NCT03604887

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

July 21, 2018

Last Update Submit

April 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The sensitivity of "Umbilical cord length index" in diagnosis of long and short umbilical cords.

    Ultrasonographic scoring of umbilical cord length

    15 minutes

Study Arms (1)

study group

All pregnant women who will attend the labor unit during the study period will be invited to participate in the study.

Diagnostic Test: ultrasonography

Interventions

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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Singleton pregnancy.
  • Pregnant ≥ 37 weeks gestation.
  • Women who will accept to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 21, 2018

First Posted

July 30, 2018

Study Start

March 1, 2019

Primary Completion

December 1, 2020

Study Completion

January 31, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations