Nuchal Cord Detection in Sonographic Evaluation by a Firs... | NCT03100929

Studies
Nuchal Cord Detection in Sonographic Evaluation by a First Year Resident.

NCT03100929

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Jan 14, 2021Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Fetal Cord Entanglement

Interventions

Ultrasound

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2017Actual

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Mar 29, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2021

Last Update Posted Date

Jan 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients undergoing elective cesarean section will undergo a routine ultrasound examination during which fetal heart rate, fetal presentation and nuchal cord presence will be documented. During surgery, after the fetus is delivered, presence or lack of nuchal cord will be documented.

The aim of the study is to show that minimal sonographic training may assist even an unexperienced sonographist in detection of such a subtle yet important phenomenon.

The study will be performed utilizing the newest resident in the OBGYN department.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elective cesarean section	Experimental	Any patient undergoing elective cesarean section. Ultrasound	Diagnostic Test: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Diagnostic Test	Pre-operational ultrasound for the detection of fetal heart rate, fetal presentation and presence of nuchal cord.	Elective cesarean section

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any woman undergoing elective cesarean section.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female-term pregnancy.

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roy Lauterbach, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam health care campus		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053589	Nuchal Cord

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005315	Fetal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided