Using a light-based scan to assess changes in the cervix during pregnancy and understand whether it could help predict when labour may start
| ISRCTN | ISRCTN11023841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11023841 |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Funders | Engineering and Physical Sciences Research Council, Yorkshire MedTech |
- Submission date
- 08/02/2026
- Registration date
- 28/09/2026
- Last edited
- 25/09/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
The cervix is the lower part of the womb. During pregnancy, the cervix normally changes and softens as the body prepares for labour and birth. These changes are partly related to collagen, a strong protein that helps give the cervix its structure. At present, there is no simple clinic test that can directly assess how collagen in the cervix is changing during pregnancy.
This study will test a new light-based scanning device called polarisation-sensitive optical coherence tomography, or PS-OCT. The device is designed to assess collagen in the cervix. The aim of the study is to find out whether cervical PS-OCT can be used to obtain high-quality measurements, whether the measurements are repeatable, and whether women find the assessment acceptable during pregnancy. The study will also compare PS-OCT measurements with laboratory tests on cervical tissue samples.
Who can participate?
-Women aged 18 to 54 may be able to take part.
-The study includes non-pregnant women having a hysterectomy for a benign condition that is not related to cervical disease; pregnant women attending antenatal clinics or the preterm birth clinic who are between 20 and 28 weeks pregnant and may be at risk of preterm birth; and a smaller group of pregnant women from the study who will be invited to take part in an interview about their experience of the PS-OCT assessment.
-Women will not be able to take part in the pregnancy part of the study if they have a twin pregnancy, are unsure how many weeks pregnant they are, have a clinical vaginal infection, are currently taking antibiotics, have active vaginal bleeding, or have ruptured membranes.
What does the study involve?
The study has three related parts.
-In the first part, cervical tissue samples will be taken from women who are already having a hysterectomy for benign, non-cervical reasons. The tissue will be scanned using the PS-OCT device and then examined in the laboratory using microscope-based tests. This will help the researchers compare the PS-OCT findings with established methods for assessing collagen in tissue.
-In the second part, pregnant women will have a PS-OCT assessment of the cervix during a routine antenatal or preterm birth clinic visit between 20 and 28 weeks of pregnancy. The PS-OCT probe has a sterile disposable cover and is gently inserted into the vagina so that the cervix can be scanned. Four measurements will be taken from different areas of the cervix. For some participants, measurements may be repeated by the same or a second trained member of the research team to assess the consistency of the readings. Each set of readings is expected to take less than three minutes.
-In the third part, a smaller group of pregnant participants will be invited to take part in a questionnaire or semi-structured interview about their experience of the PS-OCT assessment. This will include questions about comfort, anxiety, embarrassment, any symptoms afterwards, and reasons for taking part. The interview will take place within 2 to 4 weeks after the PS-OCT assessment and may be by telephone or face to face.
What are the possible benefits and risks of participating?
-Participants are not expected to benefit directly from taking part in this study. However, the information collected may help researchers develop better ways to assess changes in the cervix during pregnancy in future studies. This could help improve understanding of preterm birth risk and readiness for labour.
-The PS-OCT assessment uses light to scan the cervix and is considered low risk. The device uses a sterile disposable cover to reduce the risk of infection. Some women may find the vaginal assessment uncomfortable or embarrassing. There may also be minor discomfort similar to other vaginal examinations. Any adverse events or unexpected symptoms will be recorded by the research team.
-Participants can withdraw from the study at any time without giving a reason. Their decision will not affect their usual medical care or legal rights.
Where is the study run from?
The study is run from the Jessop Wing Maternity Unit at the Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, in collaboration with the University of Sheffield (UK).
When does the study start and how long is it expected to run for?
January 2026 to December 2027.
Who is funding the study?
The study is funded by the Engineering and Physical Sciences Research Council (EPSRC) Healthcare Technologies Investigator-led Research scheme and the Yorkshire MedTech Place-Based Impact Accelerator Application Fund (UK).
Who is the main contact?
