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IRCT2012101611132N1 IRCT 2012-12-24 Aburaihan Pharmacy company The effect of progestrone on preterm labour in patient who are pregnant with ART teqnique Evaluation the Effect of 17 alpha-hydroxyprogestrone caproate on dcreasing preterm labour and second trimester miscarriage in women pregnant with ART 2010-10-23 anticipated 106 Complete https://irct.ir/trial/11443 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this trial, 99 women who conceived through ART at 16th weeks of pregnancy were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table, Blinding description: The patients and statistical analyzer both were blind about the drug or placebo. In placebo group injections were done by a drug similar in shape and volume, but without progesterone which was prepared by the same company as placebo. All injections have done by trained nurses who were blinded about the type of drugs. 2 preterm labour. Intervention 1: control group:drug with all chachtristic of of 17alpha- hydroxyprogestrone caproate:only without efficient material of this drug:intramusculary injected from16-36weeks of gestation. Intervention 2: Drug group:17alpha-hydroxyprogestrone caproate(FEMOLIFE)intramusculary injected from16-36weeks of gestation. Yes - There is a plan to make this available What will be shared: All participant data sets are to be shared When: 2 months after the result publication To whom: A journal in which the results are published Conditions: Submission of an official application via the agent that is legally in charge Where to obtain: Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085 How to obtain: Submission of an official application via the agent that is legally in charge Comments:
public Dr. Hoora Amuzegar
Reseach and Clinical Centre for Infertility, Bouali Ave, Safaeyeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35182470856 amuzegarhoora@yahoo.com Reseach and Clinical Centre for Infertility of Yazd scientific Dr. Abbas Aflatonian
Infertility Centre, Bouali Ave, Safaeyeh, Yazd
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 abbas_aflatonian@yahoo.com Research and Clinical Centre for Infertility of Yazd Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnancy using ART Gestational age of 16 weeks Using progesterone for luteal phase support no limit no limit Female Twin or multiple pregnancies History of preterm labor History of previous abortion History of chronic diseases such as Diabetes mellitus, Hypertention, and Hypo or Hyperthyroidism Uterine anatomical problems O60,O75 complication of labour and delivery Placebo Treatment - Drugs control group:drug with all chachtristic of of 17alpha- hydroxyprogestrone caproate:only without efficient material of this drug:intramusculary injected from16-36weeks of gestation Drug group:17alpha-hydroxyprogestrone caproate(FEMOLIFE)intramusculary injected from16-36weeks of gestation Labour under37week/34-37week-32-34week and second trimestre abortion. Timepoint: weekly from16-36weeks of gestation. Method of measurement: Quastisonaries. Etiology of preterm labour. Timepoint: Weekly from16-36weeks of gestations. Method of measurement: Quastionaries. NICU admission. Timepoint: After live birth. Method of measurement: Quastionaries. Neonatal birth weigh. Timepoint: After live birth. Method of measurement: Quastionaries. Drug complication. Timepoint: Weekly from16-36 weeks of gestation. Method of measurement: Quastionaries. Aburaihan Pharmacy company Approved 2010-10-27 Shahid Sadooghi medical university of Yazd Central Committee of Medical University, Bahonar sq, Yazd Yazd Yazd Iran (Islamic Republic of)