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NCT00345254 Clinical Trial

Severing Nuchal Cord at the Time of Delivery.

Umbilical Cord Clinical Trial

Official title:
Study That Clarifies Whether Cord Around the Neck Should Be Severed at Delivery.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00345254
Other study ID # OS-SL-001
Secondary ID
Status Completed
Phase Phase 1
First received June 26, 2006
Last updated June 26, 2006
Start date September 2003

Study information
Verified date September 2003
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• severing umbilical cord

Locations
Country Name City State
Israel Deliveery Ward, Edith Wolfson Medical Center, Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary umbilical artery pH
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