DiagnosisNCT06390202
Uterine Artery Diastolic Notching & Apelin-13 and 36
An observational study of Diagnosis, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and 36 concentrations between 11 and 14 weeks of gestation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diagnosis
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Jan 2024
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 44 singleton pregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the study group (uterine artery notch positive group). 44 singleton pregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the control group (uterine artery notch negative group).
Who may be able to join
- Nonsmokers,
- Singleton pregnancies between 11 and 14 weeks of gestation
- Pregnant women who did not conceive with assisted reproductive methods
Who cannot join
- Smokers
- Pregnant women who conceived with assisted reproductive techniques
- Pregnant women with multiple pregnancies
- Pregnant women who started with multiples and continued with singletons
- Pregnant women with any pregestational disease, thrombophilia
- Pregnant women with any congenital uterine anomaly
- Pregnant women with a history of recurrent pregnancy loss
- Pregnant women using aspirin or heparin
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ümraniye Training and Research Hospital
Istanbul, Ümraniye, 34764
About this study
Official title: Investigation of the Relationship Between Uterine Artery Doppler Diastolic Notching and Serum Apelin-13 and Apelin-36 Concentrations Between the 11th and 14th Weeks of Pregnancy
This study was conducted to investigate the relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and 36 concentrations between 11 and 14 weeks of gestation.
Read the detailed description
Apelin-13 and apelin-36, which provide vasodilatation through a nitric oxide-dependent mechanism, also play a role in trophoblasts' survival, proliferation, and migration.
Based on this, we aimed to investigate serum apelin-13 and apelin-36 concentrations in pregnant women with and without diastolic notch on uterine artery Doppler between the 11th and 14th weeks of pregnancy.
We hypothesized that apelin-13 and apelin-36 might be associated with the formation of diastolic notch in uterine artery Doppler and serum apelin-13 and apelin-36 concentrations would be lower in the group with a notch in the uterine artery Doppler than in the group without a notch.
- Conditions
- Diagnosis
- Being tested
- no intervention
- Keywords
- uterine artery, apelin-13, apelin-36, Doppler
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
there is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Uterine artery notch negative group | Pregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the uterine artery notch negative group. Receives: Other: no intervention | |
| Uterine artery notch positive group | Pregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the uterine artery notch positive group. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Measured: through study completion, an average of 1 year
Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Mar 2023
- Primary completion30 Oct 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies 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
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ibrahim kale, Umraniye Education and Research Hospital
- Investigators
- İbrahim Kale, Associate professor, Study director, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390202
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/31
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Uterine Artery Doppler Diastolic Notching and Serum Apelin-13 and Apelin-36 Concentrations Between the 11th and 14th Weeks of Pregnancy
- ClinicalTrials.gov ID
- NCT06390202
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/31
- Conditions
- Diagnosis
- Keywords
- uterine artery, apelin-13, apelin-36, Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 30 Apr 2024 (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.
This study was conducted to investigate the relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and 36 concentrations between 11 and 14 weeks of gestation.
Detailed description
Apelin-13 and apelin-36, which provide vasodilatation through a nitric oxide-dependent mechanism, also play a role in trophoblasts' survival, proliferation, and migration.
Based on this, we aimed to investigate serum apelin-13 and apelin-36 concentrations in pregnant women with and without diastolic notch on uterine artery Doppler between the 11th and 14th weeks of pregnancy.
We hypothesized that apelin-13 and apelin-36 might be associated with the formation of diastolic notch in uterine artery Doppler and serum apelin-13 and apelin-36 concentrations would be lower in the group with a notch in the uterine artery Doppler than in the group without a notch.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine artery notch negative group | – | Other: no interventionPregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the uterine artery notch negative group. |
| Uterine artery notch positive group | – | Other: no interventionPregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the uterine artery notch positive group. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 44 singleton pregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the study group (uterine artery notch positive group). 44 singleton pregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the control group (uterine artery notch negative group).
Key inclusion criteria (3 listed)
- Nonsmokers,
- Singleton pregnancies between 11 and 14 weeks of gestation
- Pregnant women who did not conceive with assisted reproductive methods
Key exclusion criteria (8 listed)
- Smokers
- Pregnant women who conceived with assisted reproductive techniques
- Pregnant women with multiple pregnancies
- Pregnant women who started with multiples and continued with singletons
- Pregnant women with any pregestational disease, thrombophilia
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 |
|---|---|---|
| no interventionthere is no intervention in this study | Other | Uterine artery notch negative group, Uterine artery notch positive group |
Primary outcome
Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Time frame: through study completion, an average of 1 year
Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
Time frame: through study completion, an average of 1 year
Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
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 30 Apr 2024.
- 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.
İbrahim Kale, Associate professor study director
Umraniye Education and Research 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 Diagnosis, run by Umraniye Education and Research 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 3 inclusion and 8 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 30 Apr 2024. 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?
Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 30 Apr 2024.