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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01987869
Other study ID # 2013-88
Secondary ID
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


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
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