Umbilical Cord ProblemNCT03604887
Umbilical Cord Length Index for Prediction of Cord Abnormalities Before Delivery
An observational study of Umbilical Cord Problem, run by Assiut University at 1 site in Egypt.
Trial summary
The umbilical cord plays an essential role in intrauterine life. It is the pathway between mother, placenta and fetus during pregnancy and delivery. Complete cord occlusion often leads to fetal demise, while intermittent occlusion has been associated with intrauterine brain damage. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Umbilical Cord Problem
- What is being tested?
- ultrasonography
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 31 Jan 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are in labor will be followed up through regular fetal heart rate monitoring and clinically using partograph to monitor the progress of labor. Fetal heart rate changes and cases with abnormal progress of labor will be recorded. Mode of delivery either vaginal or cesarean will be noted. Those who are scheduled for elective CS will be evaluated during and after cesarean section.
Who may be able to join
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Women who will accept to participate in the study
Who cannot join
- Preterm deliveries.
- Amniotic fluid abnormalities (oligohydramnios, polyhydramnios).
- Intrauterine growth retardation
- Early membrane rupture
- Women need urgent cesarean section.
- Multifetal gestation.
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- Placenta previa.
- Fetuses with major congenital anomalies.
- Women with chronic maternal illness as hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Umbilical Cord Length Index as a New Ultrasonographic Method for Prediction of Cord Abnormalities Before Delivery
The umbilical cord plays an essential role in intrauterine life. It is the pathway between mother, placenta and fetus during pregnancy and delivery. Complete cord occlusion often leads to fetal demise, while intermittent occlusion has been associated with intrauterine brain damage. Compression and vasospasm in utero are important factors in fetal distress. Nuchal Umbilical Cord can be diagnosed antepartum using ultrasound, but the complications are unpredictable and unpreventable
- Conditions
- Umbilical Cord Problem
- Being tested
- ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic test
Ultrasound evaluation will be done with transducer abdominal probe. The amount of amniotic fluid and umbilical cord sections will be determined by evaluating the images obtained from the sagittal plane in the ultrasound evaluations in the 4 abdominal quadrants.
When the anatomical structure of the umbilical cord is considered, it is folded in amniotic fluid. The folds appear as umbilical cord rings, side-by-side at the sagittal sections.
Scoring of "umbilical cord length index"
- 1 point will be given for each quadrant where the umbilical cord was observed.
- 0.5 point will be given for each umbilical cord ring in one quadrant. Every quadrant will be evaluated in this manner, and the total score will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| study group | All pregnant women who will attend the labor unit during the study period will be invited to participate in the study. Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of "Umbilical cord length index" in diagnosis of long and short umbilical cords.
Ultrasonographic scoring of umbilical cord length
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Mar 2019
- Primary completion1 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord ProblemStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604887
- Sponsor's protocol ID
- UCLI
- Status last verified
- Apr 2021
- First submitted
- 21 Jul 2018
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Length Index as a New Ultrasonographic Method for Prediction of Cord Abnormalities Before Delivery
- ClinicalTrials.gov ID
- NCT03604887
- Acronym / sponsor ID
- UCLI
- Conditions
- Umbilical Cord Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 30 Jul 2018 (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.
The umbilical cord plays an essential role in intrauterine life. It is the pathway between mother, placenta and fetus during pregnancy and delivery. Complete cord occlusion often leads to fetal demise, while intermittent occlusion has been associated with intrauterine brain damage. Compression and vasospasm in utero are important factors in fetal distress. Nuchal Umbilical Cord can be diagnosed antepartum using ultrasound, but the complications are unpredictable and unpreventable
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: ultrasonographyAll pregnant women who will attend the labor unit during the study period will be invited to participate in the study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are in labor will be followed up through regular fetal heart rate monitoring and clinically using partograph to monitor the progress of labor. Fetal heart rate changes and cases with abnormal progress of labor will be recorded. Mode of delivery either vaginal or cesarean will be noted. Those who are scheduled for elective CS will be evaluated during and after cesarean section.
Key inclusion criteria (3 listed)
- Singleton pregnancy.
- Pregnant ≥ 37 weeks gestation.
- Women who will accept to participate in the study
Key exclusion criteria (9 listed)
- Preterm deliveries.
- Amniotic fluid abnormalities (oligohydramnios, polyhydramnios).
- Intrauterine growth retardation
- Early membrane rupture
- Women need urgent cesarean section.
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 |
|---|---|---|
| ultrasonographyUltrasound evaluation will be done with transducer abdominal probe. The amount of amniotic fluid and umbilical cord sections will be determined by evaluating the images obtained from the sagittal plane in the ultrasound evaluations in the 4 abdominal quadrants. When the anatomical structure of the umbilical cord is considered, it is folded in amniotic fluid. The folds appear as umbilical cord rings, side-by-side at the sagittal sections. Scoring of "umbilical cord length index" * 1 point will be given for each quadrant where the umbilical cord was observed. * 0.5 point will be given for each umbilical cord ring in one quadrant. Every quadrant will be evaluated in this manner, and the total score will be calculated. | Diagnostic test | study group |
Primary outcome
The sensitivity of "Umbilical cord length index" in diagnosis of long and short umbilical cords.
Time frame: 15 minutes
Ultrasonographic scoring of umbilical cord length
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Problem, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 23 Apr 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of "Umbilical cord length index" in diagnosis of long and short umbilical cords. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.