Severing Nuchal Cord at the Time of Delivery.

Overview

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.

Full Title of Study: “Study That Clarifies Whether Cord Around the Neck Should be Severed at Delivery.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2006

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.

Interventions

  • Procedure: severing cord
    • The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.

Arms, Groups and Cohorts

  • Experimental: severing cord
    • The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
  • No Intervention: Untouched cord
    • The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.

Clinical Trial Outcome Measures

Primary Measures

  • Umbilical Cord pH
    • Time Frame: immediately after delivery

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wolfson Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Samuel Lurie, Professor – Wolfson Medical Center
  • Overall Official(s)
    • Oscar Sadan, MD, Principal Investigator, E Wolfson Medical Center, Holon, Israel

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