This is a study on newborn babies to find out if delay in cord clamping, or cod milking at birth, could help the baby in short term out come over a period of 3 months after birth.

Comparison of effects of three umbilical cord management strategies on mean haemoglobin levels and other neonatal outcomes: A Single Centre Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068544

Enrollment

Registered

2024-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Delayed cord clamping: Delayed cord clamping by 30-60 seconds, which is the newer recommended method of care, to achieve certain benefits. Intervention2: Cord milking: Cord milking with

Eligibility

Inclusion criteria

Inclusion criteria: Singleton vigorous newborns born at 32 (0/7) to 41 (6/7) weeks of gestation from largely uncomplicated pregnancies.

Exclusion criteria

Exclusion criteria: newborns requiring resuscitation, multiple gestations, congenital anomalies, placental abnormalities, alloimmunization, foetal hydrops, fetal compromise, and maternal illness affecting foetal well-being.

Design outcomes

Primary

Measure	Time frame
Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. Frequency of IVH Frequency of NEC Frequency of neonatal hyperbilirubinemia Incidence of phototherapy Length of stay after birth. Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation Timepoint: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. Frequency of IVH Frequency of NEC Frequency of neonatal hyperbilirubinemia Incidence of phototherapy Length of stay after birth. Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation	—

Measure

Time frame

Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. Frequency of IVH Frequency of NEC Frequency of neonatal hyperbilirubinemia Incidence of phototherapy Length of stay after birth. Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation Timepoint: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. Frequency of IVH Frequency of NEC Frequency of neonatal hyperbilirubinemia Incidence of phototherapy Length of stay after birth. Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation

—

Secondary

Measure	Time frame
Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. Frequency of IVH Frequency of NEC Frequency of neonatal hyperbilirubinemia Incidence of phototherapy Length of stay after birth. Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilationTimepoint: At day 3 of life and 3 months of age	—

Countries

India

Contacts

Public ContactPooja Anthwal

Jagannath Gupta Institute of Medical Sciences

poojaanthwal2010@gmail.com09433666809

Outcome results