Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM: A Prospective Case-Control Study
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
- 是
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
Erhan Okuyan,M.D
Assoc.Prof. M.D
Batman Training and Research Hospital
