Preterm Premature Rupture of MembraneNCT06639919
Biochemical and Histological Changes in Pregnant Women With Preterm Premature Rupture of Membrane
An observational study of Preterm Premature Rupture of Membrane and Placenta Diseases, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Although preterm premature rupture of membranes (PPROM) is one of the most common causes of preterm birth, it can also lead to serious maternal and neonatal complications. Although there are many known risk factors, the cause is not fully understood . Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Premature Rupture of Membrane, Placenta Diseases
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2024to 5 Dec 2025
- How long will I take part?
- 16 Months
- Phase
- Observational
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant Women With Preterm Premature Rupture of Membrane
Who may be able to join
- Healthy pregnancy under 37 weeks
- Age range 18-50
- Being literate in Turkish
- Not having any additional disease
- Agreeing to participate in the study
Who cannot join
- High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
- Multiple pregnancy
- Pregnant women under the age of 18
- Smoking
- Medication use (excluding routinely used food supplements during pregnancy)
- Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
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- Immunosuppressive use
- Presence of active or chronic infection
- Presence of active or chronic inflammatory disease
- Patients who gave birth at an external center or later chose to withdraw from the study
- Patients who did not have any exclusion criteria at the time of PPROM or when blood was drawn for the control group, but who later developed any exclusion criteria.
- Premature birth of patients included in the control group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar University
Yunusemre, Mani̇sa, 45030
About this study
Official title: Investigation of Biochemical Changes in Maternal Blood as Well as Histological Changes in the Placenta and Amniotic Membrane of Pregnant Women Diagnosed With Preterm Premature Rupture of Membrane
Although preterm premature rupture of membranes (PPROM) is one of the most common causes of preterm birth, it can also lead to serious maternal and neonatal complications. Although there are many known risk factors, the cause is not fully understood . Proteoglycans (PG) are macromolecules containing a core protein and at least one negatively charged polysaccharide glycosaminoglycan side chain and are expressed at high levels in the placenta . Heparan sulfate proteoglycans (HSPG) represent a specific type of PG observed in the placenta. Syndecans (SDC) are the main type of HSPG found in the placenta . There are four types of syndecan, a cell transmembrane PG (syndecan-1, syndecan-2, syndecan-3, syndecan-4) . By containing heparan sulfate and chondroitin sulfate chains, syndecans interact specifically with a variety of ligands, including vascular endothelial growth factor (VEGF), transforming growth factor-beta (TGF-β), and fibronectin, all of which have important functions in the placenta . They play a role in very important physiological processes, including cell proliferation, migration angiogenesis, coagulation system and inflammation .
The aim of this study is to biochemically and histologically investigate the relationship between maternal blood syndecan levels and PPROM, and the relationship between postnatal syndecan levels in the amniotic membrane and placenta and PPROM.
Read more
According to our literature review, although there are studies on the presence of syndecan in the amnion and chorion and negative pregnancy outcomes, there are no maternal syndecan blood levels or histopathological examinations regarding PPROM. For this reason, we predict that our study may pave the way for future studies aimed at preventing PPROM and its complications that may occur directly or indirectly. We also think that it will be a pioneer for future studies.
This prospective observational study was conducted by Manisa Celal Bayar University, Department of Gynecology and Obstetrics. The research will be conducted on pregnant women who voluntarily accept to participate in the study.
Group 1: Pregnant women with PPROM (n: 14) Group 2: Control group pregnant women (n: 22) When the planned number of patients is reached, sample collection will be terminated and biochemical and histological examinations will be performed.
- Keywords
- Preterm Premature Membrane Rupture, Premature membrane rupture, Syndecan, Placenta, Amniotic membrane, Proteoglycan
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Placenta Diseases, Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Pregnant women with PPROM | |
| Group 2: | Control group pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
2% women's with PPROM placenta tissues and amnion membrane while birth. Placenta tissues and amnion membrane Staining will be Measured by syndecan 1, 2, 3, 4 immunohistochemistry.
Measured: Baseline
maternal and cord blood will be measured by syndecan 1, 2, 3, 4 biochemistry technique.
Measured: Baseline
Secondary outcomes (1)
Sociodemographic questions were measured by survey technique.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Feb 2024
- Primary completion17 Dec 2024
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembraneStudies 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
- 36 participants (actual)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639919
- Sponsor's protocol ID
- MCBU-PPROM
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes