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

Lady Hardinge Medical College

Status: Completed

Conditions: Perinatal Asphyxia; Hypoxic-Ischemic Encephalopathy

Treatments: Procedure: Umbilical cord milking; Procedure: Immediate cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT06090968

LHMC/IEC/071/UCM

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 37 to 41 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

Vaginally born, Singleton Term gestation (≥ 37 and & < 42 weeks), requiring resuscitation at birth

Exclusion criteria

• Major congenital anomaly (antenatally diagnosed or visible at birth)
• Rh negative pregnancy
• Hydrops
• Abruptio Placneta/ Placenta previa
• Fetus with absent and reversal of End Diastolic flow
• Cord avulsion
• Refusal of consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Umbilical cord milking

Experimental group

Description:

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

Treatment:

Procedure: Umbilical cord milking

Immediate cord clamping

Active Comparator group

Description:

clamping the umbilical cord as soon as possible (average 30 seconds)

Treatment:

Procedure: Immediate cord clamping