This is a randomized double blind clinical trial to investigate the effect of rectal Misoprostol and Syntometrin in prevention of post partum hemorrhage. 200 pregnant women referred to the Shabihkhany hospital in Kashan for vaginal delivery were randomly assigned into one of following groups: The first group received 1 ml Syntometrine IM and the second group received 600 mgr misoprostol rectal after placental expulsion. Then, all patients were assessed 0.5 and 1 hour after delivery for uterine tonicity, pulse rate and blood pressure. 24 hours after delivery hemoglobin was checked for estimation of postpartum hemorrhage. Need for uterotonic drugs and rate of adverse effects were also compared between the intervention groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008212854N5
Registration date:2010-09-09, 1389/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-09, 1389/06/18
Registrant information
Name
Masoumeh Abedzadeh Kalahroudi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
abedzadeh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Basic Science of Kashan University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-09-21, 1389/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rectal Misoprostol and Syntometrin in prevention of post partum hemorrhage
Public title
Comparison of the effect of rectal Misoprostol and Syntometrin in prevention of post partum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with single pregnancy and candidate for vaginal delivery Exclusion criteria: Presence of preeclampsia, hypotension, heart disease, asthma, hypertonic uterus, uterine rupture, or vaginal and cervical laceration, being high risk for postpartum bleeding such as: multiparity, uterine myoma, history of postpartum bleeding, or need for uterine curettag
Age
From 15 years old to 50 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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravand road Kashan University of Medical
City
Kashan
Postal code
Approval date
2010-08-02, 1389/05/11
Ethics committee reference number
1207/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Post partum hemorrhage
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
Uterine tone
Timepoint
0.5 and 1 hours after delivery
Method of measurement
Assessment of uterine tone
2
Description
Hemoglobin level
Timepoint
Before and 24 hours after delivery
Method of measurement
Hemoglobine assessment
3
Description
Blood Pressure
Timepoint
immadiate, 30 minute and 1 hour after delivery
Method of measurement
by sphygnomanometer
4
Description
pulse
Timepoint
immadiately, 30 minute and 1 hours after delivery
Method of measurement
by counting
Secondary outcomes
1
Description
Adverse effects
Timepoint
During Hospitalization
Method of measurement
Observation of adverse effects
2
Description
Need to adminestration of utertonic drug
Timepoint
During 24 hours after delivery
Method of measurement
dosage and amount of drug
Intervention groups
1
Description
Syntometrin, 1 ml, IM in third stage of labour after placental expulsion
Category
Prevention
2
Description
Misoprostol, 1 ml, Rectal suppository in third stage of labour
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihkhany Hospital
Full name of responsible person
Dr. Mansoureh Samimi
Street address
Shabihkhany Hospital, Beheshti Street
City
kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Basic Sciences, Kashan University of Medical Sciences
Full name of responsible person
Dr. Atlasi Mohammad Ali
Street address
Ravand road Kashan University of Medical Sciences
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Basic Sciences, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Abedzadeh kalahroudi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Midwifery Faculty, Kashan University of Medical Sciences, Ravand road,
City
kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
abedzadeh@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mansoureh Samimi
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Shabihkhany Hospital, Beheshti Street
City
kashan
Postal code
Phone
+98 36 1446 0180
Fax
Email
dr.samimi.2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Abedzadeh kalahroudi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Midwifery Faculty, Kashan University of Medical Sciences, Ravand road
City
Kashan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)