Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01987869
First received: November 13, 2013
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.


Condition
Nausea
Vomiting
Markedly Reduced Food Intake
Severe Dehydration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • serum serotonin levels in hiperemezis gravidarum [ Time Frame: 6-14week pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis [ Time Frame: 6-14week pregnancy ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg [ Time Frame: 6-14week pregnancy ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

pregnant women between six and fourteen weeks

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987869

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

Locations
Turkey
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
Investigators
Study Chair: hüseyin cengiz, md bakirkoy dr sadi konuk training and research hospital
  More Information

No publications provided

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01987869     History of Changes
Other Study ID Numbers: 2013-88
Study First Received: November 13, 2013
Last Updated: November 18, 2013
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 19, 2014