【目的】近年来“互联网+医疗”理念在孕产保健中应用逐渐增多，互联网医疗具有降低就医压力、提高孕产保健服务效率和质量的潜力。本研究将互联网医疗服务引入低风险孕妇群体的常规产检中，形成“产检新模式”，并评价新模式的安全性、可接受性和成本，探究产检新模式的可行性，为新模式的推广提供参考。

【方法】本研究采用1:1的随机对照研究（randomized controlled trial, RCT）设计，比较在不同产检模式下孕妇的妊娠安全、产检满意度、妊娠相关压力以及付出成本是否存在差异。研究地点为北京某三甲医院产科门诊。研究对象是完成医院建档（孕8周）的孕妇，对于符合纳入排除标准的孕妇，邀请参与本研究。经知情同意后，使用随机数表的方法进行随机分组。

两种产检模式由专家组讨论形成，采用相同的产检流程和内容，试验组为9次线下门诊+3次线上的产检新模式，对照组按照常规产检模式进行。研究采用临床资料收集法与问卷调查法进行资料收集，其中产检服务利用情况、安全性结局从病历中提取；满意度及妊娠压力分别使用《患者产前保健期望和满意度量表》（Patient Expectations and Satisfaction with Prenatal Care, PESPC）、《妊娠压力评定量表》（Pregnancy Stress Rating Scale, PSRS）进行测量；付出成本使用自编问卷收集。

研究采用意向性分析（Intention-To-Treat, ITT）和遵循研究方案分析（Per-Protocol, PP）方法进行处理，首先进行描述性分析，之后使用单因素及多因素分析（Logistic回归和广义估计方程）比较两组间的结局指标是否存在差异。安全性评价采用非劣效性试验设计方法进行分析。

【结果】研究从2022年3月至2023年12月共纳入低风险孕妇720名，其中试验组358人，对照组362人；试验组孕妇的平均线下就诊次数低于对照组（分别为12次和14次），平均线上就诊分别为3次和1次。

安全性分析中，非劣效性检验结果显示，以8%为界值，孕妇不良结局的组间率差与95%置信区间为-0.93% (-7.85%, 5.98%)，新生儿不良结局率差为-1.08% (-7.61%, 5.45%)，未超过界值。孕期体重增长过多的发生率之差为3.19% (-3.87%, 10.25%)，超过界值，试验组在发生这一结局的风险可能更高。

满意度分析结果显示，产检期间的满意度组间差异无统计学意义，OR值为1.33 (0.91, 1.96)；对服务全程满意度评价显示，增加线上次数会提高孕妇的满意概率，OR值为1.18 (1.00-1.39)。

孕期妊娠压力情况组间差异无统计学意义，孕早期试验组压力评分为32.5（四分位数：20.3，58.0），对照组为49.5（四分位数：24.0，63.3）；孕晚期试验组21.5（四分位数：12.3，38.5），对照组为22.5（四分位数：14.8，40.8）。

经济学分析中，间接成本方面，试验组孕妇平均耽误工作时间4.04 ± 4.24小时，对照组平均3.56 ± 1.33小时，组间差异无统计学意义（BF₁₀ = 0.206）。试验组直接医疗成本235.58 ± 307.31元，对照组249.53 ± 374.13元，组间差异无统计学意义（BF₁₀ = 0.169）。直接非医疗成本（BF₁₀ = 0.167）方面有相似结果。

【结论】研究表明，产检新模式在整体安全性上不劣于常规模式，但在孕期体重方面仍需更多关注。新模式不会对孕妇的妊娠压力以及满意度有负向影响，不增加患者付出成本，具有一定的可接受性和可行性。另外增加线上就诊次数不会对上述方面产生不良影响。经过对上述多方面评估，研究认为产检新模式具有替代常规产检模式的潜力。

 

Objective: Recently, the application of "Internet Medical service" in maternal health care has been gradually increasing, and Internet medical care is proven to have the potential to reduce the pressure of medical care and improve the efficiency and quality of maternal health care services. In this study, Internet medical services were introduced into the routine obstetric examination of low-risk pregnant women, forming a "new model of obstetric examination". The safety, acceptability and cost of the new model were evaluated to explore the feasibility of the new model.

Methods: This study used a 1:1 randomized controlled trial (RCT) design to compare whether there were differences in pregnancy safety, satisfaction, pregnancy-related stress, and costs among pregnant women in different modes of obstetric examination. The study site was the obstetrics outpatient clinic of a tertiary hospital in Beijing. The study subjects were pregnant women (≤8 weeks' gestation), and for those who met the inclusion exclusion criteria, they were invited to participate in this study. After informed consent was given, randomized groups were formed using the method of random number table.

The two modes of obstetric examination were formed by the discussion of the expert group, using the same process and content of the obstetric examination, the experimental group was a new mode of 9 offline clinic + 3 online obstetric examination, and the control group was conducted in accordance with the conventional mode of obstetric examination. The study used the clinical data collection and questionnaire survey method, in which the utilization of obstetric examination services and safety outcomes were extracted from medical records; satisfaction and pregnancy stress were measured using the Patient Expectations and Satisfaction with Prenatal Care (PESPC), and Pregnancy Stress Rating Scale (PSRS), respectively; cost of giving was collected using a self-administered questionnaire.

The study was processed using the Intention-To-Treat (ITT) and Follow the Research Protocol (Per-Protocol, PP) methods, We conducted descriptive analyses, univariate and multivariate analyses (Logistic regression and generalized estimating equations) to compare whether there was a difference in the outcome indicators between the two groups. Safety evaluations were analyzed using non-inferiority trial design methods.

