Delayed Cord ClampingNCT03878602
Umbilical Cord Clamping: What Are the Benefits
A study testing Delayed umbilical cord clamping and Immediate umbilical cord clamping in people with Delayed Cord Clamping, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Delayed Cord Clamping
- What is being tested?
- Delayed umbilical cord clamping and Immediate umbilical cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth Body Weight = appropriate for gestational age
- Delivery mode= Elective Caesarean Section
- Mothers' BMI = 19-24,9
- Mothers'age ≤ 37 years
Who cannot join
- Admission in NICU;
- Neonatal Resuscitation
- Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of foetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest
- Pathologies ;
- Smoking mothers;
- Assumption of drugs during pregnancy
- Mother toxicomaniac
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of mother and child's Health Poliambulanza Foundation
Brescia, 25124
About this study
Official title: Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. A lot of studies have shown that delayed umbilical cord clamping is associated with greater haemoglobin concentration, better iron storage between 3-6 months of life and lower incidence for transfusion and neonatal hypotension compared to immediate umbilical cord clumping. Newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section.
Read the detailed description
Umbilical cord cutting determines the separation of the newborn from mother. Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. In the spontaneous labor there are two modalities to obtain umbilical cord clamping: the first modality is immediate umbilical cord clamping within 30s from birth. The second modality is delayed umbilical cord clamping at least 1 min after birth. After 1 min, cerebral blood flow is reduced again because of lower cardiac output.
A lot of studies have shown that delayed umbilical cord clamping is better than the early umbilical clamping because delayed umbilical cord clamping is associated with a great haemoglobin concentration in the newborns and best iron storage between 3-6 months of life and less incidence for transfusion and neonatal hypotension. Experimental studies, executed on animals and humans, analysed cardiocirculatory changes in the foetus immediately after birth and the importance of the delayed clamping for the hemodynamic stabilization, particularly in the lowest gestational age.
In a recent randomized study conducted in Nepal on 540 newborns, birth by eutocic delivery with 39.2 weeks of gestational age, showed that delayed umbilical cord clamping after 3 min of life is correlated with a better haemoglobin level and less incidence of anaemia at 8 months of life. Zhou et al. conducted a meta-analysis that included hematologic parameters obtained by umbilical cord, placenta and newborns blood.
Association of Italian Hospital Gynecologists Obstetricians (AOGOI) declared contraindicated conditions to execute a delayed umbilical cord clamping:
Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of fetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest. Monochorionic twins, Fetal Hydrops, Umbilical cord damaged, Isoimmunization Rh.
Researchers concluded that newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Haematocrit difference was greater between newborns birth by elective Caesarean Section compared to those birth by Caesarean Section in labor. Nowadays, researchers found no side effects of delayed umbilical cord clamping except a slight increase of phototherapy needs.
Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section. The aim of the study protocol is to investigate the effects of the clamping after 1 min from birth by elective Caesarean Section on heart rate, saturation, body temperature, bilirubin, haematocrit and glycemia.
- Conditions
- Delayed Cord Clamping
- Being tested
- Delayed umbilical cord clamping, Immediate umbilical cord clamping
- Keywords
- Newborn, Elective Caesaren Section, Cord Clamping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed umbilical cord clampingProcedure or surgery
Umbilical cord will be clamped after 1 min after the birth of the newborn
Immediate umbilical cord clampingProcedure or surgery
Umbilical cord will be clamped immediately after the birth of the newborn
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Newborns will be subjected to umbilical cord immediate clamping Receives: Procedure: Immediate umbilical cord clamping |
| Study Group | Experimental | Newborns will be subjected to umbilical cord delayed clamping Receives: Procedure: Delayed umbilical cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Heart Rate After Delayed Umbilical Clamping
It will be measured the change of heart rate (HR)
Measured: 5 minutes and 10 minutes after birth
Change of Saturation After Delayed Umbilical Clamping
Saturation change (SpO2)
Measured: 5 minutes and 10 minutes after birth
Change of Temperature After Delayed Umbilical Clamping
Temperature change (T)
Measured: 5 minutes after birth
Secondary outcomes (3)
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping
hemo gluco test (HGT)
Measured: 120 minutes after birth
Misuration of the Hematocrit After Delayed Umbilical Clamping
hematocrit (Ht)
Measured: 72 hours of life
Misuration of the Bilirubin After Delayed Umbilical Clamping
bilirubin
Measured: 72 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start15 Oct 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Delayed 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe De Bernando, Fondazione Poliambulanza Istituto Ospedaliero
- Investigators
- Giuseppe De Bernardo, M.D., Principal investigator, Poliambulanza FoundationMaurizio Giordano, B.Sc., Study chair, University of Naples Federico II, School of MedicineLaura Linetti, Dr., Study director, Poliambulanza Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878602
- Sponsor's protocol ID
- 3176
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2019
- Last updated
- 19 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katheria A, Hosono S, El-Naggar W. A new wrinkle: Umbilical cord management (how, when, who). Semin Fetal Neonatal Med. 2018 Oct;23(5):321-326. doi: 10.1016/j.siny.2018.07.003. Epub 2018 Jul 20.
