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Severing Nuchal Cord at the Time of Delivery.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345254
First Posted: June 27, 2006
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samuel Lurie, Wolfson Medical Center
  Purpose
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.

Condition Intervention
Perinatal Outcome Procedure: severing cord

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study That Clarifies Whether Cord Around the Neck Should be Severed at Delivery.

Further study details as provided by Samuel Lurie, Wolfson Medical Center:

Primary Outcome Measures:
  • Umbilical Cord pH [ Time Frame: immediately after delivery ]

Enrollment: 60
Study Start Date: September 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: severing cord
The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
Procedure: severing cord
The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
Other Name: Cutting the umbilical cord
No Intervention: Untouched cord
The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

single loop cord around the neck active labor spontaneous vaginal delivery

Exclusion Criteria:

instrumental delivery cesarean section false positive finding of cord around the neck multiple loop cord around the neck

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345254


Locations
Israel
Deliveery Ward, Edith Wolfson Medical Center,
Holon, Israel, 56100
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Oscar Sadan, MD E Wolfson Medical Center, Holon, Israel
  More Information

Responsible Party: Samuel Lurie, Professor, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT00345254     History of Changes
Other Study ID Numbers: OS-SL-001
First Submitted: June 26, 2006
First Posted: June 27, 2006
Results First Submitted: November 11, 2016
Results First Posted: January 10, 2017
Last Update Posted: May 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No