The purpose of this study is to determine the effect of selenium on prevention of preeclampsia in pregnant women. Inclusion criteria: singleton pregnancy, gestational age 24 weeks, willingness to participate in this study, body mass index of 19 to 30 and an increase of at least 4 kg during the first 6 months of pregnancy. Exclusion criteria: abnormal ultrasonography, the risk of chronic diseases, alcohol and tobacco use. From June 2015 to June 2016 in a controlled clinical trial, 270 women will randomly divide into two groups. The target group from 24 to 40 weeks of pregnancy will get 200 micro grams of selenium per day. The control group will not get any medications. At the end the incidence of preeclampsia in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506034339N9
Registration date:2015-08-01, 1394/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Bushehr University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of selenium on preventing preeclampsia in pregnant women
Public title
The effect of selenium on preventing pregnancy induced hypertension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy; gestational age of 24 weeks; willingness to participate in the study; body mass index of 19 to 30 and at least 4 kg during the first 6 month of pregnancy weight gain as well.
Exclusion criteria:
Abnormal fetal ultrasound; the risk of chronic disease such as diabetes and hypertension; hypertension drugs requirement; chronic and sever illness of the kidney; adrenal, thyroid and parathyroid; cardiovascular; infection; malignancies, immune system disorders; use of alcohol and tobacco; severe stress in pregnancy period; consumption anti-cancer drugs; aspirin; anticoagulants; daily using over 60 mg of iron; daily using calcium and consumption of zinc.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Moallem Street, Bushehr
City
Bushehr
Postal code
7514633341
Approval date
2015-05-18, 1394/02/28
Ethics committee reference number
bpums.rec.1394.7
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O10
ICD-10 code description
Pre-existing hypertension complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Hypertension
Timepoint
24 weeks and 32 weeks of gestational age and delivery time
Method of measurement
mmHg and with Sphygmomanometer
Secondary outcomes
1
Description
urine protein
Timepoint
24wks , 32wks , delivery time
Method of measurement
urinaryanalysis
Intervention groups
1
Description
Pregnant women from 24 to 40 weeks of pregnancy (duration:16 weeks) will get 200 micrograms of selenium per day orally.
Category
Treatment - Drugs
2
Description
Pregnant women from 24 to 40weeks of pregnancy (duration: 16 weeks) based on study criteria will not get any medication.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Khalije Fars Hospital
Full name of responsible person
Elham Rahmani
Street address
Shohada Khalije Fars Hospital, Taleghani Street, Azadi Square, Bushehr, Iran
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery for Research of Bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Alamdar St, Salman Farsi St, Bushehr, Iran.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research of Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Elham Rahmani
Position
Associate professor of clinical obstetrics and gynecology and fellowship of infertility
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Moallem Street, Bushehr
City
Bushehr
Postal code
7514633341
Phone
+98 77 3252 2081
Fax
Email
Rahmani@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Elham Rahmani
Position
Associate professor of clinical obstetrics and gynecology and fellowship of infertility
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Moallem Street, Bushehr
City
Bushehr
Postal code
7514633341
Phone
+98 77 3252 2081
Fax
Email
Rahmani@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)