A prospective randomized controlled study of low intensity focused ultrasound uterine involution treatment for prevention and treatment of postpartum hemorrhage in natural childbirth women

doi:10.3877/cma.j.issn.1673-5250.2024.05.009

Objective

To investigate the clinical effects of low intensity focused ultrasound（LIFU）on the prevention and treatment of postpartum hemorrhage（PPH）and the promotion of uterine involution in natural childbirth women.

Methods

A total of 405 women who underwent natural delivery in three hospitals in Chongqing from January to December 2023 were recruited as the study subjects.Using random number table method，405 women were randomly divided into treatment group （n=202）and control group （n=203）.The treatment group received 10 days treatment of LIFU for uterine involution starting 2 h after delivery.The control group received the same procedures without energy output of therapeutic equipment.The independent-samples t test and chi-square test were used to statistically analyze the general clinical information，the fundal height and fundal descent rate before and after treatment，the three-dimensional diameter difference index of the uterus before and after treatment，the amount of vaginal bleeding，the duration of lochia，and the incidence of postpartum complications between two groups.This study was approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University （Approval No.2021-664）.Informed consent forms were obtained from all subjects.

Results

①After LIFU treatment，the fundal height of treatment group was （12.5±4.9）cm，which was lower than that of（14.6±4.7）cm of control group；while the fundal descent rate of treatment group was（41.4±5.7）%，which was higher than that of （31.2±4.7）%of control group，and the differences were statistically significant （t=4.22，-19.48，all with P ＜0.001）.②After LIFU treatment，the longitudinal，anteroposterior and transverse uterine diameters in treatment group were shorter than control group，and the three-dimensional diameter difference index of the uterus before and after treatment was higher than that in control group，and the differences were statistically significant（all with P ＜0.001）.③The amount of postpartum bleeding within 24 h after delivery，the duration of bloody and serous lochia，and the incidence of PPH，late PPH and puerperal infection in treatment group were all lower or shorter than those in control group，and the differences were statistically significant （P＜0.05）.

Conclusions

LIFU has significant effects in preventing PPH and promoting uterine involution.Extending LIFU treatment duration （treatment for 10 days）can effectively reduce the risk of late PPH and puerperal infection.

Key words: Postpartum hemorrhage, Natural childbirth, Low intensity focused ultrasound, Uterine involution, Puerperal infection, Pregnant women and puerpera

图1 LIFU 子宫复旧仪工作示意图（图1A：治疗过程；图1B：LIFU 子宫复旧仪；图1C：治疗仪参数配置界面）注：LIFU 为低强度聚焦超声

表1 2组产妇一般临床资料、宫底高度及宫底下降率比较（¯x±s）

组别	例数	年龄（岁）	BMI（kg/m²）	分娩孕龄（周）	新生儿BW（g）	宫底高度（cm）		宫底下降率（%）
组别	例数	年龄（岁）	BMI（kg/m²）	分娩孕龄（周）	新生儿BW（g）	治疗前	治疗后	宫底下降率（%）
治疗组	202	28.6±3.5	24.6±3.2	39.2±1.9	3 353±387	22.1±1.3	12.5±4.9	41.4±5.7
对照组	203	28.9±3.9	24.8±3.6	39.2±1.6	3 324±395	22.0±1.9	14.6±4.7	31.2±4.7
t值		0.62	0.44	-0.39	-0.75	-1.11	4.22	-19.48
P值		0.536	0.660	0.694	0.452	0.267	＜0.001	＜0.001

表1 2组产妇一般临床资料、宫底高度及宫底下降率比较（¯x±s）

组别	例数	年龄（岁）	BMI（kg/m²）	分娩孕龄（周）	新生儿BW（g）	宫底高度（cm）		宫底下降率（%）
组别	例数	年龄（岁）	BMI（kg/m²）	分娩孕龄（周）	新生儿BW（g）	治疗前	治疗后	宫底下降率（%）
治疗组	202	28.6±3.5	24.6±3.2	39.2±1.9	3 353±387	22.1±1.3	12.5±4.9	41.4±5.7
对照组	203	28.9±3.9	24.8±3.6	39.2±1.6	3 324±395	22.0±1.9	14.6±4.7	31.2±4.7
t值		0.62	0.44	-0.39	-0.75	-1.11	4.22	-19.48
P值		0.536	0.660	0.694	0.452	0.267	＜0.001	＜0.001

