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IRCT201508259014N77 IRCT 2015-09-08 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of painless vaginal delivery versus normal vaginal delivery on maternal and neonatal outcomes in pregnant women Effect of painless vaginal delivery versus normal vaginal delivery on maternal and neonatal outcomes in pregnant women: a clinical trial 2015-06-15 anticipated 168 Complete https://irct.ir/trial/9516 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization: The eligible pregnant women who are willing to have painless vaginal delivery will be assigned to the intervention group and those women who are not willing to have painless vaginal delivery will be assigned to the control group. Blinding: Not possible. 2 Vaginal delivery. Intervention 1: epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose. Intervention 2: spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose. Intervention 3: combined anesthesia including epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose and spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose. Intervention 4: Without receiving anesthesia medications.
public Dr Nahid Radnia
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 n.radnia@umsha.ac.ir Fatemieh Hospital scientific Dr Nahid Radnia
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) +98 81 3828 3939 n.radnia@umsha.ac.ir Fatemieh Hospital Iran (Islamic Republic of) Inclusion criteria: (a) gestational age of 37 weeks or over; (b) being eligible for vaginal delivery. Exclusion criteria: (a) having diabetes, cardiovascular diseases, or intracranial diseases; (b) having gestational diabetes, preeclampsia, or macrosomia; (c) coagulation disorders; (d) dermal infection on the location of epidural anesthesia; (e) non-treated bacteremia. 15 years 40 years Female O66 Other obstructed labour Prevention Treatment - Drugs Treatment - Drugs N/A epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose combined anesthesia including epidural anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose and spinal anesthesia with Marcaine 0.125 mg (manufacture by Astrazenca) single dose Without receiving anesthesia medications Measuring the duration of the first and second stages of vaginal delivery. Timepoint: after intervention. Method of measurement: using Friedman curve. Measuring episiotomy pain. Timepoint: 6 and 12 hours after vaginal delivery. Method of measurement: using visual analog scale (VAS). ) assessing Apgar score. Timepoint: at the first and fifth minutes after birth. Method of measurement: through physical examination. Assessing hyperthermia. Timepoint: at 4, 8, and 12 hours after vaginal delivery. Method of measurement: using oral thermometer. Assessing headache. Timepoint: 12 hours after vaginal delivery. Method of measurement: using visual analog scale (VAS). Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2015-08-15 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)