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IRCT20170917036227N1 IRCT 2018-01-14 Tehran University of Medical Sciences Effect of Epidural Anesthesia on the Progression of Labor by Bsing Meperidine Compared to Fentanyl Comparison of the Effectiveness of Epidural Anesthesia with Two Different Combination, Bupivacaine plus Meperidine versus Bupivacaine Plus Fentanyl in Duration of Labor and Cesarean Section Rate 2016-03-19 anticipated 264 Complete https://irct.ir/trial/27147 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our sample size is 264 people, with 132 people in each group. Block randomization method was designed by epidemiologist using stata version 13 software. The number of blocks considered is 6, Blinding description: The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 264 sequences of treatments will be written accordingly, and then the cards will be placed in sealed envelopes. On each 10-digit random code packet, the order is written and the framework is written that the patient identification number is relevant and the methodologist will simply be aware of the design of the code. When an anesthesiologist announces the eligibility of a patient, the methodologist will provide the anesthesiologist with the envelope. The analgesia method is selected based on the type mentioned in the envelope. None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is the third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used. N/A epidural anesthesia during labor and delivery. Intervention 1: In the first group, Epidural Anesthesia with 15 cc of bupivacaine 125 % with 50 μg fentanyl. Intervention 2: In the second group, Epidural Anesthesia with 15 cc of bupivacaine 125 % with 50 μg meperidine. No - There is not a plan to make this available Justification or reason for not sharing IPD is because we plan to use our data in another studies thus we dont intresting to sharring that
public Dr Fatemeh Jafarzadeh
Arash Women's Hospital, Rashid Ave,Tehranpars, Reslat highway
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 dr.fatemeh.gafarzadeh@gmail.com Tehran University of Medical Sciences scientific Dr Marzieh Vahid Dastjerdi
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 mvahid@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients tendency for Painless labor Age range between 18 to 40 years BMI smaller than 35 ASA Class I, II 18 years 40 years Female Obstetrics Contraindication for normal delivery Spinal Deformity Coagulopathy Subacute illness Medical Contraindication for natural delivery like Mitral valve stenosis O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Other Treatment - Other In the first group, Epidural Anesthesia with 15 cc of bupivacaine 125 % with 50 μg fentanyl In the second group, Epidural Anesthesia with 15 cc of bupivacaine 125 % with 50 μg meperidine Apgar Score. Timepoint: after intervention. Method of measurement: Scoring according to apgar score checklist. Duration of the active phase of labor. Timepoint: after intervention. Method of measurement: minutes and hours. Duration of the second stage of labor. Timepoint: after intervention. Method of measurement: minutes and hours. Score of Pain Relief. Timepoint: During Labor. Method of measurement: Visual Scale. Cesarean section Rate. Timepoint: after intervention. Method of measurement: Checklist. Tehran University of Medical Sciences Approved 2016-08-09 Ethics Committee of Tehran University of Medical Sciences Qods st, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)