In a study the effect of letrazole in combination with misoprostol on candidates for induced abortion will be assessed. The aim of the study is to find a new protocol to avoid abortion. In this randomized study intervention and control groups will receive two protocols of A or B. Women with pregnancy in 14 or less than 14 weeks and 38 years of age will be included in the study. In intervention group the patients will receive 10 mg/kg letrazole and 4 vaginal tablets (200 µg) of misoprostol for 3 dose. In control group the patients will only receive misoprostol the same way above. In case of no abortion, 48 hours after the last dose of suppository, profuse bleeding will be started or the remnant of the fetus will be confirmed by transvaginal ultrasonography one day after abortion. Hence, the patients will uner go curettage to remove fetus. The the prevalence of complete abortion, the duration of induction to complete expulsion of products of conception, the frequency of the need for surgical abortion, the consumer misoprostol side effects such as nausea, vomiting, diarrhea, headache, dizziness and pain in the lower abdomen will be assessed in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011526962N3
Registration date:2017-02-10, 1395/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Tahereh Behroozi Lak
Name of organization / entity
Educational and Treatment Kowsar Center
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 7077
Email address
behroozilak.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Urmia university of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of letrozole with misoprostol in comparison with misoprostol alone in success rate of induced abortion
Public title
The effect of letrozole in combination with misoprostol on induced abortion success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients more than 18 years of age, pregnancy in 14 or less than 14 weeks (will be on firmed by ultrasonography), Hb above 10, diastolic blood pressure of below 95 mm Hg
Exclusion criteria: Adrenal gland failure, cancer, porphyria, thromboembolism, severe hepatic diseases, bronchial asthma, hypertension, breast feeding, hepatic function tests disorders, blood tests disorders, consumption of any medicine
Age
From 18 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences Urmia Western Azarbaijan Iran, Islamic Republic Of
City
Urmia
Postal code
5714783734
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
ir.umsu.rec.1395.436
Health conditions studied
1
Description of health condition studied
induced abortion
ICD-10 code
008
ICD-10 code description
Pregnancy with abortive outcome
Primary outcomes
1
Description
Complete abortion
Timepoint
After intervention
Method of measurement
will be on firmed by ultrasonography
2
Description
the duration of induction to complete expulsion of products of conception
Timepoint
The interval between the consumer misoprostol l until the abortion
Method of measurement
Hours
Secondary outcomes
1
Description
The need for surgical abortion in the two groups
Timepoint
During intervention
Method of measurement
will be on firmed by ultrasonography
2
Description
The consumer misoprostol in two groups
Timepoint
During intervention
Method of measurement
The number of vaginal tablets used
3
Description
Age patients
Timepoint
During intervention
Method of measurement
Year
4
Description
Gestational age
Timepoint
The duration from the last period
Method of measurement
Week
Intervention groups
1
Description
In intervention group the patients will receive 10 mg/kg letrazole and 4 vaginal tablets (200 µg) of misoprostol for 3 dose
Category
Treatment - Drugs
2
Description
Administration of misoprostol alone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and treatment kowsar center
Full name of responsible person
Tahereh Behroozi Lak
Street address
Urmia university of medical sciences West Azarbaijan Iran, Islamic Republic Of
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Urmia university of medical sciences
Full name of responsible person
Iraj Mohebbi
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences Urmia West Azarbaijan Iran, Islamic Republic Of
City
urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Other areas of specialty/work
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences Urmia West Azarbaijan Iran, Islamic Republic Of
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
behroozilak.t@umsu.acir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Other areas of specialty/work
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences Urmia Western Azarbaijan Iran, Islamic Republic
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
behroozilak.t@umsu.acir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Other areas of specialty/work
Street address
Urmia, Resalat Blvd. the end of Jahad St. Research ward, Setad, Urmia university of medical sciences Urmia Western Azarbaijan Iran, Islamic
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
behroozilak.t@umsu.acir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)