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
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
- 是
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
rasha fawzy abd el kader
Principal Investigator
Ain Shams University
