Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Neonatal Mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Delayed Umbilical Cord Clamping (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.
干预措施: Immediate Umbilical Cord Clamping (Procedure)
结局指标
主要结局
Neonatal Mortality
时间窗: Within 7 days of birth (or until hospital discharge, whichever occurs first)
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.
次要结局
- Neonatal Anemia(Within 24-48 hours of birth and if possible 3 to 4 months after birth)
- Necrotizing Enterocolitis (NEC)(From Birth up to 28 days after birth)
- Intraventricular Hemorrhage (IVH)(Within first 7 days of life)
- Length of Neonatal Intensive Care Unit (NICU) Stay(From Birth up to 28 days after birth)
研究者
Mohammed Amine HANNACHI
Assistant Professor in Gynecology and Obstetrics
Faculty of Medicine of Tunis