Childbirth Acquired Perineal Trauma (Chapter) Study: Incidence of childbirth related perineal trauma (CRPT) and outcomes of women who experience CRPT

Study type
Protocol
Date of Approval
Study reference ID
22_002389
Lay Summary

Every year in the UK, 4 out of 5 women who give birth vaginally (450,000 women), experience damage to the surrounding area. This may result from tears or cuts to tissues, muscles and skin around the bladder, vagina and perineum (the skin between the vagina and back passage). This is called Childbirth Related Perineal Trauma (CRPT).

CRPT needs to be dealt with quickly and effectively. If not treated, women can be left with pelvic floor problems (e.g. incontinence) or psychological problems (e.g. bonding with baby). GPs and midwives say they lack confidence, knowledge and training on how to assess and treat CRPT, as there is little research.

This research is part of a bigger study aiming to improve care for women with CRPT. Our aims in this research are to:
1. Describe the burden of the condition and how this has changed over time.
2. To explore some of the outcomes that women with CRPT experience, including incontinence, diarrhoea, constipation, pain, sexual problems, infection, and mental health conditions. We will do this by investigating whether women who experience CRPT are more likely to have these outcomes compared to women who have given birth but who do not experience CRPT.

Technical Summary

Aims: The aims of this study are to:
1. To describe the recorded annual incidence of childbirth related perineal trauma (CRPT)
2. To explore short, medium and longer term outcomes in women who experience CRPT compared to women who do not.

Data source: The data sources for this study will be CPRD GOLD and CPRD Aurum; linked HES data will be used.

Population: Women aged 16 years and above who have given birth vaginally between 2005 and 2019 will be included. Women who underwent caesarean section will be excluded.

Study design: A series of annual cohort studies will be used to describe the recorded incidence of CRPT from 2005 to 2019. A retrospective matched cohort study will be used to compare short, medium and long-term outcomes in women who had CRPT with women who underwent childbirth and did not have CRPT. Women will be matched by age (±1 year), region and delivery date.

Outcomes: The outcomes to be explored include: anxiety, depression, post-traumatic stress disorder, bowel incontinence, urinary incontinence, constipation, diarrhoea, dyspareunia or sexual discomfort, reduced libido or sexual dysfunction, pain (general, perineal), vaginal discharge, vaginal dryness, prolapse, infection.

Analysis: Cox proportional hazards regression models will be used to calculate crude and adjusted hazard ratios for each of the outcomes comparing women with CRPT to women without CRPT. Covariates will include age at delivery, IMD deprivation quintile, ethnicity, body mass index (BMI), smoking status, and relevant comorbidities and medications.

Subgroup analysis will be conducted by degree of tear in the exposed group 1st degree, labial laceration, 2nd degree and 3rd/4th degree (and corresponding matched controls). We will also explore infection risk in stratified analyses of the study population, for instance by deprivation level, BMI/obesity, in order to aid characterisation of patients most at risk.

Health Outcomes to be Measured

Annual incidence of CRPT.

In a matched cohort study we will explore the following short, medium and longer-term outcomes in women with CRPT compared to women without CRPT:
Short to medium term outcomes: anxiety, depression, bowel incontinence, urinary incontinence, constipation, diarrhoea, dyspareunia or sexual discomfort, reduced libido or sexual dysfunction, pain (general, perineal), vaginal discharge, vaginal dryness, prolapse, infection;
Medium and long term outcomes: anxiety, depression, post-traumatic stress disorder. We will also consider other outcomes detailed in short to medium term (bowel incontinence, urinary incontinence, dyspareunia or sexual discomfort, reduced libido or sexual dysfunction, pain (general, perineal), vaginal discharge, vaginal dryness, prolapse, infection) as some women may present late for a range of reasons including stigma.
Short term will be up to 1 year, medium term 1-5 years and long term >5 years after delivery.

Collaborators

Nicola Adderley - Chief Investigator - University of Birmingham
Nicola Adderley - Corresponding Applicant - University of Birmingham
Alice Sitch - Collaborator - University of Birmingham
Katie Morris - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham
Rasiah Thayakaran - Collaborator - University of Birmingham
Victoria Hodgetts Morton - Collaborator - University of Birmingham

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;CPRD Aurum Pregnancy Register;CPRD GOLD Pregnancy Register