NCT06245811

Brief Summary

In this study, the relationship between the severity of hyperemesis gravidarum (HEG) disease and subclinical inflammatory factors such as Platelet Crit (PCT), Hemoglobin/red cell distribution width ratio (HRR), Neutrophil/lymphocyte ratio (NLR), was investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 30, 2024

Last Update Submit

February 6, 2024

Conditions

Hyperemesis Gravidarum

Keywords

Hyperemesis gravidarumPlatelet criterion (PCT)Hemoglobin/red cell distribution width ratio (HRR)Neutrophil/lymphocyte ratio (NLR)

Outcome Measures

Primary Outcomes (1)

  • The Pregnancy Unique Quantification of Emesis/Stomach scoring system

    1: Weight loss of 5% or more since the beginning of pregnancy 2: Vomiting at least three times a day 3: A ketonuria value of +1 or higher on a urinalysis test

    2 months

Secondary Outcomes (1)

  • Body mass index

    2 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsHealthy pregnant women over 18 years of age, 5-16 weeks of gestation.
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A total of 213 pregnant women, including 102 pregnant women with hyperemesis gravidarum and 113 healthy pregnant women between 5-16 weeks of age, were included in the study.

You may qualify if:

  • Healthy pregnant women over 18 years of age
  • weeks of gestation.

You may not qualify if:

  • Smoking, urinary tract infections, previously diagnosed psychological disorders, gastrointestinal disorders, multiple pregnancies, eating disorders, thyroid disorders, inflammatory disease, pregnancy with assisted fertilization technique.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University, Faculty of Medicine

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVomitingSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kazım Uçkan

    Yuzuncu Yil University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

January 20, 2022

Primary Completion

March 20, 2022

Study Completion

June 20, 2022

Last Updated

February 7, 2024

Record last verified: 2024-01

Locations

TU(1)