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Three-dimensional Umbilical Cord Coiling Index

Not yet recruiting
Conditions
Umbilical Cord Issue
Intrauterine Growth Restriction
Fetal Distress
Interventions
Diagnostic Test: Ultrasound
Registration Number
NCT05727241
Lead Sponsor
Western Galilee Hospital-Nahariya
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
250
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
The study cohort (total sample)UltrasoundAll women will undergo ultrasound examination for three-dimensional umbilical cord index.
Primary Outcome Measures
NameTimeMethod
Intrauterine growth restriction1 year

The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction

Secondary Outcome Measures
NameTimeMethod
Meconium staining2 years

The correlation between three-dimensional umbilical cord index and meconium staining at delivery

Delivery mode2 years

The correlation between three-dimensional umbilical cord index and the delivery mode

Doppler index of the umbilical cord1 year

The correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord

fetal distress during delivery2 years

The correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery

Cord pH2 years

The correlation between three-dimensional umbilical cord index and Cord pH

Two-dimensional umbilical cord index1 year

The correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index

APGAR score2 years

The correlation between three-dimensional umbilical cord index and APGAR score

Newborn intensive care unit admission2 years

The correlation between three-dimensional umbilical cord index and admission to NICU

Trial Locations

Locations (1)

Galilee Medical Center

🇮🇱

Nahariya, Hazafon, Israel

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