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Placenta Accreta, Third TrimesterNCT05376410

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

An observational study of Placenta Accreta, Third Trimester, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Placenta Accreta, Third Trimester
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Nov 2021to 1 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 3rd trimester pregnancies diagnosed with placenta accreta spectrum.

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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Trial locations and contacts

1 site in 1 country.

hasan energin, dr. contact

00905530619041

hasanenergin@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Necmettin Erbakan University Meram Medicine Faculty

    Konya

    hasan energin, dr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Keywords
Placenta Accreta, sTREM-1
Medical subject headings
Placenta Accreta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sTREM-1 levels

    sTREM-1 levels in maternal serum

    Measured: after 12 hours fasting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start14 Nov 2021
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jul 2022 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05376410
Sponsor's protocol ID
NecmettinErbakanUniversity
Status last verified
May 2022
First submitted
11 May 2022
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Placenta Accreta, Third Trimester, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact hasan energin, dr. (00905530619041, hasanenergin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sTREM-1 levels (time frame: after 12 hours fasting). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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