Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM

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.

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Private Zilan Hospital

Batman, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SERUM OSTEOPONTİN

Diagnostic Test

At the time of diagnosis, 5 mL venous blood samples were collected from all participants for biochemical analysis. The samples were centrifuged at 3,000 rpm for 10 minutes to separate the serum, which was then stored at -80°C until analysis. Serum osteopontin levels were measured using a sandwich enzyme-linked immunosorbent assay (ELISA) kit (Human Osteopontin ELISA Kit, Cat. No: E1525Hu, BT Laboratory, China) in accordance with the manufacturer's protocol.

This kit has been developed for the quantitative determination of osteopontin levels in serum, plasma, and other biological fluids. The assay principle is based on the pre-coating of microplate wells with an antibody specific to human SPP1. The osteopontin present in the samples was incubated with a biotinylated secondary antibody and a streptavidin-horseradish peroxidase (HRP) complex after binding to this antibody. Following the washing steps, a substrate solution was added, and the resulting color reaction was stopped with an ac

Other names: OSTEOPONTİN

Primary outcomes

Maternal Serum Osteopontin Concentration

Time frame: 48 hours

Description: Concentration of osteopontin (ng/mL) measured in maternal serum using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (e.g., Human Osteopontin ELISA Kit, manufacturer name and catalog number to be specified). Blood samples are collected at the time of diagnosis of PPROM or term membrane rupture, within 48 hours before delivery.

Unit of Measure: ng/mL (nanograms per milliliter) Time Frame: 48 hours (from diagnosis to sample collection) Reporting Metric: Mean osteopontin concentration (with standard deviation) will be reported for each group (PPROM and term membrane rupture). Between-group comparison will be performed using an appropriate statistical test (e.g., independent t-test or Mann-Whitney U test).

Sponsors and collaborators

Lead sponsor

Batman Training and Research Hospital

Other Gov

Collaborators

Batman University

Registry information

Official study title

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

Acronym: OPN

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 4, 2026
Registry last updated: Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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