Uterine Artery Diastolic Notching & Apelin-13 and 36

April 25, 2024 updated by: ibrahim kale, Umraniye Education and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ümraniye
      • Istanbul, Ümraniye, Turkey, 34764
        • Umraniye Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: no intervention
there is no intervention in this study
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.
Other: no intervention
there is no intervention in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umraniye Education and Research Hospital

Investigators

  • Study Director: İbrahim Kale, Associate professor, Umraniye Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B.10.1.TKH.4.34.H.GP.0.01/31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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