NCT02989337

Brief Summary

The purpose of the study is to determine serum inflammatory adhesion molecules levels in hyperemesis gravidarum

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

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

December 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

December 8, 2016

Last Update Submit

December 8, 2016

Conditions

Keywords

Hyperemesis GravidarumInflammatory adhesion moleculesDehydration

Outcome Measures

Primary Outcomes (1)

  • Serum inflammatory adhesion molecules in hyperemesis gravidarum

    4 months

Study Arms (2)

hyperemesis gravidarum with dehydration

The first group was formed of the patients diagnosed hyperemesis gravidarum with dehydration

Control group

The control group was formed of the patients who were healthy pregnant women admitted to the clinic just for routine examination without any symptoms

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of 2 groups; (1) the hyperemesis gravidarum group, consist of 25 pregnant women who developed dehydration due to HG between 6 and 13 gestational weeks and between 18 and 35 years (2) the normal pregnancy group, consisting of 25 pregnant women.

You may qualify if:

  • gestational weeks
  • between 18-35 years of age
  • Single pregnancy
  • Dehydration due to HG

You may not qualify if:

  • Other pathologies causing nausea and vomiting;
  • gastroenteritis
  • gastroparesis
  • gall duct diseases
  • hepatitis
  • peptic ulcers
  • appendicitis
  • pyelonephritis
  • urinary tract stones
  • hyperthyroidism
  • hyperparathyroidism
  • migraine
  • vestibular diseases
  • Patients were excluded from the study in the presence of parameters that may cause endothelial dysfunction such as;
  • pregestational diabetes
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Training and Research Hospital

Kayseri, 38000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hyperemesis GravidarumDehydration

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Study Officials

  • Erdem SAHİN

    Kayseri Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdem SAHİN, Principal İnvestigator

CONTACT

Yusuf MADENDAG, Central Contact Backup

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 12, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

December 12, 2016

Record last verified: 2016-12

Locations