MedTrace Logo

Development and Validation of a Logistic Regression Algorithm to Predict the Risk of Obstetric Anal Sphincter Injury.

NCT05218837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 800000

Last updated 2022-02-17

No results posted yet for this study

Summary

An obstetric anal sphincter injury (OASI) occurs during the final stage of a vaginal delivery. This tissue laceration, even if adequately sutured, poses a substantial threat to bowel continence in women.1,2 In a recent register-based study we showed that following an OASI at the first birth, the risk of a repeat injury almost tripled and that the long-term prevalence of fecal incontinence (FI) doubled in women with 1 OASI and tripled in those with 2 consecutive OASIs, in comparison with nulliparous women not affected by childbirth.3 Most OASIs occur seemingly by chance in the absence of known risk markers, and there is still no prediction model that is of use to avoid OASI in the clinical setting.4 Therefore, these injuries are often excused as inevitable and impossible to foresee.

The aim of this study is to develop and validate prediction models for the risk of an OASI in high- and low-risk scenarios.

Conditions

  • Sphincter (Anal); Perineal Rupture, Obstetric

Interventions

OTHER

Vaginal birth

Obstetric anal sphincter injury occurs at the final stage of vaginal delivery.

Sponsors & Collaborators

  • Maria Gyhagen

    lead OTHER

Principal Investigators

  • Maria Gyhagen, MD, PhD

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218837 on ClinicalTrials.gov