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

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

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

Study Overview

• Status: Completed
• Conditions: Hyperemesis Gravidarum
• Intervention / Treatment: Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)

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 Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Study will include pregnant women in the first trimester attending Ain Shams University Maternity Hospital antenatal clinic and admitted in the ward.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; Other Names: (CER TEST BIOTEC)
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.	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; Other Names: (CER TEST BIOTEC)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: rasha fawzy abd el kader

Publications and helpful links

General Publications

• 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).

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 3, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pregnancy Complications; Morning Sickness; Vomiting; Hyperemesis Gravidarum
• Other Study ID Numbers: FDAAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No