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

NCT ID: NCT02830321

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Hyperemesis Gravidarum

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

case

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.

helicopacter pylori stool antigen test (CER TEST BIOTEC)

Intervention Type: OTHER

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

control

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.

helicopacter pylori stool antigen test (CER TEST BIOTEC)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

(CER TEST BIOTEC)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

rasha fawzy abd el kader

OTHER

Sponsor Role: lead

Responsible Party

rasha fawzy abd el kader

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

References

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).

Reference Type: BACKGROUND

Other Identifiers

FDAAA

Identifier Type: -

Identifier Source: org_study_id