Neonatal Anemia
Conditions
Brief summary
To compare the short term risks and benefits of cord milking 5 times toward the neonate with delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.
Detailed description
Abstract Context: milking of the umbilical cord toward the neonate 5 times and delayed cord clamping both are good procedures to prevent anemia in neonates . Objective: To investigate the effects of delayed umbilical cord clamping for 120 seconds, compared with milking of the cord 5 times toward the neonate on hemoglobin level after 6 weeks, Intubation,Respiratory distress,Clinical jaundice,Neonatal Intensive Care unit (NICU) admission,Apgar score (after 5 minutes of delivery). -Maternal,Need for blood transfusion,Additional need for therapeutic uterotonics,Post postpartum hemorrhage (blood loss \> 500cc),Intensive Care unit admission. Design: Randomized controlled trial. Setting: Ain Shams university maternity hospital. Participants:300 full term infants born after a low risk pregnancy by cesarean section delivery. Intervention: Infants were randomized to delayed umbilical cord clamping (≥120 seconds after delivery) or cord milking (5 times to ward the neonate).
Interventions
PROCEDUREcord milking
milking of the cord 5 times toward the neonate
PROCEDUREdelayed cord clamping
delay clamping of the cord for 120 seconds
Sponsors
Ahmed Mohamed El Kotb Abdel Fattah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant females going for cesarean section that completed 37 weeks of gestation * Medically free
Exclusion criteria
* Known congenital anomalies of fetus. * Rhesus sensitization. * Fetal hydrops. * Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE). * Need for urgent resuscitation. * Multiple pregnancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Hemoglobin Level | 6 weeks after labor | neonatal 6 weeks hemoglobin measured in gram % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Postpartum Haemorrage | 24 hours after labor | (measured blood loss 1000 mL or more |
| Neonatal Intubation | 1st 2 hours after delivery | number of newborns requirng intubation in the first 2 hours after delivery |
| Neonatal Intensive Care Unit (NICU) Admission | 1st 24 hours after delivery | number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery |
| Jundice Requring Phtotherapy | two weks | number of infants requiring phtotherapy for jundice in the first 2 weeks |
| Maternal Need for Blood Transfusion. | 1st 24 hours after delivery | number of mothers with hemoglobin level \< 7mg/dl and need for blood transfusion |
| Maternal Additional Need for Therapeutic Uterotonics | 1st 24 hours of delivery | number of mothers need for \> 20 units of Oxycontin in the 1st 24 hours of delivery |
| Duration of Third Stage of Labor | immediatly after delivery | number of minutes from delivery of the baby till delivery of the placenta |
| Neonatal Apgar Score (After 5 Minutes of Delivery). | 5 minutes of delivery | * The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's: 1. Breathing effort 2. Heart rate 3. Muscle tone 4. Reflexes 5. Skin color * Each category is scored with 0, 1, or 2, depending on the observed condition. * The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. * A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth. * Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs |
Countries
Egypt
Participant flow
Recruitment details
The current RCT was conducted at Ain Shams University Maternity Hospital during the period between August 2015 to February 2016
Pre-assignment details
No significant events following participants recruitment
Participants by arm
| Arm | Count |
|---|---|
| Cord Milking milking of the umbilical cord 5 times toward the neonate
delayed cord clamping: delay clamping of the cord for 120 seconds | 145 |
| Delayed Cord Clamping delayed cord clamping for 120 seconds
cord milking: milking of the cord 5 times toward the neonate | 143 |
| Total | 288 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | Cord Milking | Delayed Cord Clamping | Total |
|---|---|---|---|
| Age, Continuous | 22.42 years STANDARD_DEVIATION 1.67 | 22.4 years STANDARD_DEVIATION 1.78 | 22.4 years STANDARD_DEVIATION 1.7 |
| Region of Enrollment Egypt | 145 participants | 143 participants | 288 participants |
| Sex: Female, Male Female | 145 Participants | 143 Participants | 288 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 | 12 / 145 | 14 / 143 |
| serious Total, serious adverse events | 4 / 145 | 2 / 143 |
Outcome results
Primary
Neonatal Hemoglobin Level
neonatal 6 weeks hemoglobin measured in gram %
Time frame: 6 weeks after labor
Population: Number of Infants Analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cord Milking | Neonatal Hemoglobin Level | 11.86 gram% | Standard Deviation 0.71 |
| Delayed Cord Clamping | Neonatal Hemoglobin Level | 11.95 gram% | Standard Deviation 0.88 |
Secondary
Duration of Third Stage of Labor
number of minutes from delivery of the baby till delivery of the placenta
Time frame: immediatly after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cord Milking | Duration of Third Stage of Labor | 5.45 minutes | Standard Deviation 2.56 |
| Delayed Cord Clamping | Duration of Third Stage of Labor | 8.56 minutes | Standard Deviation 3.15 |
Secondary
Jundice Requring Phtotherapy
number of infants requiring phtotherapy for jundice in the first 2 weeks
Time frame: two weks
Population: Number of Infants Analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cord Milking | Jundice Requring Phtotherapy | 16 participants |
| Delayed Cord Clamping | Jundice Requring Phtotherapy | 12 participants |
Secondary
Maternal Additional Need for Therapeutic Uterotonics
number of mothers need for \> 20 units of Oxycontin in the 1st 24 hours of delivery
Time frame: 1st 24 hours of delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cord Milking | Maternal Additional Need for Therapeutic Uterotonics | 8 participants |
| Delayed Cord Clamping | Maternal Additional Need for Therapeutic Uterotonics | 10 participants |
Secondary
Maternal Need for Blood Transfusion.
number of mothers with hemoglobin level \< 7mg/dl and need for blood transfusion
Time frame: 1st 24 hours after delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cord Milking | Maternal Need for Blood Transfusion. | 1 participants |
| Delayed Cord Clamping | Maternal Need for Blood Transfusion. | 2 participants |
Secondary
Neonatal Apgar Score (After 5 Minutes of Delivery).
* The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's: 1. Breathing effort 2. Heart rate 3. Muscle tone 4. Reflexes 5. Skin color * Each category is scored with 0, 1, or 2, depending on the observed condition. * The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. * A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth. * Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs
Time frame: 5 minutes of delivery
Population: Number of Infants Analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cord Milking | Neonatal Apgar Score (After 5 Minutes of Delivery). | 8.73 Scores on a Scale from 1 to 10 | Standard Deviation 0.58 |
| Delayed Cord Clamping | Neonatal Apgar Score (After 5 Minutes of Delivery). | 8.26 Scores on a Scale from 1 to 10 | Standard Deviation 0.66 |
Secondary
Neonatal Intensive Care Unit (NICU) Admission
number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery
Time frame: 1st 24 hours after delivery
Population: Number of Infants Analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cord Milking | Neonatal Intensive Care Unit (NICU) Admission | 17 participants |
| Delayed Cord Clamping | Neonatal Intensive Care Unit (NICU) Admission | 15 participants |
Secondary
Neonatal Intubation
number of newborns requirng intubation in the first 2 hours after delivery
Time frame: 1st 2 hours after delivery
Population: Number of Infants Analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cord Milking | Neonatal Intubation | 0 participants |
| Delayed Cord Clamping | Neonatal Intubation | 0 participants |
Secondary
Severe Postpartum Haemorrage
(measured blood loss 1000 mL or more
Time frame: 24 hours after labor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cord Milking | Severe Postpartum Haemorrage | 4 participants |
| Delayed Cord Clamping | Severe Postpartum Haemorrage | 2 participants |