舌下含服米索前列醇与手动负压吸引术治疗尼日利亚不完全流产的随机对照研究。
Sublingual misoprostol versus manual vacuum aspiration for treatment of incomplete abortion in Nigeria: a randomized control study.
机构信息
Departments of Obstetrics and Gynaecology, College of Health Sciences Nnamdi Azikiwe University Nnewi Campus, Anambra State, Nigeria.
Department of Obstetrics and Gynaecology, Enugu State University of Science and Technology, College of Medicine/ Teaching Hospital, Parklane, Enugu, Nigeria.
出版信息
Pan Afr Med J. 2022 Feb 1;41:90. doi: 10.11604/pamj.2022.41.90.29364. eCollection 2022.
INTRODUCTION
single-dose of sublingual misoprostol 400mcg with the participant followed-up at the gynecology clinic one week after with an ultrasound scan for the completeness of the uterine evacuation. Objective: to compare the effectiveness of single-dose sublingual misoprostol to manual vacuum aspiration in the treatment of incomplete spontaneous abortion in Enugu, Nigeria.
METHODS
the primary outcome measure was the incidence of complete uterine evacuation (complete abortion) after one week of treatment while the secondary outcome measures included incidence, types, and tolerability of treatment side effects as well as participants' satisfaction with the treatment received.
RESULTS
two hundred and three participants who met the study criteria and completed the study were randomised into the intervention group (n=102) received single-dose sublingual misoprostol 400mcg and the control group (n= 101) received manual vacuum aspiration. Incidence of complete abortion was 86.3% for the misoprostol group and 100.0% for the control group, RR = 0.86, (CI 95%: 0.80 - 0.93), p <0.001. The most common side effect was abdominal pain with an incidence of 27.5% versus 48.55 for the misoprostol and control groups respectively (p = 0.002). Most participants in each group (81.1% versus 77.6% for the misoprostol and control groups respectively) considered the side effects as tolerable. The mean visual analogue scale score for maternal satisfaction was higher in the misoprostol group (86.7 ± 14.11) than the control group (81.36 ± 11.10), p < 0.001.
CONCLUSION
the treatment of incomplete spontaneous abortion with single-dose sublingual misoprostol 400mcg produced a high rate of complete abortion among women in Enugu, Nigeria. Despite having a lower complete abortion rate, maternal satisfaction was higher when compared with women that had manual vacuum aspiration of the uterus. Trial registration: trial registration number - PACTR202009857889210, date of registration - September 23, 2020. Retrospectively registered.
引言
给予舌下含服 400mcg 米索前列醇单次剂量，参与者在一周后到妇科诊所就诊，并进行超声扫描以检查子宫排空是否完全。目的：比较单次舌下含服米索前列醇与手动吸引术治疗尼日利亚埃努古不完全自然流产的效果。
方法
主要结局测量指标为治疗一周后完全子宫排空（完全流产）的发生率，次要结局测量指标包括治疗副作用的发生率、类型和耐受性以及参与者对所接受治疗的满意度。
结果
符合研究标准并完成研究的 230 名参与者被随机分为干预组（n=102），给予舌下含服 400mcg 米索前列醇，对照组（n=101）接受手动吸引术。米索前列醇组完全流产的发生率为 86.3%，对照组为 100.0%，RR=0.86，（95%CI：0.80-0.93），p<0.001。最常见的副作用是腹痛，发生率分别为米索前列醇组 27.5%和对照组 48.55%（p=0.002）。每个组的大多数参与者（米索前列醇组分别为 81.1%和对照组分别为 77.6%）认为副作用可以耐受。米索前列醇组产妇满意度的平均视觉模拟量表评分（86.7±14.11）高于对照组（81.36±11.10），p<0.001。
结论
在尼日利亚埃努古，使用单次舌下含服 400mcg 米索前列醇治疗不完全自然流产可使妇女获得较高的完全流产率。尽管完全流产率较低，但与接受子宫手动吸引术的妇女相比，产妇满意度更高。
试验注册
试验注册号-PACTR202009857889210，注册日期-2020 年 9 月 23 日。回顾性注册。
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