This study is aimed to compare the effect of intraumbilical vein oxytocin and normal saline on the third stage of labor. Pregnant women are randomly allocated into two groups of oxytocin and normal saline. In overall, 75 patients are participated in the study. It is a double-blind study (obstetricians and patients). Inclusion criteria: cephalic presentation and patients with first pregnancy. Exclusion criteria: multi gravity; severe anemia; uterine scar. In both groups, umbilical cord at a distance of one centimeter from the introitus is clamped immediately after the expulsion of the fetus. In the first group, 20 ml of normal saline is injected into the umbilical vein using syringe, and to prevent leakage of injected fluid, cord is re-clamped from above the space of injection site. In the second group, according to the same protocol, 30 units of oxytocin solved in 17 ml of normal saline (total 20 ml), is injected by needle into the umbilical vein. Time between intravenous injection of umbilical cord and placenta is measured by using of stopwatch. In the present study, hemoglobin and hematocrit level are also measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052810340N15
Registration date:2017-06-29, 1396/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-29, 1396/04/08
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Science
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of intraumbilical vein Oxytocin injection in comparison to normal saline on third stage of labor
Public title
The effect of Oxytocin on the duration of third stage of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: First pregnancy; singleton pregnancy; gestational age term (over 37 weeks); signs of labor ( regular contractions with the appropriate power 3 per 10 minutes); cephalic presentation.
Exclusion criteria were considered as: Multi gravity; polyhydramnios; severe anemia; uterine scar; the use of forceps or vacuum; placenta previa; prolonged labor (over 20 hours); bleeding before delivery.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients would be allocated in to 2 groups using block allocation (block size 6) method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.GOUMS.REC.1396.24
Health conditions studied
1
Description of health condition studied
duration of labor
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Duration of third stage of labor
Timepoint
After intervention
Method of measurement
Stopwatch
Secondary outcomes
1
Description
Hemoglobin
Timepoint
After intervention
Method of measurement
Blood sample
2
Description
Hematocrit
Timepoint
After intervention
Method of measurement
Blood sample
Intervention groups
1
Description
Control group will receive 20ml of normal saline by injection into the intraumblical vein.
Category
Placebo
2
Description
Intervention group will receive 30 units of oxytocin, dissolved in 17 ml of normal saline, by injection into the intraumbilical vein
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi Hospital
Full name of responsible person
Ghazaleh Sadeghian
Street address
Shahid Sayyad Shirazi Hospital, Shahid Sayyad Shirazi Street, Gorgan City, Golestan Province
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mohsen Saeedi
Street address
4 Kilometer of Gorgansari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Science
Full name of responsible person
Ghazale Sadeghian
Position
Obstetricians
Other areas of specialty/work
Street address
4 Kilometer of Gorgansari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
00
Fax
Email
ghazalaljoon65@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Ghazaleh Sadeghian
Position
Obstetricians
Other areas of specialty/work
Street address
4 Kilometer of Gorgansari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
00
Fax
Email
ghazalakjoon65@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golsestan University of Medical Sciences
Full name of responsible person
Mohamma Aryaie
Position
MSc in Epidemiology
Other areas of specialty/work
Street address
4 Kilometer of Gorgansari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Phone
00
Fax
Email
aryaie@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)