Uterine Artery Diastolic Notching & Apelin-13 and 36

Diagnosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06390202
• Other study ID #: B.10.1.TKH.4.34.H.GP.0.01/31
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diagnosis

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