Three-dimensional Umbilical Cord Coiling Index

Sponsor
Western Galilee Hospital-Nahariya (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05727241
Collaborator
(none)
250
1
36
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Three-dimensional Umbilical Cord Coiling Index on Obstetrical and Neonatal Outcomes: a Prospective Study
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Intrauterine growth restriction [1 year]

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

Secondary Outcome Measures

  1. Two-dimensional umbilical cord index [1 year]

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

  2. Doppler index of the umbilical cord [1 year]

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

  3. fetal distress during delivery [2 years]

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

  4. Meconium staining [2 years]

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

  5. Delivery mode [2 years]

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

  6. Cord pH [2 years]

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

  7. APGAR score [2 years]

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

  8. Newborn intensive care unit admission [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Galilee Medical Center Nahariya Hazafon Israel

Sponsors and Collaborators

  • Western Galilee Hospital-Nahariya

Investigators

  • Principal Investigator: Marwan Odeh, MD, Galilee Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr Raneen Abu Shqara, Doctor, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT05727241
Other Study ID Numbers:
  • 0080-22-NHR
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Raneen Abu Shqara, Doctor, Western Galilee Hospital-Nahariya
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023