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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05727241
Other study ID # 0080-22-NHR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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