Severing Nuchal Cord at the Time of Delivery.

NCT ID: NCT00345254

Last Updated: 2017-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Perinatal Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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severing cord

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

Group Type EXPERIMENTAL

severing cord

Intervention Type PROCEDURE

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

Untouched cord

The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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severing cord

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

Intervention Type PROCEDURE

Other Intervention Names

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Cutting the umbilical cord

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Samuel Lurie

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar Sadan, MD

Role: PRINCIPAL_INVESTIGATOR

E Wolfson Medical Center, Holon, Israel

Locations

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Deliveery Ward, Edith Wolfson Medical Center,

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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OS-SL-001

Identifier Type: -

Identifier Source: org_study_id

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