- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945446
A Serum Galectin-3 Levels in Placenta Accreta Spectrum Pregnancies
A Comparative Study of Serum Galectin-3 Levels Between Placenta Accreta Spectrum and Normal Pregnancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Konya, Turkey
- Necmettin Erbakan University Meram Medicine Faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Normal Pregnancies (control group)
Healthy pregnancies with similar gestational age and body mass index with study group.
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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.
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Placenta accreta spectrum pregnancies (study group)
34-36 weeks of gestation.
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Galectin 3
Time Frame: 34-36 weeks of gestation
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Serum Galectin 3 levels
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34-36 weeks of gestation
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ecmettinErbakanUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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