Comparison of Effect L-Arginine and intravenous fluid Therapy in Oligohydramnios.
Design
50 eligible pregnant women are randomly assigned into the two of intervention and control groups.
Settings and conduct
One-sided blind clinical trial in Fatemieh Hospital, Hamadan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age between 28 to 36 weeks, Singleton pregnancy, AFI less than 8 cm
Exclusion criteria: Pregnancy with anomalies, Diabetes, Severe preeclampsia, Preterm Premature Rupture of Membranes (PPROM)
Intervention groups
Intervention group 1: L-arginine at a dose of 3 grams twice a day with oral fluid therapy or, if possible (not suffering from gestational hypertension), 3 liters of inject able lactate ringer in 24 hours.
Intervention group 2: Liquid therapy orally 10 to 15 glasses (100 cc) or 3 liters of inject able ringer lactate in 24 hours
Main outcome variables
Primary outcome: Amniotic fluid index Secondary outcome: gestational age at delivery; ; fetal weight, APGAR Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N5
Registration date:2020-12-15, 1399/09/25
Registration timing:registered_while_recruiting
Last update:2020-12-15, 1399/09/25
Update count:0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect L-Arginine and intravenous fluid Therapy in Oligohydramnios
Public title
Effect L-Arginine and intravenous fluid Therapy in Oligohydramnios
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 28 and 36 weeks
Single pregnancy
AFI less than 8 cm
Exclusion criteria:
Pregnancy with anomalies
Diabetes
Severe preeclampsia
Preterm Premature Rupture of Membranes (PPROM)
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
25
25 subject for each group
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to the intervention and control groups using block randomization The patients will be randomly assigned to the intervention and control groups using block randomization Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number (between 1 and 6 ) to each of them 3)Choosing random numbers between 1 and 6 4) Defining the treatment assignment list
Blinding (investigator's opinion)
Single blinded
Blinding description
the statistical analyser will be unaware of the type of intervention performed in the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.UMSHA.REC. 1399.149
Health conditions studied
1
Description of health condition studied
Oligohydramnios
ICD-10 code
O41.0
ICD-10 code description
Oligohydramnios
Primary outcomes
1
Description
Amniotic fluid index
Timepoint
One week after the intervention for up to 4 weeks
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Neonatal Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Data sheets
2
Description
Neonatal weight
Timepoint
At birth
Method of measurement
Data sheets, gram
3
Description
Gestational Age at birth
Timepoint
At the end of the study
Method of measurement
Data sheets
Intervention groups
1
Description
Intervention group: L-arginine at a dose of 3 grams twice a day with oral fluid therapy or, if possible (not suffering from gestational hypertension), 3 liters of inject able lactate ringer in 24 hours.
Category
Treatment - Drugs
2
Description
Intervention group: Liquid therapy orally 10 to 15 glasses (100 cc) or 3 liters of inject able ringer lactate in 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Shahla Nasrolahi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com
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
Shahla Nasrolahi
Position
Associate Professor of Perinatology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shahla Nasrolahi
Position
Associate Professor of Perinatology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shahla Nasrolahi
Position
Associate Professor of Perinatology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@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