表2 2组产妇治疗前、后，子宫三径长度及三径差指数比较（¯x±s）

组别	例数	治疗前（mm）			治疗后（mm）			治疗前、后子宫三径差指数（%）
组别	例数	长径	横径	前后径	长径	横径	前后径	长径	横径	前后径
治疗组	202	191.1±5.5	123.9±10.2	86.6±3.7	106.9±7.5	76.8±2.2	65.2±2.3	40.3±3.7	36.9±4.4	28.6±3.8
对照组	203	190.9±6.2	122.5±11.5	86.3±3.1	110.8±7.0	83.9±5.2	68.8±3.7	37.5±3.4	25.8±8.5	20.2±5.8
t值		-3.10	-1.27	-1.00	5.32	17.86	11.74	-8.04	-16.46	-17.32
P值		0.757	0.205	0.317	＜0.001	＜0.001	＜0.001	＜0.001	＜0.001	＜0.001

表2 2组产妇治疗前、后，子宫三径长度及三径差指数比较（¯x±s）

组别	例数	治疗前（mm）			治疗后（mm）			治疗前、后子宫三径差指数（%）
组别	例数	长径	横径	前后径	长径	横径	前后径	长径	横径	前后径
治疗组	202	191.1±5.5	123.9±10.2	86.6±3.7	106.9±7.5	76.8±2.2	65.2±2.3	40.3±3.7	36.9±4.4	28.6±3.8
对照组	203	190.9±6.2	122.5±11.5	86.3±3.1	110.8±7.0	83.9±5.2	68.8±3.7	37.5±3.4	25.8±8.5	20.2±5.8
t值		-3.10	-1.27	-1.00	5.32	17.86	11.74	-8.04	-16.46	-17.32
P值		0.757	0.205	0.317	＜0.001	＜0.001	＜0.001	＜0.001	＜0.001	＜0.001

图2 2组产妇治疗前、后，子宫三径长度测量超声图（图2A、2B 分别为对照组1例产妇治疗前、后，子宫三径长度测量值；图2C、2D 分别为治疗组1例产妇治疗前、后，子宫三径长度测量）注：图中线段1、2、3分别为子宫长径、前后径、横径，1D、2D、3D 分别为长径、前后径、横径长度。治疗组产妇采取LIFU 子宫复旧治疗，对照组采用LIFU 子宫复旧安慰治疗。LIFU 为低强度聚焦超声

表3 2组产妇阴道出血量、恶露持续时间及并发症发生率比较

组别	例数	阴道出血量（mL， $\overset{ˉ}{x}$ ±s）		恶露持续时间（d， $\overset{ˉ}{x}$ ±s）		PPH［例数（%）］	晚期PPH［例数（%）］	产褥感染［例数（%）］
组别	例数	产后2 h	产后24 h	血性	浆液性	PPH［例数（%）］	晚期PPH［例数（%）］	产褥感染［例数（%）］
治疗组	202	195.2±41.8	283.9±10.2	4.3±2.5	16.5±8.2	2（1.0）	0（0）	1（0.5）
对照组	203	197.3±46.2	311.8±10.0	4.9±2.7	18.6±8.1	9（4.4）	4（2.0）	7（3.4）
统计量		t=0.48	t=27.71	t=2.30	t=2.48	χ²=4.54	χ²=4.02	χ²=4.56
P值		0.629	＜0.001	0.022	0.013	0.033	0.045	0.033

表3 2组产妇阴道出血量、恶露持续时间及并发症发生率比较

组别	例数	阴道出血量（mL， $\overset{ˉ}{x}$ ±s）		恶露持续时间（d， $\overset{ˉ}{x}$ ±s）		PPH［例数（%）］	晚期PPH［例数（%）］	产褥感染［例数（%）］
组别	例数	产后2 h	产后24 h	血性	浆液性	PPH［例数（%）］	晚期PPH［例数（%）］	产褥感染［例数（%）］
治疗组	202	195.2±41.8	283.9±10.2	4.3±2.5	16.5±8.2	2（1.0）	0（0）	1（0.5）
对照组	203	197.3±46.2	311.8±10.0	4.9±2.7	18.6±8.1	9（4.4）	4（2.0）	7（3.4）
统计量		t=0.48	t=27.71	t=2.30	t=2.48	χ²=4.54	χ²=4.02	χ²=4.56
P值		0.629	＜0.001	0.022	0.013	0.033	0.045	0.033

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