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Completed

NCT Number: NCT02830321

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

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

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

helicopacter pylori stool antigen test (CER TEST BIOTEC)

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

Other names: (CER TEST BIOTEC)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

rasha fawzy abd el kader

Other

Registry information

Official study 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

Acronym: AOHPIPOHGIPW

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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