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Completed
NCT07626385
Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM
Conditions: Preterm Labor
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Enrollment: 71
Sponsor: Batman Training and Research Hospital
Location: Private Zilan Hospital Batman
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria (for both groups):
* Multiple pregnancy
* Major fetal anomaly
* Fetal distress
* Intrauterine growth restriction (IUGR)
* Clinical chorioamnionitis
* Systemic infection
* Autoimmune or chronic inflammatory disease
* Smoking
* History of malignancy
* Gestational trophoblastic disease
* Diabetes mellitus
* Preeclampsia
* Other serious obstetric complications
Source: ClinicalTrials.gov (NCT07626385). StuddyBuddy aggregates publicly available trial information.