The aim of this study is comparison of three different routes of sublingual, oral and vaginal misoprostol in missed abortion during the first trimester of pregnancy. In this randomized clinical trial, 195 patients candidate for abortion, hospitalized in Mobini Sabzevar in 2014 were randomly allocated to three groups of sublingual, oral and vaginal misoprostol. Patients in all three groups, will treat with 600ug dose every 6 hours (maximum 4 doses). Patient will be controlled at least 24 hours for probable drug side effects and severity of vaginal bleeding. All patients will be visited again next week. Some of the inclusion criteria are gestational age less than 14 weeks and confirmation of the need for pregnancy termination by ultrasound. Some exclusion criteria are vaginal bleeding and emergency need for surgery to pregnancy termination. This study will be determinate the best route of misoprostol administration, probable complications and patient Satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101015905N2
Registration date:2014-12-11, 1393/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-11, 1393/09/20
Registrant information
Name
Mahbobe Mohebbi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1386 1959
Email address
mohebbi_mhb@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sublingual, vaginal and oral misoprostol on treatment of missed abortion in the pregnant women in the first trimester; Comparative study
Public title
Effect of misoprostol on treatment of missed abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are gestational age less than 14 weeks; confirmation of the need for pregnancy termination by ultrasound. Exclusion criteria are the vaginal bleeding; emergency need for surgery to pregnancy termination; anemia; Coagulation disorders or taking anticoagulant;, history of diseases (liver, kidney and heart); history of allergy to prostaglandin; smoking; inflammatory diseases and hemoglobin less than 9 g/dl.
Age
From 16 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
195
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
Sabzevar University of Medical Sciences
Street address
Next to the police station to Shahroud road, Sabzevar.
City
Sabzevar
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
medsab.Rec.93020
Health conditions studied
1
Description of health condition studied
missed abortion
ICD-10 code
O02.1
ICD-10 code description
Early fetal death with retention of dead fetus
Primary outcomes
1
Description
Proportion of compelete abortion
Timepoint
Compelete abortion during 7 days
Method of measurement
Complete evacuation of the uterus by ultrasound
Secondary outcomes
1
Description
The intensity and duration of bleeding
Timepoint
Up to 7 days
Method of measurement
Higham chart
Intervention groups
1
Description
The intervention in oral group will be done by administering 600 μg of misoprostol every 6 hours (up to 4 doses) orally in pregnant women with missed abortion.
Category
Treatment - Drugs
2
Description
The intervention in vaginal group will be done by administering 600 μg of misoprostol every 6 hours (up to 4 doses) vaginally in pregnant women with missed abortion.
Category
Treatment - Drugs
3
Description
The intervention in sublingual group will be done by administering 600 μg of misoprostol every 6 hours (up to 4 doses) vaginally in pregnant women with missed abortion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini Hospital
Full name of responsible person
Dr Sewizi
Street address
Mobini Hospital, Sabzevar, Razavi Qorasan
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzear University of Medical Science
Full name of responsible person
Rahim Akrami
Street address
Next to the police station to Shahroud road, Sabzevar.
City
Sabzear
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzear University of Medical Science
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
Member of research committee in Sabzevar University of Medical Sciences
Full name of responsible person
Mahbobe Mohebbi
Position
Master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
9163856514
Phone
+98 51 4444 6070
Fax
Email
mohebbi_mhb@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty member of sabzevar University of Medical Sciences
Full name of responsible person
Dr Behnaz Sewzie
Position
Gynecologist
Other areas of specialty/work
Street address
School of medicine, next to the police station to Shahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
hoomanshn@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Member of research committee, Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Position
Master of nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
borzoee75026@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)