PubMed 30076109Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11.
PubMed 23401615Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015.
PubMed 25689406Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1399-1404. doi: 10.3889/oamjms.2018.286. eCollection 2018 Aug 20.
PubMed 30159064Ghavam S, Batra D, Mercer J, Kugelman A, Hosono S, Oh W, Rabe H, Kirpalani H. Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- and short-term outcomes. Transfusion. 2014 Apr;54(4):1192-8. doi: 10.1111/trf.12469.
PubMed 24843886Backes CH, Rivera BK, Haque U, Bridge JA, Smith CV, Hutchon DJR, Mercer JS. Placental transfusion strategies in very preterm neonates: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jul;124(1):47-56. doi: 10.1097/AOG.0000000000000324.
PubMed 24901269Nevill E, Meyer MP. Effect of delayed cord clamping (DCC) on breathing and transition at birth in very preterm infants. Early Hum Dev. 2015 Jul;91(7):407-11. doi: 10.1016/j.earlhumdev.2015.04.013. Epub 2015 May 15.
PubMed 25984654Wafaa Taha Ibrahim Elgzar, Heba Abdel-Fatah Ibrahim, Hanan Heiba Elkhateeb."Effects of Deferred Versus Early Umbilical Cord Clamping on Maternal and Neonatal Outcomes" - American Journal of Nursing Research, 2017,5(4), 115-128
Valero J, Desantes D, Perales-Puchalt A, Rubio J, Diago Almela VJ, Perales A. Effect of delayed umbilical cord clamping on blood gas analysis. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):21-3. doi: 10.1016/j.ejogrb.2012.01.020. Epub 2012 Mar 8.
PubMed 22405491Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.
PubMed 28114607Zhou 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 24290868McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
PubMed 23843134De Bernardo G, Giordano M, De Santis R, Castelli P, Sordino D, Trevisanuto D, Buonocore G, Perrone S. A randomized controlled study of immediate versus delayed umbilical cord clamping in infants born by elective caesarean section. Ital J Pediatr. 2020 May 24;46(1):71. doi: 10.1186/s13052-020-00835-2.
PubMed 32448358
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
- ClinicalTrials.gov ID
- NCT03878602
- Acronym / sponsor ID
- 3176
- Conditions
- Delayed Cord Clamping
- Keywords
- Newborn, Elective Caesaren Section, Cord Clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 19 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. A lot of studies have shown that delayed umbilical cord clamping is associated with greater haemoglobin concentration, better iron storage between 3-6 months of life and lower incidence for transfusion and neonatal hypotension compared to immediate umbilical cord clumping. Newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section.
Detailed description
Umbilical cord cutting determines the separation of the newborn from mother. Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. In the spontaneous labor there are two modalities to obtain umbilical cord clamping: the first modality is immediate umbilical cord clamping within 30s from birth. The second modality is delayed umbilical cord clamping at least 1 min after birth. After 1 min, cerebral blood flow is reduced again because of lower cardiac output.
A lot of studies have shown that delayed umbilical cord clamping is better than the early umbilical clamping because delayed umbilical cord clamping is associated with a great haemoglobin concentration in the newborns and best iron storage between 3-6 months of life and less incidence for transfusion and neonatal hypotension. Experimental studies, executed on animals and humans, analysed cardiocirculatory changes in the foetus immediately after birth and the importance of the delayed clamping for the hemodynamic stabilization, particularly in the lowest gestational age.
In a recent randomized study conducted in Nepal on 540 newborns, birth by eutocic delivery with 39.2 weeks of gestational age, showed that delayed umbilical cord clamping after 3 min of life is correlated with a better haemoglobin level and less incidence of anaemia at 8 months of life. Zhou et al. conducted a meta-analysis that included hematologic parameters obtained by umbilical cord, placenta and newborns blood.
Association of Italian Hospital Gynecologists Obstetricians (AOGOI) declared contraindicated conditions to execute a delayed umbilical cord clamping:
Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of fetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest. Monochorionic twins, Fetal Hydrops, Umbilical cord damaged, Isoimmunization Rh.
Researchers concluded that newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Haematocrit difference was greater between newborns birth by elective Caesarean Section compared to those birth by Caesarean Section in labor. Nowadays, researchers found no side effects of delayed umbilical cord clamping except a slight increase of phototherapy needs.
Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section. The aim of the study protocol is to investigate the effects of the clamping after 1 min from birth by elective Caesarean Section on heart rate, saturation, body temperature, bilirubin, haematocrit and glycemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Immediate umbilical cord clampingNewborns will be subjected to umbilical cord immediate clamping |
| Study Group | Experimental | Procedure: Delayed umbilical cord clampingNewborns will be subjected to umbilical cord delayed clamping |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth Body Weight = appropriate for gestational age
- Delivery mode= Elective Caesarean Section
- Mothers' BMI = 19-24,9
- Mothers'age ≤ 37 years
Key exclusion criteria (7 listed)
- Admission in NICU;
- Neonatal Resuscitation
- Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of foetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest
- Pathologies ;
- Smoking mothers;
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 clampingUmbilical cord will be clamped after 1 min after the birth of the newborn | Procedure or surgery | Study Group |
| Immediate umbilical cord clampingUmbilical cord will be clamped immediately after the birth of the newborn | Procedure or surgery | Control Group |
Primary outcome
Change of Heart Rate After Delayed Umbilical Clamping
Time frame: 5 minutes and 10 minutes after birth
It will be measured the change of heart rate (HR)
Change of Saturation After Delayed Umbilical Clamping
Time frame: 5 minutes and 10 minutes after birth
Saturation change (SpO2)
Change of Temperature After Delayed Umbilical Clamping
Time frame: 5 minutes after birth
Temperature change (T)
3 secondary outcomes
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping
Time frame: 120 minutes after birth
Misuration of the Hematocrit After Delayed Umbilical Clamping
Time frame: 72 hours of life
Misuration of the Bilirubin After Delayed Umbilical Clamping
Time frame: 72 hours of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30076109Katheria A, Hosono S, El-Naggar W. A new wrinkle: Umbilical cord management (how, when, who). Semin Fetal Neonatal Med. 2018 Oct;23(5):321-326. doi: 10.1016/j.siny.2018.07.003. Epub 2018 Jul 20.
- Results publication: PubMed 23401615Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11.
- Results publication: PubMed 25689406Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015.
- Results publication: PubMed 30159064Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1399-1404. doi: 10.3889/oamjms.2018.286. eCollection 2018 Aug 20.
- Results publication: PubMed 24843886Ghavam S, Batra D, Mercer J, Kugelman A, Hosono S, Oh W, Rabe H, Kirpalani H. Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- and short-term outcomes. Transfusion. 2014 Apr;54(4):1192-8. doi: 10.1111/trf.12469.
- Results publication: PubMed 24901269Backes CH, Rivera BK, Haque U, Bridge JA, Smith CV, Hutchon DJR, Mercer JS. Placental transfusion strategies in very preterm neonates: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jul;124(1):47-56. doi: 10.1097/AOG.0000000000000324.
- Results publication: PubMed 25984654Nevill E, Meyer MP. Effect of delayed cord clamping (DCC) on breathing and transition at birth in very preterm infants. Early Hum Dev. 2015 Jul;91(7):407-11. doi: 10.1016/j.earlhumdev.2015.04.013. Epub 2015 May 15.
- Results publicationWafaa Taha Ibrahim Elgzar, Heba Abdel-Fatah Ibrahim, Hanan Heiba Elkhateeb."Effects of Deferred Versus Early Umbilical Cord Clamping on Maternal and Neonatal Outcomes" - American Journal of Nursing Research, 2017,5(4), 115-128
- Results publication: PubMed 22405491Valero J, Desantes D, Perales-Puchalt A, Rubio J, Diago Almela VJ, Perales A. Effect of delayed umbilical cord clamping on blood gas analysis. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):21-3. doi: 10.1016/j.ejogrb.2012.01.020. Epub 2012 Mar 8.
- Results publication: PubMed 28114607Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.
- Results publication: 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.
- Results publication: PubMed 23843134McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
- Individual participant dataSharing planned: No
Related trials for Delayed Cord Clamping
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health
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.
Giuseppe De Bernardo, M.D. principal investigator
Poliambulanza Foundation
Maurizio Giordano, B.Sc. study chair
University of Naples Federico II, School of Medicine
Laura Linetti, Dr. study director
Poliambulanza Foundation
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 and Immediate umbilical cord clamping in people with Delayed Cord Clamping, run by Fondazione Poliambulanza Istituto Ospedaliero 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 4 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: finished, as of the sponsor's last update on 19 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change of Heart Rate After Delayed Umbilical Clamping (time frame: 5 minutes and 10 minutes after birth). 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 NCT03878602, which also lists 13 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 19 Apr 2021.