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Umbilical Cord Clamping: What Are the Benefits

Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03878602
Enrollment
142
Registered
2019-03-18
Start date
2018-10-15
Completion date
2019-06-01
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Cord Clamping

Keywords

Newborn, Elective Caesaren Section, Cord Clamping

Brief 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. 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.

Interventions

Umbilical cord will be clamped after 1 min after the birth of the newborn

Umbilical cord will be clamped immediately after the birth of the newborn

Sponsors

Fondazione Poliambulanza Istituto Ospedaliero
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
No

Inclusion criteria

* Birth Body Weight = appropriate for gestational age * Delivery mode= Elective Caesarean Section * Mothers' BMI = 19-24,9 * Mothers'age ≤ 37 years

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change of Heart Rate After Delayed Umbilical Clamping5 minutes and 10 minutes after birthIt will be measured the change of heart rate (HR)
Change of Saturation After Delayed Umbilical Clamping5 minutes and 10 minutes after birthSaturation change (SpO2)
Change of Temperature After Delayed Umbilical Clamping5 minutes after birthTemperature change (T)

Secondary

MeasureTime frameDescription
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping120 minutes after birthhemo gluco test (HGT)
Misuration of the Hematocrit After Delayed Umbilical Clamping72 hours of lifehematocrit (Ht)
Misuration of the Bilirubin After Delayed Umbilical Clamping72 hours of lifebilirubin

Countries

Italy

Participant flow

Participants by arm

ArmCount
Control Group
Newborns will be subjected to umbilical cord immediate clamping Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
66
Study Group
Newborns will be subjected to umbilical cord delayed clamping Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
66
Total132

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studycord blood donation71
Overall Studyincomplete data collection20

Baseline characteristics

CharacteristicControl GroupStudy GroupTotal
Age, Categorical
<=18 years
66 Participants66 Participants132 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Caucasian
66 participants66 participants132 participants
Region of Enrollment
Italy
66 participants66 participants132 participants
Sex: Female, Male
Female
32 Participants30 Participants62 Participants
Sex: Female, Male
Male
34 Participants36 Participants70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 660 / 66
other
Total, other adverse events
0 / 660 / 66
serious
Total, serious adverse events
0 / 660 / 66

Outcome results

Primary

Change of Heart Rate After Delayed Umbilical Clamping

It will be measured the change of heart rate (HR)

Time frame: 5 minutes and 10 minutes after birth

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupChange of Heart Rate After Delayed Umbilical Clamping5 minutes164 bpmStandard Deviation 18
Control GroupChange of Heart Rate After Delayed Umbilical Clamping10 minutes163 bpmStandard Deviation 15
Study GroupChange of Heart Rate After Delayed Umbilical Clamping5 minutes157 bpmStandard Deviation 15
Study GroupChange of Heart Rate After Delayed Umbilical Clamping10 minutes155 bpmStandard Deviation 13
Primary

Change of Saturation After Delayed Umbilical Clamping

Saturation change (SpO2)

Time frame: 5 minutes and 10 minutes after birth

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupChange of Saturation After Delayed Umbilical Clamping5 minutes88.98 percent of saturated hemoglobinStandard Deviation 7.027
Control GroupChange of Saturation After Delayed Umbilical Clamping10 minutes95.238 percent of saturated hemoglobinStandard Deviation 3.976
Study GroupChange of Saturation After Delayed Umbilical Clamping5 minutes89.169 percent of saturated hemoglobinStandard Deviation 7.453
Study GroupChange of Saturation After Delayed Umbilical Clamping10 minutes96.046 percent of saturated hemoglobinStandard Deviation 3.346
Primary

Change of Temperature After Delayed Umbilical Clamping

Temperature change (T)

Time frame: 5 minutes after birth

ArmMeasureValue (MEAN)Dispersion
Control GroupChange of Temperature After Delayed Umbilical Clamping36.60 degrees CelsiusStandard Deviation 0.64
Study GroupChange of Temperature After Delayed Umbilical Clamping36.64 degrees CelsiusStandard Deviation 0.64
Secondary

Misuration of the Bilirubin After Delayed Umbilical Clamping

bilirubin

Time frame: 72 hours of life

ArmMeasureValue (MEAN)Dispersion
Control GroupMisuration of the Bilirubin After Delayed Umbilical Clamping7.06 mg/dlStandard Deviation 2.76
Study GroupMisuration of the Bilirubin After Delayed Umbilical Clamping8.54 mg/dlStandard Deviation 2.9
Secondary

Misuration of the Hematocrit After Delayed Umbilical Clamping

hematocrit (Ht)

Time frame: 72 hours of life

ArmMeasureValue (MEAN)Dispersion
Control GroupMisuration of the Hematocrit After Delayed Umbilical Clamping51.56 percent of occupied blood volumeStandard Deviation 6.929
Study GroupMisuration of the Hematocrit After Delayed Umbilical Clamping56.71 percent of occupied blood volumeStandard Deviation 6.663
Secondary

Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping

hemo gluco test (HGT)

Time frame: 120 minutes after birth

ArmMeasureValue (MEAN)Dispersion
Control GroupMisuration of the Hemo Gluco Test After Delayed Umbilical Clamping60.32 mg/dlStandard Deviation 9.937
Study GroupMisuration of the Hemo Gluco Test After Delayed Umbilical Clamping56.02 mg/dlStandard Deviation 17.101

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026