Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03100929
Other study ID # 0405-16-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2017
Est. completion date December 31, 2020

Study information

Verified date January 2021
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria: - Any woman undergoing elective cesarean section. Exclusion Criteria: - None.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Rambam health care campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.