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IRCT20190107042266N1 IRCT 2019-03-04 Semnan University of Medical Sciences Checking the effect of oral Dydrogesterone (Duphaston) on preventing preterm labor Checking the effect of oral Dydrogesterone (Duphaston) on preventing preterm labor: A Randomized Clinical Trial 2019-03-20 anticipated 100 Complete https://irct.ir/trial/36589 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using randomized blocks due to the kind of treatment for pregnant women with the criterion of entering the study is divided into two groups: controlled and intervention groups, Blinding description: Patients will be unaware of the type of intervention. N/A Preterm labor. Intervention 1: Intervention group: Dydrogesterone capsule with the dose of 10 milligrams, 2 tablets per day is prescribed after lunch and dinner and until the gestational age of 36 weeks and 6 days or it continues until the occurrence of the labor. Intervention 2: Control group: placebo with a very similar shape and size with Dydrogesterone capsule is prescribed twice a day after lunch and dinner and continues until the gestational age of 36 weeks and 6 days or until the occurrence of the labor. 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 No more information
public Dr Mojgan Rahmanian
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 sem.ums.res@gmail.com Semnan University of Medical Sciences scientific Dr Mojgan Rahmanian
Hospital Amir-AlMomenin, Mostafa Khomeini Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3345 1336 sem.ums.res@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) From the age of 18 to 45 Gestational age of 24 to 34 weeks (calculation based on first trimester sonography) Not having PLP 48 hours after treatment Single pregnancy Not of smoking 18 years 45 years Female Placenta Previa Premature rupture of membranes Chorioamnionitis Severe preeclampsia The use of progesterone before the study Contraindication of progesterone Contraindication of Tocolytic Dilatation more than 4 centimeters Fetal anomalies Dissatisfaction of the patient to continue participating in the study Pregnancy scar Cervical cerclage O60 Preterm labor Treatment - Drugs Treatment - Drugs Intervention group: Dydrogesterone capsule with the dose of 10 milligrams, 2 tablets per day is prescribed after lunch and dinner and until the gestational age of 36 weeks and 6 days or it continues until the occurrence of the labor. Control group: placebo with a very similar shape and size with Dydrogesterone capsule is prescribed twice a day after lunch and dinner and continues until the gestational age of 36 weeks and 6 days or until the occurrence of the labor. Preterm labor before the 37th week of pregnancy. Timepoint: From the beginning of the intervention (from the beginning of preterm labor up to the gestational age of 24 to 34 weeks) until the occurrence of the preterm labor (gestational age of 36 weeks and 6 days). Method of measurement: Visiting the patient every other two weeks for the relapse of preterm labor pain, regular use of drugs, drug based side effects like nausea, dizziness and exhaustion. Semnan University of Medical Sciences Approved 2017-10-03 Ethics Committee in Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Blvd Semnan Semnan Iran (Islamic Republic of)