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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Hyperemesis Gravidarum

Intervention / Treatment
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* Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%) Exclusion Criteria: Multiple gestation pregnancy Hydatidiform molar pregnancy Other causes of vomiting: Gastroentritis Cholecystitis Pyelonephritis Liver dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case<br>Pregnant women who suffered from hyperemesis gravidarum and admitted in the hospital Age: 18-40 years old Gestational age: less than 16 weeks confirmed by pelvic u/s Excessive pregnancy - related nausea and /or vomiting that prevent adequate intake of food and fluids. All pregnant (case and control) were asked to bring a stool sample in a clean container. Collected samples were tested in a laboratory (Ain Shams Univerisity hospital). Stool samples were be tested by using one step H.pylori stool antigen test (CER TEST BIOTEC) for the detection of H. pylori antigen. | Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)<br>* Stool samples were tested by using one step H.pylori stool antigen test (CER TEST BIOTEC)for the detection of H. pylori antigen in pregnant women with hyperemesis gravidarum<br>* Other names: (CER TEST BIOTEC);|
| control<br>Control patients which are selected from pregnant women presenting to the outpatient clinics for routine antenatal care of the same gestational age, same age range and same socioeconomic standard as cases. | Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)<br>* Stool samples were tested by using one step H.pylori stool antigen test (CER TEST BIOTEC)for the detection of H. pylori antigen in pregnant women with hyperemesis gravidarum<br>* Other names: (CER TEST BIOTEC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women | 90 Participants were assessed by using H.p.S.Ag test to detect helicobacter infection in pregnant women | from march 2015 to december 2015 |