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IRCT20171030037093N28 IRCT 2020-01-18 Esfahan University of Medical Sciences Comparison of the effect of enoxaparin and UFH in pregnant patients with metallic heart valve at first trimester of pregnancy Comparative study of therapeutic effect and side effects of enoxaparin with UFH in pregnant patients with mechanical prosthetic heart valves at their first 14 weeks of pregnancy 2020-02-05 anticipated 34 Complete https://irct.ir/trial/44817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible pregnant women were divided into two groups by sequencing site (http://sealedenvelope.com) and divided into two groups using randomized blocking (with 4 blocks) method, Blinding description: For the purpose of blinding, neither the patients nor the researchers were aware of the type of treatment group received until the completion of the study. 3 Pregnancy Outcome in Women with Mechanical Prosthetic Heart Valves. Intervention 1: Intervention group: In this group, LMWH was administered subcutaneously as 1 mg/kg every 12 hours from the beginning of pregnancy until the end of the first 14 weeks, and then the patient was followed up with anti-factor 10a to achieve the desired therapeutic range. Intervention 2: Intervention group: In this group, UFH was administered in the first trimester, warfarin in the second trimester, and UFH in the third trimester. UFH during initial hospitalization (80 mg / kg stat dose) and then 18 mg / kg infusion. It was repeatedly administered and the dose increased until PTT reached the therapeutic limit. Or subcutaneous discharge of 20,000 to 30,000 UFH per day. 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 I will decide until finishing the study
public Minoo Movahedi
Alzahra hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3445 2031 movahedi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Minoo Movahedi
Alzahra hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3445 2031 movahedi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) No drug allergy to any of the drugs studied No history of recurrent miscarriage or stillbirth associated with antiphospholipid syndrome Being monitored by the researcher from the beginning of pregnancy Having Class I or II heart disease Having a metal heart valve Having a pregnancy week of 14 weeks or less no limit no limit Female Non-cooperation after inclusion Lack of access to the patient and follow-up Forced to terminate pregnancy immediately Warfarin use in the first 3 months Patients not able to follow up anti-10a factor Thrombocytopenia (less than 75,000) Treatment - Drugs Treatment - Drugs Intervention group: In this group, LMWH was administered subcutaneously as 1 mg/kg every 12 hours from the beginning of pregnancy until the end of the first 14 weeks, and then the patient was followed up with anti-factor 10a to achieve the desired therapeutic range. Intervention group: In this group, UFH was administered in the first trimester, warfarin in the second trimester, and UFH in the third trimester. UFH during initial hospitalization (80 mg / kg stat dose) and then 18 mg / kg infusion. It was repeatedly administered and the dose increased until PTT reached the therapeutic limit. Or subcutaneous discharge of 20,000 to 30,000 UFH per day. Maternal complications. Timepoint: After intervention. Method of measurement: Check list. Fetal complications. Timepoint: After intervention. Method of measurement: Check list. Esfahan University of Medical Sciences Approved 2019-03-18 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)