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临床试验/NCT06639919
NCT06639919已完成不适用

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

Celal Bayar University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
2% women's with PPROM placenta tissues and amnion membrane while birth. Placenta tissues and amnion membrane Staining will be Measured by syndecan 1, 2, 3, 4 immunohistochemistry.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy pregnancy under 37 weeks
  • Age range 18-50
  • Being literate in Turkish
  • Not having any additional disease
  • Agreeing to participate in the study

排除标准

  • High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
  • Multiple pregnancy
  • Pregnant women under the age of 18
  • Medication use (excluding routinely used food supplements during pregnancy)
  • Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
  • Immunosuppressive use
  • Presence of active or chronic infection
  • Presence of active or chronic inflammatory disease
  • Patients who gave birth at an external center or later chose to withdraw from the study
  • Patients who did not have any exclusion criteria at the time of PPROM or when blood was drawn for the control group, but who later developed any exclusion criteria.
  • Premature birth of patients included in the control group

研究组 & 干预措施

Group 2:

Control group pregnant women

Group 1:

Pregnant women with PPROM

结局指标

主要结局

2% women's with PPROM placenta tissues and amnion membrane while birth. Placenta tissues and amnion membrane Staining will be Measured by syndecan 1, 2, 3, 4 immunohistochemistry.

时间窗: Baseline

maternal and cord blood will be measured by syndecan 1, 2, 3, 4 biochemistry technique.

时间窗: Baseline

次要结局

  • Sociodemographic questions were measured by survey technique.(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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