Intrauterine Growth Restriction (IUGR)NCT07031583
Intrauterine Growth Restriction and Intrauterine Fetal Death
A study testing Delayed Umbilical Cord Clamping (DCC) and Early Umbilical Cord Clamping (ECC) in people with Intrauterine Growth Restriction (IUGR) and Oxidative Stress in Neonates, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated whether delaying the clamping of the umbilical cord after birth can reduce harmful oxidative stress in newborns, especially in those who did not grow well during pregnancy (intrauterine growth restriction - IUGR). Read more about this study
- Who is it for?
- Ages 0 hours to 1 hourHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction (IUGR), Oxidative Stress in Neonates, Umbilical Cord Clamping Time
- What is being tested?
- Delayed Umbilical Cord Clamping (DCC) and Early Umbilical Cord Clamping (ECC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2025to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 hours to 1 hour
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates born at ≥29 weeks of gestation
- Diagnosed with Intrauterine Growth Restriction (IUGR) or classified as Appropriate for Gestational Age (AGA) based on prenatal ultrasonography
- For IUGR group: estimated fetal weight below the 10th percentile and abnormal umbilical artery Doppler findings (e.g., elevated resistance index, absent or reversed end-diastolic flow)
- Neonates delivered at Kayseri City Hospital
- Informed consent obtained from parents or legal guardians
Who cannot join
- Major congenital anomalies or structural malformations
- Intrauterine infections
- Preterm birth before 29 weeks of gestation
- Fetal hydrops
- Maternal conditions such as preeclampsia, gestational diabetes, or systemic disease
- Emergency cesarean delivery
- Neonates requiring immediate postnatal intubation or invasive resuscitation
- Signs of severe perinatal distress preventing umbilical cord sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Early Versus Delayed Cord Clamping on Oxidative Stress in Neonates With Intrauterine Growth Restriction: A Prospective Comparative Study
This study investigated whether delaying the clamping of the umbilical cord after birth can reduce harmful oxidative stress in newborns, especially in those who did not grow well during pregnancy (intrauterine growth restriction - IUGR). By comparing early and delayed cord clamping in 90 newborns, researchers found that delayed clamping improved antioxidant protection and reduced signs of oxidative damage. These benefits were more significant in babies with IUGR. The results suggest that delaying cord clamping could help support better early health outcomes in vulnerable newborns.
Read the detailed description
This prospective, randomized clinical study examined the effects of early versus delayed umbilical cord clamping on oxidative stress in newborns, with a specific focus on those diagnosed with intrauterine growth restriction (IUGR). Oxidative stress occurs when the body has an imbalance between harmful molecules (oxidants) and protective defenses (antioxidants), which may negatively affect newborns, especially those who experienced limited growth in the womb.
A total of 90 newborns were included and grouped based on their growth status (IUGR or appropriate for gestational age) and the timing of cord clamping (early: within 60 seconds; delayed: after 60-180 seconds). Blood samples were taken from the umbilical cord immediately after birth to measure markers of oxidative stress and antioxidant activity.
The study found that delayed cord clamping was associated with improved antioxidant levels and reduced oxidative stress, particularly in growth-restricted infants. These findings suggest that delaying cord clamping may provide protective health benefits for high-risk newborns.
- Conditions
- Intrauterine Growth Restriction (IUGR), Oxidative Stress in Neonates, Umbilical Cord Clamping Time
- Being tested
- Delayed Umbilical Cord Clamping (DCC), Early Umbilical Cord Clamping (ECC)
- Keywords
- Umbilical Cord Clamping, Fetal Growth Restriction, Oxidative Stress, Total Antioxidant Capacity, Total Oxidant Status
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Umbilical Cord Clamping (DCC)Procedure or surgery
The umbilical cord was clamped between 60 and 180 seconds after birth or after the cessation of cord pulsation, in accordance with WHO recommendations. This procedure allows for additional placental transfusion and potential enhancement of neonatal antioxidant capacity.
Early Umbilical Cord Clamping (ECC)Procedure or surgery
The umbilical cord was clamped within the first 60 seconds after birth. This represents the standard or traditional approach used for comparison with delayed clamping in terms of oxidative stress outcomes.
| Study group | Role | What they receive |
|---|---|---|
| IUGR-Delayed Cord Clamping (IUGR-DCC) | Experimental | Neonates diagnosed with intrauterine growth restriction (IUGR) received delayed umbilical cord clamping, performed 60-180 seconds after birth. Umbilical cord blood samples were collected immediately for oxidative stress analysis. Receives: Procedure: Delayed Umbilical Cord Clamping (DCC) |
| IUGR - Early Cord Clamping (IUGR-ECC) | Active comparator | Neonates with IUGR underwent early umbilical cord clamping, within 60 seconds after birth. Umbilical cord blood samples were collected for comparison with delayed clamping groups. Receives: Procedure: Early Umbilical Cord Clamping (ECC) |
| AGA - Delayed Cord Clamping (AGA-DCC) | Experimental | Neonates appropriate for gestational age (AGA) underwent delayed cord clamping, performed 60-180 seconds after birth. Biochemical markers of oxidative stress were measured using cord blood samples. Receives: Procedure: Delayed Umbilical Cord Clamping (DCC) |
| AGA - Early Cord Clamping (AGA-ECC) | Active comparator | AGA neonates received early umbilical cord clamping, within the first 60 seconds post-delivery. Cord blood was analyzed for oxidative stress markers as a baseline comparator. Receives: Procedure: Early Umbilical Cord Clamping (ECC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Antioxidant Status (TAS)
TAS levels in umbilical cord blood will be measured using a validated colorimetric method (Erel, 2004). Higher values indicate greater antioxidant capacity.
Measured: At birth (within 30 minutes postpartum)
Total Oxidant Status (TOS)
TOS levels in umbilical cord blood will be assessed using a spectrophotometric assay (Erel, 2005). Elevated levels reflect greater oxidative stress.
Measured: At birth (within 30 minutes postpartum)
Oxidative Stress Index (OSI)
OSI will be calculated as the ratio of TOS to TAS multiplied by 10. It provides a combined indicator of oxidative balance.
Measured: At birth (within 30 minutes postpartum)
Secondary outcomes (3)
Catalase Enzyme Activity
Catalase activity in umbilical cord blood will be measured via spectrophotometry. Catalase is an endogenous antioxidant enzyme that reflects neonatal oxidative defense capacity.
Measured: At birth (within 30 minutes postpartum)
1-Minute and 5-Minute APGAR Scores
Clinical scoring system evaluating neonatal adaptation at 1 and 5 minutes of life (heart rate, respiration, muscle tone, reflex, color). Higher scores indicate better clinical condition.
Measured: Within 5 minutes after birth
Birth Weight
Neonatal birth weight (in grams) will be recorded and compared across groups to evaluate any association with clamping time and oxidative status.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start11 Mar 2025
- Primary completion1 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Growth Restriction (IUGR)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-group parallel design based on neonatal growth status and cord clamping timing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri City Hospital
- Responsible party
- Principal investigator, Ozge Baykan COPUROGLU, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031583
- Sponsor's protocol ID
- KayseriCityHospital
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel Ghany EA, Alsharany W, Ali AA, Youness ER, Hussein JS. Anti-oxidant profiles and markers of oxidative stress in preterm neonates. Paediatr Int Child Health. 2016 May;36(2):134-40. doi: 10.1179/2046905515Y.0000000017.
PubMed 25940692Demir MB, Copuroglu M, Ozdemir A, Kocer D. Impact of early versus delayed cord clamping on oxidative stress in neonates with intrauterine growth restriction: a prospective randomized controlled trial. BMC Pregnancy Childbirth. 2025 Dec 5;25(1):1291. doi: 10.1186/s12884-025-08335-z.
PubMed 41350641
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Versus Delayed Cord Clamping on Oxidative Stress in Neonates With Intrauterine Growth Restriction: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07031583
- Acronym / sponsor ID
- KayseriCityHospital
- Conditions
- Intrauterine Growth Restriction (IUGR), Oxidative Stress in Neonates, Umbilical Cord Clamping Time
- Keywords
- Umbilical Cord Clamping, Fetal Growth Restriction, Oxidative Stress, Total Antioxidant Capacity, Total Oxidant Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Kayseri City Hospital
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 22 Jun 2025 (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 study investigated whether delaying the clamping of the umbilical cord after birth can reduce harmful oxidative stress in newborns, especially in those who did not grow well during pregnancy (intrauterine growth restriction - IUGR). By comparing early and delayed cord clamping in 90 newborns, researchers found that delayed clamping improved antioxidant protection and reduced signs of oxidative damage. These benefits were more significant in babies with IUGR. The results suggest that delaying cord clamping could help support better early health outcomes in vulnerable newborns.
Detailed description
This prospective, randomized clinical study examined the effects of early versus delayed umbilical cord clamping on oxidative stress in newborns, with a specific focus on those diagnosed with intrauterine growth restriction (IUGR). Oxidative stress occurs when the body has an imbalance between harmful molecules (oxidants) and protective defenses (antioxidants), which may negatively affect newborns, especially those who experienced limited growth in the womb.
A total of 90 newborns were included and grouped based on their growth status (IUGR or appropriate for gestational age) and the timing of cord clamping (early: within 60 seconds; delayed: after 60-180 seconds). Blood samples were taken from the umbilical cord immediately after birth to measure markers of oxidative stress and antioxidant activity.
The study found that delayed cord clamping was associated with improved antioxidant levels and reduced oxidative stress, particularly in growth-restricted infants. These findings suggest that delaying cord clamping may provide protective health benefits for high-risk newborns.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four-group parallel design based on neonatal growth status and cord clamping timing.
| Arm | Type | Receives |
|---|---|---|
| IUGR-Delayed Cord Clamping (IUGR-DCC) | Experimental | Procedure: Delayed Umbilical Cord Clamping (DCC)Neonates diagnosed with intrauterine growth restriction (IUGR) received delayed umbilical cord clamping, performed 60-180 seconds after birth. Umbilical cord blood samples were collected immediately for oxidative stress analysis. |
| IUGR - Early Cord Clamping (IUGR-ECC) | Active comparator | Procedure: Early Umbilical Cord Clamping (ECC)Neonates with IUGR underwent early umbilical cord clamping, within 60 seconds after birth. Umbilical cord blood samples were collected for comparison with delayed clamping groups. |
| AGA - Delayed Cord Clamping (AGA-DCC) | Experimental | Procedure: Delayed Umbilical Cord Clamping (DCC)Neonates appropriate for gestational age (AGA) underwent delayed cord clamping, performed 60-180 seconds after birth. Biochemical markers of oxidative stress were measured using cord blood samples. |
| AGA - Early Cord Clamping (AGA-ECC) | Active comparator | Procedure: Early Umbilical Cord Clamping (ECC)AGA neonates received early umbilical cord clamping, within the first 60 seconds post-delivery. Cord blood was analyzed for oxidative stress markers as a baseline comparator. |
Who may qualify
- Ages
- 0 hours to 1 hour
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Neonates born at ≥29 weeks of gestation
- Diagnosed with Intrauterine Growth Restriction (IUGR) or classified as Appropriate for Gestational Age (AGA) based on prenatal ultrasonography
- For IUGR group: estimated fetal weight below the 10th percentile and abnormal umbilical artery Doppler findings (e.g., elevated resistance index, absent or reversed end-diastolic flow)
