Incontinence Clinical Trial
— COMPaREOfficial title:
The Impact of Severe Perineal Trauma on Maternal Mental Health and Intra-family Relationships
NCT number | NCT05935371 |
Other study ID # | 327802 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 26, 2023 |
Est. completion date | October 2025 |
Verified date | June 2023 |
Source | London North West Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 87 |
Est. completion date | October 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | London Northwest Healthcare NHS Trust | London | Brent |
Lead Sponsor | Collaborator |
---|---|
London North West Healthcare NHS Trust | Imperial College Healthcare NHS Trust |
United Kingdom,
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. — View 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. — View 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. — View 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. — View 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.
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the impact of an obstetric anal sphincter injury on | the incidence of depression using the patient health questionnaire-9 screening tool. The binary outcome cut off is 10 for this questionnaire. The higher the score the worse the outcome. Mininum score 0. Maximum score 27. | study to be completed within 12 months | |
Primary | the impact of an obstetric anal sphincter injury on | the presence and severity of post-traumatic stress disorder using the post-traumatic stress disorder checklist (PCL-5) screening tool. Outcome is continuous. The higher the score, the worse the outcome. Minimum score 0. Maximum score 80. | study to be completed within 12 months | |
Primary | the impact of an obstetric anal sphincter injury on | patient self-esteem using the rosenberg self-esteem scale. The binary outcome cut off is 15. Range is 0-30. Scores below 15 suggest low self esteem. | study to be completed within 12 months | |
Primary | the impact of an obstetric anal sphincter injury on | sexual dysfunction (quantifying sex drive, arousal, vaginal lubrication/penile erection, ability to reach and satisfaction from orgasm) using the arizona sexual experiences scale. Range of score from 5-30. A total score > or equal to 19 or any 1 item with an individual score of more than or equal to 5 or any 3 items with individual scores of more than or equal to 4 are highly correlated with the presence of sexual dysfunction. | study to be completed within 12 months | |
Primary | the impact of an obstetric anal sphincter injury on | quality of a relationship within an intact couple using the abbreviated dyadic adjustment scale (DAS-4). A score of 14 is the binary outcome cut off.0-21 range. Higher the score the better the relationship. | study to be completed within 12 months | |
Primary | the impact of an obstetric anal sphincter injury on | anxiety using the generalised anxiety disorder-7 screening tool. The binary outcome cut off is 10. Range is 0-21. The higher the score, the greater the anxiety. | study to be completed within 12 months | |
Primary | the impact of an obstetric anal sphincter injury on | mother to infant bonding using the mother to infant bonding scale. Range score 0-24. The higher the score, the more likely bonding is disrupted. | study to be completed within 12 months | |
Secondary | 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): | age | study to be completed over a 12 month period | |
Secondary | 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): | type of delivery (e.g. instrumental/assisted or spontaneous vaginal delivery) | study to be completed over a 12 month period | |
Secondary | 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): | number of vaginal births | study to be completed over a 12 month period | |
Secondary | 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): | history of previous obstetric anal sphincter injury. The researchers will attempt to obtain this information by reviewing the patient's medical records and asking the patient if they have been previously diagnosed with an obstetric anal sphincter injury. | study to be completed over a 12 month period | |
Secondary | 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): | grade of tear (assessed clinically or radiologically) | study to be completed over a 12 month period | |
Secondary | 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): | Obstetric Anal sphincter Injury (OASI) induced incontinence and severity (as assessed by St Mark's incontinence scale). St Mark's score ranges from 0-24. Abnormal is scores more than 5. The greater the score, the greater the incontinence score. | study to be completed over a 12 month period |
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