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Clinical Trials/NCT06757374
NCT06757374
Completed
Not Applicable

Evaluation of First-Trimester Maternal Serum Resistin in Hyperemesis Gravidarum

Dr. Lutfi Kirdar Kartal Training and Research Hospital1 site in 1 country210 target enrollmentDecember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperemesis Gravidarum - Severe
Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Enrollment
210
Locations
1
Primary Endpoint
PUQE
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2022
End Date
June 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Mete Kırlangıç

Assoc Prof

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

PUQE

Time Frame: Immediately after admission in the first trimester

the PUQE-24 questionnaire was used to evaluate the severity of HG, and those with a score of ≤6 were considered as mild HG, 6-12 as moderate HG, and ≥13 as severe HG

Secondary Outcomes

  • Resistin levels(Immediately after admission in the first trimester)
  • OGTT(admission in 24-28 th week in pregnancy)

Study Sites (1)

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