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Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis

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ClinicalTrials.gov Identifier: NCT01987869
Recruitment Status : Unknown
Verified November 2013 by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Recruitment status was:  Recruiting
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.

Condition or disease
Nausea Vomiting Markedly Reduced Food Intake Severe Dehydration

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

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis
Study Start Date : October 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. serum serotonin levels in hiperemezis gravidarum [ Time Frame: 6-14week pregnancy ]

Secondary Outcome Measures :
  1. ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis [ Time Frame: 6-14week pregnancy ]

Other Outcome Measures:
  1. ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg [ Time Frame: 6-14week pregnancy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
pregnant women between six and fourteen weeks

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • with metabolic disorders such as diabet, thyroid
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987869

Contact: hediye dağdeviren, md 5079872463 hediyedagdeviren@gmail.com

Bakirkoy Dr Sadi Konuk Training and Research Hospital Recruiting
Istanbul, Turkey, 34140
Contact: hediye dagdeviren, md    5079872463    hediyedagdeviren@gmail.com   
Principal Investigator: huseyin cengiz, md         
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study Chair: hüseyin cengiz, md bakirkoy dr sadi konuk training and research hospital
More Information

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01987869     History of Changes
Other Study ID Numbers: 2013-88
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
hiperemesis gravidarum,vomiting,serotonin levels,ketonuria

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs