Ministry of Education-Shanghai Key Laboratory of Children's Environmental Health, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Obstetrics and Gynecology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
BMC Med. 2020 Feb 14;18(1):27. doi: 10.1186/s12916-020-1491-6.
Cesarean section (CS) rate has risen dramatically and stayed at a very high level in China over the past two to three decades. Given the short- and long-term adverse effects of CS, effective strategies are needed to reduce unnecessary CS. We aimed to evaluate whether a multifaceted intervention would decrease the CS rate in China.
We carried out a cluster-randomized field trial with a multifaceted intervention in Shanghai, China, from 2015 to 2017. A total of 20 hospitals were randomly allocated into an intervention or a control group. The intervention consisted of more targeted health education to pregnant women, improved hospital CS policy, and training of midwives/doulas for 8 months. The study included a baseline survey, the intervention, and an evaluation survey. The primary outcome was the changes of overall CS rate from the pre-intervention to the post-intervention period. A subgroup analysis stratified by the Robson classification was also conducted to examine the CS change among women with various obstetric characteristics.
A total of 10,752 deliveries were randomly selected from the pre-intervention period and 10,521 from the post-intervention period. The baseline CS rates were 42.5% and 41.5% in the intervention and control groups, respectively, while the post-intervention CS rates were 43.4% and 42.4%, respectively. Compared with the control group, the intervention did not significantly reduce the CS rate (adjusted OR = 0.92; 95% CI 0.73, 1.15). Similar results were obtained in subgroup analyses stratified by the risk level of pregnancy, maternal age, number of previous CS, or parity. Scarred uterus and maternal request remained the primary reasons for CS after the interventions in both groups. The intervention did not alter the perinatal outcomes (adjusted change of risk score = - 0.06; 95%CI - 0.43, 0.31).
A multifaceted intervention including more targeted prenatal health education, improved hospital CS policy, and training of midwives/doulas, did not significantly reduce the CS rate in Shanghai, China. However, our experience in implementing a multifaceted intervention may provide useful information to other similar areas with high CS use.
This trial was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn) (ChiCTR-IOR-16009041) on 17 August 2016.
在过去的二三十年里，中国的剖宫产率急剧上升并一直保持在很高的水平。鉴于剖宫产的短期和长期不良影响，需要采取有效的策略来减少不必要的剖宫产。我们旨在评估多方面的干预措施是否会降低中国的剖宫产率。
我们在中国上海进行了一项多方面干预的整群随机临床试验，从 2015 年至 2017 年。共有 20 家医院被随机分配到干预组或对照组。干预措施包括针对孕妇的更有针对性的健康教育、改进医院剖宫产政策以及对助产士/导乐进行 8 个月的培训。研究包括基线调查、干预和评估调查。主要结局是从干预前到干预后期间整体剖宫产率的变化。还进行了按罗伯逊分类分层的亚组分析，以检查具有不同产科特征的妇女的剖宫产变化。
从干预前期间随机选择了 10752 次分娩，从干预后期间随机选择了 10521 次分娩。干预组和对照组的基线剖宫产率分别为 42.5%和 41.5%，而干预后的剖宫产率分别为 43.4%和 42.4%。与对照组相比，干预并未显著降低剖宫产率（调整后的 OR=0.92；95%CI 0.73，1.15）。在按妊娠风险水平、产妇年龄、剖宫产次数或产次分层的亚组分析中也得到了类似的结果。干预后，两组的剖宫产主要原因仍然是瘢痕子宫和产妇要求。干预并未改变围产期结局（调整后的风险评分变化= -0.06；95%CI -0.43，0.31）。
包括更有针对性的产前健康教育、改进医院剖宫产政策以及培训助产士/导乐在内的多方面干预措施，并未显著降低中国上海的剖宫产率。然而，我们在实施多方面干预方面的经验可能为其他剖宫产率较高的类似地区提供有用的信息。
该试验于 2016 年 8 月 17 日在中国临床试验注册中心（www.chictr.org.cn）（ChiCTR-IOR-16009041）注册。