- Neonates delivered at Kayseri City Hospital
- Informed consent obtained from parents or legal guardians
Key exclusion criteria (8 listed)
- Major congenital anomalies or structural malformations
- Intrauterine infections
- Preterm birth before 29 weeks of gestation
- Fetal hydrops
- Maternal conditions such as preeclampsia, gestational diabetes, or systemic disease
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 |
|---|---|---|
| Delayed Umbilical Cord Clamping (DCC)The umbilical cord was clamped between 60 and 180 seconds after birth or after the cessation of cord pulsation, in accordance with WHO recommendations. This procedure allows for additional placental transfusion and potential enhancement of neonatal antioxidant capacity. | Procedure or surgery | AGA - Delayed Cord Clamping (AGA-DCC), IUGR-Delayed Cord Clamping (IUGR-DCC) |
| Early Umbilical Cord Clamping (ECC)The umbilical cord was clamped within the first 60 seconds after birth. This represents the standard or traditional approach used for comparison with delayed clamping in terms of oxidative stress outcomes. | Procedure or surgery | AGA - Early Cord Clamping (AGA-ECC), IUGR - Early Cord Clamping (IUGR-ECC) |
Primary outcome
Total Antioxidant Status (TAS)
Time frame: At birth (within 30 minutes postpartum)
TAS levels in umbilical cord blood will be measured using a validated colorimetric method (Erel, 2004). Higher values indicate greater antioxidant capacity.
Total Oxidant Status (TOS)
Time frame: At birth (within 30 minutes postpartum)
TOS levels in umbilical cord blood will be assessed using a spectrophotometric assay (Erel, 2005). Elevated levels reflect greater oxidative stress.
Oxidative Stress Index (OSI)
Time frame: At birth (within 30 minutes postpartum)
OSI will be calculated as the ratio of TOS to TAS multiplied by 10. It provides a combined indicator of oxidative balance.
3 secondary outcomes
Catalase Enzyme Activity
Time frame: At birth (within 30 minutes postpartum)
1-Minute and 5-Minute APGAR Scores
Time frame: Within 5 minutes after birth
Birth Weight
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Results publication: PubMed 25940692Abdel Ghany EA, Alsharany W, Ali AA, Youness ER, Hussein JS. Anti-oxidant profiles and markers of oxidative stress in preterm neonates. Paediatr Int Child Health. 2016 May;36(2):134-40. doi: 10.1179/2046905515Y.0000000017.
- Derived from this study: PubMed 41350641Demir MB, Copuroglu M, Ozdemir A, Kocer D. Impact of early versus delayed cord clamping on oxidative stress in neonates with intrauterine growth restriction: a prospective randomized controlled trial. BMC Pregnancy Childbirth. 2025 Dec 5;25(1):1291. doi: 10.1186/s12884-025-08335-z.
- Individual participant dataSharing planned: No
Related trials for Intrauterine Growth Restriction (IUGR)
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Assessment of Invasive Genetic Testing in Fetuses With Isolated Intrauterine Growth Restriction Diagnosed After 28 Weeks of Gestation at Strasbourg University Hospitals (2016-2023)
Isolated Intrauterine Growth Restriction (IUGR)
Not yet recruitingObservational study
Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness
Fetal Macrosomia, Intrauterine Growth Disorders (IUGR and Macrosomia)
RecruitingObservational study
PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
Pre-eclampsia, Oocyte Donation
Enrolling by invitationObservational study
Determination of Clinical Phenotypes of Intrauterine Growth Restriction in Term Infants Based on Body Composition
Intrauterine Growth Restriction (IUGR)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Umbilical Cord Clamping (DCC) and Early Umbilical Cord Clamping (ECC) in people with Intrauterine Growth Restriction (IUGR) and Oxidative Stress in Neonates, run by Istanbul Arel 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Antioxidant Status (TAS) (time frame: At birth (within 30 minutes postpartum)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07031583, which also lists 2 linked publications.
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 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.