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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830321
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
rasha fawzy abd el kader, Ain Shams University

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
Hyperemesis Gravidarum 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.

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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 : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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 Name: (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 Name: (CER TEST BIOTEC)




Primary Outcome Measures :
  1. The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women [ Time Frame: from march 2015 to december 2015 ]
    90 Participants were assessed by using H.p.S.Ag test to detect helicobacter infection in pregnant women



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

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).

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Responsible Party: rasha fawzy abd el kader, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT02830321    
Other Study ID Numbers: FDAAA
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms