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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University Meram Medicine Faculty
Konya
hasan energin, dr
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.
- Conditions
- Placenta Accreta, Third Trimester
- 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.
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.
- First posted17 May 2022
- Study start14 Nov 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta, Third TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Energin, Necmettin Erbakan University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Maternal Soluble Trigger Receptor Expressed on Myeloid Cells-1 (sTREM-1) and Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT05376410
- Acronym / sponsor ID
- NecmettinErbakanUniversity
- Conditions
- Placenta Accreta, Third Trimester
- Keywords
- Placenta Accreta, sTREM-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3rd trimester pregnancies diagnosed with placenta accreta spectrum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sTREM-1 levels
Time frame: after 12 hours fasting
sTREM-1 levels in maternal serum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.