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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06245811
Other study ID # UCKAN001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2022
Est. completion date June 20, 2022

Study information

Verified date January 2024
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

A total of 215 pregnant women, 102 with hyperemesis gravidarum and 113 healthy pregnant women, were included in the study. HEG patients were divided into three groups according to the modified PUQE classification: mild (n=38), moderate (n=32) and severe (n=32). In our study, we proposed using a new prognostic marker for HEG patients. We think that our study will be a source for future studies on HEG.


Recruitment information / eligibility

Status Completed
Enrollment 215
Est. completion date June 20, 2022
Est. primary completion date March 20, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy pregnant women over 18 years of age - 5-16 weeks of gestation. Exclusion Criteria: Smoking, urinary tract infections, previously diagnosed psychological disorders, gastrointestinal disorders, multiple pregnancies, eating disorders, thyroid disorders, inflammatory disease, pregnancy with assisted fertilization technique.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Yuzuncu Yil University, Faculty of Medicine Van

Sponsors (1)

Lead Sponsor Collaborator
Izzet Celegen

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Body mass index (BMI) (kg/m2) was obtained by dividing body weight (kg) by height (m2) squared 2 months
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