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IRCT20220122053780N1 IRCT 2022-01-29 Neyshabour University of Medical Sciences The comparison of low dose with high dose of oxytocin in prevention of postpartum hemorrhage OXT The comparison of low dose with high dose of oxytocin in prevention of postpartum hemorrhage 2021-12-25 anticipated 60 Complete https://irct.ir/trial/61418 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked Randomization with Randomly Selected Block Sizes will be used for random allocation. Through random 4, 8 and 12 blocks, each participant will be placed in one of the intervention groups. The allocation sequence will be generated using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists and with the help of the methodology consultant. Since all participants are registered in a hospital (center), white envelopes will be used to hide the sequence. In this way, each sequence will be placed in a white envelope and the envelopes will be placed next to each other and the envelopes will be numbered. An envelope will be opened for each person in the order of their entry into the study and will be assigned to the groups, Blinding description: To blind the study (three-blind); The researcher, outcome evaluator (assistant researcher), participant and statistical analyst will not know the dose of oxytocin in serums. 2 Postpartum hemorrhage. Intervention 1: Intervention group: Receiving10 unit Oxytocin in 500 cc Ringer serum. Intervention 2: Intervention group: Receiving 60 unit Oxytocin in 500 cc Ringer serum. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals. When: Start from 2021 To whom: There is no restriction. Conditions: There is no restriction. Where to obtain: Maryam Zamani Zamanim1@nums.ac.ir 00989151546300 How to obtain: One week Comments:
public Maryam Zamani
Medical Sciences Campus, Moqavmat Boulevard, Baghcheban
Neyshabur Iran (Islamic Republic of) 93186-14139 +98 915 154 6300 zamanim1@nums.ac.ir Neyshabour University of Medical Sciences scientific Maryam Zamani
Medical Sciences Campus, Moqavmat Boulevard, Baghcheban
Neyshabur Iran (Islamic Republic of) 93186-14139 +98 915 154 6300 zamanim1@nums.ac.ir Neyshabour University of Medical Sciences Iran (Islamic Republic of) Primiparous Age 18-45 years old Gestational age 37-41 weeks Singleton pregnancy Cephalic presentation 18 years 45 years Female History of medical and obstetric diseases Fetal malformations Fetal weight estimate over 4000 g Diagnosis of cryoamniosis Placental abruption First and second stage of long labor Cesarean section Labor dystocia Shoulder dystocia Prenatal bleeding Instrumental labor O72 Postpartum hemorrhage Prevention Prevention Intervention group: Receiving10 unit Oxytocin in 500 cc Ringer serum Intervention group: Receiving 60 unit Oxytocin in 500 cc Ringer serum Postpartum hemorrhage amount. Timepoint: Immediately after delivery and each quarter to 2 hours after delivery. Method of measurement: Using measured Drape sheets for blood collection (disposable, funnelled, plastic collector bag) and reporting to cc. Neyshabour University of Medical Sciences Approved 2021-12-25 Ethics Committee of Neyshabur University of Medical Sciences Farhangian Ave., Neyshabur city Neyshaur Razavi Khorasan Iran (Islamic Republic of)