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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03604887
Other study ID # UCLI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date January 31, 2021

Study information

Verified date April 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 31, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Singleton pregnancy. - Pregnant = 37 weeks gestation. - Women who will accept to participate in the study Exclusion Criteria: - Preterm deliveries. - Amniotic fluid abnormalities (oligohydramnios, polyhydramnios). - Intrauterine growth retardation - Early membrane rupture - Women need urgent cesarean section. - Multifetal gestation. - Placenta previa. - Fetuses with major congenital anomalies. - Women with chronic maternal illness as hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ultrasonography
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.

Locations

Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The sensitivity of "Umbilical cord length index" in diagnosis of long and short umbilical cords. Ultrasonographic scoring of umbilical cord length 15 minutes
See also
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