The aim of this study is to Assess the efficacy of using intraumbilical vein injection of oxytocin in active management of the third stage of labor.
women who had a term pregnancy and parity1 to 3 undergoing vaginal delivery without any risk factor for postpartum hemorrhage recruited.200 women were divided into 2 groups (100cases and 100 controls).
20 units of oxytosin diluted in 1 liter of ringer (speed:200 miliunits in a minute) was used in both,after delivery of baby.
intervention group assigned to receive10 international units of oxytocin diluted in 9cc ringer by intraumbilical vein injection and 10cc ringer by peripheral vein injection. control group assigned to receive 10cc ringer by intraumbilical vein injection and 10 international units of oxytocin diluted in 9cc ringer by peripheral vein injection.
Then decrease in hemoglobin levels in 24 hours from labor, duration of the third stage of labor,using transfusion, additional uterotonics,manual or instrumental removal of placenta were assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204179491N1
Registration date:2012-05-04, 1391/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-04, 1391/02/15
Registrant information
Name
Reyhaneh Ramezaninezhad
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6374
Email address
rramezaninezhad@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciencs
Expected recruitment start date
2011-12-28, 1390/10/07
Expected recruitment end date
2012-03-18, 1390/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the efficacy of using intraumbilical vein injection of oxytocin in active management of the third stage of labor
Public title
Assessment of the efficacy of using intraumbilical vein injection of oxytocin after delivery of newborn in reducing postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : vaginal delivery;gestational age 37-42 weeks;singleton pregnancy;live fetus;cephalic presentation;neonatal birth weight 2500-4500 gram;parity 1-3.
exclusion criteria : blood pressure140/90 or greater;placenta previa;placental abruption;abnormal placentation;instrumental delivery;history of postpartum hemorrhage;
history of curretage or cesarean delivery or any uterine scar;coagulopathy;hydramnios;known uterine anomaly;large episiotomy or vaginal lacerations those were repaired in operation room.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Qazvin university of medical sciences
Street address
Qazvin University of Medical Sciences , Shahid bahonar Blvd , Qazvin
City
Qazvin
Postal code
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
د/20/4450
Health conditions studied
1
Description of health condition studied
postpartum hemorrhage
ICD-10 code
O72.0
ICD-10 code description
Third-stage haemorrhage
Primary outcomes
1
Description
Assessment of the efficacy of using intraumbilical vein injection of oxytocin in active management of the third stage of labor in reducing postpartum hemorrhage
Timepoint
24 hours after intervention
Method of measurement
hemoglobin level(gr/dl)
Secondary outcomes
1
Description
incidence of retained placenta need for manual removal of placenta in each group
Timepoint
in third stage of labor
Method of measurement
percentage
2
Description
incidence of using additional uterotonics in each group
Timepoint
during the third stage of labor and 24 hours later
Method of measurement
percentage
3
Description
incidence of falling hemoglobin levels in each group
Timepoint
during the third stage of labor and 24 hours later
Method of measurement
gr/dl
4
Description
duration of the third stage of labor in each group
Timepoint
during the third stage of labor
Method of measurement
minutes and seconds
5
Description
incidence of transfusion after delivery in each group
Timepoint
during 24 hours after delivery
Method of measurement
percentage
Intervention groups
1
Description
Intervention group:
in the third stage of labor,after clamping of umbilicus,10 international units of oxytocin diluted in 9 mililiter of ringer was injected in intraumbilical vein(proximal to the clamp). 10 mililiter of ringer as placebo was injected in peripheral vein during 2 minutes.
Category
Treatment - Drugs
2
Description
Control group:in the third stage of labor,after clamping of the umbilicus,10 milliliter of ringer was injected intraumbilical vein and 10 international units of oxytocin diluted in 9 milliliter of ringer was injected in peripheral vein during 2 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Reyhaneh Ramezaninezhad
Street address
Kosar Hospital , Kosar Avenue ,Taleghni Street , Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Qazvin University of Medical Sciences , Shahid bahonar Blvd , Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Reyhaneh Ramezaninezhad
Position
Resident
Other areas of specialty/work
Street address
Kosar Hospital , Kosar Avenue , Taleghni Street , Qazvin