Childbirth-related perineal trauma Pregnancy and Childbirth
Conditions
Interventions
Potentially eligible participants will be identified and approached by members of their clinical care team, namely the midwife or obstetrician caring for them around the time of birth. The initial app
Sponsors
Birmingham Women’s and Children’s NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
16 Years to 52 Years
Inclusion criteria
Inclusion criteria: 1. Women (>16 years) who have given birth vaginally, either spontaneously or operatively 2. Women who have sustained childbirth related perineal trauma 3. Able and willing to give informed consent in a participating maternity unit during the data collection period. *Women who have failed instrument delivery and have given birth via caesarean section and women with multiple births who give birth vaginally and via c-section can still be included in CHAPTER as long as they have sustained CRPT. ** Women who sustain an Obstetric Anal Sphincter Injuries (OASI) CRPT will not be excluded.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perineal infection within 6-weeks post-partum measured via both the bespoke patient-reported CHAPTER study 6-week questionnaire and through clinician-reported outcomes on the presence of a perineal infection using the online 6 week eCRF | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical Outcomes: Clinical outcomes based on routinely collected data held in patient notes transcribed into electronic case report forms (eCRFs) 1.1. Antibiotic use for perineal infection within 6 weeks post-partum assessed using the 6 week eCRF 1.2. Number of participants who experienced wound breakdown by 6 weeks post-partum assessed using 6 week eCRF 1.3. Number of participants experiencing urinary and faecal incontinence at 6 weeks assessed using the 6 week eCRF 1.4. Use of analgesia at 6 weeks assessed using the 6 week eCRF 1.5. Number of participants requiring readmission or triage visit for CRPT-related complications assessed using the 6 week eCRF 1.6. Number of participants requiring referral or review within a Specialist Perineal clinic assessed using the 6 week eCRF 2. Patient reported outcomes: At 6-weeks, 6 and 12-months post-partum: 2.1. Urinary incontinence via the Revised Urinary Incontinence Scale (RUIS) 2.2. Faecal incontinence via the Revised Faecal Incontinence Scale (RFIS) 2.3. Anxiety and depression via the Edinburgh Postnatal Depression Scale 2.4. General health related quality of life using the EQ-5D-5L 2.5. PTSD via selected domains from the City Birth Trauma Scale. At 6 and 12-months post-partum: At 6 and 12 months post-partum, all of the validated questionnaires above are used plus additional questions, together this is referred to as the “CHAPTER Bespoke Questionnaire”. The following are assessed using the “CHAPTER Bespoke Questionnaire”: 2.6. Sexual function via the Bespoke Chapter Questionnaire 2.7. Physical activity via the Pelvic Floor Impact Questionnaire 2.8. Pelvic organ prolapse symptoms via selected domains from the Revised Postpartum Pelvic Floor and Birth Questionnaire 2.9. Maternal satisfaction 2.10. Ability to feed according to mother’s preference 2.11. Ability to care for baby 2.12. Social isolation 2.13. Ability to care for older children 2.14. Impact on seeking healthcare 2.15. Future pregnancy and subsequent mode o | — |
Countries
England, United Kingdom
Outcome results
None listed