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IRCT20210426051094N1 IRCT 2021-06-07 Kurdistan University of Medical Sciences "Survey of the Effect of Omega-3 in the Prevention of Preeclampsia” Survey of the Effect of Omega-3 in the Prevention of Preeclampsia in Pregnant Women Suffering Hyperlipidemia 2021-05-02 anticipated 72 Complete https://irct.ir/trial/56013 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization of patients will do by randomization method of 4 blocks (AA, BB-AB, AB-BA, BA-AA, BB). So exactly the same numbers of participants enter the intervention and control groups in the consecutive but equal intervals. Therefore, two groups are considered. Patients in intervention group A, that received omega-3 and placebo group B, that received placebo. Intervention group A receives omega-3 in the form of one gram tablet containing Eicosapentaenoic acid and Docosahexaenoic acid daily until the end of pregnancy. The placebo group receives the placebo daily in the form of gelatin capsules until the end of pregnancy. Patients will be referred for blood pressure measurement during pregnancy and will be evaluated for triglyceride measurements. The necessary information for the study is collected using a checklist and finally the incidence of eclampsia between the intervention and placebo groups will be analyzed and compared, Blinding description: The control group receives a placebo, which is in the form of gelatin capsules and will be used daily until the end of pregnancy. N/A Preeclampsia in Pregnant Women Suffering Hyperlipidemia. Intervention 1: Intervention group: From the first month to the end of pregnancy for 9 months, the intervention group receives omega-3 daily as one gram capsule containing eicosapentalenoic acid and docosahexaenoic acid. This group includes 36 pregnant women and will take the capsules with some water. The manufacturing factory of this capsule is Zahravi Pharmaceutical Company in Iran. Intervention 2: Placebo group: From the first month to the end of pregnancy for 9 months, the intervention group receives Gelatin capsules daily as 100 mg capsule. This group includes 36 pregnant women and will take the capsules with some water. The manufacturer of this capsule is Isfahan School of Pharmacy in Iran. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no more information."
public Shima Mahdavian Naghash Zargar
Abidar Street, Besat Hospital, Infertility Treatment Center
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3366 0089 mnz_shima@yahoo.com Kurdistan University of Medical Sciences scientific Shima Mahdavian Naghash Zargar
Abidar Street, Besat Hospital, Infertility Treatment Center
Sanandaj Iran (Islamic Republic of) 66177-13446 +98 87 3366 0089 mnz_shima@yahoo.com Kurdistan University of Medical Sciences Iran (Islamic Republic of) Pregnant Women Suffering Hyperlipidemia that triglyceride levels is above 150 Milligrams per Deciliter. 20 years 40 years Female Pregnant women that are suffering metabolic diseases. Pregnant women that have the age of less than 20 years and over the age of 40 years. Pregnant women that have a history of preeclampsia in a previous pregnancy or in a first-degree relative. Pregnant women that have a history of having twins. Pregnant women that have a body mass index equal to or greater than 29. Pregnant women that have kidney disease, high blood pressure, diabetes and hyperthyroidism. Pregnant women that use of aspirin, calcium, anticoagulants and insulin. Pregnant women that do not have history of omega-3 allergies. Treatment - Drugs Placebo Intervention group: From the first month to the end of pregnancy for 9 months, the intervention group receives omega-3 daily as one gram capsule containing eicosapentalenoic acid and docosahexaenoic acid. This group includes 36 pregnant women and will take the capsules with some water. The manufacturing factory of this capsule is Zahravi Pharmaceutical Company in Iran. Placebo group: From the first month to the end of pregnancy for 9 months, the intervention group receives Gelatin capsules daily as 100 mg capsule. This group includes 36 pregnant women and will take the capsules with some water. The manufacturer of this capsule is Isfahan School of Pharmacy in Iran. Preeclampsia. Timepoint: Before the intervention in the first month of pregnancy and 9 months after the intervention in the last month of pregnancy. Method of measurement: Blood pressure above 140 to 90 mm Hg, swelling of the hands and face, overweight, based on the results of clinical trials of the patient's blood, including protein in the urine, increased liver enzymes, decreased platelet count, increased creatine and ultrasound. Kurdistan University of Medical Sciences Approved 2020-01-23 دانشگاه علوم پزشکی کردستان Abidar Street, Besat Hospital, Infertility Treatment Center Sanandaj Kurdistan Iran (Islamic Republic of)