Objective: To compare the effect of 400 µg of oral misoprostrol with 10 IU of intravenous oxytocin in preventing postpartum hemorrhage. A randomized controlled trial conducted on 300 pregnant women with these inclusion criteria: pregnant women with singleton pregnancy, cephalic, spontaneous and induced delivery, term pregnancy. Hemoglobin and Hematocrit were measured in admission and 24h after delivery in order to compare drugs in reduction of postpartum hemorrhage. Studied women received either 400µg of oral misoprostrol or 10 IU of intravenous oxytocin after delivery of the anterior shoulder or within1 min of delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812223548N1
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Simindokht Moradi
Name of organization / entity
Qazvin university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1366 6770
Email address
smoradi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin university of medical scienceس
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-02-19, 1388/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of misoprostrol and oxytocin in reduction of postpartum hemorrhage
Public title
The effect of misoprostrol in reduction of postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with singleton pregnancy, cephalic, spontaneous and induced delivery, term pregnancy. Exclusion criteria: instrumental delivery, TL during 24h after delivery, past history of abruption placenta, history of asthma, coagulopathy, history of postpartum hemorrhage, history of C/S.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Qazvin university ofmedical sciences
Street address
Bahonar Blv.
City
Qazvin
Postal code
Approval date
2009-11-09, 1388/08/18
Ethics committee reference number
229
Health conditions studied
1
Description of health condition studied
reduction of postpartum haemorrhage
ICD-10 code
O72.1
ICD-10 code description
Other immediate postpartum haemorrhage
Primary outcomes
1
Description
reduction of postpartum hemorrhage
Timepoint
in admission at labour and 24h after delivery
Method of measurement
blood sampling and CBC
Secondary outcomes
empty
Intervention groups
1
Description
10 IU oxytocin administration
Category
Treatment - Drugs
2
Description
400 microgram misoprostrol administration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospitol
Full name of responsible person
Simindokht Moradi
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Saeed Assefzadeh
Street address
Shahid Bahonar Bulvar
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
Simindokht Moradi
Position
Resident of GYN & OB
Other areas of specialty/work
Street address
Kosar Hospital
City
Qazvin
Postal code
Phone
+98 28 1366 6770
Fax
Email
simindokht56@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Simindokht Moradi
Position
Resident of GYN & OB
Other areas of specialty/work
Street address
Kosar Hospital
City
Qazvin
Postal code
Phone
+98 28 1366 6770
Fax
Email
simindokht56@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Simindokht Moradi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)