NCT03100929

Brief Summary

The investigators aim to prove that minimal sonographic training for nuchal cord detection in an unexperienced first year medical resident is more than enough to detect the phenomenon. Patients undergoing elective cesarean section will undergo a routine ultrasound (that is performed to detect the fetal heart rate and the fetal presentation) during which the resident will attempt to detect nuchal cord. The resident will then attend the patient's surgery to verify the findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

March 29, 2017

Last Update Submit

January 12, 2021

Conditions

Fetal Cord Entanglement

Outcome Measures

Primary Outcomes (1)

  • Detection rate for nuchal cord.

    Detection of nuchal cord in a pre-op ultrasound and verification of the sonographic findings during surgery.

    up to 6 hours from admission for elective surgery.

Study Arms (1)

Elective cesarean section

EXPERIMENTAL

Any patient undergoing elective cesarean section. Ultrasound

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Pre-operational ultrasound for the detection of fetal heart rate, fetal presentation and presence of nuchal cord.

Elective cesarean section

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale-term pregnancy.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Any woman undergoing elective cesarean section.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Nuchal Cord

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

July 10, 2017

Primary Completion

September 30, 2020

Study Completion

December 31, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)