Umbilical Cord ClampingNCT07833059
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
A study testing Pulsation-Based Delayed Cord Clamping and 30-Second Cord Clamping in people with Umbilical Cord Clamping, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Clamping
- What is being tested?
- Pulsation-Based Delayed Cord Clamping and 30-Second Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Seyhan State Hospital MARSA Additional Service Building
Adana
İrem Ayran, +90 05467661532, 254131011@tarsus.edu.tr
About this study
Official title: Effects of 30-Second and Pulsation-Based Delayed Cord Clamping on Neonatal Metabolic Adaptation: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Umbilical Cord Clamping
- Being tested
- Pulsation-Based Delayed Cord Clamping, 30-Second Cord Clamping
- Keywords
- Delayed Cord Clamping, Pulsation-Based Cord Clamping, Umbilical Cord Blood, Umbilical Arterial Lactate, Neonatal Metabolic Adaptation, Term Newborn, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsation-Based Delayed Cord ClampingProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsation-Based Delayed Cord Clamping | Experimental | 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. Receives: Procedure: Pulsation-Based Delayed Cord Clamping |
| 30-Second Cord Clamping | Active comparator | 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. Receives: Procedure: 30-Second Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after birth, following umbilical cord clamping
Secondary outcomes (8)
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.
Measured: Immediately after birth, following umbilical cord clamping
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.
Measured: Immediately after birth, following umbilical cord clamping
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.
Measured: Immediately after birth, following umbilical cord clamping
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.
Measured: Immediately after birth, following umbilical cord clamping
Umbilical Arterial Base Deficit
Umbilical arterial base deficit 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.
Measured: Immediately after birth, following umbilical cord clamping
Apgar Score at 1 Minute
Neonatal condition will be assessed using the Apgar score at 1 minute after birth. The total Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition.
Measured: 1 minute after birth
Apgar Score at 5 Minutes
Neonatal condition will be assessed using the Apgar score at 5 minutes after birth. The total Apgar score ranges from 0 to 10, with higher scores indicating better neonatal condition.
Measured: 5 minutes after birth
Maternal Postpartum Blood Loss
Maternal postpartum blood loss will be assessed after delivery and recorded in milliliters (mL).
Measured: During the immediate postpartum period after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord ClampingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem KOÇ, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833059
- Sponsor's protocol ID
- IREM-AYRAN-DCC-2026
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because no IPD sharing plan has been established for this master's thesis study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 30-Second and Pulsation-Based Delayed Cord Clamping on Neonatal Metabolic Adaptation: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07833059
- Acronym / sponsor ID
- IREM-AYRAN-DCC-2026
- Conditions
- Umbilical Cord Clamping
- Keywords
- Delayed Cord Clamping, Pulsation-Based Cord Clamping, Umbilical Cord Blood, Umbilical Arterial Lactate, Neonatal Metabolic Adaptation, Term Newborn, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsation-Based Delayed Cord Clamping | Experimental | Procedure: Pulsation-Based Delayed Cord ClampingThe 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. |
| 30-Second Cord Clamping | Active comparator | Procedure: 30-Second Cord ClampingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsation-Based Delayed Cord ClampingThe 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. | Procedure or surgery | Pulsation-Based Delayed Cord Clamping |
| 30-Second Cord ClampingThe 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. | Procedure or surgery | 30-Second Cord Clamping |
Primary outcome
Umbilical Arterial Lactate Level
Time frame: 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.
8 secondary outcomes
Umbilical Arterial pH
Time frame: Immediately after birth, following umbilical cord clamping
Umbilical Arterial Partial Pressure of Carbon Dioxide (pCO₂)
Time frame: Immediately after birth, following umbilical cord clamping
Umbilical Arterial Partial Pressure of Oxygen (pO₂)
Time frame: Immediately after birth, following umbilical cord clamping
Umbilical Arterial Bicarbonate (HCO₃-)
Time frame: Immediately after birth, following umbilical cord clamping
Umbilical Arterial Base Deficit
Time frame: Immediately after birth, following umbilical cord clamping
Apgar Score at 1 Minute
Time frame: 1 minute after birth
Apgar Score at 5 Minutes
Time frame: 5 minutes after birth
Maternal Postpartum Blood Loss
Time frame: During the immediate postpartum period after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because no IPD sharing plan has been established for this master's thesis study.
Related trials for Umbilical Cord Clamping
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Not yet recruiting
"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"
Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes
Recruiting
Delayed Versus Immediate Cord Clamping in Preterm Birth
Preterm Birth Complication, Neonatal Morbidity and Mortality
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsation-Based Delayed Cord Clamping and 30-Second Cord Clamping in people with Umbilical Cord Clamping, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem KOÇ, PhD (05520839594, ozlemkoc@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical Arterial Lactate Level (time frame: Immediately after birth, following umbilical cord clamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.