30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns

N/ANot Yet RecruitingNCT07833059

Tarsus University122 enrolled

Overview

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.

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. Because of the nature of the intervention, the investigator performing cord clamping and the clinical delivery team cannot be blinded to group assignment. Laboratory personnel analyzing the coded umbilical arterial blood samples and the investigator performing the statistical analysis will be blinded to group allocation.

Interventions

Pulsation-Based Delayed Cord ClampingPROCEDURE

The umbilical cord will remain intact after birth until cord pulsation spontaneously and completely ceases. During this period, the newborn will be placed on the mother's abdomen for skin-to-skin contact and routine thermal protection. After complete cessation of cord pulsation, the umbilical cord will be clamped and cut. The actual time from birth to cord clamping will be recorded in seconds.

30-Second Cord ClampingPROCEDURE

The umbilical cord will be clamped and cut 30 seconds after birth. During this period, the newborn will be placed on the mother's abdomen for skin-to-skin contact and routine thermal protection. The actual time from birth to cord clamping will be recorded in seconds.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Umbilical Arterial Lactate Level

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.