An interventional study of Delayed umbilical cord clamping and Immediate umbilical cord clamping in Delayed Cord Clamping, sponsored by Fondazione Poliambulanza Istituto Ospedaliero. Completed at 1 site in Italy. Open to participants aged 37 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Fondazione Poliambulanza Istituto Ospedaliero · Not applicable, Interventional, and Prevention
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.
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.
Fondazione Poliambulanza Istituto Ospedaliero is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Newborns will be subjected to umbilical cord immediate clamping
Procedure: Immediate umbilical cord clamping
Newborns will be subjected to umbilical cord delayed clamping
Procedure: Delayed umbilical cord clamping
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
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
Change of Saturation After Delayed Umbilical Clamping
Saturation change (SpO2)
Time frame: 5 minutes and 10 minutes after birth
Change of Temperature After Delayed Umbilical Clamping
Temperature change (T)
Time frame: 5 minutes after birth
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping
hemo gluco test (HGT)
Time frame: 120 minutes after birth
Misuration of the Hematocrit After Delayed Umbilical Clamping
hematocrit (Ht)
Time frame: 72 hours of life
Misuration of the Bilirubin After Delayed Umbilical Clamping
bilirubin
Time frame: 72 hours of life
| Milestone | Immediate Clamping | Delayed Clamping |
|---|---|---|
| Started | 75 | 67 |
| Completed | 66 | 66 |
| Not completed | 9 | 1 |
| Withdrew: Cord blood donation | 7 | 1 |
| Withdrew: Incomplete data collection | 2 | 0 |
It will be measured the change of heart rate (HR)
| bpm | Control Group | Study Group |
|---|---|---|
| 5 minutes | 164 ± 18 | 157 ± 15 |
| 10 minutes | 163 ± 15 | 155 ± 13 |
Saturation change (SpO2)
| percent of saturated hemoglobin | Immediate Clamping | Delayed Clamping |
|---|---|---|
| 5 minutes | 88.98 ± 7.027 | 89.169 ± 7.453 |
| 10 minutes | 95.238 ± 3.976 | 96.046 ± 3.346 |
Temperature change (T)
| degrees Celsius | Immediate Clamping | Delayed Clamping |
|---|---|---|
| Change of Temperature After Delayed Umbilical Clamping | 36.60 ± 0.64 | 36.64 ± 0.64 |
hemo gluco test (HGT)
| mg/dl | Immediate Clamping | Delayed Clamping |
|---|---|---|
| Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping | 60.32 ± 9.937 | 56.02 ± 17.101 |
hematocrit (Ht)
| percent of occupied blood volume | Immediate Clamping | Delayed Clamping |
|---|---|---|
| Misuration of the Hematocrit After Delayed Umbilical Clamping | 51.56 ± 6.929 | 56.71 ± 6.663 |
bilirubin
| mg/dl | Immediate Clamping | Delayed Clamping |
|---|---|---|
| Misuration of the Bilirubin After Delayed Umbilical Clamping | 7.06 ± 2.76 | 8.54 ± 2.90 |
Collected over adverse event data were collected through discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| Study Group | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| Age, Categorical(Participants) | Control Group | Study Group | Total |
|---|---|---|---|
| <=18 years | 66 | 66 | 132 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Control Group | Study Group | Total |
|---|---|---|---|
| Female | 32 | 30 | 62 |
| Male | 34 | 36 | 70 |
| Race/Ethnicity, Customized(participants) | Control Group | Study Group | Total |
|---|---|---|---|
| Caucasian | 66 | 66 | 132 |
| Region of Enrollment(participants) | Control Group | Study Group | Total |
|---|---|---|---|
| Italy | 66 | 66 | 132 |
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