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临床试验/NCT06902155
NCT06902155已完成不适用

Impact of Diabetes Subtypes on Urinary Incontinence During Pregnancy and Postpartum: A Study on BMI and Glycemic Control

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
147
试验地点
1
主要终点
Maternal serum HbA1c levels for pregnancy-related and postpartum UI

研究概览

简要总结

Objective: This study investigated the relationship between diabetes mellitus and urinary incontinence (UI) during pregnancy and postpartum, focusing on metabolic factors like body mass index (BMI) and glycemic control.

Methods: A prospective observational study was conducted at Başakşehir Çam and Sakura City Hospital, including 147 pregnant women in their third trimester (≥30 weeks). Participants were categorized into type 1 diabetes mellitus (n = 16), type 2 diabetes mellitus (n = 32), gestational diabetes mellitus (GDM) (n = 51), and a control group (n = 48). UI was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and metabolic parameters were retrieved from hospital records. Subgroup comparisons and ROC curve analysis were performed to determine BMI and HbA1c cut-off values for predicting postpartum UI.

详细描述

This prospective observational study was conducted at ...... between ......with participants recruited from the obstetrics department. A total of 147 pregnant women in their third trimester (≥30 weeks) were enrolled and categorized into four groups: type 1 diabetes mellitus (T1DM) group (n = 16), type 2 diabetes mellitus (T2DM) group (n = 32), gestational diabetes mellitus (GDM) group (n = 51), and a control group (CG) consisting of healthy pregnant women with uncomplicated pregnancies (n = 48). Participants were aged between 18 and 40 years and had good physical and mental health. Eligibility criteria included singleton pregnancy, gestational age of at least 30 weeks, and no history of known urological disorders, while exclusion criteria encompassed multiple pregnancies, chronic kidney disease, and prior urogynecological surgery.

Maternal age, insulin use, and history of pre-pregnancy urinary incontinence (UI) were obtained through direct patient interviews. Third-trimester HbA1c levels and complete urinalysis results were extracted from the hospital's digital medical records. Urinary incontinence was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), a validated instrument with a Cronbach's alpha of 0.88. This tool consists of four items: three scored questions evaluating leakage frequency (0-5), volume (0-6), and impact on quality of life (0-10), summing to a total score of 0-21, and one unscored question identifying situations where incontinence occurs. Two separate analyses were performed: total ICIQ-SF score and responses to question 6, which identified UI-triggering situations.

To minimize selection bias, only participants meeting strict inclusion and exclusion criteria were enrolled. The study size was determined based on previous studies to ensure adequate statistical power for subgroup analyses.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Aged between 18 and 40 years
  • •Had good physical and mental health.
  • •Had singleton pregnancy
  • •Had no history of known urological disorders
  • •At least 30 weeks gestational aged , pregnants

排除标准

  • •multiple pregnancies
  • •pregnants with chronic kidney disease, and prior urogynecological surgery.

结局指标

主要结局

Maternal serum HbA1c levels for pregnancy-related and postpartum UI

时间窗: From the time of inclusion in the study until the first postpartum month.

HbA1c levels were significantly associated with an increased severity of incontinence in women with GDM.

BMI for pregnancy-related and postpartum UI

时间窗: From the time of inclusion in the study until the first postpartum month.

BMI was a strong predictor of postpartum incontinence persistence in both the type 1 diabetes and GDM groups,

insulin use for pregnancy-related and postpartum UI

时间窗: From the time of inclusion in the study until the first postpartum month.

insulin use did not significantly impact UI severity during pregnancy in any of the diabetes subgroups.

maternal age and history of urinary tract infection for pregnancy-related and postpartum UI

时间窗: From the time of inclusion in the study until the first postpartum month.

maternal age and history of urinary tract infection were not significantly associated with UI severity or postpartum incontinence in any diabetes group.

次要结局

未报告次要终点

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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