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Resuscitation of newborns with intact versus clamped umbilical cord

Resuscitation with umbilical cord intact in term and late preterm neonates - RECORD-IN

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063374
Enrollment
1836
Registered
2024-02-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: P00-P96- Certain conditions originating in the perinatal period

Interventions

Intervention1: Resuscitation with intact cord: The neonate will be resuscitated with the umbilical cord intact. The cord will be clamped after the onset of spontaneous breathing or at least 180 second

Sponsors

Dr Deepak Chawla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates born to mothers with any of the following and not breathing or crying at birth Preeclampsia or eclampsia Maternal hypertension Polyhydramnios or oligohydramnios Fetal macrosomia Intrauterine growth restriction No prenatal care Emergency cesarean delivery Forceps or vacuum assisted delivery Breech or other fetal malpresentation Category II or III fetal heart rate pattern Intrapartum bleeding not due to placental abruption Chorioamnionitis Shoulder dystocia Meconium-stained amniotic fluid Prolonged labor

Exclusion criteria

Exclusion criteria: Congenital malformation or chromosomal abnormalities in fetus diagnosed in the antenatal period Twin or higher-order pregnancy Abruption placenta or cord abnormalities with active bleeding Invasive placentation like accreta and percreta Anterior placenta previa (in case of cesarean section) Fetal hydrops Ruptured uterus

Design outcomes

Primary

MeasureTime frame
Composite of moderate or severe HIE or neonatal death by 7 days of ageTimepoint: By 7 days of age

Secondary

MeasureTime frame
Post-operative wound infection (cesearan or episiotomy) before discharge in womenTimepoint: Before discharge from birth hospital;Postpartum hemorrhage needing interventionTimepoint: within 72 h of delivery;Proportion of neonates who die within 28 completed days of age due to any causeTimepoint: 28 days of age;Proportion of neonates who received chest compressions, epinephrine, or volume expanders during birth resuscitationTimepoint: At birth;Proportion of neonates who were given positive pressure ventilation during birth resuscitationTimepoint: At birth;Proprtion of neonates who qualified criteria for NICU admissionTimepoint: Till discharge from hospital

Countries

India

Contacts

Public ContactDeepak Chawla

Government Medical College Hospital

drdeepak@gmch.gov.in9646121559

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026