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IRCT20121006011020N14 IRCT 2020-11-03 Tehran University of Medical Sciences Epidural versus Spinal Analgesia in labor Assessment of the Effect of Epidural versus Spinal Analgesia on Labor Length and Maternal Satisfaction 2019-10-23 anticipated 132 Complete https://irct.ir/trial/42628 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The epidemiologist will assign the patient into two groups using the Stata software and the block randomization method. The size of the blocks will be six, Blinding description: Participants are unaware of the type of analgesia that is performed for them (Epidural or Spinal). The person responsible for collecting the relevant data and completing the form is unaware of the type of analgesia in patients. The anesthesiologists who perform the analgesia and the clinical caregivers of the participants know the type of analgesia. 3 -. Intervention 1: Intervention group 1: Epidural analgesia with bupivacaine 0.125% 16 cc and fentanyl 10 mg. Intervention 2: Intervention group 2: Spinal analgesia with 0.5% bupiracaine 2.5 mg or 0.5 cc with 10 mg fentanyl. 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 The research team has not yet made a decision on how the data will be published.
public Dr. Zeinab Shaababni
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 z.shabani1988@gmail.com Tehran University of Medical Sciences scientific Dr. Maryam Khooshide
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 khooshide@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Term pregnancy Cephalic position Active phase of the first stage of labor Normal prenatal care Cervical dilatation above 5-6 cm Aged between 18 to 35 years old Height above 150 cm Body mass index (BMI) between 18-25 18 years 35 years Female Gestational disorders Abnormal spinal cord Dermal infections Coagulopathies Cephalopelvic disproportion (CPD) Preterm pregnancy Abnormal fetal heart rate (unstable NST) - - Treatment - Drugs Treatment - Drugs Intervention group 1: Epidural analgesia with bupivacaine 0.125% 16 cc and fentanyl 10 mg Intervention group 2: Spinal analgesia with 0.5% bupiracaine 2.5 mg or 0.5 cc with 10 mg fentanyl Labor Duration. Timepoint: During Labor (From 0 to 4 stage of labor). Method of measurement: Chronometer Watch. Mother's Satisfaction. Timepoint: At the end of the study. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2019-05-13 Ethics committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)