Results: A total of 720 low-risk pregnant women were enrolled in the study from March 2022 to December 2023, 358 in the test group and 362 in the control group; pregnant women in the test group had a lower mean number of offline visits than those in the control group (12 and 14, respectively), and a mean number of online visits of 3 and 1, respectively.

In the safety analysis, using a cutoff value of 8%, the noninferiority test showed that the between-group rate difference with 95% confidence intervals for adverse outcomes was -0.93% (-7.85%, 5.98%) for pregnant women and -1.08% (-7.61%, 5.45%) for newborns, which did not exceed the cutoff value. The difference in the incidence of excess gestational weight gain was 3.19% (-3.87%, 10.25%), which exceeded the cut-off value, and the test group may be at higher risk of this outcome.

Satisfaction analysis showed no statistically significant between-group difference in satisfaction during labor and delivery [OR: 1.33 (0.91, 1.96)]; evaluation of satisfaction throughout the service showed that increasing the number of lines increased the probability of satisfaction among pregnant women [OR: 1.18 (1.00-1.39)].

There was no statistically significant difference between the groups in terms of pregnancy stress profile, with a stress score of 32.5 (quartiles: 20.3, 58.0) in the early pregnancy test group and 49.5 (quartiles: 24.0, 63.3) in the control group, and 21.5 (quartiles: 12.3, 38.5) in the late pregnancy test group and 22.5 (quartiles: 14.8, 40.8) in the control group.

In the economic analysis, in terms of indirect costs, pregnant women in the test group were delayed in work for an average of 4.04 ± 4.24 hours and in the control group for an average of 3.56 ± 1.33 hours, with no statistically significant difference between the groups (BF₁₀ = 0.206). Direct medical costs were 235.58 ± 307.31 in the experimental group and 249.53 ± 374.13 in the control group, with no statistically significant difference between groups (BF₁₀ = 0.169). Similar results were found for direct non-medical costs (BF₁₀ = 0.167).

Conclusion: Studies have shown that the new model is non-inferior to the conventional model in terms of overall safety, but still needs more attention in terms of pregnancy weight. The new model does not negatively affect pregnancy stress and satisfaction, does not increase patient costs, and is acceptable and feasible. Additionally increasing the number of online visits will not have an adverse effect on these aspects. The study concludes that the new model has the potential to replace the conventional model of labor and delivery.

第一章 引言.....................................................1
1.1 研究背景....................................................1
1.1.1 互联网医疗概述............................................1
1.1.2 互联网医疗在产前保健服务中的应用现状......................1
1.1.3 互联网医疗背景下产前保健新模式的研究现状..................3
1.2 研究意义....................................................5
1.3 研究目的....................................................5
第二章 对象与方法...............................................6
2.1 研究设计....................................................6
2.2 伦理审查....................................................6
2.3 研究对象....................................................6
2.3.1 研究对象招募..............................................6
2.3.2 纳入标准..................................................7
2.3.3 排除标准..................................................7
2.3.4 样本量计算................................................7
2.3.5 随机分配、分组隐蔽和单盲..................................8
2.4 产检新模式的试验内容与方法..................................9
2.4.1 实施现场和人员............................................9
2.4.2 产检新模式的试验内容......................................9
2.5 评价内容与指标.............................................10
2.5.1 评价内容.................................................10
2.5.2 评价指标.................................................10
2.6 数据收集...................................................12
2.6.1 临床资料收集.............................................13
2.6.2 问卷调查.................................................13
2.7 数据整理...................................................13
2.8 统计分析方法...............................................14
2.8.1 意向性治疗分析和遵循研究方案分析.........................14
2.8.2 孕妇基本信息、产检服务利用情况及成本评估.................14
2.8.3 产检新模式的安全性评估...................................15
2.8.4 产检新模式的可接受性评估.................................16
2.9 质量控制...................................................17
2.9.1 研究设计阶段.............................................17
2.9.2 现场调查阶段.............................................17
2.9.3 数据整理和分析阶段.......................................18
第三章 结果....................................................19
3.1 研究对象基本特征及产检服务利用情况.........................19
3.1.1 研究对象的基本特征.......................................19
3.1.2 产检服务利用情况.........................................21
3.2 产检新模式的安全性评估.....................................23
3.2.1 意向性分析...............................................23
3.2.2 符合研究方案分析.........................................25
3.3 产检新模式的可接受性评估...................................26
3.3.1 产前保健服务满意度评估...................................26
3.3.2 妊娠相关压力评估.........................................31
3.4 产检新模式的成本评估.......................................36
3.4.1 为产检投入的时间成本.....................................38
3.4.2 为产检投入的直接成本.....................................38
3.5 研究结果小结...............................................40
第四章 讨论....................................................41
4.1 产检新模式的效果评价.......................................41
4.1.1 产检新模式可以基本保证安全性.............................41
4.1.2 可接受性评价.............................................42
4.1.3 产检新模式未增加患者投入成本..............................43
4.2 产检新模式的执行情况达到预期...............................44
4.3 本研究的创新性与局限性.....................................46
4.3.1 创新性...................................................46
4.3.2 局限性...................................................46
第五章 结论及展望..............................................48
参考文献........................................................49
附录A 附表 ................................................55
附录B 研究所用问卷..............................................62
文献综述........................................................68
致谢............................................................80
北京大学学位论文原创性声明和使用授权说明........................82
个人简历、在学期间发表的学术论文与研究成果......................83
学位论文答辩委员会名单..........................................84
学位论文答辩委员会决议书........................................85

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