PretermNCT05513768
PRETERM DELİVERY and MYOCINE BINDING PROTEIN C LEVELs
An observational study of Preterm, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY. SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm
- What is being tested?
- level of myosin binding protein c in serum
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Oct 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Includes participants whose serum samples were collected in the first trimester, stored, and then divided into two according to timing of delivery fırst grup ıs preterm group, and second one ıs those who gave birth on time
Who may be able to join
- being pregnant in the first trimester
- be between 18-40 years old
Who cannot join
- no history of preterm birth
- being pregnant with assisted reproductive techniques
- having a multiple pregnancy
- have cervical insufficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 32225
About this study
Official title: Can First Trimester Serum Myocine Binding Protein c Level Predict Preterm Birth
IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.
SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.
Read the detailed description
IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.
SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.A TOTAL OF 90 WOMEN WERE PLANNED TO INCLUDE 45 STUDY 45 CONTROL GROUP IN THE STUDY.
- Conditions
- Preterm
- Being tested
- level of myosin binding protein c in serum
- Keywords
- PRETERM DELİVERY, MBPC,
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of myosin binding protein c in serumDiagnostic test
Serum samples will be taken from the participants in the first trimester, transferred to eppendorf tubes after appropriate procedures, and stored at -80 degrees until the time of deliveryParticipants will be divided into two groups according to the timing of birthThe first group is those who gave birth earlier than 37 weeks those who gave birth on time in the other group The mbpc levels will be looked at and compared.
| Study group | Role | What they receive |
|---|---|---|
| women who gave birth prematurely | women who had serum taken in the first trimester and gave birth earlier than 37 weeks according to the time of delivery Receives: Diagnostic Test: level of myosin binding protein c in serum | |
| those who gave birth on time | women who have had serum taken in the first trimester, stored and delivered on time Receives: Diagnostic Test: level of myosin binding protein c in serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of prediction value of serum mbpc levels in preterm delivery
identifying prediction value of first trmester serum mbpc levels by comparing by serum levels of mbpc in groups
Measured: 10 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Jan 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Yıldız, Gaziosmanpasa Research and Education Hospital
- Investigators
- elif yıldız, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513768
- Sponsor's protocol ID
- GaziosmanpasaTREHKHD
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can First Trimester Serum Myocine Binding Protein c Level Predict Preterm Birth
- ClinicalTrials.gov ID
- NCT05513768
- Acronym / sponsor ID
- GaziosmanpasaTREHKHD
- Conditions
- Preterm
- Keywords
- PRETERM DELİVERY, MBPC,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 24 Aug 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.
IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.
SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.
Detailed description
IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY.
SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.A TOTAL OF 90 WOMEN WERE PLANNED TO INCLUDE 45 STUDY 45 CONTROL GROUP IN THE STUDY.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women who gave birth prematurely | – | Diagnostic Test: level of myosin binding protein c in serumwomen who had serum taken in the first trimester and gave birth earlier than 37 weeks according to the time of delivery |
| those who gave birth on time | – | Diagnostic Test: level of myosin binding protein c in serumwomen who have had serum taken in the first trimester, stored and delivered on time |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Includes participants whose serum samples were collected in the first trimester, stored, and then divided into two according to timing of delivery fırst grup ıs preterm group, and second one ıs those who gave birth on time
Key inclusion criteria (2 listed)
- being pregnant in the first trimester
- be between 18-40 years old
Key exclusion criteria (4 listed)
- no history of preterm birth
- being pregnant with assisted reproductive techniques
- having a multiple pregnancy
- have cervical insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| level of myosin binding protein c in serumSerum samples will be taken from the participants in the first trimester, transferred to eppendorf tubes after appropriate procedures, and stored at -80 degrees until the time of deliveryParticipants will be divided into two groups according to the timing of birthThe first group is those who gave birth earlier than 37 weeks those who gave birth on time in the other group The mbpc levels will be looked at and compared. | Diagnostic test | those who gave birth on time, women who gave birth prematurely |
Primary outcome
detection of prediction value of serum mbpc levels in preterm delivery
Time frame: 10 mounths
identifying prediction value of first trmester serum mbpc levels by comparing by serum levels of mbpc in groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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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.
elif yıldız principal investigator
Gaziosmanpasa Research and Education Hospital
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 Preterm, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of prediction value of serum mbpc levels in preterm delivery (time frame: 10 mounths). 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 23 Nov 2022.