Preterm LaborOPNNCT07626385
Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM
An observational study of Preterm Labor, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- SERUM OSTEOPONTİN
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2026to 12 May 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Case Group (PPROM): Women were eligible for the PPROM group if they met all the following criteria: confirmed diagnosis of PPROM by clinical and/or ancillary tests, gestational age between 24+0 and 36+6 weeks, singleton pregnancy, age 18 years or older, and provision of written informed consent. Control Group (Term ROM): Women were included in the control group if they met all the following criteria: rupture of membranes at term (gestational age ≥37+0 weeks), singleton pregnancy, age 18 years or older, provision of written informed consent, absence of signs of active infection, and no history of additional systemic diseases.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Multiple pregnancy
- Major fetal anomaly
- Fetal distress
- Intrauterine growth restriction (IUGR)
- Clinical chorioamnionitis
- Systemic infection
Show all 13Show fewer
- Autoimmune or chronic inflammatory disease
- Smoking
- History of malignancy
- Gestational trophoblastic disease
- Diabetes mellitus
- Preeclampsia
- Other serious obstetric complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM: A Prospective Case-Control Study
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.
Read the detailed description
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.
- Conditions
- Preterm Labor
- Being tested
- SERUM OSTEOPONTİN
- Keywords
- preterm labor, osteopontin
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SERUM OSTEOPONTİNDiagnostic test
Also called OSTEOPONTİN
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
| Study group | Role | What they receive |
|---|---|---|
| PRETERM LABOR (1) | The study group included pregnant women with a diagnosis of preterm premature rupture of membranes (PPROM) confirmed by clinical and/or diagnostic tests. The diagnosis was confirmed by observing the discharge of amniotic fluid from the cervical os during a sterile speculum examination and, when necessary, by confirmatory diagnostic tests. The study included pregnant women without additional systemic diseases and with blood pressure measurements within the normal range. Receives: Diagnostic Test: SERUM OSTEOPONTİN | |
| Control /Term labor (2) | The control group included pregnant women with a singleton pregnancy who experienced membrane rupture at 37 weeks + 0 days of gestation or later, had no signs of active infection and no history of additional systemic diseases. It was confirmed that none of these cases had a history of membrane rupture prior to the 37th week of gestation. The control group was selected from volunteers who met the eligibility criteria at the time of their admission to the delivery ward, and written informed consent was obtained after they were informed about the study. Receives: Diagnostic Test: SERUM OSTEOPONTİN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Serum Osteopontin Concentration
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).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start9 Apr 2026
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Batman University
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626385
- Sponsor's protocol ID
- Decision No: 2026/04-09
- Acronym
- OPN
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared as participants consented solely to the use of their data for journal publication, not to broader individual-level data sharing."
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Serum Osteopontin Levels in Pregnant Women Diagnosed With PPROM: A Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT07626385
- Acronym / sponsor ID
- OPN / Decision No: 2026/04-09
- Conditions
- Preterm Labor
- Keywords
- preterm labor, osteopontin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Collaborators
- Batman University
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRETERM LABOR (1) | – | Diagnostic Test: SERUM OSTEOPONTİNThe study group included pregnant women with a diagnosis of preterm premature rupture of membranes (PPROM) confirmed by clinical and/or diagnostic tests. The diagnosis was confirmed by observing the discharge of amniotic fluid from the cervical os during a sterile speculum examination and, when necessary, by confirmatory diagnostic tests. The study included pregnant women without additional systemic diseases and with blood pressure measurements within the normal range. |
| Control /Term labor (2) | – | Diagnostic Test: SERUM OSTEOPONTİNThe control group included pregnant women with a singleton pregnancy who experienced membrane rupture at 37 weeks + 0 days of gestation or later, had no signs of active infection and no history of additional systemic diseases. It was confirmed that none of these cases had a history of membrane rupture prior to the 37th week of gestation. The control group was selected from volunteers who met the eligibility criteria at the time of their admission to the delivery ward, and written informed consent was obtained after they were informed about the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Case Group (PPROM): Women were eligible for the PPROM group if they met all the following criteria: confirmed diagnosis of PPROM by clinical and/or ancillary tests, gestational age between 24+0 and 36+6 weeks, singleton pregnancy, age 18 years or older, and provision of written informed consent. Control Group (Term ROM): Women were included in the control group if they met all the following criteria: rupture of membranes at term (gestational age ≥37+0 weeks), singleton pregnancy, age 18 years or older, provision of written informed consent, absence of signs of active infection, and no history of additional systemic diseases.
Key inclusion criteria (14 listed)
- For the case group (PPROM):
- Gestational age between 24+0 and 36+6 weeks
- Singleton pregnancy
- Age ≥18 years
- Provision of written informed consent
Key exclusion criteria (13 listed)
- Multiple pregnancy
- Major fetal anomaly
- Fetal distress
- Intrauterine growth restriction (IUGR)
- Clinical chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SERUM OSTEOPONTİNAlso: OSTEOPONTİNAt 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 | Diagnostic test | Control /Term labor (2), PRETERM LABOR (1) |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. IPD will not be shared as participants consented solely to the use of their data for journal publication, not to broader individual-level data sharing."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Serum Osteopontin Concentration (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.