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IRCT20170924036365N2 IRCT 2019-03-18 Iran University of Medical Sciences effect of intra dermal and sub dermal injection of sterile water on active labor pain The effect of sterile water injection on active labor pain Comparison between analgesic effect of intra dermal and sub dermal injection of sterile water on active labor pain 2018-12-16 anticipated 120 Complete https://irct.ir/trial/35578 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1-Randomization will be done by using random allocation table. The gynecologic resident will do all of the injections, Blinding description: The midwife of labor will do all of the VAS tests. The gynecologic resident of this research will do all of the injections in LDR. The midwife of labor dose not know that witch method is done for each mother. 3 labor pain. Intervention 1: First intervention group- To 40 patient, 0.5 cc sterile water will be injected subdermal with the insulin needle in the four sacral area (two injections in the posterior superior iliac spine and two other injections of one centimeter outer and two centimeters upper than the first place). Intervention 2: Second intervention group- in 40 women, 0.5 cc sterile water will be injected intradermal with the insulin needle in the four sacral area (two injections in the posterior superior iliac spine and two other injections of two centimeter outer and two centimeters upper than the first place). Intervention 3: Control group- Just touch the tip of the needle with the skin of sacral area. Yes - There is a plan to make this available What will be shared: By publishing article resulted from this research When: One year later To whom: All of the people that read the article Conditions: Only Dr Fariba Almassi Where to obtain: 1-By reading the article 2-By contact with Dr Fariba Almassi How to obtain: Until 1 year after publication, during 6 months after contact the data will be emailed Comments:
public Fariba Almassi
Iran University of medical sciences, Hemmat high way
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6650 9283 almassi.f@iums.ac.ir Iran University of Medical Sciences scientific Fariba Almassi
Hemmat high way
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6650 9283 almassi.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) first pregnancy(nulliparyte) dilatation of cervix 4cm or more cephalic baby gestational age 37w or more and planned for vaginal delivery 15 years 40 years Female No inform consent Multi parity History of low back pain or abdominal pain unrelated to delivery fetal demise Skin lesion or infection on injection site coagulation disorders of mother 047.1 047.1 Treatment - Other Treatment - Other Treatment - Other First intervention group- To 40 patient, 0.5 cc sterile water will be injected subdermal with the insulin needle in the four sacral area (two injections in the posterior superior iliac spine and two other injections of one centimeter outer and two centimeters upper than the first place) Second intervention group- in 40 women, 0.5 cc sterile water will be injected intradermal with the insulin needle in the four sacral area (two injections in the posterior superior iliac spine and two other injections of two centimeter outer and two centimeters upper than the first place) Control group- Just touch the tip of the needle with the skin of sacral area Severity of pain. Timepoint: before intervention and 10,30,60,90, and 120 minute after intervention. Method of measurement: visual analogue scale. Iran University of Medical Sciences Approved 2017-05-21 Ethics committee of Iran University of Medical Sciences Iran University medical sciences ethic committee, Hemmat high way, Tehran , Iran Tehran Tehran Iran (Islamic Republic of)