Evaluation of the effect of misoprostol with and without letrozole as premedication on induction of abortion in pregnant women with missed abortion at their first trimester of pregnancy
The Impact Of Letrozole With &Without Misoprostol As a Premedication In Induction Of Abortion In MISSED ABORTION before 12 weeks
Design
Two arm parallel group (63 patients in each group)randomised clinical trial with blinded outcome assessment.double blinded
Settings and conduct
The trial was done on the missed-aborted patient with gestational age less than 12 week, who came to the ALZAHRA AND SHAHID SADOUGHI HOSPITAL ,ISFAHAN,IRAN
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Gestational age less than 12 weeks
Patients with missed aborted
Acceptance of patients
Age above 18 years
Hemoglobin above 12
No evidence of renal or hepatic impairment
Exclusion criteria:
RENAL OR hepatic or adrenal impairment
Coagulation abnprmality
Peresent of IUD
Cardiovascular disease
Classic scar (t shape) on the uterus
Intervention groups
Missed aborted ,Pregnant women before 12 weeks devided in two groups
intervention group received misoprostol+letrozol
control group received misoprostol+placebo
Main outcome variables
Time interval of induction to abortion
Incidence of abortion
Misoprostol_+ letrozol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190730044380N1
Registration date:2019-11-11, 1398/08/20
Registration timing:retrospective
Last update:2019-11-11, 1398/08/20
Update count:0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Maryam Goharian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3266 9201
Email address
mrym.gn72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-10-25, 1397/08/03
Actual recruitment start date
2016-10-22, 1395/08/01
Actual recruitment end date
2019-05-23, 1398/03/02
Trial completion date
2019-06-23, 1398/04/02
Scientific title
Evaluation of the effect of misoprostol with and without letrozole as premedication on induction of abortion in pregnant women with missed abortion at their first trimester of pregnancy
Public title
Evaluation of the effect of misoprostol with and without letrozol in missed aborted
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1:Gestational age less than 12 week(confirmed with ultrasonogarphy)
patient with missed abortion (confirmed with ultrasonography)
acceptance of participant
patient age above 18 years old
hemoglobin above 12
Exclusion criteria:
Clinical manifestation or history of adrenal gland impairment
History of any malignancy
History or clinical evidence of any thromboembolic impairment
History of hepatic or renal diseases
Have IUD
History of cardiovascular disease that prescription of misoprostol or letrozol forbidden based on cardiologist opinion.
History of use corticosteroid
Present of classic scar or t shape scar on the uterus
Impairment of coagulation test
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
126
Actual sample size reached:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random sequence generation
Used random allocation software
Allocation concealment ;Sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Double -blinded
Participants and researcher and outcome assessor who was same as the researcher were blinded. Participants were divided into two random groups after informed consent, and then the drug was administered without knowing the nature of the drug being prescribed. To blind the researcher, the researcher was not present at the beginning and at the time of administration of the drug and was prescribed by a clinical caregiver and a clinical caregiver was present
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
SOFFEH blvd,alzahra hospital
City
ISFAHAN
Province
Isfehan
Postal code
8174675731
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.MUI.REC.1396.3.243
Health conditions studied
1
Description of health condition studied
Missed abortion
ICD-10 code
O02.1
ICD-10 code description
Missed abortion
Primary outcomes
1
Description
PRESENT OF ABORTION:COMPLETE,in complete
Timepoint
every 12 hours
Method of measurement
ultrasonography
Secondary outcomes
1
Description
time interval from induction to abortion
Timepoint
hours
Method of measurement
questionaire
Intervention groups
1
Description
Intervention group: missed aborted women with geatational age less than 12 weeks- The case group received 10 mg of letrozole daily for three days, then received 800 μg of vaginal misoprostol, and finally received the same dose of misoprostol after four hours
Category
Treatment - Drugs
2
Description
Control group: missed aborted women with geatational age less than 12 weeks-The CONTROL group calcium carbonate tablet daily for three days, then received 800 μg of vaginal misoprostol, and finally received the same dose of misoprostol after four hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
DR.Maryam Goharian
Street address
Soffeh blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
MRYM.GN72@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
DR.Haghjou
Street address
Soffeh blvd
City
ISFAHAN
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
MRYM.GN72@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Goharian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Soffeh blvd,alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mrym.gn72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Goharian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Soffeh,Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
MRYM.GN72@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Goharian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Soffeh ,Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3266 9201
Email
MRYM.GN72@GMAIL.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
information of main consequence can be shared
When the data will become available and for how long
1 YEAR after publish of the result
To whom data/document is available
academic researcher
Under which criteria data/document could be used
in clinical research
From where data/document is obtainable
mrym.gn72@gmail.com
What processes are involved for a request to access data/document