Delayed Versus Immediate Cord Clamping in Preterm Birth

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorFaculty of Medicine of Tunis

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Delayed Umbilical Cord Clamping

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Delayed Umbilical Cord ClampingExperimental treatment 1 intervention
Group B: Immediate Umbilical Cord ClampingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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