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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
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Tracking Information
First Submitted Date November 13, 2013
First Posted Date November 19, 2013
Last Update Posted Date November 19, 2013
Study Start Date October 2013
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2013)
serum serotonin levels in hiperemezis gravidarum [ Time Frame: 6-14week pregnancy ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 18, 2013)
ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis [ Time Frame: 6-14week pregnancy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 18, 2013)
ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg [ Time Frame: 6-14week pregnancy ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis
Official Title Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population pregnant women between six and fourteen weeks
Condition
  • Nausea
  • Vomiting
  • Markedly Reduced Food Intake
  • Severe Dehydration
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 18, 2013)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2014
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT01987869
Other Study ID Numbers 2013-88
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study Sponsor Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Collaborators Not Provided
Investigators
Study Chair: hüseyin cengiz, md Bakırkoy Dr. Sadi Konuk Training and Research Hospital
PRS Account Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Verification Date November 2013