Comparison The effect of sildenafil citrate consumption on the improvement of amniotic fluid index in oligohydraminos patients and placebo group(control)
effect of sildenafil citrate on improving the amniotic fluid index in oligohydramnios patients referred to Hamadan Fatemieh Hospital.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 42 patients. A table of numbers is used for randomization.
Settings and conduct
The effect of Sildenafil Citrate in improving the amniotic fluid index in oligohydramnios patients - in Hamadan Fatemieh Hospital -
In the intervention group (Sildenafil Citrate with a dose of 50 mg three times a day is prescribed to the patient along with receiving 3 liters of intravenous fluid and every week to two weeks amniotic fluid is evaluated by ultrasound).
The method was double-blind (patient and sonologist). None of these people were aware of their division into intervention and control groups.
Participants/Inclusion and exclusion criteria
Include all pregnant women with an age range between 15-50 years and a gestational age of 24-36 weeks and an amniotic fluid index below 8.
All patients with preeclampsia, history of taking blood pressure lowering drugs, and patients with sildenafil allergy will be excluded from this study.
Intervention groups
In the intervention group (Sildenafil Citrate with a dose of 50 mg three times a day is prescribed to the patient along with receiving 3 liters of intravenous fluid and every week to two weeks amniotic fluid is evaluated by ultrasound).
In the control group (internally, it is prescribed to the patient three times a day along with receiving 3 liters of intravenous fluid and every week to two weeks amniotic fluid is evaluated by ultrasound).
Main outcome variables
Amniotic fluid index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220903055868N1
Registration date:2022-10-08, 1401/07/16
Registration timing:registered_while_recruiting
Last update:2022-10-08, 1401/07/16
Update count:0
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
leila torkashvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 7013
Email address
l.torkashvand23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The effect of sildenafil citrate consumption on the improvement of amniotic fluid index in oligohydraminos patients and placebo group(control)
Public title
The effect of sildenafil citrate in oligohydramnios patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women
Age range between 15-50 years
Gestational age 24-36 weeks
The amniotic fluid index is below 8
Exclusion criteria:
Patients with preeclampsia
History of taking antihypertensive drugs
Patients with sildenafil allergy
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Quadruple block method and table of random numbers were used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the sonologist who evaluate the test results blindly. In this way, none of the patients and the sonologist are aware of the grouping of the patients in the placebo group and the main drug group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ibn- Sina University of Medical Sciences, Hamadan
Street address
Department of Ethics in Medicine., Ibn-Sina University of Medical Sciences., Shahid fahmideh St
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.UMSHA.REC.1401.361
Health conditions studied
1
Description of health condition studied
Oligohydroaminos
ICD-10 code
O41.0
ICD-10 code description
Oligohydramnios
Primary outcomes
1
Description
Amniotic fluid index
Timepoint
Every week to two weeks
Method of measurement
Abdominal sonography
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" sildenafil citrate tablets manufactured by Pharmachemy Company are prescribed to the patient orally at a dose of 50 mg every 8 hours for two weeks.
Category
Treatment - Drugs
2
Description
"Control group:" Placebo pills are prescribed every 8 hours for two weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh hospital in Hamedan
Full name of responsible person
Shahla Nasrolahi
Street address
Fatemiyeh Hospital., Pasdaran St
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
Hp.fatemieh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Hamedan University of Medical Sciences., Shahid Fahmideh St.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 4058
Fax
Email
Info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Leila Torkashvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital., Pasdaran St
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3834 0266
Email
L.torkashvand23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Leila Torkashvand
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemiyeh Hospital., Pasdaran St
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7013
Fax
Email
L.torkashvand23@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Leila Torkashvand
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemiyeh Hospital., Pasdaran St
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7013
Fax
Email
L.torkashvand23@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