Clinical trial NCT02830321: The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperemesis Gravidarum
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women
timeFrame: from march 2015 to december 2015
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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).