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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05945446
Other study ID # ecmettinErbakanUniversity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date January 1, 2023

Study information

Verified date July 2023
Source Necmettin Erbakan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Placenta Accreta Spectrum (PAS) represents a significant cause of maternal morbidity and mortality, causing complications that surpass those posed by most routine obstetric issues. As such, early detection and proper management of PAS can significantly improve pregnancy outcomes. This study provides an in-depth examination of the serum levels of Galectin-3, a β-galactoside-binding protein, in women experiencing Placenta Accreta Spectrum compared to those with normal pregnancies.


Description:

Placenta Accreta Spectrum (PAS) represents a significant cause of maternal morbidity and mortality, causing complications that surpass those posed by most routine obstetric issues. As such, early detection and proper management of PAS can significantly improve pregnancy outcomes. This study provides an in-depth examination of the serum levels of Galectin-3, a β-galactoside-binding protein, in women experiencing Placenta Accreta Spectrum compared to those with normal pregnancies. Galectin-3 has been implicated in various physiological processes such as cell-cell interaction, cell-matrix adhesion, and immune responses. Moreover, recent evidence suggests an increased level of Galectin-3 is also associated with inflammation, fibrosis, and adverse outcomes in several pathological conditions like cardiovascular diseases and cancer. These multiple roles of Galectin-3 underline its potential implications and predictive ability in many pathological conditions including PAS disease progression during pregnancy. In obstetric context, research on the role and level of Galectin-3 is sparse. This study aims at filling this gap by comparing the serum Galectin-3 levels in PAS and normal pregnancies. It seeks to investigate whether there is a significant difference between the two cohorts, which could highlight the potential use of Galectin-3 as a possible biological marker in predicting or diagnosing placenta accreta spectrum.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - PAS diagnosis Exclusion Criteria:Systemic diseases (e.g. chronic hypertension, diabetes, hypothyroidism, chronic renal-liver diseases, etc.), autoimmune disorders, multiple pregnancies, or the presence of fetal structural and chromosomal anomalies. Cholestasis of pregnancy, preterm delivery, or evidence of chronic and active infection. -

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Galectin 3
Women diagnosed with Placenta Accreta Spectrum (PAS) were invited to join the study, providing they had no known systemic diseases (e.g. chronic hypertension, diabetes, hypothyroidism, chronic renal-liver diseases, etc.), autoimmune disorders, multiple pregnancies, or the presence of fetal structural and chromosomal anomalies. They also did not have cholestasis of pregnancy, preterm delivery, or evidence of chronic and active infection.

Locations

Country Name City State
Turkey Necmettin Erbakan University Meram Medicine Faculty Konya

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bojic-Trbojevic Z, Jovanovic Krivokuca M, Vilotic A, Kolundzic N, Stefanoska I, Zetterberg F, Nilsson UJ, Leffler H, Vicovac L. Human trophoblast requires galectin-3 for cell migration and invasion. Sci Rep. 2019 Feb 14;9(1):2136. doi: 10.1038/s41598-018-38374-w. — View Citation

Pankiewicz K, Szczerba E, Fijalkowska A, Szamotulska K, Szewczyk G, Issat T, Maciejewski TM. The association between serum galectin-3 level and its placental production in patients with preeclampsia. J Physiol Pharmacol. 2020 Dec;71(6). doi: 10.26402/jpp.2020.6.08. Epub 2021 Mar 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Galectin 3 Serum Galectin 3 levels 34-36 weeks of gestation
See also
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Not yet recruiting NCT05191316 - the Efficacy and Safety of the 3-steps Conservative Approach in the Management of Placenta Accreta Spectrum (a Novel Technique)
Recruiting NCT03947047 - Detection of Placenta Accreta Via Exhaled Women Breath
Not yet recruiting NCT05513092 - Placenta Accreta Index Score in Placenta Accreta Spectrum