Umbilical Cord IssueNCT05727241
Three-dimensional Umbilical Cord Coiling Index
An observational study of Umbilical Cord Issue and Intrauterine Growth Restriction, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Issue, Intrauterine Growth Restriction, Fetal Distress
- What is being tested?
- Ultrasound
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2023to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Singleton pregnancy
- Pregnancy week > or = 24.0
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Galilee Medical Center
Nahariya, Northern District
Amal Shahen, amals@gmc.gov.il
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound
- Keywords
- Coiling index, Neonatal outcome, Intrauterine Growth Restriction, Antepartum screening
- Medical subject headings
- Fetal Growth Retardation, Fetal Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| The study cohort (total sample) | All women will undergo ultrasound examination for three-dimensional umbilical cord index. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine growth restriction
The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction
Measured: 1 year
Secondary outcomes (8)
Two-dimensional umbilical cord index
The correlation between three-dimensional umbilical cord index and the two-dimensional umbilical cord index
Measured: 1 year
Doppler index of the umbilical cord
The correlation between three-dimensional umbilical cord index and the doppler index of the umbilical cord
Measured: 1 year
fetal distress during delivery
The correlation between three-dimensional umbilical cord index and the rate of fetal distress during delivery
Measured: 2 years
Meconium staining
The correlation between three-dimensional umbilical cord index and meconium staining at delivery
Measured: 2 years
Delivery mode
The correlation between three-dimensional umbilical cord index and the delivery mode
Measured: 2 years
Cord pH
The correlation between three-dimensional umbilical cord index and Cord pH
Measured: 2 years
APGAR score
The correlation between three-dimensional umbilical cord index and APGAR score
Measured: 2 years
Newborn intensive care unit admission
The correlation between three-dimensional umbilical cord index and admission to NICU
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Raneen Abu Shqara, Western Galilee Hospital-Nahariya
- Investigators
- Marwan Odeh, MD, Principal investigator, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727241
- Sponsor's protocol ID
- 0080-22-NHR
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22496697Ma'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.
PubMed 28672757Strong 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.
PubMed 8437796Degani 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.
PubMed 7501354Sharma 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.
PubMed 24293842Rana 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.
PubMed 7898836Machin 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.
PubMed 10890931de 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.
PubMed 16076615
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three-dimensional Umbilical Cord Coiling Index on Obstetrical and Neonatal Outcomes: a Prospective Study
- ClinicalTrials.gov ID
- NCT05727241
- Acronym / sponsor ID
- 0080-22-NHR
- Keywords
- Coiling index, Neonatal outcome, Intrauterine Growth Restriction, Antepartum screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study cohort (total sample) | – | Diagnostic Test: UltrasoundAll women will undergo ultrasound examination for three-dimensional umbilical cord index. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Pregnancy week > or = 24.0
Key exclusion criteria (8 listed)
- Twin pregnancy
- Pregnancy week<24
- Single umbilical cord
- Insufficient prenatal care
- Abnormal anatomical fetal findings, abnormal results of aneuploidy screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundThe intervention is ultrasound examination with three dimensional umbilical cord index, two-dimensional umbilical cord index, and doppler examination of the umbilical cord artery. | Diagnostic test | The study cohort (total sample) |
Primary outcome
Intrauterine growth restriction
Time frame: 1 year
The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction
8 secondary outcomes
Two-dimensional umbilical cord index
Time frame: 1 year
Doppler index of the umbilical cord
Time frame: 1 year
fetal distress during delivery
Time frame: 2 years
Meconium staining
Time frame: 2 years
Delivery mode
Time frame: 2 years
Cord pH
Time frame: 2 years
APGAR score
Time frame: 2 years
Newborn intensive care unit admission
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 22496697Chitra 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.
- Background: PubMed 28672757Ma'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.
- Background: PubMed 8437796Strong 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.
- Background: PubMed 7501354Degani 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.
- Background: PubMed 24293842Sharma 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.
- Background: PubMed 7898836Rana 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.
- Background: PubMed 10890931Machin 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.
- Background: PubMed 16076615de 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan Odeh, MD principal investigator
Galilee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Cord Issue and Intrauterine Growth Restriction, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raneen Abu Shqara, MD (+972549793591, rabushqara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine growth restriction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05727241, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.