Hyperemesis GravidarumAOHPIPOHGIPWNCT02830321
The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women
An observational study of Hyperemesis Gravidarum, run by rasha fawzy abd el kader.
Trial summary
The purpose of this study to explore the association between Hyperemesis Gravidarum in pregnant women and Helicobacter pylori infection. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum
- What is being tested?
- helicopacter pylori stool antigen test (CER TEST BIOTEC)
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study will include pregnant women in the first trimester attending Ain Shams University Maternity Hospital antenatal clinic and admitted in the ward.
Who may be able to join
- 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%)
Who cannot join
- Multiple gestation pregnancy
- Hydatidiform molar pregnancy
- Other causes of vomiting:
- Gastroentritis
- Cholecystitis
- Pyelonephritis
- Liver dysfunction
About this study
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
The purpose of this study to explore the association between Hyperemesis Gravidarum in pregnant women and Helicobacter pylori infection.
Read the 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.
- Conditions
- Hyperemesis Gravidarum
- Being tested
- helicopacter pylori stool antigen test (CER TEST BIOTEC)
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helicopacter pylori stool antigen test (CER TEST BIOTEC)Other
Also called (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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: helicopacter pylori stool antigen test (CER TEST BIOTEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from march 2015 to december 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- rasha fawzy abd el kader
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, rasha fawzy abd el kader, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830321
- Sponsor's protocol ID
- FDAAA
- Acronym
- AOHPIPOHGIPW
- Status last verified
- Jul 2016
- First submitted
- 3 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02830321
- Acronym / sponsor ID
- AOHPIPOHGIPW / FDAAA
- Conditions
- Hyperemesis Gravidarum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- rasha fawzy abd el kaderUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)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. |
| control | – | Other: helicopacter pylori stool antigen test (CER TEST BIOTEC)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study will include pregnant women in the first trimester attending Ain Shams University Maternity Hospital antenatal clinic and admitted in the ward.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (7 listed)
- Multiple gestation pregnancy
- Hydatidiform molar pregnancy
- Other causes of vomiting:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| helicopacter pylori stool antigen test (CER TEST BIOTEC)Also: (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 | case, control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- BackgroundIncreased 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).
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis Gravidarum, run by rasha fawzy abd el kader.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women (time frame: from march 2015 to december 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.