NauseaNCT01987869
Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis
An observational study of Nausea and Vomiting, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Nausea, Vomiting, Markedly Reduced Food Intake
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2013to Mar 2014
- 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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: pregnant women between six and fourteen weeks
Who may be able to join
- 6-14 week pregnant women
- nausea
- protracted vomiting
- inability to tolerate food intake accompanied by obvious dehydration
- severe enough to justify hospitalisation
- at least 2+ ketonuria on dipstick urinanalysis.
Who cannot join
- with metabolic disorders such as diabet, thyroid
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34140
hediye dagdeviren, md, 5079872463, hediyedagdeviren@gmail.com
huseyin cengiz, md
About this study
Official title: Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis
Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.
Read the detailed description
The occurrence of severe nausea and vomiting of early pregnancy (hiperemezis gravid arum) is estimated between 0.3% to 1% of all pregnancies. Although hiperemezis gravid arum has been recognized for a long time, its pathophysiologic mechanisms are still poorly understood. Many theories have been advocated, but to date none of these have been convincing.
It has been demonstrated that the nausea and vomiting associated with increased in serotonin liberation. This has provided a rationale for the treatment of these symptoms with specific serotonin antagonists.
The aim of this trial was to investigate the possible relationship between hiperemezis gravid arum and serotonin liberation.
- Conditions
- Nausea, Vomiting, Markedly Reduced Food Intake, Severe Dehydration
- Keywords
- hiperemesis gravidarum,vomiting,serotonin levels,ketonuria
- Medical subject headings
- Nausea, Vomiting, Dehydration
What is being measured
The primary outcome is the main question the study is designed to answer.
serum serotonin levels in hiperemezis gravidarum
Measured: 6-14week pregnancy
Secondary outcomes (1)
ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis
Measured: 6-14week pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- hüseyin cengiz, md, Study chair, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987869
- Sponsor's protocol ID
- 2013-88
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis
- ClinicalTrials.gov ID
- NCT01987869
- Acronym / sponsor ID
- 2013-88
- Conditions
- Nausea, Vomiting, Markedly Reduced Food Intake, Severe Dehydration
- Keywords
- hiperemesis gravidarum,vomiting,serotonin levels,ketonuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 19 Nov 2013 (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.
Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.
Detailed description
The occurrence of severe nausea and vomiting of early pregnancy (hiperemezis gravid arum) is estimated between 0.3% to 1% of all pregnancies. Although hiperemezis gravid arum has been recognized for a long time, its pathophysiologic mechanisms are still poorly understood. Many theories have been advocated, but to date none of these have been convincing.
It has been demonstrated that the nausea and vomiting associated with increased in serotonin liberation. This has provided a rationale for the treatment of these symptoms with specific serotonin antagonists.
The aim of this trial was to investigate the possible relationship between hiperemezis gravid arum and serotonin liberation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pregnant women between six and fourteen weeks
Key inclusion criteria (6 listed)
- 6-14 week pregnant women
- nausea
- protracted vomiting
- inability to tolerate food intake accompanied by obvious dehydration
- severe enough to justify hospitalisation
Key exclusion criteria (1 listed)
- with metabolic disorders such as diabet, thyroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum serotonin levels in hiperemezis gravidarum
Time frame: 6-14week pregnancy
1 secondary outcome
ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis
Time frame: 6-14week pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
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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.
hüseyin cengiz, md study chair
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hediye dağdeviren, md (5079872463, hediyedagdeviren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum serotonin levels in hiperemezis gravidarum (time frame: 6-14week pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2013.