Nesfatin-1NCT03808571
Cord Blood Nesfatin-1 and Irisin in the Intrauterine Growth Restricted Fetuses
An observational study of Nesfatin-1 and Irisin, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
: The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Nesfatin-1, Irisin, Intrauterine Growth Restriction
- What is being tested?
- cord blood specimen during the delivery
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 15 Jan 2019
- 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 45 years
- Women only
- Adult
Study population: Pregnant women
Who may be able to join
- Pregnant women with intrauterine grwoth rectricted fetuses.
- Healthy pregnancies
Who cannot join
- Pregnant women with chronic medical conditions
- multiple pregnancies
- fetuses with fetal malfomations or genetic syndromes
- pregnant women older than 45 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
Van, 65000
About this study
Official title: The Association of Cord Blood Nesfatin-1 and Irisin Level With Fetal Doppler Parameters in Pregnancies Complicated With Intrauterine Growth Restricted Fetuses
: The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not.
Read the detailed description
This study was conducted at Yüzüncü Yıl University Medical Faculty Obstetrics and Gynecology Clinic. The study group included 34 pregnant women ranged from 18 to 45 years old who have intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no abnormality on prenatal follow-up and underwent elective ceserean seciton served as control group. The maternal age, height, weight, body mass index (BMI), systolic and diastolic blood pressures were recorded in both groups of patients. Maternal serum total blood count and biochemical parameters were obtained from the laboratory parameters. Gestational week at birth, birth weight, sex, 1st and 5th minute APGAR scores were recorded. Blood samples were collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and irisin by doubly clamped umbilical cord. Blood samples were immediately centrifuged in sterile tubes and maintained at -80 ° C until assessed.
- Conditions
- Nesfatin-1, Irisin, Intrauterine Growth Restriction
- Being tested
- cord blood specimen during the delivery
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cord blood specimen during the deliveryOther
The cord blood will be taken during the delivery of baby.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Pregnancies complicated with intrauterine growth restricted fetuses Receives: Other: cord blood specimen during the delivery | |
| Control group | Healthy pregnancies Receives: Other: cord blood specimen during the delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cord blood nesfatn-1 level measurement
cord blood levels of nesfatin-1 in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.
Measured: 9 months
Secondary outcomes (1)
Cord blood irisin level measurement
ord blood levels of irisin in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Jan 2018
- Primary completion10 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nesfatin-1Studies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, erbil karaman, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808571
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Cord Blood Nesfatin-1 and Irisin Level With Fetal Doppler Parameters in Pregnancies Complicated With Intrauterine Growth Restricted Fetuses
- ClinicalTrials.gov ID
- NCT03808571
- Acronym / sponsor ID
- 1
- Conditions
- Nesfatin-1, Irisin, Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 17 Jan 2019 (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.
: The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not.
Detailed description
This study was conducted at Yüzüncü Yıl University Medical Faculty Obstetrics and Gynecology Clinic. The study group included 34 pregnant women ranged from 18 to 45 years old who have intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no abnormality on prenatal follow-up and underwent elective ceserean seciton served as control group. The maternal age, height, weight, body mass index (BMI), systolic and diastolic blood pressures were recorded in both groups of patients. Maternal serum total blood count and biochemical parameters were obtained from the laboratory parameters. Gestational week at birth, birth weight, sex, 1st and 5th minute APGAR scores were recorded. Blood samples were collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and irisin by doubly clamped umbilical cord. Blood samples were immediately centrifuged in sterile tubes and maintained at -80 ° C until assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: cord blood specimen during the deliveryPregnancies complicated with intrauterine growth restricted fetuses |
| Control group | – | Other: cord blood specimen during the deliveryHealthy pregnancies |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (2 listed)
- Pregnant women with intrauterine grwoth rectricted fetuses.
- Healthy pregnancies
Key exclusion criteria (4 listed)
- Pregnant women with chronic medical conditions
- multiple pregnancies
- fetuses with fetal malfomations or genetic syndromes
- pregnant women older than 45 years old
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 |
|---|---|---|
| cord blood specimen during the deliveryThe cord blood will be taken during the delivery of baby. | Other | Control group, Study group |
Primary outcome
cord blood nesfatn-1 level measurement
Time frame: 9 months
cord blood levels of nesfatin-1 in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.
1 secondary outcome
Cord blood irisin level measurement
Time frame: 9 months
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 22 Jan 2019.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nesfatin-1 and Irisin, run by Yuzuncu Yil University 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 22 Jan 2019. 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?
cord blood nesfatn-1 level measurement (time frame: 9 months). 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 22 Jan 2019.