeth Hospital
Stadium Road
Woolwich
London
SE18 4QH
United Kingdom
| Phone | +44 (0)2088366000 |
|---|---|
| imogen.glover@nhs.net |
Study information
| Study design | Observational basic science measurement study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 47569_PIS.pdf |
| Scientific title | Depth for intramuscular medication injection in pregnancy to the vastus lateralis |
| Study acronym | DIMPL |
| Study objectives | With an increasing number of patients living with obesity in our population, at a certain body mass index (BMI), the distance between the skin and the vastus lateralis muscle (the muscle within the lateral thigh most commonly used to deliver intramuscular medication in pregnancy) might increase. This might impact the delivery of medication intended to reach this muscle. Thus, using standard needle lengths commonly used in clinical practice at a certain BMI, the medication might be injected into the adipose tissue as opposed to the intended muscle layer. |
| Ethics approval(s) |
Not yet submitted, Ethics committee name not provided (Address not provided, City not provided, Zip/postal code not provided; Telephone number not provided; Email@notprovided.com), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Distance between skin and vastus lateralis muscle in pregnant patients |
| Intervention | Basic bedside ultrasound scans will be performed to obtain measurements of the lateral thigh of patients attending for elective caesarean section and patients in labour on the maternity ward at both sites of Lewisham and Greenwich NHS Trust (Queen Elizabeth Hospital and Lewisham Hospital). Anaesthetists at both sites who have volunteered to assist with data collection will be trained to perform the non-invasive bedside scan with the same standardised technique. This will be performed at the middle third of the lateral leg at a 45 degree angle with a ‘reasonable application of pressure.’ Once trained, this scan will take less than 5 minutes to perform. The scans will be performed on consented patients on the day of their elective caesarean section prior to surgery or within 2 hours of delivery and on any patient undergoing the labour process on the maternity wards. |
| Intervention type | Other |
| Primary outcome measure | The distance measured in millimeters (mm) between the skin and vastus lateralis muscle measured using bedside ultrasound scanning at one time point |
| Secondary outcome measures | Body mass index (BMI) calculated using the weight in kgs divided by the height in metres squared, measured using data recorded in the clinical notes system (iCare) during the initial booking appointment (usually within 10 weeks of being pregnant) |
| Overall study start date | 27/06/2025 |
| Completion date | 13/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | Patients included will be patients presenting for elective caesarian section (c-section) or who are in the labour process |
| Key exclusion criteria | 1. Any patient who does not consent to be part of the study 2. Any patient who is over 2 hours post-delivery from a caesarian section (c-section) 3. Confirmed pre-eclampsia 4. Cardiac disorder 5. Kidney disease 6. Patients taking diuretic medication |
| Date of first enrolment | 04/08/2025 |
| Date of final enrolment | 13/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Woolwich
London
SE18 4QH
United Kingdom
Lewisham High Street
London
SE13 6LH
United Kingdom
Sponsor information
Hospital/treatment centre
Queen Elizabeth Hospital
Stadium Road
Woolwich
London
SE18 4QH
England
United Kingdom
| Phone | +44 (0)2088365972 |
|---|---|
| karen.corbett-smith@nhs.net | |
| Website | https://www.lewishamandgreenwich.nhs.uk/ |
"ROR" |
https://ror.org/05tn2bq24 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 29/09/2026 |
|---|---|
| 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 peer-reviewed journal and presentation at a national anaesthetic conference |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | 30/06/2025 | No | Yes |
Additional files
Editorial Notes
03/07/2025: Study's existence confirmed by the Lewisham and Greenwich NHS Trust.
