Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center
| Registry | NCT07699666, acronym PREM-CORD |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 200 (Estimated) |
| Sponsor | Faculty of Medicine of Tunis (Other) |
| Conditions | Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping, Anemia, NEC - Necrotizing Enterocolitis, Intraventricular Hemorrhage Neonatal, Respiratory Distress Neonatal |
| Interventions | Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping (Procedure) |
| Dates | start 2025-10-02, primary completion 2026-08-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-07-13, last updated 2026-07-13 |
| Locations | 1 site in Tunisia |
Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Birth Complication All trials for Neonatal Morbidity and Mortality All trials of Delayed Umbilical Cord Clamping All trials of Immediate Umbilical Cord Clamping
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Delayed Umbilical Cord Clamping | Experimental | Procedure: Delayed Umbilical Cord Clamping | 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. |
| Immediate Umbilical Cord Clamping | Experimental | Procedure: Immediate 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. |
Sex: All, ages: 0 Days to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry
| Facility | City | Country | Status |
|---|---|---|---|
| Maternity and neonatology center of Tunis | Tunis, Tunis Governorate | Tunisia | Recruiting |