NCT05727241

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

February 4, 2023

Last Update Submit

April 24, 2023

Conditions

Umbilical Cord IssueIntrauterine Growth RestrictionFetal Distress

Keywords

Coiling indexNeonatal outcomeIntrauterine Growth RestrictionAntepartum screening

Outcome Measures

Primary Outcomes (1)

  • Intrauterine growth restriction

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

    1 year

Secondary Outcomes (8)

  • Two-dimensional umbilical cord index

    1 year

  • Doppler index of the umbilical cord

    1 year

  • fetal distress during delivery

    2 years

  • Meconium staining

    2 years

  • Delivery mode

    2 years

  • +3 more secondary outcomes

Study Arms (1)

The study cohort (total sample)

All women will undergo ultrasound examination for three-dimensional umbilical cord index.

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

The intervention is ultrasound examination with three dimensional umbilical cord index, two-dimensional umbilical cord index, and doppler examination of the umbilical cord artery.

The study cohort (total sample)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is obstetrical
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Singleton pregnancy
  • Pregnancy week \> or = 24.0

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galilee Medical Center

Nahariya, Northern District, Israel

Location

Related 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.

    PMID: 22496697BACKGROUND

  • 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.

    PMID: 28672757BACKGROUND

  • 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.

    PMID: 8437796BACKGROUND

  • 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.

    PMID: 7501354BACKGROUND

  • 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.

    PMID: 24293842BACKGROUND

  • 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.

    PMID: 7898836BACKGROUND

  • 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.

    PMID: 10890931BACKGROUND

  • 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.

    PMID: 16076615BACKGROUND

MeSH Terms

Conditions

Fetal Growth RetardationFetal Distress

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Marwan Odeh, MD

    Galilee Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raneen Abu Shqara, MD

CONTACT

+972549793591rabushqara@gmail.com

Marwan Odeh, MD

CONTACT

+972507887486marwano@gmc.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 4, 2023

First Posted

February 14, 2023

Study Start

July 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2026

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

IL(1)