Trial Outcomes & Findings for Milking Versus Delayed Cord Clamping in Full Term Neonates (NCT NCT02454101)

NCT ID: NCT02454101

Last Updated: 2016-06-28

Results Overview

neonatal 6 weeks hemoglobin measured in gram %

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 6 weeks after labor
• Results posted on: 2016-06-28

Participant Flow

The current RCT was conducted at Ain Shams University Maternity Hospital during the period between August 2015 to February 2016

No significant events following participants recruitment

Participant milestones

Measure	Cord Milking milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Overall Study STARTED	150	150
Overall Study COMPLETED	145	143
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Cord Milking milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

Milking Versus Delayed Cord Clamping in Full Term Neonates

Baseline characteristics by cohort

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate	Total n=288 Participants Total of all reporting groups
Age, Continuous	22.42 years STANDARD_DEVIATION 1.67 • n=5 Participants	22.4 years STANDARD_DEVIATION 1.78 • n=7 Participants	22.4 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants	143 Participants n=7 Participants	288 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Egypt	145 participants n=5 Participants	143 participants n=7 Participants	288 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks after labor

Population: Number of Infants Analyzed

neonatal 6 weeks hemoglobin measured in gram %

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Neonatal Hemoglobin Level	11.86 gram% Standard Deviation 0.71	11.95 gram% Standard Deviation 0.88

SECONDARY outcome

Timeframe: two weks

Population: Number of Infants Analyzed

number of infants requiring phtotherapy for jundice in the first 2 weeks

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Jundice Requring Phtotherapy	16 participants	12 participants

SECONDARY outcome

Timeframe: 24 hours after labor

(measured blood loss 1000 mL or more

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Severe Postpartum Haemorrage	4 participants	2 participants

SECONDARY outcome

Timeframe: 1st 2 hours after delivery

Population: Number of Infants Analyzed

number of newborns requirng intubation in the first 2 hours after delivery

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Neonatal Intubation	0 participants	0 participants

SECONDARY outcome

Timeframe: 1st 24 hours after delivery

Population: Number of Infants Analyzed

number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Neonatal Intensive Care Unit (NICU) Admission	17 participants	15 participants

SECONDARY outcome

Timeframe: 5 minutes of delivery

Population: Number of Infants Analyzed

• 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

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Neonatal Apgar Score (After 5 Minutes of Delivery).	8.73 Scores on a Scale from 1 to 10 Standard Deviation 0.58	8.26 Scores on a Scale from 1 to 10 Standard Deviation 0.66

SECONDARY outcome

Timeframe: 1st 24 hours after delivery

number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Maternal Need for Blood Transfusion.	1 participants	2 participants

SECONDARY outcome

Timeframe: 1st 24 hours of delivery

number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Maternal Additional Need for Therapeutic Uterotonics	8 participants	10 participants

SECONDARY outcome

Timeframe: immediatly after delivery

number of minutes from delivery of the baby till delivery of the placenta

Outcome measures

Measure	Cord Milking n=145 Participants milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 Participants delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Duration of Third Stage of Labor	5.45 minutes Standard Deviation 2.56	8.56 minutes Standard Deviation 3.15

Adverse Events

Cord Milking

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Delayed Cord Clamping

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cord Milking n=145 participants at risk milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 participants at risk delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Blood and lymphatic system disorders post partum haemorrage	2.8% 4/145 • Number of events 4 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery	1.4% 2/143 • Number of events 2 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery

Other adverse events

Measure	Cord Milking n=145 participants at risk milking of the umbilical cord 5 times toward the neonate delayed cord clamping: delay clamping of the cord for 120 seconds	Delayed Cord Clamping n=143 participants at risk delayed cord clamping for 120 seconds cord milking: milking of the cord 5 times toward the neonate
Blood and lymphatic system disorders need for blood trasnfusion	0.69% 1/145 • Number of events 1 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery	1.4% 2/143 • Number of events 2 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery
Surgical and medical procedures Need for manual Removal of the placenta	2.1% 3/145 • Number of events 3 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery	1.4% 2/143 • Number of events 2 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery
Surgical and medical procedures Need for Therapeutic Uterotonics	5.5% 8/145 • Number of events 8 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery	7.0% 10/143 • Number of events 10 • 6 MONTHS Postpartum haemorrage defined as loss of more than 1000 ml blood during the first 24 hours after delivery

Additional Information

ahmed kotb

AinShamsU

Phone: 0100868199

Email: ahmedmkotp@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place