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

Hyperemesis Gravidarum Clinical Trial

— AOHPIPOHGIPW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830321
• Other study ID #: FDAAA
• Status: Completed
• Phase: N/A
• First received: July 3, 2016
• Last updated: July 11, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperemesis Gravidarum

Intervention

Other:
• helicopacter pylori stool antigen test (CER TEST BIOTEC)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
rasha fawzy abd el kader

References & Publications (1)

Increased estrogen production causes decreased secretions of hydrochloric acids; therefore peptic ulcer formation or flare - up of existing peptic ulcers is uncommon during pregnancy and may improve (Winbery and Blaho, 2001).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes