Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM (NCT07626385) | Clinical Trial Compass
CompletedNot Applicable
Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM
Turkey (Türkiye)71 participantsStarted 2026-04-09
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.