Determine the efficacy of indomethacin in reducing abortion In operations of the reduction of embryos in multiple pregnancies
Design
Two arm parallel group randomized trial with control group not blinded and 45 participation in each group
Settings and conduct
study setting is Yas hospital of Tehran University of Medical Sciences in 2018. Balanced block randomization were used to allocate subjects to mentioned groups and finally 45 patients were assigned to each group.
Participants/Inclusion and exclusion criteria
Mothers with multiple pregnancies in the first trimester of pregnancy; Having the consent to participate in the study; Not a history of allergy to indomethacin
Intervention groups
Intervention group: indomethacin suppository 50 mg was given anal for mother for half an hour before embryo reduction.
Control group: without any intervention
Main outcome variables
The effect on abortion in operations of the reduction of embryos
General information
Reason for update
Acronym
TFRS
IRCT registration information
IRCT registration number:IRCT20190113042349N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Zahedeh Kamali Taghavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 8553
Email address
z_kamalit@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Indometacin suppository on decreasing of abortion in multi fetal pregnancy for fetal reduction
Public title
Effect of Indometacin on abortion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women in first trimester pregnancy
No allergy to Indometacin
Satisfaction to entry on study
Multiple pregnancy
Exclusion criteria:
Allergy to Indometacin
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
We used balance block randomization to devote participation in two groups.
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
Ethical approval for the study was obtained from the institutional review board of Tehran University
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-12-06, 1396/09/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.303
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
miscarriag
ICD-10 code description
miscarriage
Primary outcomes
1
Description
The effect of abortion in reduction of embryos of multiple pregnancies operation
Timepoint
21 day after intervention
Method of measurement
Research made questionnaire
2
Description
The effect on Pain
Timepoint
21 day after intervention
Method of measurement
Research made questionnaire
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: Indomethacin suppository 50 mg, half an hour before fetus reduction via rectal, made in Toliddaroo Company
Category
Treatment - Drugs
2
Description
Control group: without any intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Zahedeh Kamali Taghavi
Street address
North Nejatollahi street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Email
zahedeh_kamali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Poursia Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
zahedeh_kamali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology TUMS
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
Tehran University of Medical Sciences
Full name of responsible person
Zahedeh Kamali Taghavi
Position
Student in obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Poursina
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8899 5767
Email
zahedeh_kamali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahedeh Kamali Taghavi
Position
Assistant in obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Poursina
City
Tehran
Province
Tehran
Postal code
1256321458
Phone
+98 21 8899 5767
Email
zahedeh_kamali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahedeh Kamali Taghavi
Position
Assistant in obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Poursina
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3047
Email
zahedeh_kamali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
We do not decide share our documents
When the data will become available and for how long
We do not decide share our documents
To whom data/document is available
We do not decide share our documents
Under which criteria data/document could be used
We do not decide share our documents
From where data/document is obtainable
We do not decide share our documents
What processes are involved for a request to access data/document