Research Plan for Development and Validation of a Logistic Regression Derived Algorithm to Estimate the Risk of Obstetric Anal Sphincter Injury in High- and Low-risk Scenarios.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800,000
- 试验地点
- 1
- 主要终点
- Obstetric anal sphincter injury in term pregnancy ≥ 37+0 and a singleton pregnancy
研究概览
简要总结
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.
详细描述
Research plan for development and validation of a logistic regression derived algorithm to estimate the risk of obstetric anal sphincter injury
Aim The aim of this study is to develop and validate prediction models for the risk of an OASI in high- and low-risk scenarios.
Study design The study will be restricted to cover 10 years from 2009 to 2018. The primary data source will be the Swedish Medical Birth Register (MBR). In addition, data will be retrieved from the National Patient Register, which comprises data on health care episodes in inpatient (hospital) and outpatient specialist care maintained by the Swedish National Board of Health and Welfare and the Swedish Longitudinal Integrated Database for Health Insurance and Labor Market Studies maintained by Statistics Sweden.
The following inclusion criteria will be applied:
- The 1st and the 2nd vaginal delivery, with secured information on the number of births and the mode of delivery
- Singleton pregnancies
- Gestational week ≥37+0
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The 1st and the 2nd vaginal delivery, with secured information on the number of births and the mode of delivery
- •Singleton pregnancies
- •Gestational week ≥37+0
排除标准
- •Preterm deliveries <37 weeks
- •. Multifetal pregnancies
结局指标
主要结局
Obstetric anal sphincter injury in term pregnancy ≥ 37+0 and a singleton pregnancy
时间窗: 2009-2018
The Swedish medical birth register (MBR) follow the International Classification of Diseases, 10th revision (ICD-10), for OASI. For identification of the outcome OASI, the following codes will be used. * ICD 070.2, O70.2C, O70.2D, O70.2E, O70.2F, O70.2X (third-degree tear, which involves part of or the entire anal sphincter), and/or * ICD O70.3 (fourth-degree tear, which extends further to the rectal mucosa) and/or * the variable "Sphincter, (SFINKTER)" is "1" * the surgical Diagnosis Related Groups (DRG code) is MBC33 (suture of a third- or a fourth-degree perineal tear).
次要结局
未报告次要终点
研究者
Maria Gyhagen
Principal Investigator Maria Gyhagen MD, PhD.
Sodra Alvsborgs Hospital