The goal of research is to compare the efficacy of oral castor oil with vaginally misoprostol and vaginally misoprostol alone in the treatment of missed abortion .The method of study is randomized ,triple blind, placebo controlled clinical trial. Study population are pregnant women with missed abortion referred to Taleghani Hospital. Inclusion criteria: missed abortion according to sonography exclusion criteria: severe anemia; sensitivity to prostaglandine : coagulopathy ;acute liver disease; heart disease.72 subjects are randomly divided in 2 groups (intervention and control). Intervention group receive misoprostol 800 microgram vaginally plus castor oil 60 ml orally. Control group receive misoprostol 800 microgram vaginally plus placebo 60 ml orally. If it does not response to primary dose, mioprostol would be repeated up to three times with 24 hours interval. Primary outcome is cervical dilatation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403244686N11
Registration date:2014-04-13, 1393/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-13, 1393/01/24
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice president of education and research ,Arak University of Medical Sciences
Expected recruitment start date
2014-03-30, 1393/01/10
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of oral castor oil with vaginally misoprostol and vaginally misoprostol alone in the treatment of missed abortion
Public title
The comparison of the efficacy of oral castor oil with vaginally misoprostol and vaginally misoprostol alone in the treatment of missed abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: missed abortion according sonography .
Exclusion criteria: sever anemia; sensitivity to prostaglandine; coaglopathy; acute liver disease; heart disease.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Basij Square
City
Arak
Postal code
3816149369
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
18-158-92
Health conditions studied
1
Description of health condition studied
treatment of missed abortion
ICD-10 code
O02.1
ICD-10 code description
Missed abortion Early fetal death with retention of dead fetus
Primary outcomes
1
Description
treatment of missed abortion
Timepoint
before intervention and four hour after intervention
Method of measurement
vaginal exam
Secondary outcomes
1
Description
drug side effects
Timepoint
before intervention and four hour after intervention
Method of measurement
vaginal exam
Intervention groups
1
Description
Intervention group receive misoprostol 800 microgram vaginally plus castor oil 60 ml orally. If it does not response to primary dose, mioprostol would be repeated up to three times with 24 hours interval.
Category
Treatment - Drugs
2
Description
Control group receive misoprostol 800 microgram vaginally plus placebo 60 ml orally. If it does not response to primary dose, mioprostol would be repeated up to three times with 24 hours interval.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak.University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Street address
Taleghani Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Ali Asghar Yaghobi
Street address
Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology ,Assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3816149369
Phone
+98 86 3278 0660
Fax
Email
mjamilian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology,assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
381969187
Phone
+98 86 3278 0660
Fax
Email
mjamilian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 3278 0660
Fax
Email
mjamilian@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)