Determination of the effect of supplementation of omega-3 on the risk of preeclampsia in Nulliparous pregnant mothers
Design
Clinical trials with intervention and control group ,parallel, double blind, randomized, with placebo , with 144 cases
Settings and conduct
The study is a double-blind, so that the patient and the person distributing the medications and the person who measures the patient's pressure are not aware of the type of treatment and drug. The medications are placed inside the two envelopes A and B, which are same shape. Given to the individual distributor of medications.This study will be conducted at Shahid Sayyid Shirazi Hospital in Gorgan
Participants/Inclusion and exclusion criteria
inclusion criteria:
Nulliparous Pregnant women with 18 - 20 gestational age
20 to 40 yeas old
Women with high risk of preeclampsia (age below 20 years of age and over 40 years , history of pre-eclampsia in the previous pregnancy or in the first-degree family , twin pregnancy , BMI equal to or greater than 29, kidney disease and hypertension)
Do not use calcium, aspirin, anticoagulants and insulin
No history of allergy to omega-3
exclusion criteria:
Unwilling to participate in the study
Forced to use aspirin, calcium and heparin during the study
Not being able to continue taking medication due to digestive problems or due to an allergic reaction
Intervention groups
The first intervention group uses an omega-3 pearl containing Eicosapentalenoic acid (EPA) and Duxa hexaenoic acid ( DHA )(Omega-3 capsule without mercuric ) daily until the end of pregnancy.
The control group received the drug that is in the form of pearl containing gelatin , which is used daily until the end of pregnancy.
Main outcome variables
Preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038196N4
Registration date:2018-07-29, 1397/05/07
Registration timing:retrospective
Last update:2018-07-29, 1397/05/07
Update count:0
Registration date
2018-07-29, 1397/05/07
Registrant information
Name
Amir Hossein Salimi Kordasiabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 361 5549
Email address
hosseininejad.s.mohsen@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of omega-3 supplementation intake on the risk of preeclampsia in nulliparous pregnant women
Public title
Evaluation of omega-3 supplementation intake on the risk of preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
nulliparous Pregnant women with 14 to 18 weeks gestational age
Satisfaction to participate in the study
Women without a high risk of preeclampsia (age under 20 and over 40 years, history of preeclampsia in a previous pregnancy or in the family, twins pregnancy, body mass index equal or greater than 29, kidney disease and hypertension )
Do not use calcium, aspirin, anticoagulants and insulin
No history of allergy to omega-3
20 to 40 years old
Exclusion criteria:
Unwillingness to cooperate
Forced to use aspirin, calcium and heparin during the study
Not being able to continue taking medication due to digestive problems or because of an allergic reaction
Women with a high risk of preeclampsia
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Using SAS statistical software and block randomization. patients will be divided into two groups: Group 1: Omega-3 and Group 2: Placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind, so that the patient and the person distributing the medications and the person who measures the patient's pressure are not aware of the type of treatment and drug. The medications are placed inside the two envelopes A and B, which are same shape and will Give to the person distributing the medications.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of gorgan University of Medical Sciences
Street address
Golestan university of medical science ,Beginin of Shastkola Street, 5th Kilometers of Gorgan Sari Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
1234567890
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.Goums.REC.1397.029
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
Pre-eclampsia Prevalence in Nulliparous Pregnant Women
Timepoint
From the beginning of the study to the end of pregnancy
Method of measurement
Pressure gauge and criteria for diagnosis of pre-eclampsia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group uses a gram of an EPA with DHA as an omega-3 pearl until the end of pregnancy.
Category
Prevention
2
Description
Control group: The control group received the placebo, which is in the form of pearl containing gelatin