Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience

NCT ID: NCT05935371

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2025-10-31

Brief Summary

The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury 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. It ought to be highlighted that the sequelae of obstetric anal sphincter injuries, including anal incontinence, may manifest later on in the female life course and therefore life-long accessibility to help and therapies is advocated for these women.

Detailed Description

Obstetric anal sphincter injuries encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa. Obstetric anal sphincter injuries occur following a vaginal delivery and are more common in primiparae women, occurring with an incidence in the UK of 6.1% compared to 1.7% in those who are multiparae. Although obstetric anal sphincter injuries is fairly uncommon, the rate of these injuries in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising obstetric anal sphincter injury rates, the obstetric anal sphincter injury care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of these injuries. Prevention of these injuries, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients post-partum. This is especially important as these injuries 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. It is not surprising, therefore, that sustaining such an injury may impact a woman's decision to have another baby. Severe perineal trauma, with or without complications may, understandably, cause a negative impact on the mental health of afflicted mothers.

Suffering from the complications of these injuries may impact on an individual's quality of life and day-to-day functioning, further augmenting the psychological impact of obstetric anal sphincter injuries. Research has highlighted obstetric anal sphincter injuries to be a risk factor for the development of post traumatic stress disorder symptoms. At present, mothers with these injuries are not routinely screened for these conditions in the post-natal period. Preliminary research has shown that acquiring such an injury negatively affects the relationship between a mother and her child, which invariably has a deleterious effect on a child's development.

This study delivers a questionnaire which incorporates existing, screening tools including the Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Post-traumatic stress disorder checklist (PCL-5), Rosenberg self-esteem score, Arizona sexual experiences scale, Dyadic Adjustment Scale and the Mother infant bonding scale (MIBS) to assess the impact of these injuries on a women's mental health and intra-family relationships. The PHQ-9 has been shown to be on par with the Edinburgh postnatal depression scale in screening for depression in the perinatal period.

Recognition of mental health dysfunction within this cohort, if present, would facilitate early intervention which may in turn reduce the long-term consequences of a traumatic child birth.

Conditions

Obstetric Complication; Obstetric Trauma; Perineal Tear; Incontinence; Mental Health Impairment; Relation, Family; Relation, Mother-Child

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group - women with obstetric anal sphincter injuries

• Adult women who have had a vaginal delivery
• ≥ 18 years
• Capacity to consent
• English-speaking
• Primiparous/multi-parous

No interventions assigned to this group

Control group - women without perineal tears

• Adult women who have had a vaginal delivery
• ≥ 18 years
• Capacity to consent
• English-speaking
• Primiparous/multi-parous

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• as aforementioned previously

• Adult women who have had a vaginal delivery
• ≥ 18 years
• Capacity to consent
• English-speaking
• Primiparous/multi-parous

Exclusion Criteria

• Women who have had a caesarean section
• Women who are unable to consent
• Patient who do not speak English

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

London North West Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

London Northwest Healthcare NHS Trust

London, Brent, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Sunder CHITA

Role: primary

sunderchita@nhs.net

0208 8695829

NADA ELSAID

Role: backup

n.elsaid@nhs.net

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15769225 (View on PubMed)

Other Identifiers

327802

Identifier Type: -

Identifier Source: org_study_id