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临床试验/NCT02830321
NCT02830321已完成不适用

Study to Explore the Association Between Hyperemesis Gravidarum in Pregnant Women and Helicobacter Pylori Infection by Using H.P. Stool Antigen Test to Diagnose H Pylori Infection

rasha fawzy abd el kader0 个研究点目标入组 90 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
主要终点
The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women

研究概览

简要总结

The purpose of this study to explore the association between Hyperemesis Gravidarum in pregnant women and Helicobacter pylori infection.

详细描述

This study included 90 pregnant women during their first trimester who attended Ain Shams University Maternity Hospital antenatal clinic and admitted in the ward.

Patients were divided into two groups: 46 cases of pregnant women with H.G and 44 healthy control pregnant women with no vomiting.

Both groups were matched regarding the inclusion criteria which includes maternal age (18-40 years), gestational age (<16 wks), and signs and symptoms of H.G for cases (vomiting affecting the general condition, ketonuria, weight loss) and excluding cases or controls with multiple gestation, hyadatiform disease or maternal disease causes vomiting such as ; pyelonephritis, gastroenteritis, cholecystitis or hepatitis.

The two groups were subjected to full history taking, clinical examination, routine laboratory investigations (urine analysis, CBC, liver, kidney function tests Na, k, PT, PTT & INR) Abdominal ultrasound was done to assess fetal life and gestational age and to exclude gestational trophoblastic disease and multiple gestation pregnancy.H.Pylori infection was assessed by using One step H.pylori Stool Antigen Test.

(CER TEST BIOTEC) pol. Industrial Rio Gallego II,Calle J, No 1, 50840, San Mateo de Gallego, Zaragoza (SPAIN) for the detection of H. pylori antigen.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age: 18-40 years old
  • Gestational age: less than 16 weeks confirmed by U/S
  • Excessive pregnancy - related nausea and /or vomiting that prevent adequate intake of food and fluids.
  • Measuring weight loss(>5% of pre-pregnancy weight)
  • Signs of dehydration:
  • Ketonuria (+1 or more)
  • Hemoconcentration (normal Female hematocrit value (36.1-44.3%)

排除标准

  • Multiple gestation pregnancy
  • Hydatidiform molar pregnancy
  • Other causes of vomiting:
  • Gastroentritis
  • Cholecystitis
  • Pyelonephritis
  • Liver dysfunction

结局指标

主要结局

The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women

时间窗: from march 2015 to december 2015

90 Participants were assessed by using H.p.S.Ag test to detect helicobacter infection in pregnant women

次要结局

未报告次要终点

研究者

发起方
rasha fawzy abd el kader
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

rasha fawzy abd el kader

Principal Investigator

Ain Shams University

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