The purpose of this clinical trial, with two triple-blind parallel arms, is to determine the effect of garlic tablet on the plasma levels of nitric oxide and prevention of preeclampsia which will be tested on 400 pregnant women with gestational age of 20 weeks, nulliparous and without a history of hypertension who referred to Health centers in Rasht. Eligible people after obtaining written informed consent, with randomized block method, with four and six blocks and allocation ratio of 1:1 would be allocated in two groups. To conceal allocation and preservation of blinding of participants and people involved in sampling and data collection, tablets containing 400 mg of garlic powder (construction Dineh pharmaceutical company, containing of 1100 to 1400 micrograms allicin) and placebo quite similar to garlic tablet by a uninvolved person in the sampling and data collection will be placed in a sealed opaque envelope with consecutive numbers. Persons will intake prescription tablets daily (every 12 hours 1 tablet) for 16 weeks. The plasma nitric oxide levels 12 weeks after intervention and blood pressure measurements (to determine the frequency of preeclampsia incidence) in the specified visits as a primary consequences, the frequency of preterm delivery incidence, anthropometric indexes, the satisfaction level of received drug and side events as a secondary consequences will be assessed and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602163027N33
Registration date:2016-04-08, 1395/01/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic tablet on plasma nitric oxide levels and prevention of preeclampsia in healthy nulliparous women: A randomized controlled trial
Public title
The effect of garlic tablet on plasma nitric oxide levels and prevention of preeclampsia in healthy nulliparous women: A randomized controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having ultrasound based on singleton pregnancy and baby health, 20 weeks pregnancy (according to gestational age in the early pregnancy ultrasound), pregnant women 18-35 years, failure to alcohol and tobacco, having at least read and write, having telephone number for follow-up
Exclusion criteria: Systemic diseases such as diabetes mellitus, heart disease, kidney and... according to pregnant women statement, history of clotting disorders, history of hypertension disorder before pregnancy and during current pregnancy,
body mass index equal to or greater than 30 kilograms per square meter, systolic blood pressure lower than 100 mmhg, history of allergy to garlic according to pregnant women statement, intake garlic more than 1 serving a day or more than 10 serving per week, participate in other similar studies.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor Of Research, Number 2 Central Building, Tabriz University of Medical Sciences, Golgasht ave, Tabriz, Iran
City
Tabriz
Postal code
5165665931
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
TBZMED.REC.1394.1028
Health conditions studied
1
Description of health condition studied
Supervision of normal first pregnancy for prevention of preeclampsia
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy
Primary outcomes
1
Description
Plasma nitric oxide level
Timepoint
12 weeks after intervention
Method of measurement
Nitric oxide kit
2
Description
The frequency of preeclampsia incidence
Timepoint
Before intervention, 6-10,11-14, 15-17 and 18-20 weeks after intervention
Method of measurement
The blood pressure according to millimeter of mercury using a mercury sphygmomanometer and random urine albumin using diagnostic strips for urine protein assay
Secondary outcomes
1
Description
The frequency of side events incidence
Timepoint
8 and 16 weeks after intervention
Method of measurement
The side events check list
2
Description
Neonatal anthropometric indexes
Timepoint
After the termination of pregnancy
Method of measurement
Growth monitoring card
3
Description
The frequency of preterm delivery incidence
Timepoint
During 16 weeks after intervention
Method of measurement
The folder summary sheet in Health centers
4
Description
The patients satisfaction level of received drug
Timepoint
8 and 16 weeks after intervention
Method of measurement
The check list of satisfaction of received drug
Intervention groups
1
Description
Intervention group: Garlic tablet, 400 milligram, oral, every 12 hours 1 tablet for 16 weeks
Category
Prevention
2
Description
Control group: Placebo, oral, quite similar to garlic tablet, every 12 hours 1 tablet for 16 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Center Number 8
Full name of responsible person
Darvishi, Farzaneh
Street address
No.43 In Front of the Faculty of Nursing and Midwifery, Student Park, Hamidian Ave, Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mirghafourvand
Street address
Faculty of Nursing and Midwifery, Shariati Ave, Tabriz, Iran
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Shafaie Sehhatie Fahimeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariati Ave, Tabriz, Iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
sehhatief@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Shafaie Sehhatie Fahimeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariati Ave, Tabriz, Iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
sehhatief@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing and midwifery
Full name of responsible person
Shafaie Sehhatie Fahimeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Shariati Ave, Tabriz, Iran
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3475 2839
Email
sehhatief@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)