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IRCT20181023041427N1 IRCT 2018-12-19 Kerman University of Medical Sciences Effect of subcutaneous sterile water injection on back pain of Women with Active Phase of Labor Survey of Back Pain Reduction With and Without Subcutaneous Sterile Water Injection In Women With Active Phase of Labor 2018-12-22 anticipated 90 Complete https://irct.ir/trial/34701 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization Randomization unit: individual, Blinding description: In this study, participants will blinded. N/A Active labor phase. Intervention 1: Intervention group: Injection of 0.5 ml sterile water subcutaneously in 4 site of sacrum. Intervention 2: Control group : Insertion of needle without injection of certain material in 4 site of sacrum. Intervention 3: Sham group: Without injection. Yes - There is a plan to make this available What will be shared: Data will be shared after coding. When: Access period 6 months after the publishing of results To whom: Researchers working in Universities Conditions: Any redistribution or use of the information is permitted by reference to the source. Where to obtain: Farzaneh khajeh nazari, f.khajehnazari@gmail.com How to obtain: By email and by Presenting valid identification card Comments:
public Farzane khajehnazari
Jomhoori blvd, Hotel Pars town
Kerman Iran (Islamic Republic of) 7618841646 +98 34 4200 8281 F.khajehnazari@gmIl.com Kerman University of Medical Sciences scientific Farzaneh khajehnazari
Jomhoori blvd, Hotel Pars town
Kerman Iran (Islamic Republic of) 7618841646 +98 34 4200 8281 F.khajehnazari@gmal.com Kerman University of Medical Sciences Iran (Islamic Republic of) Nulliparous women with an Iranian nationality Women 18-35 years old Term pregnancy (38-42 weeks) Start of uterine contractions and active phase of labor pain in the lower back ُSingleton live fetus with a weight of over 2500 grams The embryo with anterior occiputa position the absence of sedative drugs, systemic and topical analgesic drugs use up to ninety minutes after intervention 18 years 35 years Female No Informed consent Any systemic disease associated with pregnancy including diabetes, hypertension, heart diseases, etc., History of narcotic and alcohol consumption, history of psychiatric illness and depression Trauma created during childbirth (when using labor tools such as forceps or vacuum, a large perineal rupture, postpartum hemorrhage, etc.) Any need for emergency intervention for maternal and fetal reasons such as placenta abruption Maternal hospitalization during pregnancy Emergency cesarean delivery for any reason during labor Treatment - Drugs Placebo Other Intervention group: Injection of 0.5 ml sterile water subcutaneously in 4 site of sacrum Control group : Insertion of needle without injection of certain material in 4 site of sacrum Sham group: Without injection Labor pain. Timepoint: 10, 45 and 90 Minutes after injection. Method of measurement: Visual analog scale. Kerman University of Medical Sciences Approved 2018-02-03 Ethics Committee of Kerman University of Medical Sciences Haft bagh Alavi BLVD, Principal of Kerman University of Medical Sciences Kerman Kerman Iran (Islamic Republic of)