First Trimester Resistin Levels in HG

Republic of Turkey Ministry of Health

Status: Completed

Conditions: Gestational Diabetes Mellitus (GDM); Hyperemesis Gravidarum - Severe; Resistin

Treatments: Diagnostic Test: Resistin

Study type: Interventional

Funder types: Other

Identifiers

NCT06757374

09.2020.1141

Details and patient eligibility

About

This cross-sectional case-control study was conducted in Tuzla State Hospital Obstetrics Clinic in Turkey. The study evaluated 400 pregnant women during their first trimester of pregnancy. Many pregnant women (50-90%) experience nausea and vomiting during their first trimester; however, some patients have a disease called "hyperemesis gravidarum" (HG) characterized by very severe nausea and vomiting that may require hospitalization. resistin" is a peptide which is secreted primarily by human adipocytes and mononuclear cells. Evidence suggests that resistin increases plasma glucose concentration, reduces glucose intake by adipocytes, and promotes insulin resistance. Considering the HG effect on endocrinologic and metabolic complications, we hypothesized that resistin levels in maternal serum may change in the presence of HG; therefore, the aim of the present study was to evaluate these resistin levels during the first trimester and their correlation with HG severity.

Enrollment: 210 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Those who applied in the first trimester and had a mid-trimester OGTT result

Exclusion criteria

1. multifetal pregnancy, 2) fetal chromosomal or structural anomalies, 3) pregestational DM, 4) chronic hypertension or history of preeclampsia, 5) thyroid disease, 5) chronic kidney disease, 6) autoimmune disease, or 7) long-term use of aspirin or glucocorticoids 8) without OGTT results.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Mild HG

Experimental group

Description:

In pregnant women admitted in the first trimester, blood samples were first taken and the PUQE-24 questionnaire was used to evaluate the severity of HG, and those with a score of ≤6 were considered as mild HG

Treatment:

Diagnostic Test: Resistin

Modarete HG

Experimental group

Description:

In pregnant women admitted in the first trimester, blood samples were first taken and the PUQE-24 questionnaire was used to evaluate the severity of HG, and those with a score of 7-12 were considered as modarete HG

Treatment:

Diagnostic Test: Resistin

Severe HG

Experimental group

Description:

In pregnant women admitted in the first trimester, blood samples were first taken and the PUQE-24 questionnaire was used to assess the severity of HG, and those with a score of ≥13 were considered to have severe HG.

Treatment:

Diagnostic Test: Resistin