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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-05

Study Completion Date

2024-03-04

Brief Summary

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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.

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Detailed Description

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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

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Hypoxic-Ischemic Encephalopathy Perinatal Asphyxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Umbilical cord milking

Intervention Type PROCEDURE

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

Immediate cord clamping

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

Group Type ACTIVE_COMPARATOR

Immediate cord clamping

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Immediate cord clamping

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

37 Weeks

Maximum Eligible Age

41 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No