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

Sponsor
rasha fawzy abd el kader (Other)
Overall Status
Completed
CT.gov ID
NCT02830321
Collaborator
(none)
90
Enrollment
9
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • rasha fawzy abd el kader

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    rasha fawzy abd el kader, Principal Investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02830321
    Other Study ID Numbers:
    • FDAAA
    First Posted:
    Jul 12, 2016
    Last Update Posted:
    Jul 12, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hyperemesis Gravidarum

    Study Results

    No Results Posted as of Jul 12, 2016