An observational study in Umbilical Cord Issue, Intrauterine Growth Restriction and Fetal Distress, sponsored by Western Galilee Hospital-Nahariya. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Western Galilee Hospital-Nahariya · Observational
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.
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.
262 studies on the registry are indexed under Fetal Growth Retardation; 69 are open to participants now.
This study's planned enrollment of 250 is above the median of 200 across 145 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Western Galilee Hospital-Nahariya is the lead sponsor of 89 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will include low-risk singleton pregnancies, above 24 weeks of pregnancy, women with normal anatomical scan results and normal aneuploidy screening results. Women who have polyhydramnios, Oligohydramnios or intrauterine growth restriction at the time of recruitment will be ruled out.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All women will undergo ultrasound examination for three-dimensional umbilical cord index.
Diagnostic Test: Ultrasound
The intervention is ultrasound examination with three dimensional umbilical cord index, two-dimensional umbilical cord index, and doppler examination of the umbilical cord artery.
Intrauterine growth restriction
The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction
Time frame: 1 year
Two-dimensional umbilical cord index
The correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index
Time frame: 1 year
Doppler index of the umbilical cord
The correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord
Time frame: 1 year
fetal distress during delivery
The correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery
Time frame: 2 years
Meconium staining
The correlation between three-dimensional umbilical cord index and meconium staining at delivery
Time frame: 2 years
Delivery mode
The correlation between three-dimensional umbilical cord index and the delivery mode
Time frame: 2 years
Cord pH
The correlation between three-dimensional umbilical cord index and Cord pH
Time frame: 2 years
APGAR score
The correlation between three-dimensional umbilical cord index and APGAR score
Time frame: 2 years
Newborn intensive care unit admission
The correlation between three-dimensional umbilical cord index and admission to NICU
Time frame: 2 years
Plan to share: Undecided
Start is estimated for Jul 2023; primary completion for Mar 2024, 8 months later.
Of 72 non-industry observational studies under Fetal Growth Retardation, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 170. This study's planned 8 months is below that.
Counting every sponsor, half of 73 studies reached it within 52 months; a quarter within 24 and three quarters within 170.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Western Galilee Hospital-Nahariya