An interventional study of Delayed Umbilical Cord Clamping and Immediate Umbilical Cord Clamping in Preterm Birth Complication, Neonatal Morbidity and Mortality and Cord Clamping, sponsored by Faculty of Medicine of Tunis. Recruiting at 1 site in Tunisia. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Faculty of Medicine of Tunis · Not applicable, Interventional, and Treatment
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 200 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
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Exclusion Criteria:
Delayed umbilical cord clamping is performed in preterm infants according to the study protocol. The umbilical cord is clamped after a predefined delay following birth (at least 30 seconds), allowing continued placental transfusion to the neonate before cord clamping. The intervention is applied immediately after delivery while ensuring neonatal stabilization according to standard clinical practice.
Procedure: Delayed Umbilical Cord Clamping
Immediate umbilical cord clamping is performed in preterm infants according to standard practice. The umbilical cord is clamped shortly after birth without intentional delay, typically within seconds of delivery, before significant placental transfusion occurs. Neonatal care is provided immediately after clamping according to routine clinical protocols.
Procedure: Immediate Umbilical Cord Clamping
Delayed 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 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.
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.
Time frame: Within 7 days of birth (or until hospital discharge, whichever occurs first)
Neonatal Anemia
Hemoglobin concentration below the predefined threshold for gestational age or need for red blood cell transfusion during the early neonatal period.
Time frame: Within 24-48 hours of birth and if possible 3 to 4 months after birth
Necrotizing Enterocolitis (NEC)
Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants.
Time frame: From Birth up to 28 days after birth
Intraventricular Hemorrhage (IVH)
Presence of intraventricular hemorrhage diagnosed by cranial ultrasound, classified according to standard grading system (Papile classification).
Time frame: Within first 7 days of life
Length of Neonatal Intensive Care Unit (NICU) Stay
Duration of admission in neonatal intensive care unit measured in days.
Time frame: From Birth up to 28 days after birth
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Faculty of Medicine of Tunis