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Investigation and comparison of neonatal complications of two methods of umbilical cord milking and early cord clamping in neonates

Protocol summary

Study aim
Determination and comparison of neonatal complications of two methods of umbilical cord milking and early cord clamping in preterm infants from 28 to 34 weeks.
Design
Clinical trial includes control group, with parallel groups, without blinding and randomization, performed on 160 preterm infants
Settings and conduct
In developing countries, due to low available blood resources and the possibility of transmission of blood-borne infections, decrease in the need for transfusion is a valuable achievement. This is a randomized clinical trial study which will be applied to preterm infants born in Imam Reza and Ghaem Hospitals. Naturally delivered preterm infants or those born with cesarean section who qualify based on inclusion criteria of study are randomly assigned to two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All infants who are not suspected of placental abruption and in sonography, for a gestational age of 28 to 34 weeks, there should be no sign of placenta previa, anemia, hydrops and embryonic major abnormalities. Exclusion criteria: In a case that the infant is not hospitalized in NICU or during the study, parents do not agree with the presence of their infant in the study, less than 25 cm length of umbilical cord, thick meconium, the true knot of the umbilical cord, major anomalies of umbilical cord
Intervention groups
In control group, early cord clamping method and in the intervention group, the umbilical cord milking method are applied to preterm infants of 28 to 34 weeks.
Main outcome variables
The amount of transfused blood, the amount of bilirubin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180201038586N1
Registration date: 2018-03-19, 1396/12/28
Registration timing: registered_while_recruiting

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Atena Sadat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2806
Email address
sadata931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of neonatal complications of two methods of umbilical cord milking and early cord clamping in neonates
Public title
Investigation and comparison of neonatal complications of two methods of umbilical cord milking and early cord clamping in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The infant's parents should give written informed consent for the infant to enter the study َAll infants who are not suspected of placental abruption For a gestational age of 28 to 34 weeks, in sonography, there should be no sign of placenta previa, anemia, hydrops and embryonic major abnormalities.
Exclusion criteria:
Less than 25 cm length of umbilical cord Thick meconium The true knot of the umbilical cord Major anomalies of umbilical cord In a case that the infant is not hospitalized in NICU or during the study, the parents do not agree with the presence of their infant in the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation table for patients will be generated by a computer. The numbered envelopes are then provided and the intervention or control group is placed in a sealed envelope according to the random allocation table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.MUMS.REC.1396.171

Health conditions studied

1

Description of health condition studied
preterm infants
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]

Primary outcomes

1

Description
The amount of transfused blood
Timepoint
The amount of transfused blood in the first 120 hours
Method of measurement
Blood sampling

2

Description
The amount of bilirubin
Timepoint
The amount of bilirubin is measured daily
Method of measurement
Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Control group: shortly after the birth, early cord clamping is performed
Category
Treatment - Devices

2

Description
Intervention group: After the birth, the umbilical cord milking method is applied. The milking method is that after the birth, the infant while being at or slightly below the mother's body level, a piece of 25 cm of the cord remains tangential to the body of the fetus. Then, this piece is milked by the midwife who places the infant under the warmer, 3 times, each of which takes 2 to 3 seconds. The milking is performed from the placenta of the umbilical cord to the embryo (total of 10 seconds). In this situation, about 20 cc of blood is injected into the infats's body.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Sara Mirzaeian
Street address
Ahmad Abad Ave, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2477
Email
mirzaeians@mums.ac.ir

2

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Atena Sadat
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2806
Email
sadata931@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
951472
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atena Sadat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2806
Email
sadata931@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Mirzaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801
Email
mirzaeians@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atena Sadat
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2806
Email
sadata931@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.
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