NCT01987869

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

November 13, 2013

Last Update Submit

November 18, 2013

Conditions

NauseaVomitingMarkedly Reduced Food IntakeSevere Dehydration

Keywords

hiperemesis gravidarum,vomiting,serotonin levels,ketonuria

Outcome Measures

Primary Outcomes (1)

  • serum serotonin levels in hiperemezis gravidarum

    6-14week pregnancy

Secondary Outcomes (1)

  • ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis

    6-14week pregnancy

Other Outcomes (1)

  • ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg

    6-14week pregnancy

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women between six and fourteen weeks

You may qualify if:

  • 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.

You may not qualify if:

  • with metabolic disorders such as diabet, thyroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

NauseaVomitingDehydration

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Officials

  • hüseyin cengiz, md

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

hediye dağdeviren, md

CONTACT

5079872463hediyedagdeviren@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 19, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

TU(1)