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

Completed

• Conditions: Hyperemesis Gravidarum
• Interventions: Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)

• Registration Number: NCT02830321
• Lead Sponsor: rasha fawzy abd el kader

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-03
• Study First Submitted QC: 2016-07-11
• Last Update Submitted: 2016-07-11
• Study First Posted: 2016-07-12
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case	helicopacter pylori stool antigen test (CER TEST BIOTEC)	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.
control	helicopacter pylori stool antigen test (CER TEST BIOTEC)	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.

Primary Outcome Measures

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