Relationship Between Maternal Soluble Trigger Receptor Expressed on Myeloid Cells-1 (sTREM-1) and Placenta Accreta Spectrum

May 11, 2022 updated by: Hasan Energin, Necmettin Erbakan University
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.

Study Overview

Status

Recruiting

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.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Konya, Turkey
        • Recruiting
        • Necmettin Erbakan University Meram Medicine Faculty
        • Contact:
          • hasan energin, dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

3rd trimester pregnancies diagnosed with placenta accreta spectrum.

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sTREM-1 levels
Time Frame: after 12 hours fasting
sTREM-1 levels in maternal serum
after 12 hours fasting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 14, 2021

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (ACTUAL)

May 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NecmettinErbakanUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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