Perineum; WoundNCT06551493
Postnatal Perineal Wound Assessment
An observational study of Perineum; Wound, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
Around 85% of women who give birth vaginally experience a perineal wound, which could be a tear or an incision between the vaginal opening and the anus. Despite that, there is often insufficient exploration of how postnatal perineal wound assessment is conducted in healthcare research. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineum; Wound
- What is being tested?
- Observation of postnatal wound assessment and Interview
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Midwives and postnatal women
Who may be able to join
- Midwives:
- NMC Registered midwives
- Working in the NHS
- Working in the community or postnatal ward
- Who assess perineal wounds
- Women:
Show all 11Show fewer
- Postnatal women who had a vaginal birth within the last ten days and had an uncomplicated perineal tear (first, second-degree or episiotomy).
- Had a healthy newborn (for example, the newborn is not currently admitted to newborn intensive care or the woman did not have a stillbirth)
- Located in the community or in hospital being cared for by midwives, within ten days postpartum when postnatal perineal wound assessment occurs.
- Over the age of 18, who can consent to participation
- English-speaking
Who cannot join
- Midwives:
- Non-registered midwives and those working outside the NHS
- Who do not perform postnatal perineal wound assessment due to clinical settings or task restrictions.
- Women:
- Who had a cesarean section
- Who had a stillbirth or fetal/neonatal complications
Show all 11Show fewer
- Who had a vaginal birth but sustained severe perineal tears (third or fourth-degree tears)
- Who have not received NHS care or are outside standard postnatal locations
- Who are over 10 days postpartum at the time of perineal wound assessment
- Who are below the age of 18
- Non-English-speaking women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospital NHS Foundation Trust
Oxford, Oxfordshire, OX39DU
Giada Giusmin, 01865603166, ggiusmin@brookes.ac.uk
About this study
Official title: The Assessment of Postnatal Perineal Wound: Perspectives of Midwives and Women.
Around 85% of women who give birth vaginally experience a perineal wound, which could be a tear or an incision between the vaginal opening and the anus. Despite that, there is often insufficient exploration of how postnatal perineal wound assessment is conducted in healthcare research.
Clinical guidelines from the National Institute for Health and Care Excellence (NICE) touch on the typical signs of wound infection but do not offer detailed guidance on the execution of perineal assessment. Existing research evidence is mostly focused on long-term complications, management of perineal trauma immediately after birth or severe perineal trauma. The limited research on perineal wound care highlights how poor communication and information provision harm women at a physical and psychological level, negatively affecting daily tasks such as caring for their newborns.
Read more
Although there have been few studies examining women's or midwives' perspectives on perineal wound assessment in the context of uncomplicated wounds, their perspectives have never been jointly investigated to produce a comprehensive overview. Moreover, no research has had a clinical focus, investigating how the assessment is conducted in practice and what informs this practice, except from women's reports of perceived sub-standard care received.
Therefore, this proposed research is clinically grounded and aims to explore women's and midwives' perspectives on postnatal perineal wound assessment. This is needed to identify evidence-based practices, or lack thereof, in order to determine ways in which the experience can be improved for women and to have a more positive impact on their wellbeing.
Eight to ten pairs of midwives-women will be first observed whilst the routine assessment is conducted to understand what happens during this episode of care, and then they will be separately interviewed within a few days to gather further understanding. Recruitment will be in a single centre, which is a tertiary unit in the UK.
- Conditions
- Perineum; Wound
- Being tested
- Observation of postnatal wound assessment, Interview
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of postnatal wound assessmentOther
Observation of postnatal wound assessment
InterviewOther
Interview to elicit individual perspectives of wound assessment
| Study group | Role | What they receive |
|---|---|---|
| Postnatal women | Not described Receives: Other: Observation of postnatal wound assessment; Other: Interview | |
| Registered midwives | Not described Receives: Other: Observation of postnatal wound assessment; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey. How midwives conduct postnatal perineal wound assessment step-by-step.
Measured: 10 days postnatal
Survey women's experiences of postnatal perineal wound assessment, i.e. emotional or physical discomfort.
Measured: 10 days postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start20 Nov 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineum; WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giada Giusmin, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551493
- Sponsor's protocol ID
- 334946
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Postnatal Perineal Wound: Perspectives of Midwives and Women.
- ClinicalTrials.gov ID
- NCT06551493
- Acronym / sponsor ID
- 334946
- Conditions
- Perineum; Wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Around 85% of women who give birth vaginally experience a perineal wound, which could be a tear or an incision between the vaginal opening and the anus. Despite that, there is often insufficient exploration of how postnatal perineal wound assessment is conducted in healthcare research.
Clinical guidelines from the National Institute for Health and Care Excellence (NICE) touch on the typical signs of wound infection but do not offer detailed guidance on the execution of perineal assessment. Existing research evidence is mostly focused on long-term complications, management of perineal trauma immediately after birth or severe perineal trauma. The limited research on perineal wound care highlights how poor communication and information provision harm women at a physical and psychological level, negatively affecting daily tasks such as caring for their newborns.
Although there have been few studies examining women's or midwives' perspectives on perineal wound assessment in the context of uncomplicated wounds, their perspectives have never been jointly investigated to produce a comprehensive overview. Moreover, no research has had a clinical focus, investigating how the assessment is conducted in practice and what informs this practice, except from women's reports of perceived sub-standard care received.
Therefore, this proposed research is clinically grounded and aims to explore women's and midwives' perspectives on postnatal perineal wound assessment. This is needed to identify evidence-based practices, or lack thereof, in order to determine ways in which the experience can be improved for women and to have a more positive impact on their wellbeing.
Eight to ten pairs of midwives-women will be first observed whilst the routine assessment is conducted to understand what happens during this episode of care, and then they will be separately interviewed within a few days to gather further understanding. Recruitment will be in a single centre, which is a tertiary unit in the UK.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postnatal women | – | Other: Observation of postnatal wound assessment, Other: Interview |
| Registered midwives | – | Other: Observation of postnatal wound assessment, Other: Interview |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Midwives and postnatal women
Key inclusion criteria (11 listed)
- NMC Registered midwives
- Working in the NHS
- Working in the community or postnatal ward
- Who assess perineal wounds
- Postnatal women who had a vaginal birth within the last ten days and had an uncomplicated perineal tear (first, second-degree or episiotomy).
Key exclusion criteria (11 listed)
- Non-registered midwives and those working outside the NHS
- Who do not perform postnatal perineal wound assessment due to clinical settings or task restrictions.
- Who had a cesarean section
- Who had a stillbirth or fetal/neonatal complications
- Who had a vaginal birth but sustained severe perineal tears (third or fourth-degree tears)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of postnatal wound assessmentObservation of postnatal wound assessment | Other | Postnatal women, Registered midwives |
| InterviewInterview to elicit individual perspectives of wound assessment | Other | Postnatal women, Registered midwives |
Primary outcome
Survey. How midwives conduct postnatal perineal wound assessment step-by-step.
Time frame: 10 days postnatal
Survey women's experiences of postnatal perineal wound assessment, i.e. emotional or physical discomfort.
Time frame: 10 days postnatal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Childbirth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineum; Wound, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giada Giusmin (01865603166, ggiusmin@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey. How midwives conduct postnatal perineal wound assessment step-by-step. (time frame: 10 days postnatal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.