Severing Nuchal Cord at the Time of Delivery.
Study That Clarifies Whether Cord Around the Neck Should be Severed at Delivery.
1 other identifier
interventional
60
1 country
1
Brief Summary
Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the practice of severing the cord, which was encircled once around the neck of the fetus, after delivery of the anterior shoulder and prior to extraction of the body. The study and the control groups will include 30 women, each one. After diagnosis of cord around the neck during labor by ultrasound, the women will inter a randomization process. After delivery of the head, it will be cut intentionally in the study group and left intact in the control group. Neonatal outcome will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2003
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 26, 2006
CompletedFirst Posted
Study publicly available on registry
June 27, 2006
CompletedResults Posted
Study results publicly available
January 10, 2017
CompletedMay 11, 2017
April 1, 2017
2.3 years
June 26, 2006
November 11, 2016
April 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Umbilical Cord pH
immediately after delivery
Study Arms (2)
severing cord
EXPERIMENTALThe cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
Untouched cord
NO INTERVENTIONThe cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
Interventions
The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
Eligibility Criteria
You may qualify if:
- single loop cord around the neck active labor spontaneous vaginal delivery
You may not qualify if:
- instrumental delivery cesarean section false positive finding of cord around the neck multiple loop cord around the neck
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deliveery Ward, Edith Wolfson Medical Center,
Holon, 56100, Israel
Results Point of Contact
- Title
- Samuel Lurie
- Organization
- Edith Wolf son Medical Cemter
Study Officials
- PRINCIPAL INVESTIGATOR
Oscar Sadan, MD
E Wolfson Medical Center, Holon, Israel
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 26, 2006
First Posted
June 27, 2006
Study Start
September 1, 2003
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
May 11, 2017
Results First Posted
January 10, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share