Clinical trial NCT05935371: Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience
Official title: The Impact of Severe Perineal Trauma on Maternal Mental Health and Intra-family Relationships
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstetric Complication
Obstetric Trauma
Perineal Tear
Incontinence
Mental Health Impairment
Relation, Family
Relation, Mother-Child
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2023-07-07
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English-speaking women, over the age of 18, with capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher) and who have had a vaginal delivery are eligible to participate in this study.

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.

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

Primary outcomes:
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
measure: the impact of an obstetric anal sphincter injury on
timeFrame: study to be completed within 12 months
Secondary outcomes:
measure: The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
timeFrame: study to be completed over a 12 month period
measure: The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
timeFrame: study to be completed over a 12 month period
measure: The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
timeFrame: study to be completed over a 12 month period
measure: The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
timeFrame: study to be completed over a 12 month period
measure: The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
timeFrame: study to be completed over a 12 month period
measure: The influence of the following factor in predicting severity and risk of mental health disorders and relationship dysfunction (specifically pertaining to relationship with partner and child):
timeFrame: study to be completed over a 12 month period
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Northwest Healthcare NHS Trust
state: Brent
Study officials:
References:
citation: Skari H, Skreden M, Malt UF, Dalholt M, Ostensen AB, Egeland T, Emblem R. Comparative levels of psychological distress, stress symptoms, depression and anxiety after childbirth--a prospective population-based study of mothers and fathers. BJOG. 2002 Oct;109(10):1154-63. doi: 10.1111/j.1471-0528.2002.00468.x.
citation: Ertan D, Hingray C, Burlacu E, Sterle A, El-Hage W. Post-traumatic stress disorder following childbirth. BMC Psychiatry. 2021 Mar 16;21(1):155. doi: 10.1186/s12888-021-03158-6.
citation: Thornton C, Schmied V, Dennis CL, Barnett B, Dahlen HG. Maternal deaths in NSW (2000-2006) from nonmedical causes (suicide and trauma) in the first year following birth. Biomed Res Int. 2013;2013:623743. doi: 10.1155/2013/623743. Epub 2013 Aug 19.
citation: Garthus-Niegel S, Horsch A, Handtke E, von Soest T, Ayers S, Weidner K, Eberhard-Gran M. The Impact of Postpartum Posttraumatic Stress and Depression Symptoms on Couples' Relationship Satisfaction: A Population-Based Prospective Study. Front Psychol. 2018 Sep 19;9:1728. doi: 10.3389/fpsyg.2018.01728. eCollection 2018.
citation: Bick Obe D, Hall J, Keighley MRB. The impact of severe perineal trauma on a woman's relationship with her child: a hidden consequence. Midwifery. 2022 May;108:103323. doi: 10.1016/j.midw.2022.103323. Epub 2022 Mar 22. No abstract available.
citation: Shonkoff M, Duncan GJ, Yoshikawa H, et al. Maternal depression can undermine the development of young children. Centre on the developing child, Harvard University; 2009.
citation: Sabourin S, Valois P, Lussier Y. Development and validation of a brief version of the dyadic adjustment scale with a nonparametric item analysis model. Psychol Assess. 2005 Mar;17(1):15-27. doi: 10.1037/1040-3590.17.1.15.