Effectiveness of acupoint hot compress on early puerperal rehabilitation of parturients after natural childbirth: study protocol for a prospective, multi-center, randomized controlled clinical trial

Abstract

Effectiveness of acupoint hot compress on early puerperal rehabilitation of parturients after natural childbirth: study protocol for a prospective, multi-center, randomized controlled clinical trial Yuhang Zhu1 , Aihua Zhang1 , Chang Liu2 , Nicola Robinson3 , Myeong Soo Lee4 , Xiaoyang Mio Hu5 , Hye Won Lee4 , Rong Zhang6,7,8,9 , Fan Qu1, * 1Women’s Hospital, School of Medicine, Zhejiang University, 310006 Hangzhou, Zhejiang, China 2 The Second Clinical Medical College of Zhejiang Chinese Medical University, 310053 Hangzhou, Zhejiang, China 3 School of Health and Social Care, London South Bank University, SE1 0AA London, UK 4 Korea Institute of Oriental Medicine, 34054 Daejeon, Republic of Korea 5 Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, SO16 5ST Southampton, UK 6Neuroscience Research Institute, Peking University, 100191 Beijing, China 7Department of Neurobiology, School of Basic Medical Sciences, Peking University, 100191 Beijing, China 8 Key Laboratory for Neuroscience, Ministry of Education of China, Neuroscience Research Institute, 100191 Beijing, China 9 Key Laboratory for Neuroscience, National Committee of Health and Family Planning of China, 100191 Beijing, China *Correspondence: syqufan@zju.edu.cn (Fan Qu) DOI:10.31083/j.ceog4806214 This is an open access article under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/). Submitted: 26 April 2021 Revised: 24 June 2021 Accepted: 1 July 2021 Published: 15 December 2021 Background: Early puerperal rehabilitation can interfere with a woman's ability to care for herself and her infant. Acupoint hot compress, with a combination of acupoints and natural physical agent heat, has significant potential to alleviate symptoms experienced during early puerperium. Current evidence regarding the effects of acupoint hot compress therapy on early puerperal rehabilitation is insufficient. The aim of this study is to address this with a multicenter design and large sample size. Methods: This is a prospective, multi-center, and randomized controlled clinical trial. A total of 1400 nulliparous women with a singleton pregnancy experiencing natural childbirth from 14 hospitals will be enrolled and randomly allocated to either an intervention group or a control group in a 1:1 ratio. Subjects in the control group will only receive routine postpartum care. In addition to routine postpartum care, the subjects in the intervention group will be administered a 4-hour acupoint hot compress with a constant temperature of 45 ± 2 ◦ C respectively within 30 minutes after delivery, 24 hours and 48 hours after delivery. The primary outcome will be the time elapsed from delivery to the first urination. The secondary outcomes will be postpartum uterine contraction pain intensity, the Edinburgh Postnatal Depression Scale for screening postpartum depression and the assessment of lactation including recording the lactation initiation time, postpartum diet, appetite, weight, neonatal weight. Discussion: These results will provide evidence for obstetricians and parturients on considering nonpharmacologic and noninvasive intervention in early puerperal rehabilitation. Keywords Acupoint hot compress; Early puerperal rehabilitation; Study protocol; Randomized controlled clinical trial