Evaluation of the effects of sildenaphil on amniotic fluid index in cases of oligohydramnios.
Design
190 eligible pregnant women are randomly assigned into the two groups oof intervention and control groups.
Settings and conduct
Triple blind clinical trial in Akbarabadi Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Singleton pregnancy and gestational age of 30-37 weeks and amniotic fluid index (AFI) less than 5 cm which is discoveredduring third-trimester ultrasonography. The women with abnormal fetal Doppler, fetal anomalies, fetal growth restriction, fetal distress like nonreactive non stress test(NST), maternal chronic hypertension, pre-gestational diabetes, active labor, rupture of membranes, treatment with prostaglandin synthase inhibitors, maternal diseases contraindicating bolus fluid therapy (kidney, lung, or heart disease) are excluded from the study.
Intervention groups
Intervention group will receive sildenafil ( 25 milligram every 8 hours) plus 2 liter intravenous hydration( 250 milliliter/ hour every 4 hours isotonic solution) and control group will receive placebo plus 2 liter intravenous hydration( 250 milliliter/ hour every 4 hours isotonic solution).
Main outcome variables
Main outcome is increasing in amniotic
fluid index at 6 weeks of intervention or before delivery, whichever occurred first.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091023002624N21
Registration date:2017-12-17, 1396/09/26
Registration timing:prospective
Last update:2017-12-17, 1396/09/26
Update count:0
Registration date
2017-12-17, 1396/09/26
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of sildenaphil on oligohydramnios in pregnant women.
Public title
The effects of sildenaphil on oligohydramnios
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Singleton pregnancy
Gestational age 30-37 weeks
Amniotic fluid index (AFI) less than 5 cm which was discoveredduring third-trimester ultrasonography
Exclusion criteria:
Abnormal fetal Doppler
Fetal anomalies
Fetal growth restriction
Fetal distress like nonreactive non stress test(NST)
Maternal chronic hypertension
Pre-gestational diabetes,
Active labor
Rupture of membranes
Treatment with prostaglandin synthase inhibitors
Maternal diseases contraindicating bolus fluid therapy (kidney, lung, or heart disease)
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using sealed envelops.
Blinding (investigator's opinion)
Triple blinded
Blinding description
participants, principle investigator, investigator and midwives who care for participants during the trial, and data analyser are blinded to the study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Chamran Cross
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.IUMS.REC 1396.31246
Health conditions studied
1
Description of health condition studied
Oligohydramnios
ICD-10 code
O41.0
ICD-10 code description
Oligohydramnios
Primary outcomes
1
Description
increasing in amniotic fluid index
Timepoint
at 6 weeks of intervention or before delivery, whichever occurs first.
Method of measurement
ultrasonogram
Secondary outcomes
1
Description
gestational age at delivery
Timepoint
Delivery
Method of measurement
Data sheets
2
Description
rout of delivery
Timepoint
Delivery
Method of measurement
Data sheets
3
Description
Neonatal weight
Timepoint
At birth
Method of measurement
Data sheets, gram
4
Description
Neonatal Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Data sheets
5
Description
Umbilical artery pH
Timepoint
at birth
Method of measurement
Data sheets
6
Description
Admission to NICU
Timepoint
any time after birth
Method of measurement
Data sheets
7
Description
Length of NICU stay
Timepoint
After discharge
Method of measurement
Data sheets, Days
Intervention groups
1
Description
Intervention group: sildenafil ( 25 milligram every 8 hours) plus 2 liter intravenous hydration( 250 milliliter/ hour every 4 hours isotonic solution) will be prescribed.
Category
Treatment - Drugs
2
Description
Control group: control group will receive placebo plus 2 liter intravenous hydration( 250 milliliter/ hour every 4 hours isotonic solution).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi Street, Molavi Cross.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakooti
Street address
Hemmat Highway, Chamran Cross.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Street, Molavi Cross.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi Street, Molavi Cross.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molavi street, Molavi Cross.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5563 3244
Email
maryamkashanian@yahoo.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
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
Title and more details about the data/document
Presenting at a paper, congress or seminars.
When the data will become available and for how long
After finishing the study.
To whom data/document is available
Iran University of Medical Sciences.
Under which criteria data/document could be used
Permission from Iran University of Medical Sciences.
From where data/document is obtainable
From Iran University of Medical Sciences.
What processes are involved for a request to access data/document