Hiperemezis and Serotonin Elevated Serum Serotonin Levels... | NCT01987869

Studies
Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis

NCT01987869

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Status

Unknown status

Last Update Posted

Nov 19, 2013Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Nausea
Vomiting
Markedly Reduced Food Intake
Severe Dehydration

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Nov 13, 2013

First Submission Date that Met QC Criteria

Nov 18, 2013

First Posted Date

Nov 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2013

Last Update Posted Date

Nov 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

pregnant women between six and fourteen weeks

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hediye dağdeviren, md	Contact	5079872463		hediyedagdeviren@gmail.com

Overall Officials

Name	Affiliation	Role
hüseyin cengiz, md	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bakirkoy Dr Sadi Konuk Training and Research Hospital	Recruiting	Istanbul	Istanbul	34140	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting
D003681	Dehydration

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014883	Water-Electrolyte Imbalance

Browse Leaves

Not provided

Browse Branches

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