Professor Dilly OC Anumba, d.o.c.anumba@sheffield.ac.uk
Contact information
Public, Scientific, Principal investigator
The University of Sheffield
Jessop Wing, Tree Root Walk
Sheffield
S10 2SF
United Kingdom
 ORCID ID |
0000-0003-2502-3033 |
|---|---|
| Phone | +44 (0)7833388971 |
| d.o.c.anumba@sheffield.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cross sectional study |
| Scientific title | Polarisation-sensitive Optical Coherence Tomography (PS-OCT) for assessing cervical remodelling changes predictive of spontaneous human birth |
| Study acronym | CervOScan |
| Study objectives | Three interrelated studies are proposed to address our aims and objectives. Study A will recruit non-pregnant women who are undergoing a hysterectomy for a benign gynaecological condition who will donate their cervical tissue specimens for microscopic and spectroscopic structural studies. Study B will be pregnant women attending ANC who will volunteer to participate in studies to assess the feasibility and accuracy of measuring cervical optical coherence tomography using a new device - the CervOScan. The objectives include: 1. Determining the capacity of cervical PS-OCT to localise and quantify cervical collagen 2. Defining data collection protocols for pregnant women 3. Determining and selecting PS OCT quantitative parameters for defining cervical collagen distribution and density for future ML-enhanced predictive indices 4. Developing a research team for PPIE-supported grant applications for clinical studies |
| Ethics approval(s) |
Approved 16/12/2025, Yorkshire & The Humber - Sheffield Research Ethics Committee (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle Upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8010; sheffield.rec@hra.nhs.uk), ref: 25/YH/0249 |
| Health condition(s) or problem(s) studied | Cervical remodelling |
| Methodology | Study A: Correlating cervical tissue microscopy for collagen identification with PSOCT collagen birefringence assessment In this ex vivo study, we will characterise the histological organisation of cervical collagen from non-pregnant hysterectomy cervical specimens and compare our findings with collagen assessment by the PSOCT device. Ten non-pregnant women undergoing total abdominal hysterectomy (TAH) for benign reasons will be recruited. Immediately after surgical removal, a full-thickness wedge biopsy of the cervical tissue will be taken for histological examination and PSOCT assessment. Women will be identified and approached by research staff when they attend the preoperative assessment clinic several days before their scheduled operation. They will have been previously informed about the study by medical and nursing staff involved in their care, as well as through leaflets provided in the gynaecological and preoperative clinics. Since they will have been approached before admission for their surgery, potential participants will have had sufficient time to consider the study and decide whether to participate or not. Informed written consent will then be obtained from those women who choose to take part. The biopsy will be obtained after the surgeons have successfully removed the uterus with the cervix; PSOCT assessment will be conducted immediately, the tissue snapped frozen, and then transported to the laboratory for fixation and processing. Study B: Repeatability and reproducibility of cervical PSOCT measurements This initial clinical study will assess the feasibility, reproducibility, and acceptability of cervical PSOCT evaluation during pregnancy (between 20 and 28 weeks) for predicting the risk of preterm birth before 37 weeks and for determining cervical inducibility of labour at term in future studies. Participants will include pregnant women attending antenatal clinics (n = 20). Over 200 of these women attend the Jessop Wing Preterm Birth Clinic (PTBC) annually. We will ensure to approach all women accessing antenatal care at the Jessop Wing in Sheffield, including women from minority ethnic groups and those who do not speak English or do not have English as their first language. They will be informed about the study by medical and midwifery staff involved in their antenatal care, as well as through advert leaflets provided in the antenatal clinics. During recruitment, we will introduce and explain the study to them using the relevant hospital translation platform (Language Line Solutions UK) available, employing approved participant leaflets for the study. Prospective participants will have sufficient time to consider the study and decide whether to participate or not. Women who express interest in participating will then meet with a member of the research team, who will explain the study's aims and protocols in detail. Informed written consent will be obtained from those women who choose to take part. Participants can withdraw from the study at any time after giving their consent. This will not affect the quality of care they receive. On all occasions, the investigator will ensure that the patient receives suitable follow-up at the clinic as needed. Experimental procedure. Participants will be studied once between 20 and 28 weeks when they attend the antenatal clinic or preterm birth clinic. Study C: Acceptability of cervical PS-OCT assessment A subset of consenting participants in Study B will be scheduled for a qualitative assessment of the acceptability of cervical PSOCT during pregnancy (n = 10). We will adapt the interview prompts used in similar acceptability studies of previous devices, developed with input from past patients and maternity service users. A semi-structured interview approach will be employed. Interviews will be conducted within 2-4 weeks of the assessment. Participants can choose to have the interview via telephone or face-to-face. Key areas covered will include experiences of the intervention, comfort during the procedure, levels of anxiety and embarrassment, any unexpected symptoms afterwards, and motivations for participating. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cervical Polarisation Sensitive Optical Coherence Tomography (PS-OCT) Device (CervOScan) |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target sample size at registration | 30 |
| Key inclusion criteria | Age >18 years, <55 years Study A: Cervical tissue samples obtained from non-pregnant uterine specimens obtained at hysterectomy for benign non-cervical pathology (n = 10) Study B: Feasibility/reproducibility studies of pregnant women at risk of preterm birth attending the antenatal clinics studied between 20 and 28 weeks gestation (n = 20) Study C: Acceptability of cervical PS OCT during pregnancy (n=10, subset of Study B participants) |
| Key exclusion criteria | Study A: Surgery for cervical pathology or suspected genital tract cancer Study B: 1. Twin pregnancy 2. Inability to understand the study 3. Uncertain pregnancy duration 4. Established clinical vaginal infection 5. Current antibiotic treatment 6. Active vaginal bleeding 7. Ruptured fetal membranes |
| Date of first enrolment | 02/03/2026 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sheffield
S10 2SF
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
09/02/2026: Study's existence confirmed by the NIHR.
