Umbilical Cord ManagementNCT03549884
Delayed Cord Clamping in Infants Born by Cesarean Section
A study testing Delayed cord clamping and Early cord clamping in people with Umbilical Cord Management and Elective Cesarean Section, run by University Hospital Padova at 1 site in Italy.
Trial summary
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Management, Elective Cesarean Section
- What is being tested?
- Delayed cord clamping and Early cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2018to 31 Jul 2018
- 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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Elective cesarean section
- Gestational age > or = 39 weeks
- No labor
- Single pregnancy
- Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian
Who cannot join
- Emergent or urgent cesarean sections
- Twin pregnancies
- Parental refusal to participate to the study
- Major congenital malformations (such as cardiopathies)
- Chromosomic abnormalities
- Fetal hydrops
Show all 9Show fewer
- Severe maternal diseases (such as hypertension)
- Cord abnormalities (length < 20 cm, funicular prolapse, funicular knots)
- Intrauterine growth restriction (IUGR)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Therefore, during an elective cesarean section umbilical cord management may play a relevant role on blood passage to the neonate and, as consequence, it may affect neonatal hematological values and cardiovascular parameters. The most effective way to manage umbilical cord in in elective cesarean section remains to be established.
Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the hematocrit on the second day of life; in addition, we will assess the effect on perinatal and postnatal cardiovascular parameters.
Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by cesarean sections. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2 of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate (HR) during the first ten minutes after the birth, arterial blood pressures during the first 3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.
- Being tested
- Delayed cord clamping, Early cord clamping
- Keywords
- Early cord Clamping, Delayed cord clamping, Full term infant, Elective cesarean section, Hematocrit, Postnatal adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingProcedure or surgery
Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section
Early cord clampingProcedure or surgery
Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Delayed cord clamping (DCC) | Experimental | Cord clamping will be performed after 60 seconds of life Receives: Procedure: Delayed cord clamping |
| Early cord clamping (ECC) | Active comparator | Cord clamping will be performed within 10 seconds of life Receives: Procedure: Early cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit
Measured: Day 2 of life
Secondary outcomes (8)
Preductal transcutaneous saturation (TcSaO2)
Measured: During the first 10 minutes of life
Heart rate
(bpm)
Measured: During the first 10 minutes of life
Arterial blood pressure
(mmHg)
Measured: At day 1, 2, 3 of life
Total transcutaneous bilirubin
(mg/dl)
Measured: Day 3 of life
Maternal blood losses
ml
Measured: At delivery
Temperature at Normal nursery admission
Celsius degrees
Measured: At the time of normal nursery admission
Time to the first breath
seconds
Measured: At birth
Weight
g
Measured: Day 3 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start17 Apr 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
- Investigators
- Daniele Trevisanuto, MD, Principal investigator, University of Padova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549884
- Sponsor's protocol ID
- 4443/AO/18
- Status last verified
- Apr 2020
- First submitted
- 26 May 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
PubMed 26477415Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.
PubMed 26472855Katheria AC, Brown MK, Rich W, Arnell K. Providing a Placental Transfusion in Newborns Who Need Resuscitation. Front Pediatr. 2017 Jan 25;5:1. doi: 10.3389/fped.2017.00001. eCollection 2017.
PubMed 28180126Zhou YB, Li HT, Zhu LP, Liu JM. Impact of cesarean section on placental transfusion and iron-related hematological indices in term neonates: a systematic review and meta-analysis. Placenta. 2014 Jan;35(1):1-8. doi: 10.1016/j.placenta.2013.10.011. Epub 2013 Nov 20.
PubMed 24290868Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.
PubMed 22094494Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.
PubMed 29097178
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03549884
- Acronym / sponsor ID
- 4443/AO/18
- Keywords
- Early cord Clamping, Delayed cord clamping, Full term infant, Elective cesarean section, Hematocrit, Postnatal adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 8 Jun 2018 (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.
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Therefore, during an elective cesarean section umbilical cord management may play a relevant role on blood passage to the neonate and, as consequence, it may affect neonatal hematological values and cardiovascular parameters. The most effective way to manage umbilical cord in in elective cesarean section remains to be established.
Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the hematocrit on the second day of life; in addition, we will assess the effect on perinatal and postnatal cardiovascular parameters.
Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by cesarean sections. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2 of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate (HR) during the first ten minutes after the birth, arterial blood pressures during the first 3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed cord clamping (DCC) | Experimental | Procedure: Delayed cord clampingCord clamping will be performed after 60 seconds of life |
| Early cord clamping (ECC) | Active comparator | Procedure: Early cord clampingCord clamping will be performed within 10 seconds of life |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Elective cesarean section
- Gestational age > or = 39 weeks
- No labor
- Single pregnancy
- Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian
Key exclusion criteria (9 listed)
- Emergent or urgent cesarean sections
- Twin pregnancies
- Parental refusal to participate to the study
- Major congenital malformations (such as cardiopathies)
- Chromosomic abnormalities
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 cord clampingCord clamping will be performed after 60 seconds of life in infants delivered by cesarean section | Procedure or surgery | Delayed cord clamping (DCC) |
| Early cord clampingCord clamping will be performed within 10 seconds of life in infants delivered by cesarean section | Procedure or surgery | Early cord clamping (ECC) |
Primary outcome
Hematocrit
Time frame: Day 2 of life
8 secondary outcomes
Preductal transcutaneous saturation (TcSaO2)
Time frame: During the first 10 minutes of life
Heart rate
Time frame: During the first 10 minutes of life
Arterial blood pressure
Time frame: At day 1, 2, 3 of life
Total transcutaneous bilirubin
Time frame: Day 3 of life
Maternal blood losses
Time frame: At delivery
Temperature at Normal nursery admission
Time frame: At the time of normal nursery admission
Time to the first breath
Time frame: At birth
Weight
Time frame: Day 3 of life
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 7 Apr 2020.
- Background: PubMed 26477415Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 26472855Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.
- Background: PubMed 28180126Katheria AC, Brown MK, Rich W, Arnell K. Providing a Placental Transfusion in Newborns Who Need Resuscitation. Front Pediatr. 2017 Jan 25;5:1. doi: 10.3389/fped.2017.00001. eCollection 2017.
- Background: PubMed 24290868Zhou YB, Li HT, Zhu LP, Liu JM. Impact of cesarean section on placental transfusion and iron-related hematological indices in term neonates: a systematic review and meta-analysis. Placenta. 2014 Jan;35(1):1-8. doi: 10.1016/j.placenta.2013.10.011. Epub 2013 Nov 20.
- Background: PubMed 22094494Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.
- Background: PubMed 29097178Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.
- Individual participant dataSharing planned: Yes
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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.
Daniele Trevisanuto, MD principal investigator
University of Padova, Italy
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 cord clamping and Early cord clamping in people with Umbilical Cord Management and Elective Cesarean Section, run by University Hospital Padova at 1 site in Italy.
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 9 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 7 Apr 2020. 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 Italy. 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?
Hematocrit (time frame: Day 2 of life). 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 NCT03549884, which also lists 6 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 7 Apr 2020.