About this trial
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
Preterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.
In this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.
The study is conducted in a tertiary maternity center in Tunisia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm neonates born at gestational age between 32 and 37 weeks
Live-born infants delivered in the study center
Singleton pregnancies
Parental consent obtained when applicable according to institutional ethical requirements
Disqualifiers
Major congenital malformations or chromosomal abnormalities
Need for immediate advanced resuscitation at birth
Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation
Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)
Trial design
Parallel
Treatments tested in this trial
Delayed Umbilical Cord Clamping
Procedure/SurgeryDelayed umbilical cord clamping is performed in preterm infants by delaying umbilical cord clamping for a predefined duration after birth (at least 30 seconds), allowing continued placental transfusion prior to neonatal separation from the placenta. The procedure is applied immediately after delivery, with neonatal stabilization provided according to standard clinical practice.
Immediate Umbilical Cord Clamping
Procedure/SurgeryImmediate umbilical cord clamping is performed in preterm infants by clamping the umbilical cord shortly after birth without intentional delay, typically within seconds following delivery, before significant placental transfusion occurs. Neonatal care is initiated immediately after clamping according to standard practice.
Treatment groups
Trial outcomes
Primary outcomes
Neonatal Mortality
Death of the neonate occurring within the first 7 days of life or during initial hospitalization in preterm infants allocated to delayed versus immediate umbilical cord clamping.
Secondary outcomes
Neonatal Anemia
Hemoglobin concentration below the predefined threshold for gestational age or need for red blood cell transfusion during the early neonatal period.
Necrotizing Enterocolitis (NEC)
Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants.
Intraventricular Hemorrhage (IVH)
Presence of intraventricular hemorrhage diagnosed by cranial ultrasound, classified according to standard grading system (Papile classification).
Length of Neonatal Intensive Care Unit (NICU) Stay
Duration of admission in neonatal intensive care unit measured in days.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.