Effects of 30-Second and Pulsation-Based Delayed Cord Clamping on Neonatal Metabolic Adaptation: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Umbilical Arterial Lactate Level
研究概览
简要总结
This randomized controlled trial aims to compare the effects of 30-second cord clamping and pulsation-based delayed cord clamping on neonatal metabolic adaptation in term newborns delivered vaginally. Eligible mother-newborn pairs will be randomly assigned in a 1:1 ratio to either 30-second cord clamping or pulsation-based delayed cord clamping. In the intervention group, the umbilical cord will be clamped after spontaneous cessation of cord pulsation, whereas in the control group, the cord will be clamped 30 seconds after birth. The primary outcome is umbilical arterial lactate level. Secondary outcomes include umbilical arterial pH, pCO2, pO2, HCO3-, base deficit, 1- and 5-minute Apgar scores, and maternal postpartum blood loss.
详细描述
This is a prospective, two-arm, parallel-group randomized controlled trial that will be conducted in the delivery unit of Seyhan State Hospital MARSA Additional Service Building in Adana, Türkiye. The study will include eligible term pregnant women undergoing vaginal delivery and their newborns.
Participants will be randomly assigned in a 1:1 ratio to the intervention or control group. Randomization will be stratified by parity (nulliparous or multiparous), with variable block sizes of 4 and 6. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes.
In the pulsation-based delayed cord clamping group, the newborn will be placed on the mother's abdomen immediately after birth for skin-to-skin contact and thermal protection. The umbilical cord will remain intact while cord pulsation is assessed by palpation. The cord will be clamped and cut after pulsation has spontaneously and completely ceased.
In the 30-second cord clamping group, the newborn will similarly be placed on the mother's abdomen for skin-to-skin contact and thermal protection, and the umbilical cord will be clamped and cut 30 seconds after birth.
In both groups, the actual interval from birth to cord clamping will be recorded in seconds. Following cord clamping, an umbilical arterial blood sample will be obtained from the isolated cord segment and analyzed as soon as possible and within 15 minutes. Umbilical arterial lactate will be evaluated as the primary outcome. Umbilical arterial pH, pCO2, pO2, HCO3-, and base deficit will be evaluated as secondary biochemical outcomes. Additional clinical outcomes will include 1- and 5-minute Apgar scores and maternal postpartum blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women admitted to the Delivery Unit of Seyhan State Hospital MARSA Additional Service Building for vaginal delivery
- •Aged 18 years or older
- •Term pregnancy
- •Singleton, live pregnancy
- •Fetus in cephalic (vertex) presentation
- •Established vaginal labor and in the active phase of labor
- •Voluntary agreement to participate in the study and provision of written informed consent
排除标准
- •Planned elective or emergency cesarean delivery at admission or at the beginning of labor
- •Preterm or post-term pregnancy
- •Multiple pregnancy
- •Diagnosis of fetal growth restriction (IUGR) or fetal macrosomia
- •Intrauterine fetal death or major fetal congenital anomaly
- •High-risk maternal or obstetric conditions, including severe preeclampsia, eclampsia, placental abruption, or placenta previa
- •Meconium-stained amniotic fluid or a depressed newborn requiring advanced neonatal resuscitation, such as endotracheal intubation or chest compressions
研究组 & 干预措施
Pulsation-Based Delayed Cord Clamping
The newborn will be placed on the mother's abdomen immediately after birth for skin-to-skin contact and thermal protection. The umbilical cord will remain intact until cord pulsation spontaneously and completely ceases. The cord will then be clamped and cut. The actual time from birth to cord clamping will be recorded in seconds.
干预措施: Pulsation-Based Delayed Cord Clamping (Procedure)
30-Second Cord Clamping
The newborn will be placed on the mother's abdomen immediately after birth for skin-to-skin contact and thermal protection. The umbilical cord will be clamped and cut 30 seconds after birth. The actual time from birth to cord clamping will be recorded in seconds.
干预措施: 30-Second Cord Clamping (Procedure)
结局指标
主要结局
Umbilical Arterial Lactate Level
时间窗: Immediately after birth, following umbilical cord clamping
Umbilical arterial lactate level will be measured from an arterial blood sample obtained from the isolated umbilical cord segment after cord clamping and reported in mmol/L. Lactate levels will be compared between the pulsation-based delayed cord clamping group and the 30-second cord clamping group.
次要结局
- Apgar Score at 5 Minutes(5 minutes after birth)
- Maternal Postpartum Blood Loss(During the immediate postpartum period after delivery)
- Umbilical Arterial pH(Immediately after birth, following umbilical cord clamping)
- Umbilical Arterial Partial Pressure of Carbon Dioxide (pCO₂)(Immediately after birth, following umbilical cord clamping)
- Umbilical Arterial Partial Pressure of Oxygen (pO₂)(Immediately after birth, following umbilical cord clamping)
- Umbilical Arterial Bicarbonate (HCO₃-)(Immediately after birth, following umbilical cord clamping)
- Umbilical Arterial Base Deficit(Immediately after birth, following umbilical cord clamping)
- Apgar Score at 1 Minute(1 minute after birth)
研究者
Özlem KOÇ
Principal Investigator
Tarsus University