Effect of time of umbilical cord clamping on hemoglobin consentration,newborn period and developmental process of infants up to 4 months age: a randomised controlled trial.
The present research intends to carry out further and different follow-up studies on children with developmental disorders in their early years and determine factors related to incidence of developmental disorders in any community. Women without any history of medical and pregnancy problems and with 38-week pregnancy duration can enter the study. Moreover, breast-fed infants must be healthy with birth-time Apgar scores and weights of higher than seven and more than 2500 grams, respectively. Women with assisted birth (forceps and/or vacuum), prolonged labor, and/or complications such as bleeding and dystocia will be excluded from the research. This clinical trial research will be conducted on 400 pregnant women and their four-month old babies who visit the healthcare-treatment centers of Esfahan University of Medical Sciences and Healthcare Services in 2015 using the continuous sampling method. The women satisfying the inclusion criteria will be randomly divided into the intervention group with the umbilical cord clamped more than 90-120 seconds after birth and the control group in whom the umbilical cord is clamped less than 60 seconds after birth. Then, blood cord blood hemoglobin will be measured immediately after birth in both groups and The developmental status of infants in both groups at the age of 4 months will be evaluated using the ASQ questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702066807N19
Registration date:2017-08-14, 1396/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of time of umbilical cord clamping on hemoglobin consentration,newborn period and developmental process of infants up to 4 months age: a randomised controlled trial.
Public title
The relationship between hemoglobin umbilical cord blood at birth and developmental status at 4 months age
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian citizens, 18-35 years of age, given birth to four or fewer children, no history of known medical problems at present and during pregnancy such as diabetes, cardiovascular, renal, pulmonary or autoimmune diseases; no history of problems during pregnancy including preeclampsia, placental abruption, polyhydramnios; no history of known congenital abnormalities in the mother’s or the husband’s families; the recent childbirth without using forceps or vacuum; the recent delivery not a drawn-out one accompanied by complications such as bleeding and/or dystocia or by prolonged labor; pregnancy duration of exactly 38 weeks.
Inclusion criteria for breast-fed infants: born in a single pregnancy; Apgar scores at birth not lower than seven; no history of reduced fetal growth; birth weight more than 2500 grams; healthy at their entry into the research (as confirmed by the physician at the center).
Exclusion criteria: Inclusion criteria are not satisfied.
Age
To 4 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Beheshti University of Medical Sciences
Street address
Vali Asr Ave, Niayesh Cross Road, School of Nursing & Midwifery
City
Tehran
Postal code
1985717443
Approval date
2015-02-01, 1393/11/12
Ethics committee reference number
sbmu.rec.1393.631
Health conditions studied
1
Description of health condition studied
The amount of hemoglobin in the newborn’s blood
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin
Timepoint
Immediately after birth
Method of measurement
Umbilical Cord Blood
2
Description
The development of infants
Timepoint
At the age of 4 months
Method of measurement
Questionnaire
Secondary outcomes
1
Description
complications of neonatal period (jaundice,infections,death,hospitalization
Timepoint
4 months
Method of measurement
questionnaire
Intervention groups
1
Description
The control group:Clamping the umbilical cord of newborns lees than 60 seconds.
Category
Prevention
2
Description
Groups:Clamping the umblical cord since birth 90-120 seconds
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isa Ben Maryam Hospital
Full name of responsible person
Soheila Nouraei
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Vali Asr Aveery, Niayesh Cross Road, School of Nursing & Midwif
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddigheh Amir Ali Akbari
Position
PHD
Other areas of specialty/work
Street address
Vali Asr Ave, Niayesh Cross Road, school of Nursing & Midwifery
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
asa_akbari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddigheh Amir Ali Akbari
Position
PHD
Other areas of specialty/work
Street address
Vali Asr Ave, Niayesh Cross Road, School of Nursing & Midwifery
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
asa_akbari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddigheh Amir Ali Akbari
Position
PHD
Other areas of specialty/work
Street address
Vali Asr Ave, Niayesh Cross Road, School of Nursing & Midwifery
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)