The effect of letrozole with misoprostol on induced abortion in the second trimester
Design
Study Design : Randomized ; Target population: Pregnant women with under 13 weeks nonviable pregnancy. Inclusion criteria : pregnancy with under 13 weeks nonviable fetus .Exclusion criteria : any condition requiring emergency intervention .76 participants were randomized into two groups.control group use Misoprostol for abortion and intervention group will receive Letrozole plus Misoprostol .
Settings and conduct
76 consecutive pregnant women with gestational age of 13-26 weeks who were candidate for stopping pregnancy due to fetal reasons who come to Tabriz,Alzahra hospital.76 participants were randomized into two groups. Control group use Misoprostol for abortion (gold standard treatment) and intervention group will receive Letrozole plus Misoprostol .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age of 13 to 26 with an indication for termination of pregnancy in medical method; Reason for termination of pregnancy, such as missed abortion; Pregnancy NULL; Therapeutic abortion legal authorization and consent of patients
ٍExclusion criteria:Pain and bleeding; Drug sensitivity to misoprostol; history of corticosteroid use
Intervention groups
Intervention group: 7.5 mg ، letrozole (Manufacturing Iran Hormones Company) prescribed up to three doses at home, the patient was hospitalized on the fourth and Misoprostol 400 micrograms (made by SEARLE UK) is administered sublingually every 3 hours to a maximum of 5 doses.
Control group: The group received placebo for 4 days (Folic acid as blind-made by IRAN DARO) and then misoprostol according to the ACOG protocol.
Main outcome variables
Primary out come is rate of complete abortion and Secondary outcomes are rate and duration of bleeding and other side effects such as nausea , vomiting , diarrhea , dizziness , headache.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130626013777N2
Registration date:2019-02-14, 1397/11/25
Registration timing:registered_while_recruiting
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Shamsi Abbasalizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
abbasalizadehs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-13, 1397/11/24
Expected recruitment end date
2020-02-13, 1398/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of letrozole with misoprostol on induced abortion in the second trimester
Public title
Comparison the effect of Letrozole with Misoprostol on induction of second trimester abortion in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients more than 18 years of age
Gestational age of 13 to 26 with an indication for termination of pregnancy in medical method
Hb above 10
Reason for termination of pregnancy, such as missed abortion; Pregnancy NULL; Therapeutic abortion legal authorization and consent of patients
BMI between 25-25
Exclusion criteria:
Pain and bleeding
Drug sensitivity to misoprostol;
Severe anemia
Coagulopathy or taking anticoagulants
Active liver disease
Cardiovascular disease and uncontrolled seizures
Adrenal disease
history of corticosteroid use
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to two groups of 38 A (receiving Letrozole and Misoprostol) and B (Misoprostol) by using the random numbers table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.TBZMED.REC.1397.855
Health conditions studied
1
Description of health condition studied
Termination of pregnancy in the second trimester
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
abortion
Timepoint
The start of the intervention up to 24
Method of measurement
Ultrasound
2
Description
Time between medication abortion
Timepoint
The start of the intervention up to 24
Method of measurement
hour
3
Description
The need for curettage
Timepoint
Seven days after abortion
Method of measurement
Clinical
Secondary outcomes
1
Description
Side effects
Timepoint
Intervention to 24 hours after administration
Method of measurement
Clinical
Intervention groups
1
Description
Intervention group: 7.5 mg ، letrozole (Manufacturing Iran Hormones Company) prescribed up to three doses at home, the patient was hospitalized on the fourth and Misoprostol 400 micrograms (made by SEARLE UK) is administered sublingually every 3 hours to a maximum of 5 doses.
Category
Treatment - Drugs
2
Description
Control group: The group received placebo for 4 days (Folic acid as blind-made by IRAN DARO) and then misoprostol according to the ACOG protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Shamsi Abbasalizadeh
Street address
Alzahra Hospital, South Artesh St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
Full name of responsible person
Abolghasem Juiban
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تبریز
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Abbasalizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Abbasalizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Abbasalizadeh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Azadi Avenue, Golgashte St, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available