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

NCT02830321 | Completed

• 1 other identifier: FDAAA
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hyperemesis Gravidarum

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

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)

Interventions

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

Also known as: (CER TEST BIOTEC)

case; control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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%)

You may not qualify if:

• Multiple gestation pregnancy
• Hydatidiform molar pregnancy
• Other causes of vomiting:
• Gastroentritis
• Cholecystitis
• Pyelonephritis
• Liver dysfunction

Sponsors & Collaborators

• rasha fawzy abd el kader: lead

Related Publications (1)

• 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).

  BACKGROUND

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 12, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share