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

NCT05935371 | Unknown DMC

• 1 other identifier: 327802
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• 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):

  study to be completed over a 12 month period

• 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):

  study to be completed over a 12 month period

• 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):

  study to be completed over a 12 month period

• 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):

  study to be completed over a 12 month period

• 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):

  study to be completed over a 12 month period

Study Arms (2)

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

Control group - women without perineal tears

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

London Northwest Healthcare NHS Trust

London, Brent, NW107NS, United Kingdom

RECRUITING

Related Publications (7)

• 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.

  PMID: 12387470 BACKGROUND

• 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.

  PMID: 33726703 BACKGROUND

• 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.

  PMID: 24024205 BACKGROUND

• 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.

  PMID: 30283380 BACKGROUND

• 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.

  PMID: 35366595 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15769225 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: July 7, 2023
• Study Start: October 26, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)