Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis

Nausea Clinical Trial

Official title:

Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01987869
• Other study ID #: 2013-88
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: November 18, 2013
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2013
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: hediye dagdeviren, md
• Phone: 5079872463
• Email: hediyedagdeviren[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dehydration
• Markedly Reduced Food Intake
• Nausea
• Severe Dehydration
• Vomiting

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	is there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg		6-14week pregnancy	No
Primary	serum serotonin levels in hiperemezis gravidarum		6-14week pregnancy	No
Secondary	is there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis		6-14week pregnancy	No