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IRCT20180626040241N1 IRCT 2018-09-22 Tabriz University of Medical Sciences Effects of Epidural and Combined Analgesia on the Fetal Heart Rate. Comparison of the Fetal Heart Rate changes between Epidural Analgesia Delivery and Combined Spinal-Epidural Analgesia Delivery 2018-07-06 anticipated 100 Complete https://irct.ir/trial/32831 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Blinding description: The pregnant woman in this study gives consent to the Analgesia while she is blind from its type. A trained Anesthesia technician and an midwife who are blinded from the analgesia type monitor and record the fetal heart rate, fetal motion and then the Apgar score. N/A -. Intervention 1: Intervention group (Epidural analgesia group): The neuroaxial block is performed with epidural needle number 18 G . First, for the test dose: 3 ml of lidocaine 1.5%, 50 μg of fentanyl and 2.5 mg of bupivacaine are used. Then as a preservative dose 6 cc / h from this solution is injected through the catheter. Intervention 2: Intervention group (Combined spinal-epidural analgesia group): First with a spinal needle 25G, the spinal block with 1.5ml of the same solution is performed and then the epidural block will be performed using the same method of epidural group. Yes - There is a plan to make this available What will be shared: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences When: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences To whom: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences Conditions: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences Where to obtain: Central Library of Tabriz University of Medical Sciences and Faculty of Medicine How to obtain: We will act according to the laws of the Ministry of Health and Medical Education and Tabriz University of Medical Sciences Comments:
public Nabiha aldarir
Shayan mehr dorm, eqbal aazar ave, Resalat Street
Tabriz Iran (Islamic Republic of) 5178757395 +98 41 3441 1230 nonitahasan@gmail.com Tabriz University of Medical Sciences scientific Nabiha aldarir
Shayan mehr dorm, eqbal aazar ave, Resalat Street
Tabriz Iran (Islamic Republic of) 5178757395 +98 41 3441 1230 nonitahasan@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Ability to have a normal vaginal delivery Existence of labor pain and the delivery is in the active phase. Pregnant mother wants to reduce labor pain itself. Consent of the patient and her husbend. no limit no limit Female Missing consent of pregnant woman or spouse. Inability of the pregnant to remain motionless while doing work(e.g. Parkinson disease). Coagulation disorder Increased intracranial pressure (SOL). Local infections at the puncture site History of sensitivity to analgesics and other medication used in this investigation Acute lesions of the CNS Hemodynamic Disorders (e.g. hypotension or Hypovolemia). Cardiovascular Diseases that reduce the cardiac output Embryonic distress. GA <37 w Abnormal fetal presentations History of C/S or any surgery on the uterus BMI> 40 Treatment - Drugs Treatment - Drugs Intervention group (Epidural analgesia group): The neuroaxial block is performed with epidural needle number 18 G . First, for the test dose: 3 ml of lidocaine 1.5%, 50 μg of fentanyl and 2.5 mg of bupivacaine are used. Then as a preservative dose 6 cc / h from this solution is injected through the catheter. Intervention group (Combined spinal-epidural analgesia group): First with a spinal needle 25G, the spinal block with 1.5ml of the same solution is performed and then the epidural block will be performed using the same method of epidural group. Fetal heart rate. Timepoint: 5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus. Method of measurement: With the use of the fetal monitor. Fetal motion. Timepoint: 5 min before performing the analgesia and then 5, 10, 20,40, 60 min after and then every 30 min until the exit of the fetus. Method of measurement: With the use of the fetal monitor. Apgar scor. Timepoint: After the delivery at the minute 1 and 5. Method of measurement: calculating. Tabriz University of Medical Sciences Approved 2018-06-11 Ethics committee of Tabriz University of Medical Sciences Central Office of the University of Medical Sciencesو Golgast Streetو Azadi Avenueو Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)