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临床试验/NCT07626385
NCT07626385已完成不适用

Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM: A Prospective Case-Control Study

Batman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2026年4月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
1

研究概览

简要总结

Preterm prelabor rupture of membranes (PPROM) is defined as the rupture of the fetal membranes prior to the onset of labor and before 37 weeks of gestation; it occurs in approximately 2-3% of all pregnancies and accounts for a significant proportion of preterm births .

Current data indicate that PPROM is not merely a clinical condition limited to membrane rupture; rather, it is a biological process associated with loss of structural integrity in the fetal membranes, an inflammatory-oxidative stress response, and cellular aging . The fetal membranes constitute a dynamic barrier that provides mechanical and immunological protection for the fetus throughout pregnancy .

There is limited data in the literature investigating the relationship between osteopontin and preterm birth. In particular, it has been reported that osteopontin levels may be higher in amniotic fluid samples collected during the second trimester from pregnant women who subsequently experienced spontaneous preterm birth . However, the changes in maternal serum osteopontin levels in cases of PPROM and the clinical significance of these changes remain unclear. Therefore, osteopontin levels may vary across different biological compartments and at different stages of pregnancy. To address this knowledge gap, the present study aimed to compare maternal serum osteopontin levels between pregnant women diagnosed with PPROM and those with term membrane rupture.

详细描述

This study was designed as a single-center, prospective, observational case-control study. The study protocol was approved by the Ethics Committee of the Faculty of Social and Humanities, Faculty of Science, Engineering, and Health Sciences at Batman University (Decision No: 2026/04-09; Date: 02.04.2026). Work began after the ethics committee approved the study. The research was conducted in accordance with the principles of the Declaration of Helsinki, and written informed consent was obtained from all participants.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • For the case group (PPROM):
  • Gestational age between 24+0 and 36+6 weeks
  • Singleton pregnancy
  • Age ≥18 years
  • Provision of written informed consent
  • Confirmed diagnosis of PPROM by clinical and/or ancillary tests
  • For the control group (term rupture of membranes):
  • Gestational age ≥37+0 weeks
  • Rupture of membranes
  • No signs of active infection
  • Singleton pregnancy
  • Age ≥18 years
  • Provision of written informed consent
  • No history of additional systemic diseases

排除标准

  • (for both groups):
  • Multiple pregnancy
  • Major fetal anomaly
  • Fetal distress
  • Intrauterine growth restriction (IUGR)
  • Clinical chorioamnionitis
  • Systemic infection
  • Autoimmune or chronic inflammatory disease
  • History of malignancy
  • Gestational trophoblastic disease
  • Diabetes mellitus
  • Preeclampsia
  • Other serious obstetric complications

研究者

发起方
Batman Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Erhan Okuyan,M.D

Assoc.Prof. M.D

Batman Training and Research Hospital

研究点 (1)

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