NCT06551493

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 8, 2024

Last Update Submit

August 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Survey. How midwives conduct postnatal perineal wound assessment step-by-step.

    10 days postnatal

  • Survey women's experiences of postnatal perineal wound assessment, i.e. emotional or physical discomfort.

    10 days postnatal

Study Arms (2)

Postnatal women

Other: Observation of postnatal wound assessmentOther: Interview

Registered midwives

Other: Observation of postnatal wound assessmentOther: Interview

Interventions

Observation of postnatal wound assessment

Postnatal womenRegistered midwives

Interview to elicit individual perspectives of wound assessment

Postnatal womenRegistered midwives

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Midwives and postnatal women

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospital NHS Foundation Trust

Oxford, Oxfordshire, OX39DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Midwifery

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 13, 2024

Study Start

November 20, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

August 8, 2025

Record last verified: 2024-08

Locations