NCT06390202

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 22, 2024

Last Update Submit

April 25, 2024

Conditions

Keywords

uterine arteryapelin-13apelin-36Doppler

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

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

Interventions

there is no intervention in this study

Uterine artery notch negative groupUterine artery notch positive group

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • Nonsmokers,
  • Singleton pregnancies between 11 and 14 weeks of gestation
  • Pregnant women who did not conceive with assisted reproductive methods

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ümraniye Training and Research Hospital

Istanbul, Ümraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • İbrahim Kale, Associate professor

    Umraniye Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 30, 2024

Study Start

March 1, 2023

Primary Completion

October 30, 2023

Study Completion

January 1, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations