Umbilical Cord Clamping: What Are the Benefits

• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero (Other)
• Overall Status: Completed
• CT.gov ID: NCT03878602
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 18.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delayed Cord Clamping	Procedure: Delayed umbilical cord clamping; Procedure: Immediate umbilical cord clamping	N/A

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

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits
• Actual Study Start Date: Oct 15, 2018
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Newborns will be subjected to umbilical cord immediate clamping	Procedure: Immediate umbilical cord clamping; Umbilical cord will be clamped immediately after the birth of the newborn
Experimental: Study Group 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

Outcome Measures

Primary Outcome Measures

1. Change of Heart Rate After Delayed Umbilical Clamping [5 minutes and 10 minutes after birth]

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

2. Change of Saturation After Delayed Umbilical Clamping [5 minutes and 10 minutes after birth]

   Saturation change (SpO2)

3. Change of Temperature After Delayed Umbilical Clamping [5 minutes after birth]

   Temperature change (T)

Secondary Outcome Measures

1. Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping [120 minutes after birth]

   hemo gluco test (HGT)

2. Misuration of the Hematocrit After Delayed Umbilical Clamping [72 hours of life]

   hematocrit (Ht)

3. Misuration of the Bilirubin After Delayed Umbilical Clamping [72 hours of life]

   bilirubin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 37 Weeks to 42 Weeks
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of mother and child's Health Poliambulanza Foundation	Brescia		Italy	25124

Sponsors and Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero

Investigators

• Principal Investigator: Giuseppe De Bernardo, M.D., Poliambulanza Foundation
• Study Chair: Maurizio Giordano, B.Sc., University of Naples Federico II, School of Medicine
• Study Director: Laura Linetti, Dr., Poliambulanza Foundation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2018

More Information

Publications

None provided.

• Responsible Party: Giuseppe De Bernando, Principal Investigator, Fondazione Poliambulanza Istituto Ospedaliero
• ClinicalTrials.gov Identifier: NCT03878602
• Other Study ID Numbers: 3176
• First Posted: Mar 18, 2019
• Last Update Posted: Apr 19, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Giuseppe De Bernando, Principal Investigator, Fondazione Poliambulanza Istituto Ospedaliero: Newborn; Elective Caesaren Section; Cord Clamping

Study Results

Participant Flow

Arm/Group Title	Immediate Clamping	Delayed Clamping
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	75	67
COMPLETED	66	66
NOT COMPLETED	9	1

Baseline Characteristics

Arm/Group Title	Control Group	Study Group	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	66	66	132
Age (Count of Participants)
<=18 years	66 100%	66 100%	132 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	32 48.5%	30 45.5%	62 47%
Male	34 51.5%	36 54.5%	70 53%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	66 100%	66 100%	132 100%
Region of Enrollment (participants) [Number]
Italy	66 100%	66 100%	132 100%

Outcome Measures

1. Primary Outcome

Title	Change of Heart Rate After Delayed Umbilical Clamping
Description	It will be measured the change of heart rate (HR)
Time Frame	5 minutes and 10 minutes after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Study Group
Arm/Group Description	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	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
Measure Participants	66	66
5 minutes	164 (18)	157 (15)
10 minutes	163 (15)	155 (13)

2. Primary Outcome

Title	Change of Saturation After Delayed Umbilical Clamping
Description	Saturation change (SpO2)
Time Frame	5 minutes and 10 minutes after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Clamping	Delayed Clamping
Arm/Group Description	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	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
Measure Participants	66	66
5 minutes	88.98 (7.027)	89.169 (7.453)
10 minutes	95.238 (3.976)	96.046 (3.346)

3. Primary Outcome

Title	Change of Temperature After Delayed Umbilical Clamping
Description	Temperature change (T)
Time Frame	5 minutes after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Clamping	Delayed Clamping
Arm/Group Description	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	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
Measure Participants	66	66
Mean (Standard Deviation) [degrees Celsius]	36.60 (0.64)	36.64 (0.64)

4. Secondary Outcome

Title	Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping
Description	hemo gluco test (HGT)
Time Frame	120 minutes after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Clamping	Delayed Clamping
Arm/Group Description	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	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
Measure Participants	66	66
Mean (Standard Deviation) [mg/dl]	60.32 (9.937)	56.02 (17.101)

5. Secondary Outcome

Title	Misuration of the Hematocrit After Delayed Umbilical Clamping
Description	hematocrit (Ht)
Time Frame	72 hours of life

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Clamping	Delayed Clamping
Arm/Group Description	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	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
Measure Participants	66	66
Mean (Standard Deviation) [percent of occupied blood volume]	51.56 (6.929)	56.71 (6.663)

6. Secondary Outcome

Title	Misuration of the Bilirubin After Delayed Umbilical Clamping
Description	bilirubin
Time Frame	72 hours of life

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Immediate Clamping	Delayed Clamping
Arm/Group Description	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	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
Measure Participants	66	66
Mean (Standard Deviation) [mg/dl]	7.06 (2.76)	8.54 (2.90)

Adverse Events

Time Frame	adverse event data were collected through discharge
Arm/Group Title	Control Group		Study Group
Arm/Group Description	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		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
All Cause Mortality
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)
Serious Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Study Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/66 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.