Perinatal Outcome
Conditions
Brief 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.
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
PROCEDUREsevering cord
The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Umbilical Cord pH | immediately after delivery |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Severing Cord The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.
severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body. | 30 |
| Untouched Cord The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Severing Cord | Untouched Cord | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Israel | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Umbilical Cord pH
Time frame: immediately after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Severing Cord | Umbilical Cord pH | 7.29 pH | Standard Deviation 0.07 |
| Untouched Cord | Umbilical Cord pH | 7.32 pH | Standard Deviation 0.06 |
p-value: 0.1t-test, 2 sided