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IRCT20140111016161N6 IRCT 2018-03-04 Tehran University of Medical Sciences Epidural anesthesia beginning time and Labor progression and delivery type Evaluation of the effect of Epidural anesthesia beginning time on Labor progression and conversion of Vaginal delivery to Cesarean Section 2017-01-20 anticipated 426 Complete https://irct.ir/trial/15212 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our sample size is 426 people, with 213 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, 426 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. Intervention 1: Group 1: Epidural anesthesia in low dilatation (3 cm). Intervention 2: Group 2: Epidural anesthesia in high dilatation (5 cm). No - There is not a plan to make this available Justification or reason for not sharing IPD is Because we have plan to use our data in another studies, we are not interested to sharing the data at this time
public Dr Reihane hoseini
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 rayh_h@yahoo.com Tehran University of Medical Sciences scientific Dr Reihane hoseini
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 rayh_h@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) First Pregnancy Tendency for Painless labor Age between 18 to 40 years Normal pregnancy without any complication Cervix dilatation above 3 cm 18 years 40 years Female weight above 120 kg Height below 140 cm Cardiac arrhythmia Spinal Deformity Allergies to the drugs used in the trail Neuropathy Contraindication for Spinal Analgesia malignancy DVT Skin lesions O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Drugs Treatment - Drugs Group 1: Epidural anesthesia in low dilatation (3 cm) Group 2: Epidural anesthesia in high dilatation (5 cm) Labor progression. Timepoint: During Trial. Method of measurement: Parthographe chart (a chart in which the progression of labor is recorded in terms of labor time to delivery, length of the active stage of labor (5-10 cm dilatation) and the length of the second stage). Apgar Score. Timepoint: After birth. Method of measurement: Scoring according to apgar score standard checklist. Delivery type. Timepoint: after intervention. Method of measurement: File. Tehran University of Medical Sciences Approved 2016-12-17 Ethics Committee of Tehran University of Medical Sciences , Deputy of Research Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)