Clinical trial NCT06639919: Biochemical and Histological Changes in Pregnant Women With Preterm Premature Rupture of Membrane
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Premature Rupture of Membrane
Placenta Diseases
Keywords: Preterm Premature Membrane Rupture
Premature membrane rupture
Syndecan
Placenta
Amniotic membrane
Proteoglycan
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant Women With Preterm Premature Rupture of Membrane

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: 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.
timeFrame: Baseline
measure: maternal and cord blood will be measured by syndecan 1, 2, 3, 4 biochemistry technique.
timeFrame: Baseline
Secondary outcomes:
measure: Sociodemographic questions were measured by survey technique.
timeFrame: Baseline
Other outcomes:
Locations:
city: Yunusemre
country: Turkey
facility: Manisa Celal Bayar University
state: Mani̇sa
Study officials:
References: