The effect of the timing of umbilical cord clamping on hemoglobin levels and growth and developmental status in infants at 6 months old
Design
The clinical trial, with parallel groups, randomized, Double blind, single-center trial, sample size 60 people.
Settings and conduct
Amir Al-Momenin Hospital. The umbilical cord in both groups is closed and severed while the baby is in the arms at the same level as the vaginal opening during delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Newborns (37-40 weeks); Natural childbirth; Healthy and without any complications.
Exclusion criteria: Premature babies; Existence of congenital anomalies; Weight less than 2500 g and more than 4000 g; Twin babies.
Intervention groups
Intervention group: In this group, the umbilical cord of 51 newborns is clamped rate between 60 to 90 seconds after birth.
Control group: In this group, the umbilical cord of 51 newborns is prematurely clamped in the first 20 seconds after birth and is only for comparison with the intervention group.
Main outcome variables
Hemoglobin level; Growth status.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N66
Registration date:2021-05-05, 1400/02/15
Registration timing:registered_while_recruiting
Last update:2021-05-05, 1400/02/15
Update count:0
Registration date
2021-05-05, 1400/02/15
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-08, 1400/01/19
Expected recruitment end date
2021-10-11, 1400/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the timing of umbilical cord clamping on hemoglobin levels and growth and developmental status in infants at 6 months old
Public title
The effect of the timing of umbilical cord clamping on growth and developmental status in infants at 6 months old
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Newborns (37-40 weeks)
Natural childbirth
Healthy and without any complications
Exclusion criteria:
Premature babies
Existence of congenital anomalies
Weight less than 2500 g and more than 4000 g
Twin babies
Age
From 259 days old to 280 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 26 units of 4 blocks will be selected so that we consider having 51 people in the group (A) and 51 people in the group (B). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants and outcome assessors are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.SEMUMS.REC.1400.005
Health conditions studied
1
Description of health condition studied
Umbilical cord
ICD-10 code
O69
ICD-10 code description
Labor and delivery complicated by umbilical cord complications
Primary outcomes
1
Description
Hemoglobin level
Timepoint
From birth to 6 months of age
Method of measurement
Blood test
2
Description
Growth status
Timepoint
From birth to 6 months of age
Method of measurement
Head height and circumference (cm) and weight (kg)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the umbilical cord of 51 newborns is clamped rate between 60 to 90 seconds after birth.
Category
Treatment - Other
2
Description
Control group: In this group, the umbilical cord of 51 newborns is prematurely clamped in the first 20 seconds after birth and is only for comparison with the intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Mehri Ayati
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mehri Ayati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehri Ayati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nazila Ameli
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available