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Trials / Completed

CompletedNCT06639919

Biochemical and Histological Changes in Pregnant Women With Preterm Premature Rupture of Membrane

Investigation of Biochemical Changes in Maternal Blood as Well as Histological Changes in the Placenta and Amniotic Membrane of Pregnant Women Diagnosed With Preterm Premature Rupture of Membrane

Status
Completed
Phase
Study type
Observational
Enrollment
36 (actual)
Sponsor
Celal Bayar University · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

Although preterm premature rupture of membranes (PPROM) is one of the most common causes of preterm birth, it can also lead to serious maternal and neonatal complications. Although there are many known risk factors, the cause is not fully understood . Proteoglycans (PG) are macromolecules containing a core protein and at least one negatively charged polysaccharide glycosaminoglycan side chain and are expressed at high levels in the placenta . Heparan sulfate proteoglycans (HSPG) represent a specific type of PG observed in the placenta. Syndecans (SDC) are the main type of HSPG found in the placenta . There are four types of syndecan, a cell transmembrane PG (syndecan-1, syndecan-2, syndecan-3, syndecan-4) . By containing heparan sulfate and chondroitin sulfate chains, syndecans interact specifically with a variety of ligands, including vascular endothelial growth factor (VEGF), transforming growth factor-beta (TGF-β), and fibronectin, all of which have important functions in the placenta . They play a role in very important physiological processes, including cell proliferation, migration angiogenesis, coagulation system and inflammation . The aim of this study is to biochemically and histologically investigate the relationship between maternal blood syndecan levels and PPROM, and the relationship between postnatal syndecan levels in the amniotic membrane and placenta and PPROM. According to our literature review, although there are studies on the presence of syndecan in the amnion and chorion and negative pregnancy outcomes, there are no maternal syndecan blood levels or histopathological examinations regarding PPROM. For this reason, we predict that our study may pave the way for future studies aimed at preventing PPROM and its complications that may occur directly or indirectly. We also think that it will be a pioneer for future studies. This prospective observational study was conducted by Manisa Celal Bayar University, Department of Gynecology and Obstetrics. The research will be conducted on pregnant women who voluntarily accept to participate in the study. Group 1: Pregnant women with PPROM (n: 14) Group 2: Control group pregnant women (n: 22) When the planned number of patients is reached, sample collection will be terminated and biochemical and histological examinations will be performed.

Conditions

Timeline

Start date
2024-02-14
Primary completion
2024-12-17
Completion
2025-12-05
First posted
2024-10-15
Last updated
2026-04-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06639919. Inclusion in this directory is not an endorsement.