NCT05945446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

July 6, 2023

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Galectin 3

    Serum Galectin 3 levels

    34-36 weeks of gestation

Study Arms (2)

Normal Pregnancies (control group)

Healthy pregnancies with similar gestational age and body mass index with study group.

Diagnostic Test: Galectin 3

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.

Diagnostic Test: Galectin 3

Interventions

Galectin 3DIAGNOSTIC_TEST

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.

Normal Pregnancies (control group)Placenta accreta spectrum pregnancies (study group)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • PAS diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Meram Medicine Faculty

Konya, Turkey (Türkiye)

Location

Related 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.

    PMID: 30765738BACKGROUND
  • 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.

    PMID: 33727431BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor doctor

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

December 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Data will be shared if asked for proper reason

Locations