NCT06915051

Brief Summary

The maximum efficiency of umbilical cord blood flow depends on a specific number of coils. With modern ultrasound techniques, investigators can now detect cord abnormalities even before birth. In recent years, there has been a renewed interest in the umbilical cord, and several articles have been published regarding the number of coils.In this study, the relationship between the umbilical cord coiling index and fetal cardiac functions was evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

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, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

March 25, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

Umbilical cord coiling indexfetal cardiac functionsumbilical cordfetal circulation

Outcome Measures

Primary Outcomes (1)

  • The correlation between the fetal umbilical cord coiling number and the concurrently performed fetal echocardiography findings.

    This study will be a single-center study conducted on two hundred randomly selected pregnant women with uncomplicated singleton pregnancies in the late second trimester (20-24 weeks) who visit our hospital's perinatology outpatient clinic for routine prenatal check-ups. The umbilical cord coiling number and fetal cardiac function measurements will be performed within one hour by the same maternal-fetal medicine specialist.To optimize the quality of Doppler waveforms when assessing vascular structures, measurements will be obtained in the absence of uterine contractions and fetal activity, with an insonation angle as close to zero as possible and less than 30.Three parameters will be used to assess cardiac function: 1. Diastolic function 2. Systolic function 3. Both systolic and diastolic function

    The correlation between the fetal umbilical cord coiling index and the echocardiographic findings of the fetus within the first hour will be investigated.

Study Arms (1)

This is a single-center study conducted on 200 randomly selected pregnant women with uncomplicated.

Diagnostic Test: Determining the relationship between the coiling number and fetal echocardiography findings.

Interventions

Fetal echocardiography findings to be performed simultaneously with the determination of the coiling number.

This is a single-center study conducted on 200 randomly selected pregnant women with uncomplicated.

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care will be included.

You may qualify if:

  • Singleton uncomplicated pregnancies between 20-24 weeks seeking routine antenatal care.

You may not qualify if:

  • Multiple pregnancy
  • Preterm rupture of membranes
  • Chorioamnionitis
  • Placental abruption
  • Severe fetal growth restriction
  • Congenital anomalies of the fetus
  • Preeclampsia
  • Oligohydramnios
  • Maternal diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 8, 2025

Study Start

March 1, 2025

Primary Completion

June 15, 2025

Study Completion

August 30, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations