- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551493
Postnatal Perineal Wound Assessment
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giada Giusmin
- Phone Number: 01865603166
- Email: ggiusmin@brookes.ac.uk
Study Locations
-
-
Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX39DU
- Recruiting
- Oxford University Hospital NHS Foundation Trust
-
Contact:
- Giada Giusmin
- Phone Number: 01865603166
- Email: ggiusmin@brookes.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Midwives:
- NMC Registered midwives
- Working in the NHS
- Working in the community or postnatal ward
- Who assess perineal wounds
Women:
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Postnatal women
|
Observation of postnatal wound assessment
Interview to elicit individual perspectives of wound assessment
|
|
Registered midwives
|
Observation of postnatal wound assessment
Interview to elicit individual perspectives of wound assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Survey. How midwives conduct postnatal perineal wound assessment step-by-step.
Time Frame: 10 days postnatal
|
10 days postnatal
|
|
Survey women's experiences of postnatal perineal wound assessment, i.e. emotional or physical discomfort.
Time Frame: 10 days postnatal
|
10 days postnatal
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 334946
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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