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Three-dimensional Umbilical Cord Coiling Index

The Effect of Three-dimensional Umbilical Cord Coiling Index on Obstetrical and Neonatal Outcomes: a Prospective Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05727241
Enrollment
250
Registered
2023-02-14
Start date
2023-07-01
Completion date
2026-03-01
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Distress, Intrauterine Growth Restriction, Umbilical Cord Issue

Keywords

Coiling index, Neonatal outcome, Intrauterine Growth Restriction, Antepartum screening

Brief summary

Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death. The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.

Detailed description

The umbilical cord connects the growing fetus to the placenta and contains 3 blood vessels, 2 arteries and a vein. The umbilical cord is protected by a layer of Wharton jelly and is characterized by being coiled. This coiling provides the umbilical cord with strength and flexibility simultaneously, and as a result lowers the risk of complications such as torsion of the umbilical cord. The reason for the formation of this coiling is unknown, but there are many hypotheses such as mobility and rotation of the fetus around the axis of the umbilical cord, a different growth pattern of the blood vessels in the umbilical cord and a special arrangement of the muscles in the walls of the arteries of the umbilical cord. Umbilical cord index (UCI) is the distance between one coil of the umbilical cord. it is calculated from the inner edge of the wall of an umbilical cord artery or vein to the outer edge of the same vessel in the next coil, the direction is from the edge of the placenta to the fetus. The final value is the average of three readings in three different segments of the umbilical cord. Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death. The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.

Interventions

DIAGNOSTIC_TESTUltrasound

The intervention is ultrasound examination with three dimensional umbilical cord index, two-dimensional umbilical cord index, and doppler examination of the umbilical cord artery.

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Singleton pregnancy * Pregnancy week \> or = 24.0

Exclusion criteria

* Twin pregnancy * Pregnancy week\<24 * Single umbilical cord * Insufficient prenatal care * Abnormal anatomical fetal findings, abnormal results of aneuploidy screening * Premature rupture of membranes * Polyhydramnios or Oligohydramnios at the time of recruitment. * Intrauterine growth restriction at the time of recruitment

Design outcomes

Primary

MeasureTime frameDescription
Intrauterine growth restriction1 yearThe correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction

Secondary

MeasureTime frameDescription
Doppler index of the umbilical cord1 yearThe correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord
fetal distress during delivery2 yearsThe correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery
Meconium staining2 yearsThe correlation between three-dimensional umbilical cord index and meconium staining at delivery
Two-dimensional umbilical cord index1 yearThe correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index
Cord pH2 yearsThe correlation between three-dimensional umbilical cord index and Cord pH
APGAR score2 yearsThe correlation between three-dimensional umbilical cord index and APGAR score
Newborn intensive care unit admission2 yearsThe correlation between three-dimensional umbilical cord index and admission to NICU
Delivery mode2 yearsThe correlation between three-dimensional umbilical cord index and the delivery mode

Countries

Israel

Contacts

Primary ContactRaneen Abu Shqara, MD
rabushqara@gmail.com+972549793591
Backup ContactMarwan Odeh, MD
marwano@gmc.gov.il+972507887486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026