The appropriate moment for clamping the umbilical cord is controversial. Immediate cord clamping (ICC) is an item of active management of the third stage of labor (AMTSL). Unclamped umbilical cord may cause inconvenience in preterm neonates because they commonly need some levels of emergent services. Some studies revealed delayed cord clamping (DCC) of preterm neonates results in better health conditions like lower rates of RDS, less morbidities in labor room and lower risk of postpartum hemorrhage.
In this single‑center randomized control trial (RCT) study, Sixty premature neonate (gestational age ≤34 weeks) were randomly assigned to delayed clamping (45 sec. after delivery) or early clamping (below 10 sec. after delivery), and followed up in NICU. Primary outcomes were 1st and 5th minute APGAR score, Intra ventricle hemorrhage and need some levels of resuscitation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015013010026N5
Registration date:2015-02-14, 1393/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Amir mohammad Armanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1235 5059
Email address
armanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-02-05, 1393/11/16
Expected recruitment end date
2015-06-29, 1394/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Is "delayed umbilical cord clamping" beneficial for premature newborns?
Public title
Is "delayed umbilical cord clamping" beneficial for premature newborns?
Purpose
Prevention
Inclusion/Exclusion criteria
infants with gestational age of ≤ 34 weeks and admitted to the tertiary referral NICUs of the Isfahan University of Medical Sciences at Alzahra and Shahid Beheshti Hospitals, were eligible for participation in the study. Infants who had major congenital anomalies, asphyxia, congenital cyanotic heart disease were excluded.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
292270
Health conditions studied
1
Description of health condition studied
clamping the umbilical cord
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Time of umbilical cord clamping
Timepoint
After birth
Method of measurement
Time
Secondary outcomes
1
Description
1 & 5 min Apgar score
Timepoint
After birth
Method of measurement
Apgar score
2
Description
Hematocrit
Timepoint
After birth
Method of measurement
Blood sample
3
Description
Blood transfusion
Timepoint
During Hospitalization time
Method of measurement
Daily recorded sheets
4
Description
IVH, PDA
Timepoint
During Hospitalization time
Method of measurement
Daily recorded sheets
5
Description
Mortality
Timepoint
During hospitalization time
Method of measurement
Daily recorded sheets
6
Description
Sepsis
Timepoint
During Hospitalization time
Method of measurement
Daily recorded sheets
7
Description
Neonatal resuscitation
Timepoint
After birth
Method of measurement
Daily recorded sheets
Intervention groups
1
Description
Delayed clamping group, preterm neonates (≤34 weeks' gestation) after delivery routine conducted in 45 seconds (DCC )
Category
Other
2
Description
Preterm neonates (≤34 weeks' gestation) after delivery routine conducted in 10 seconds( ICC )
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU at Alzahra and Shahid Beheshti hospitals in Isfahan IRAN
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
number 133, Shahid Ansari alley, Saeb street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ddr Siavash
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar-Jerib St.,
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Ansari
Position
MD, ob & gyn resident
Other areas of specialty/work
Street address
Department of ob & gyn, Isfahan University of Medical Sciences,
City
Isfahan
Postal code
81638-93113
Phone
+98 31 3236 7001
Fax
Email
drm_ansari@yahoo.mail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Neonatologist
Other areas of specialty/work
Street address
Number 133, Shahid Ansari Alley, Saeb Street, Isfahan
City
Isfahan
Postal code
8184757851
Phone
+98 31 3235 5059
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Hata Ghasemi Tehrani
Position
MD, Ob & gyneocologist
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
armanian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)