Objectives: to compare the efficacy of intraumbilical vein injection and intravenous infusion of oxytocin in the active management of third stage of labor.
Design: randomized clinical trial
Setting and conduct: this study was done on 102 primiparous women that had had a vaginal delivery in Ahvaz Razi hospital
Participations including major eligibility criteria: 18 to 35 years old women with a normal term pregnancy. the case of usage of fundal pressure or labor induction or stimulation with Oxytocin were excluded.
Intervention: Women in first group (n=51) received 20 units of diluted oxytocin injected in the umbilical vein. Women in second group (n=51) received 20 units of diluted oxytocin intravenously.
Main outcome measures variables: duration of third stage of labor.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206182204N3
Registration date:2012-06-23, 1391/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-23, 1391/04/03
Registrant information
Name
Somayeh Makvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 604 2247
Email address
s-makvandi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jundishapour Ahvaz university of medical sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intraumbilical oxytocin on the third stage of labor: A randomized clinical trial
Public title
Active management of third stage of labor
Purpose
Prevention
Inclusion/Exclusion criteria
Including criteria: 18 to 35 years old primiparous women; Normal pregnancy; single fetus; Gestational age of 37 to 42 weeks; cephalic presentation; having a normal vaginal delivery;-baby weight of 2500 to 4500 grams
Excluding criteria: fundal pressure; labor induction or stimulation via oxytocin
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
2
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
Jundishapour Ahvaz University of Medical Sciences Ethics Committee
Street address
Golestan
City
Ahvaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
u7
Health conditions studied
1
Description of health condition studied
Third-stage haemorrhage
ICD-10 code
O72.0
ICD-10 code description
Haemorrhage associated with retained, trapped or adherent placenta
Primary outcomes
1
Description
duration of third stage of labor
Timepoint
after placenta delivery
Method of measurement
observation
Secondary outcomes
1
Description
Hemoglobin level
Timepoint
24 hours after birth
Method of measurement
CBC test
Intervention groups
1
Description
injetion of 20 units of diluted oxytocin in the umbilical vein+infusuion of 1000 CC of ringer serum in case group
Category
Prevention
2
Description
Infusuion of 1000 CC of ringer serum in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz razi hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jundishapour Ahvaz university of medical sciences
Full name of responsible person
Mostafa Feqhi
Street address
Farhangshahr
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapour Ahvaz 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
Jundishapour Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Zargar Shoushtari
Position
MS of midwifery student
Other areas of specialty/work
Street address
Golestan
City
Ahvaz
Postal code
Phone
+98 611367547
Fax
Email
shri_zar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university Ahvaz branch
Full name of responsible person
Somayeh Makvandi
Position
MS of midwifery
Other areas of specialty/work
Street address
farhangshahr
City
Ahvaz
Postal code
Phone
+98 61 1334 8351
Fax
Email
somayemakvandi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university Ahvaz branch
Full name of responsible person
Somayeh Makvandi
Position
MS of midwifery
Other areas of specialty/work
Street address
City
Ahvaz
Postal code
Phone
+98 61 1334 8351
Fax
Email
somayemakvandi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)