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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06390202
Other study ID # B.10.1.TKH.4.34.H.GP.0.01/31
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date January 1, 2024

Study information

Verified date April 2024
Source Umraniye Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date January 1, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: 1. Nonsmokers, 2. Singleton pregnancies between 11 and 14 weeks of gestation 3. Pregnant women who did not conceive with assisted reproductive methods Exclusion Criteria: 1. Smokers 2. Pregnant women who conceived with assisted reproductive techniques 3. Pregnant women with multiple pregnancies 4. Pregnant women who started with multiples and continued with singletons 5. Pregnant women with any pregestational disease, thrombophilia 6. Pregnant women with any congenital uterine anomaly 7. Pregnant women with a history of recurrent pregnancy loss 8. Pregnant women using aspirin or heparin

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
there is no intervention in this study

Locations

Country Name City State
Turkey Ümraniye Training and Research Hospital Istanbul Ümraniye

Sponsors (1)

Lead Sponsor Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 1 year
Primary 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. through study completion, an average of 1 year
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