Determining the effect of quadruped or lateral decubitus position on correction of gestational hydronephrosis in the third trimester of pregnancy
Design
Clinical trial without control group on 45 patients
Settings and conduct
Patients referred to Hajar teaching Center in Shahrekord will be examined from Mordad 1401 to Mordad 1401
Participants/Inclusion and exclusion criteria
Participants are pregnant women with gestational age of 28-40 weeks with a renal pelvis diameter of larger or equal to 5 mm.
Intervention groups
Patients are in the Quadruped position for 10 minutes and if they are unable to position the Lateral Decubitus position, so that the side which has hydronephrosis is upwards.
Main outcome variables
AP diameter of renal pelvis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171118037525N2
Registration date:2022-07-01, 1401/04/10
Registration timing:prospective
Last update:2022-07-01, 1401/04/10
Update count:0
Registration date
2022-07-01, 1401/04/10
Registrant information
Name
Flora Mazaheri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36246171
Email address
flora.mazaheri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of quadruped or lateral decubitus position on correction of gestational hydronephrosis in thethird trimester of pregnancy: A clinical trial
Public title
The effect of quadruped or lateral decubitus position on correction of gestational hydronephrosis in thethird trimester of pregnancy: A clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender and pregnant Gestational age 28-40 weeks Hydronphrosis with pelvis diameter of more than or equal to 5 mm
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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 of Shahrekord University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Building No. 2, University Headquarters, Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.SKUMS.MED.REC.1401.001
Health conditions studied
1
Description of health condition studied
Hydronephrosis in pregnancy
ICD-10 code
N13.3
ICD-10 code description
Other and unspecified hydronephrosis
Primary outcomes
1
Description
AP diameter of renal pelvis
Timepoint
Before the intervention, immediately after intervention, 6 weeks after delivery
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Quadruped or lateral decubitus position
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Flora Mazaheri
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Email
flora.mazaheri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Vice Chancellor for Research, Building No. 2, University Headquarters, Ayatollah Kashani Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
Sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Flora Mazaheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
flora.mazaheri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Flora Mazaheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
flora.mazaheri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Flora Mazaheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar hospital, Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 8575
Email
flora.mazaheri@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
Information is kept confidential
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Dr. Flora Mazaheri, Shahrekord University of Medical Sciences
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided