Perinatal outcome and Growth after radiofrequency ablation in complicated monochorion diamnion twin pregnancies (Yas Hospital-Tehran University of Medical Sciences)
Evaluation of the consequences of Radio-frequency in complicated monochorion diamnion pregnancies, with one twin with IUGR or TTTS or TRAP or anomaly.
Design
This is a prospective intervention study with single group. In this study, MCDA pregnancies complicated with IUGR or TTTS or anomalies or TRAP, encounter with FR waves and followed up by pregnancy outcomes.
Settings and conduct
Location: Yas Hospital, Tehran, Iran. Pregnant women with MCDA twin suffering from complicated pregnancies candidate for using radio frequency waveform.
Participants/Inclusion and exclusion criteria
Complicated monochorion diamnion pregnancies, with one twin with IUGR or TTTS or TRAP or anomaly.
Intervention groups
The use of radio frequency waves in reducing complicated twin in monochorion diamnion pregnancies
Main outcome variables
Increasing the chances of survival and health in uncomplicated twin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180409039247N1
Registration date:2018-08-19, 1397/05/28
Registration timing:registered_while_recruiting
Last update:2018-08-19, 1397/05/28
Update count:0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Marjan Ghaemibidgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4858
Email address
m_ghaemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Perinatal outcome and Growth after radiofrequency ablation in complicated monochorion diamnion twin pregnancies (Yas Hospital-Tehran University of Medical Sciences)
Public title
Perinatal outcome and Growth after radiofrequency ablation in complicated monochorion diamnion twin pregnancies (Yas Hospital-Tehran University of Medical Sciences)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dichorion diamniotic twin Including IUGR or TTTS, or one twin Anomalie or TRAP
Exclusion criteria:
Dissatisfaction with entering the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Research Vice-President of Tehran University of Medical Sciences
Street address
Yas hospital, North Villa street, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
12123
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4772
Health conditions studied
1
Description of health condition studied
IUGR; TRAP sequence, TTTS; anomaly of one twin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The main consequence is increase in the survival of the unaffected twin in twin MCDA pregnancies which one twin reducted with radio frequency waves.
Timepoint
Evaluation will be performed immediately after the RF and one after the delivery, which implies neonatal outcomes through questionnaire
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The use of radio frequency waves in reducting complicated twin in MCDA twins
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Marjan Ghaemi Bidgoli
Street address
Yas hospital, North Villa street, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
13312
Phone
+98 21 8885 3138
Email
Marjan_ghaemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeeian
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
13231
Phone
+98 21 8163 3698
Email
ehealthsw@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemi Bidgoli
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Villa street
City
Tehran
Province
Tehran
Postal code
131234
Phone
+98 21 8885 3138
Email
majan_ghaemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemi Bidgoli
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Villa street
City
Tehran
Province
Tehran
Postal code
131234
Phone
+98 21 8885 3138
Email
majan_ghaemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemi Bidgoli
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Villa street
City
Tehran
Province
Tehran
Postal code
131234
Phone
+98 21 8885 3138
Email
majan_ghaemi@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
Not disclosing the identity of the participants
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