Effect of electro-acupuncture on postpartum urinary retention —— A protocol for multicenter, randomized and placebo-controlled trial
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Background Postpartum urinary retention (PUR) is one of the serious and common clinical complications after delivery. Although urinary catheterization can provide temporary relief from voiding disorders, it may cause discomfort, pain, and even urethral injury to the mother, thereby increasing the risk of urinary system infection. Acupuncture was shown it has unique advantages in relieving the clinical symptoms of PUR, promoting bladder recovery. However, there is not sufficient high-quality evidence to strongly support the effectiveness of electroacupuncture in the prevention and treatment of PUR. Therefore, we have designed a multi-center, large-sample, randomized controlled clinical trial to assess the impact of electroacupuncture intervention on the incidence of PUR and the recovery of bladder function. Methods This is a multicenter, randomized, parallel-group clinical trial conducted in China to investigate the impact of electroacupuncture intervention on the incidence of PUR. Patient screening and enrollment will take place at four hospitals in China: the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin Shuige Hospital and Second People's Hospital of Fengrun District, Tangshan City. Patients will be randomly assigned to either the electroacupuncture group or the sham acupuncture group, with 330 patients in each group. Each acupuncture treatment will comprise three 30-minute sessions over 2 days (the first hour, the first day, and the second day after delivery). The primary outcome measure is the incidence of PUR. Adverse events will be recorded, and their impact will be analyzed at the end of the trial. Discussion This study will provide high-quality evidence support for the effectiveness of electroacupuncture in preventing and treating PUR, and provide scientific basis for the application of non-drug therapy in postpartum rehabilitation. Trial registration ClinicalTrials.gov: ChiCTR2300078039.Registered on 27 November 2023.