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IRCT20190208042655N1 IRCT 2021-05-11 Tehran University of Medical Sciences Comparison of the effect of TENS with the injection of pethidine and promethazine in labor pain reduction Comparison of the effect of transcutaneous electrical nerve stimulation (TENS) with the injection of pethidine and promethazine in labor pain reduction 2021-05-31 anticipated 90 Complete https://irct.ir/trial/55886 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 45 letters A and 45 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot. 3 Painless delivery. Intervention 1: Intervention group: In the active phase of labor (cervical dilation: 4 cm with uterine contractions), in the first group of intervention, 100 milligrams of pethidine and 250 micrograms of promethazine will be injected intramuscular, if the pregnant women will not respond to the primary dose, the second dose will be applied. Intervention 2: Intervention group: In the active phase of labor (cervical dilation: 4 cm with uterine contractions), TENS continuously for 120 minutes will be applied. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Saedi, and any analysis must be done with her opinion. Where to obtain: Dr. Nafiseh Saedi How to obtain: Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Nafiseh Saedi. Comments:
public Nafiseh Saedi
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 nsaedi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Nafiseh Saedi
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8608 9089 nsaedi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Pregnant women 16 to 40 years and term pregnancy (gestational age: 37 to 41 weeks) Singleton pregnancy Cephalic presentation Spontaneous vaginal delivery 16 years 40 years Female Preeclampsia Gestational diabetes with insulin therapy Intrauterine growth restriction History of C/section Meconium in amniotic fluid History of transmural myomectomy History of uterus rupture F45.41 Pain disorder exclusively related to psychological factors Treatment - Drugs Treatment - Devices Intervention group: In the active phase of labor (cervical dilation: 4 cm with uterine contractions), in the first group of intervention, 100 milligrams of pethidine and 250 micrograms of promethazine will be injected intramuscular, if the pregnant women will not respond to the primary dose, the second dose will be applied. Intervention group: In the active phase of labor (cervical dilation: 4 cm with uterine contractions), TENS continuously for 120 minutes will be applied. The labor pain. Timepoint: Before the intervention and half time after the intervention. Method of measurement: By Visual Analogue Scale. Tehran University of Medical Sciences Approved 2019-04-15 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St Tehran Tehran Iran (Islamic Republic of)