Three-dimensional Umbilical Cord Coiling Index

Intrauterine Growth Restriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05727241
• Other study ID #: 0080-22-NHR
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2023
• Source: Western Galilee Hospital-Nahariya
• Contact: Raneen Abu Shqara, MD
• Phone: +972549793591
• Email: rabushqara[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Distress
• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Umbilical Cord Issue

Intervention

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.

Locations

Country	Name	City	State
Israel	Galilee Medical Center	Nahariya	Hazafon

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & Publications (8)

Chitra T, Sushanth YS, Raghavan S. Umbilical coiling index as a marker of perinatal outcome: an analytical study. Obstet Gynecol Int. 2012;2012:213689. doi: 10.1155/2012/213689. Epub 2012 Feb 14. — View Citation

de Laat MW, Franx A, van Alderen ED, Nikkels PG, Visser GH. The umbilical coiling index, a review of the literature. J Matern Fetal Neonatal Med. 2005 Feb;17(2):93-100. doi: 10.1080/14767050400028899. — View Citation

Degani S, Lewinsky RM, Berger H, Spiegel D. Sonographic estimation of umbilical coiling index and correlation with Doppler flow characteristics. Obstet Gynecol. 1995 Dec;86(6):990-3. doi: 10.1016/0029-7844(95)00307-d. — View Citation

Ma'ayeh M, McClennen E, Chamchad D, Geary M, Brest N, Gerson A. Hypercoiling of the umbilical cord in uncomplicated singleton pregnancies. J Perinat Med. 2018 Aug 28;46(6):593-598. doi: 10.1515/jpm-2017-0034. — View Citation

Machin GA, Ackerman J, Gilbert-Barness E. Abnormal umbilical cord coiling is associated with adverse perinatal outcomes. Pediatr Dev Pathol. 2000 Sep-Oct;3(5):462-71. doi: 10.1007/s100240010103. — View Citation

Rana J, Ebert GA, Kappy KA. Adverse perinatal outcome in patients with an abnormal umbilical coiling index. Obstet Gynecol. 1995 Apr;85(4):573-7. doi: 10.1016/0029-7844(94)00435-G. — View Citation

Sharma B, Bhardwaj N, Gupta S, Gupta PK, Verma A, Malviya K. Association of umbilical coiling index by colour Doppler ultrasonography at 18-22 weeks of gestation and perinatal outcome. J Obstet Gynaecol India. 2012 Dec;62(6):650-4. doi: 10.1007/s13224-012-0230-0. Epub 2012 Aug 17. — View Citation

Strong TH Jr, Elliott JP, Radin TG. Non-coiled umbilical blood vessels: a new marker for the fetus at risk. Obstet Gynecol. 1993 Mar;81(3):409-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrauterine growth restriction	The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction	1 year
Secondary	Two-dimensional umbilical cord index	The correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index	1 year
Secondary	Doppler index of the umbilical cord	The correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord	1 year
Secondary	fetal distress during delivery	The correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery	2 years
Secondary	Meconium staining	The correlation between three-dimensional umbilical cord index and meconium staining at delivery	2 years
Secondary	Delivery mode	The correlation between three-dimensional umbilical cord index and the delivery mode	2 years
Secondary	Cord pH	The correlation between three-dimensional umbilical cord index and Cord pH	2 years
Secondary	APGAR score	The correlation between three-dimensional umbilical cord index and APGAR score	2 years
Secondary	Newborn intensive care unit admission	The correlation between three-dimensional umbilical cord index and admission to NICU	2 years