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CompletedNCT06639919Updated Apr 6, 2026

Biochemical and Histological Changes in Pregnant Women With Preterm Premature Rupture of Membrane

An observational study in Preterm Premature Rupture of Membrane and Placenta Diseases, sponsored by Manisa Celal Bayar University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Manisa Celal Bayar University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 . 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.

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.

02

Conditions studied

  • Preterm Premature Rupture of Membrane
  • Placenta Diseases

Keywords

  • Preterm Premature Membrane Rupture
  • Premature membrane rupture
  • Syndecan
  • Placenta
  • Amniotic membrane
  • Proteoglycan
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Pregnant Women With Preterm Premature Rupture of Membrane

Inclusion criteria

  • Healthy pregnancy under 37 weeks
  • Age range 18-50
  • Being literate in Turkish
  • Not having any additional disease
  • Agreeing to participate in the study

Exclusion criteria

Exclusion Criteria:

  • 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.)
  • 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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
36 participants (actual)
Target follow-up
16 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1:

    Pregnant women with PPROM

  • Group 2:

    Control group pregnant women

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. maternal and cord blood will be measured by syndecan 1, 2, 3, 4 biochemistry technique.

    Time frame: Baseline

Secondary outcomes

  1. Sociodemographic questions were measured by survey technique.

    Time frame: Baseline

06

Study locations

1 site
  • Manisa Celal Bayar University
    Yunusemre, Mani̇sa 45030, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06639919
Lead sponsor
Manisa Celal Bayar University
Responsible party
Sponsor
First posted
Oct 15, 2024
Start date
Feb 14, 2024
Primary completion
Dec 17, 2024
Completion
Dec 5, 2025
Last update
Apr 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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