Clinical trial NCT05376410: Relationship Between Maternal Soluble Trigger Receptor Expressed on Myeloid Cells-1 (sTREM-1) and Placenta Accreta Spectrum
Official title: Relationship Between Maternal Soluble Trigger Receptor Expressed on Myeloid Cells-1 (sTREM-1) and Placenta Accreta Spectrum
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta, Third Trimester
Keywords: Placenta Accreta, sTREM-1
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3rd trimester pregnancies diagnosed with placenta accreta spectrum.

Brief summary: We planed to evaluate soluble the triggering receptors expressed on myeloid cell-1 (s TREM-1) levels in serum of pregnant women diagnosed with placenta accreta spectrum and compare it with healthy pregnant women's s TREM-1 serum levels.

Detailed description: Placenta accreta, which was a rare diagnosis before, is now one of the most important causes of postpartum hemorrhage and hysterectomy. Trigger receptor expressed on myeloid cells (TREM), interacts with Toll-like receptors (TLRs) that play an important role in the immune response (TLRs are found in many immune system cells, such as natural killer cells, macrophages, lymphocytes), and TLR-induced signaling modulates the incoming immune response by amplifying or suppressing it. One of the most appealing features of the TREM family is the release of soluble receptors. Soluble TREM-1 (sTREM-1) is a 17-kDa fragment; which is hypothesized to be pro- duced by alternative splicing of the Trem 1 gene or by proteolytic cleavage by metalloproteinases (MMPs).

Although major risk factors of placenta accreta are previous cesarian deliverers and placenta previa It can be seen in nulliparous women without any low lying placenta. The pathophysiology of the disease is still unknown. Some authors hypothesized that immune system play role in its pathophysiology.

We planed to evaluate soluble the triggering receptors expressed on myeloid cell-1 (s TREM-1) levels in serum of pregnant women diagnosed with placenta accreta spectrum and compare it with healthy pregnant women's s TREM-1 serum levels.

The study is planned as a case control study. 30 pregnant women diagnosed with placenta accreta and 60 healthy pregnant women will be included in the study. The study is planned to last 9 months in total. TREM-1 will be studied from the blood taken routinely from the participants during their follow-up in the outpatient clinic or service.

Inclusion criteria for the study were determined as being in the 3rd trimester, not having any additional disease, not in labor, not having multiple pregnancy.

Exclusion criteria: Not being at the specified gestational week, having multiple pregnancy, having any additional disease, having an infection, being in labor.

After the diagnosis of placenta accreta , a 5 cm3 of venous blood samples of the patients will be collected from their antecubital veins after 12h of fasting in 24h. Serum samples will be isolated by centrifugation at 3000rpm for min. The samples will be maintained at 80C before performing assays. Serum triggering receptor expressed on myeloid cells 1 concentrations will be measured using a commercially available enzyme- linked immunosorbent assay (ELISA) kit.

Eligibility criteria: Inclusion Criteria: placenta accreta spectrum diagnosis. 3rd trimester pregnancy, not having any additional disease, not in labor, not having multiple pregnancy.

Exclusion Criteria:having multiple pregnancy, having any additional disease (preeclampsia, gestational diabetes mellitus, etc) , having an infection, being in labor.

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Primary outcomes:
measure: sTREM-1 levels
timeFrame: after 12 hours fasting
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medicine Faculty
Study officials:
References: