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临床试验/NCT06962644
NCT06962644招募中不适用

Association of Urinary Tract Infection With Preeclampsia During Pregnancy

Pakistan Air Force (PAF) Hospital Islamabad1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Preeclampsia

研究概览

简要总结

Urinary tract infections (UTIs) are a major clinical issue, especially in pregnant women, due to physiological changes that increase susceptibility. If untreated, UTIs can lead to severe complications like preterm labor and low birth weight. Preeclampsia, a hypertensive disorder affecting 0.2-9.2% of pregnancies, is another leading cause of maternal and fetal complications. The relationship between UTIs and preeclampsia remains controversial, with some studies suggesting an association while others show conflicting results. Research gaps highlight the need for region-specific studies, particularly in Pakistan, where both conditions contribute significantly to maternal and neonatal morbidity.

This study aims to investigate the association between UTIs and preeclampsia in pregnant women in Pakistan. It will use a cohort design, enrolling 160 patients (80 with UTIs, 80 without) from the Obstetrics Department of PAF Hospital, Islamabad. Participants will be followed until delivery, with preeclampsia diagnosed based on blood pressure and proteinuria criteria. Data will be analyzed using SPSS to calculate relative risk (RR), with statistical significance set at RR >1 and p ≤ 0.05. The findings could help improve prenatal care and reduce adverse outcomes in high-risk populations.

详细描述

INTRODUCTION Urinary tract infections (UTIs) are a significant clinical concern, representing one of the most common bacterial infections in women, particularly during pregnancy. Globally, UTIs account for a substantial proportion of healthcare visits and are implicated in severe complications, including maternal and neonatal morbidity. The physiological and anatomical changes that occur during pregnancy, such as urinary stasis, hormonal influences, and alterations in the immune system, increase susceptibility to both asymptomatic bacteriuria and symptomatic UTIs. These infections can escalate to severe outcomes if untreated, with potential risks to maternal and fetal health, including preterm labor, low birth weight, and perinatal mortality. Concurrently, preeclampsia, a hypertensive disorder of pregnancy, which 0.2 to 9.2% of pregnancies, remains a leading cause of maternal and fetal complications. With its multifactorial etiology involving placental ischemia, systemic inflammation, and endothelial dysfunction, preeclampsia poses a critical challenge in obstetric care.

The relationship between UTIs and preeclampsia is an area of considerable clinical interest yet remains controversial. While some studies have highlighted an association between maternal infections, including UTIs, and an increased risk of preeclampsia, others have yielded conflicting results. Factors such as immune system dysregulation, systemic inflammation, and endothelial dysfunction, which are central to preeclampsia, may be exacerbated by UTIs. Despite extensive research, inconsistencies in prevalence estimates, study designs, and patient populations have hindered a definitive understanding of this association. One study found that 40% and 17.5% patients developed preeclampsia with and without UTI exposure respectively (p value 0.036). The relative risk (RR) was 2.47 (95%CI 1.1789 to 5.1777) with p value of 0.0166. Another study showed that UTI increases the risk of preeclampsia the OR was significant, but RR was not significant. [OR=1.86, (95% Confidence: 2.235-1.608) (p<0.043), RR 1.2028 (95%CI 0.9018 to 1.6041, p = 0.2089).

The results of a study showed that among 393 pregnant women enrolled, 110 (28.0%), had significant bacteriuria and women with preeclampsia had 7.7 odds of having significant bacteriuria (p-value <0.001). Radu, V. D., et al. found that there was no association of UTI and preeclampsia (aOR 2.07 with 95% CI 0.63-6.65, P value = 0.22). These knowledge gaps underscore the need for region-specific studies to assess whether UTIs contribute to preeclampsia and how they might influence maternal and perinatal outcomes, particularly in populations with distinct socioeconomic, healthcare, and environmental factors.

This study aims to investigate the association between UTIs and preeclampsia during pregnancy in Pakistan, where both conditions significantly contribute to maternal and neonatal morbidity and mortality. Pakistan's high burden of maternal infections and hypertensive disorders of pregnancy necessitates targeted research to identify preventable risk factors and improve clinical outcomes. 3, 6 By exploring the interplay between UTIs and preeclampsia, this research seeks to provide evidence-based insights that can inform public health strategies, enhance prenatal care protocols, and ultimately reduce the adverse effects of these conditions on maternal and fetal health in this region.

OBJECTIVE To find association of urinary traction infection with preeclampsia in pregnancy.

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patients attending OPD for routine antenatal checkup
  • •Patients diagnosed with UTI as per operational definitions
  • •Gestational age greater than 20 weeks as per LMP
  • •Age between 18 to 35 years

排除标准

  • •History of medical conditions such as:
  • •Diabetes mellitus
  • •Chronic hypertension
  • •Chronic liver or kidney diseases
  • •Chronic pulmonary conditions
  • •History of urological surgical interventions in the past 3 months
  • •History of renal transplants
  • •Patients on immunosuppressive therapy
  • •History of comorbid conditions including:
  • •Diabetes mellitus
  • •Gestational diabetes mellitus
  • •Hypertension
  • •Chronic hepatic diseases
  • •Chronic liver diseases
  • •Chronic pulmonary diseases
  • •Ischemic heart diseases

结局指标

主要结局

Preeclampsia

时间窗: 37 weeks of pregnancy

It will be defined as BP \>140/90 mmHg on minimum two occasions after 20 weeks of pregnancy alongside presence of proteinuria (≥300 mg/day or at least 1+ dipstick testing or spot urine protein/creatinine ratio of ≥30 mg/mmol).

次要结局

未报告次要终点

研究者

发起方
Pakistan Air Force (PAF) Hospital Islamabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wajeeha Fatima

Principal Investigator

Pakistan Air Force (PAF) Hospital Islamabad

研究点 (1)

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