NCT06090968

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation

Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Lady Hardinge Medical College · Other Government
• Sex: All
• Age: 37 Weeks – 41 Weeks
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.

Detailed description

Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump. Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds). Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR \> 100/min

Conditions

• Hypoxic-Ischemic Encephalopathy
• Perinatal Asphyxia

Interventions

Type	Name	Description
PROCEDURE	Umbilical cord milking	20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times. The entire procedure can be done in 15-20 seconds
PROCEDURE	Immediate cord clamping	clamping the umbilical cord as soon as possible (average 30 seconds)

Timeline

• Start date: 2022-02-05
• Primary completion: 2024-02-04
• Completion: 2024-03-04
• First posted: 2023-10-19
• Last updated: 2024-07-09

Locations

1 site across 1 country: India