30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
ConditionUmbilical Cord Clamping
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTarsus University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsation-Based Delayed Cord Clamping
Procedure/SurgeryThe 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 Clamping
Procedure/SurgeryThe 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.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Pulsation-Based Delayed Cord ClampingExperimental treatment 1 intervention
Group B: 30-Second Cord ClampingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately after birth, following umbilical cord clampingSecondary outcomes
1
Umbilical Arterial pH
Umbilical Arterial pH Umbilical arterial pH will be measured from an arterial blood sample obtained from the isolated umbilical cord segment after cord clamping. Values will be compared between the pulsation-based delayed cord clamping group and the 30-second cord clamping group.
Time frame
Immediately after birth, following umbilical cord clamping2
Umbilical Arterial Partial Pressure of Carbon Dioxide (pCO₂)
Umbilical arterial pCO₂ will be measured from an arterial blood sample obtained from the isolated umbilical cord segment after cord clamping and reported in mmHg. Values will be compared between the two study groups.
Time frame
Immediately after birth, following umbilical cord clamping3
Umbilical Arterial Partial Pressure of Oxygen (pO₂)
Umbilical arterial pO₂ will be measured from an arterial blood sample obtained from the isolated umbilical cord segment after cord clamping and reported in mmHg. Values will be compared between the two study groups.
Time frame
Immediately after birth, following umbilical cord clamping4
Umbilical Arterial Bicarbonate (HCO₃-)
Umbilical arterial bicarbonate (HCO₃-) will be measured from an arterial blood sample obtained from the isolated umbilical cord segment after cord clamping and reported in mmol/L. Values will be compared between the two study groups.
Time frame
Immediately after birth, following umbilical cord clampingSponsors and contacts
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Source ClinicalTrials.gov
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