Three-dimensional Umbilical Cord Coiling Index

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intrauterine Growth Restriction; Fetal Distress; Umbilical Cord Issue
• Intervention / Treatment: Diagnostic test: Ultrasound

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Raneen Abu Shqara, MD; Phone Number: +972549793591; Email: rabushqara@gmail.com
• Study Contact Backup: Name: Marwan Odeh, MD; Phone Number: +972507887486; Email: marwano@gmc.gov.il

Study Locations

• Israel
  • Hazafon
    • Nahariya, Hazafon, Israel
      • Galilee Medical Center
      • Contact: Amal Shahen; Email: amals@gmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The study cohort (total sample); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrauterine growth restriction	The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-dimensional umbilical cord index	The correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index	1 year
Doppler index of the umbilical cord	The correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord	1 year
fetal distress during delivery	The correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery	2 years
Meconium staining	The correlation between three-dimensional umbilical cord index and meconium staining at delivery	2 years
Delivery mode	The correlation between three-dimensional umbilical cord index and the delivery mode	2 years
Cord pH	The correlation between three-dimensional umbilical cord index and Cord pH	2 years
APGAR score	The correlation between three-dimensional umbilical cord index and APGAR score	2 years
Newborn intensive care unit admission	The correlation between three-dimensional umbilical cord index and admission to NICU	2 years

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: February 4, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Intrauterine Growth Restriction; Neonatal outcome; Coiling index; Antepartum screening
• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Fetal Growth Retardation; Fetal Distress
• Other Study ID Numbers: 0080-22-NHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No