Umbilical Cord Clinical Trial
Official title:
Study That Clarifies Whether Cord Around the Neck Should Be Severed at Delivery.
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 |
Verified date | September 2003 |
Source | Wolfson Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Deliveery Ward, Edith Wolfson Medical Center, | Holon |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | umbilical artery pH |
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