Comparing the effect of delayed versus immediate cord clamping on the incidence of intraventricular hemorrhage (IVH) in preterm neonates with gestational age ≤34 weeks in Hafez & Zeynab hospitals from September 2012 to December 2013
The goal of the study is to compare the effect of delayed versus immediate cord clamping on incidence of intraventricular hemorrhage(IVH) in preterm neonate and decide the best time for umbilical cord clamping to decrease their prematurity complications. The study is randomized and double blind performed in two centers. Study populations are premature neonates (gestational age is equal to 26-34 weeks). Exclusion criteria are refuse of parents or the obstetrician; severe congenital anomaly; placenta abruption or previa; need for immediate resuscitate in mother or the neonate sample size is calculated as 114 neonates, 57 neonates for case and 57 neonates for control group. Intervention is a 30-45seconds delay in clamping of the umbilical cord after birth in preterm neonate with gestational age of 26-34 weeks , who are kept between mother’s legs in normal vaginal delivery or on mother’s leg during cesarean section (at level of vaginal). Evaluation of IVH is performed by cranial ultrasonography on day 3-4 and day 7-10 after birth and analyzed the result for IVH, hemoglobin, hematocrit, bilirubin. Need for transfusion IVH risk factors and other DCC complications or benefits.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031116936N1
Registration date:2014-05-17, 1393/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Fariba Hemmati
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5481
Email address
hemmatif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Science
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of delayed versus immediate cord clamping on the incidence of intraventricular hemorrhage (IVH) in preterm neonates with gestational age ≤34 weeks in Hafez & Zeynab hospitals from September 2012 to December 2013
Public title
The effect of delayed cord clamping on IVH in premature neonate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: premature neonates with gestational age 26-34 weeks born in Shiraz Hafez and Hazrat Zeynab hospitals from September 2012 to December 2013
Exclusion criteria: decline to participate; refuse of neonate logiest or obstetrician; severe congenital anomalies; need for immediate resuscitation after birth in neonate or mothers; placenta abruption or placenta previa; umbilical cord clamped in a time other than what is considered.
Age
To 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Of Medical Science
Street address
Building of Shiraz University Of Medical Science, Zand street, Shiraz