Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis

November 18, 2013 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34140
        • Recruiting
        • Bakirkoy Dr Sadi Konuk Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant women between six and fourteen weeks

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum serotonin levels in hiperemezis gravidarum
Time Frame: 6-14week pregnancy
6-14week pregnancy

Secondary Outcome Measures

Outcome Measure
Time Frame
ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis
Time Frame: 6-14week pregnancy
6-14week pregnancy

Other Outcome Measures

Outcome Measure
Time Frame
ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg
Time Frame: 6-14week pregnancy
6-14week pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Study Chair: hüseyin cengiz, md, Bakırköy Dr. Sadi Konuk Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-88

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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