This study was performed to compare the oxytocin bolus and infusion effects on maternal hemodynamics and also the outcome of the third stage of labor. This double-blinded clinical trial was carried out on 200 normal vaginal delivery (NVD) patients of Shabihkhani Hospital in Kashan during 2007-2008. The patients were divided into 2 equal groups (n=100): the intervention group received 10 IU oxytocin as bolus post- delivery and the control group received 10 IU oxytocin in 500 cc normalsalin 125 cc/h. Maternal hemodynamic (pulse rate, systolic and diastolic blood pressures at the admission time and 1, 5, 10, and 20 min post-delivery) and the outcome of the third stage of labor (duration of the third stage of labor, requirement for uterotonic agents, hemoglobin at the in admission time and 6 hour after delivery, and placental retention) were compared between both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812043413N1
Registration date:2010-04-15, 1389/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-15, 1389/01/26
Registrant information
Name
Zohreh Sadat
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 9956
Email address
sadat@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences, Vice-chancellor for Research
Expected recruitment start date
2007-01-20, 1385/10/30
Expected recruitment end date
2008-03-01, 1386/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison two methods of oxytocin use after delivery
Public title
Comparison two methods of oxytocin use after delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: woman with vaginal delivery after 20 week gestation without instrumentation, age between 18 and 40 yrs, singleton pregnancies, parity equal or less than 5, Iranian nationality.
Exclusion criteria: Allergy to oxytocin, Presence of any medical or obstetric diseases (including pregnancy-induced hypertension disorders, hypertention, heart diseases, coagulation disorder), known risk factors for postpartum haemorrhage (including abnormal placentation, uterine fibroids, history of postpartum hemorrhage or uterine atony, polyhydramnious , clinical chorioamnionitis , precipitant labor)
Age
From 18 years old to 40 years old
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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences, Kashan
Street address
Kashan University of Medical Sciences, 5th km of Ravand Road, Kashan.
City
Kashan
Postal code
87111-87155
Approval date
2009-08-20, 1388/05/29
Ethics committee reference number
پ/29/5/1/1477
Health conditions studied
1
Description of health condition studied
control of third stage
ICD-10 code
O72.0
ICD-10 code description
Third-stage haemorrhage
Primary outcomes
1
Description
Maternal pulse rate and blood pressure
Timepoint
At the admission time and 1, 5, 10, 20 min after delivery
Method of measurement
Maternal pulse rate per mim and blood pressure left hand by using mercury mannometer in supine position by obstetric and gynecologist resident physician
Secondary outcomes
1
Description
Third stage delivery outcome
Timepoint
Immediately after delivery to half an hour for duration of third stage and placenta retention, an hour after delivery for determination of additional uterotonic agent and Hb at the admission time and 6 hours after delivery
Method of measurement
Maternal pulse rate per mim and blood pressure of left hand by using mercury mannometer in supine position by obstetric and gynecologist resident physician
Intervention groups
1
Description
Oxytocin, 10 unit as bolus after delivery
Category
Prevention
2
Description
Oxytocin, 10 IU infusion in 500 cc normal saline with a rate of 125 cc/h
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan skabihkhani maternity hospital
Full name of responsible person
Zohreh Sadat
Street address
Midwifery group, Kashan University of Medical Sciences, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences, Vice-chancellor for Research
Full name of responsible person
Gholam Ali Hamidi
Street address
Department of Physiology & Pharmacology, Kashan University of Medical Sciences, Kashan, Iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences, Vice-chancellor for Research
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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fatameh Foroozanfard
Position
Obststrician and Gynecologist, Assistant Professor
Other areas of specialty/work
Street address
Department of obststrics and Gynecology, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
87155-87111
Phone
+98 36 1446 0180
Fax
+98 36 1555 6633
Email
fatemehforoozanfard@yahoo.com
Web page address
www.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Fatameh Foroozanfard
Position
Obststrician and Gynecologist, Assistant Professor
Other areas of specialty/work
Street address
Department of obststrics and Gynecology, Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
87155-87111
Phone
+98 36 1446 0180
Fax
+98 36 1555 6633
Email
fatemehforoozanfard@yahoo.com
Web page address
www.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
.Department of Midwifery, Kashan University of Medical Sciences
Full name of responsible person
Zohreh Sadat
Position
Msc in Midwifery, Academic Member, Department of Midwifery
Other areas of specialty/work
Street address
Department of Midwifery, Kashan University of Medical Sciences,
City
Kashan
Postal code
87155-87111
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
sadat@kaums.ac.ir
Web page address
www.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)