COMPaRE Study V 1.0

• Research type

  Research Study

• Full title

  Long study title: The Impact of Severe Perineal Trauma on Maternal Mental Health and Intra-family Relationships Short study title (Acronym): COMPaRE Study (Consequences of OASIS on Maternal Psychology and Relationship Experience)

• IRAS ID

  327802

• Sponsor organisation

  London NorthWest Healthcare NHS Trust

• Clinicaltrials.gov Identifier

  327802, ClinicalTrials.gov

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Historically, pregnancy and childbirth has been erroneously considered to be an innocuous physiological event. However, it is now well-established that some women may experience various mental health conditions, including depression, anxiety, post-traumatic stress disorder, panic disorder, obsessive-compulsive disorder and psychosis during pregnancy and following birth, with one study stating suicide as one of the leading non-medical causes of death in the post-partum period. Poor mental health, in turn, may have a deleterious effect on intra-family relationships, including relationships with partner and child and subsequent child development.

  Obstetric anal sphincter injuries (OASIS) encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa. They occur infrequently following a vaginal birth with an incidence of 2.9% in the UK. OASIS may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse.

  This study delivers a questionnaire which incorporates existing, screening tools including the PHQ-9, GAD-7, PCL-5, Rosenberg self-esteem score, Arizona sexual experiences scale, Dyadic Adjustment Scale and the Mother infant bonding scale to assess the impact of OASIS on a women’s mental health and intra-family relationships. The questionnaire will be delivered to each participant at three time intervals post-partum (10-12 weeks, 5-6 months, 12 months).

  The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury(OASI) negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women’s perception of herself and her self-esteem. Research in this field will ensure that the correct care and adequate support is provided for these patients in the post-natal period and beyond. Recognition of these conditions and the provision of support for these patients may improve relationships, leading to improved parenting and positive outcomes for the child.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  23/NW/0219

• Date of REC Opinion

  8 Sep 2023

• REC opinion

  Further Information Favourable Opinion