To assess the effect of L-arginine versus control group on the prevention of preeclampsia in primiparous pregnant women
Design
This is a single-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 172 primiparous pregnant women. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 45 years;
Primiparous:
Singleton;
Gestational age of 20 weeks;
Exclusion criteria:
History of hypertension;
Affected with chronic diseases such as thyroid disorder and diabetes;
Using selenium supplement;
Intervention groups
Intervention group:
Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks plus L-arginine 500 mg tablets (manufactured by Karen Pharmaceutical Co.) from 20th weeks of pregnancy once a day for 12 weeks
Control group:
Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks
Main outcome variables
Primary outcome:
Preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N416
Registration date:2022-01-12, 1400/10/22
Registration timing:prospective
Last update:2022-01-12, 1400/10/22
Update count:0
Registration date
2022-01-12, 1400/10/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-30, 1400/11/10
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-arginine versus control group on the prevention of preeclampsia in primiparous pregnant women: a single-blind randomized controlled trial
Public title
Effect of L-arginine versus control group on the prevention of preeclampsia in primiparous pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 45 years;
Primiparous:
Singleton;
Gestational age of 20 weeks;
Exclusion criteria:
History of hypertension;
Affected with chronic diseases such as thyroid disorder and diabetes;
Using selenium supplement;
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
172
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single -blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.UMSHA.REC.1400.538
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Preeclampsia
Timepoint
Every two weeks until the end of pregnancy
Method of measurement
By taking a history (headache, blurred vision, epigastric pain, seizures), clinical examination (hypertension) and laboratory methods (oliguria, proteinuria, and increased liver enzymes)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks plus L-arginine 500 mg tablets (manufactured by Karen Pharmaceutical Co.) from 20th weeks of pregnancy once a day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Supplements (iron tablets and multivitamin capsules and calcium tablets) from 16th weeks of pregnancy once a day for 16 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr. Shahedeh Khansari
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
dr_sh_kh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
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
Dr. Shahedeh Khansari
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr_sh_kh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shahla Nasrolahi
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sh.nasrolahi@ yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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