ChiCTR2400088945 版本V1.0 版本创建时间2024/08/29 14:18:35 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400088945 

最近更新日期：

Date of Last Refreshed on：

2024-08-29 14:18:30 

注册时间：

Date of Registration：

2024-08-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

远程血压监控联合远程胎监与门诊监护子痫前期患者前瞻性随机对照临床研究

Public title：

A prospective randomized controlled clinical study on remote blood pressure monitoring combined with remote fetal monitoring and outpatient monitoring in patients with preeclampsia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

远程血压监控联合远程胎监与门诊监护子痫前期患者前瞻性随机对照临床研究

Scientific title：

A prospective randomized controlled clinical study on remote blood pressure monitoring combined with remote fetal monitoring and outpatient monitoring in patients with preeclampsia

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

姚润斯 

研究负责人：

姚润斯 

Applicant：

Yao Runsi 

Study leader：

Yao Runsi 

申请注册联系人电话：

Applicant telephone：

+86 135 9011 9271

研究负责人电话：

Study leader's telephone：

+86 135 9011 9271

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

mao0413@126.com

研究负责人电子邮件：

Study leader's E-mail：

mao0413@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

深圳市福田区笋岗西路3002号深圳市第二人民医院产科

研究负责人通讯地址：

深圳市福田区笋岗西路3002号深圳市第二人民医院产科

Applicant address：

Obstetrics Department of Shenzhen Second People's Hospital, No. 3002 Sungang West Road, Futian District, Shenzhen

Study leader's address：

Obstetrics Department of Shenzhen Second People's Hospital, No. 3002 Sungang West Road, Futian District, Shenzhen

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

深圳市第二人民医院

Applicant's institution：

Shenzhen Second People's Hospital

研究负责人所在单位：

深圳市第二人民医院

Affiliation of the Leader：

Shenzhen Second People's Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-101-02PJ

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

深圳市第二人民医院临床科研伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Shenzhen Second People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2023-05-08 00:00:00

伦理委员会联系人：

杨鸿瑜

Contact Name of the ethic committee：

Yang Hongyu

伦理委员会联系地址：

深圳市福田区笋岗西路体育大厦707室

Contact Address of the ethic committee：

Room 707, Sports Building, Sungang West Road, Futian District, Shenzhen

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 755 8346 4301

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

深圳市第二人民医院

Primary sponsor：

Shenzhen Second People's Hospital

研究实施负责（组长）单位地址：

深圳市福田区笋岗西路3002号深圳市第二人民医院

Primary sponsor's address：

Shenzhen Second People's Hospital, No. 3002 Sungang West Road, Futian District, Shenzhen

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

深圳

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

深圳市第二人民医院

具体地址：

深圳市福田区笋岗西路3002号

Institution
hospital：

Shenzhen Second People's Hospital

Address：

No. 3002 Sungang West Road, Futian District, Shenzhen

经费或物资来源：

深圳市第二人民医院

Source(s) of funding：

Shenzhen Second People's Hospital

Target disease：

Maternal-Fetal Medicine

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

1.通过对远程血压监控联合远程胎监用于孕期监护子痫前期患者的有效性及安全性进行分析评估，明确该项技术是否可替代且优于目前子痫前期患者门诊监护这一传统管理手段。 2.研究制定相应监管标准，在尽量减少入院次数、节约时间成本及提供患者方便的基础上改善妊娠结局，为子痫前期患者的母胎安全提供保障  

Objectives of Study：

1. Analyze and evaluate the effectiveness and safety of remote blood pressure monitoring combined with remote fetal monitoring for monitoring preeclampsia patients during pregnancy, and determine whether this technology can replace and outperform the traditional management method of outpatient monitoring for preeclampsia patients. 2. Research and develop corresponding regulatory standards to improve pregnancy outcomes while minimizing hospital admissions, saving time and costs, and providing patient convenience, in order to ensure the safety of mother and fetus for preeclampsia patients.

药物成份或治疗方案详述：

无 

Description for medicine or protocol of treatment in detail：

None 

纳入标准：

1.成年孕产妇（≥18岁）；孕周≥30周且≤36周，知情签署患者知情同意书。 2.诊断标准:妊娠20周后血压升高，收缩压大于等于140mm Hg和(或)舒张压大于等于90mmHg，伴有24h尿蛋白定量大于0.3g或随机尿蛋白(+)或合并血小板减少、肝功能损害、肾功能损害、肺水肿、新发生的中枢神经系统异常或视觉障碍。 3.单胎妊娠或双胎妊娠。

Inclusion criteria

1. Analyze and evaluate the effectiveness and safety of remote blood pressure monitoring combined with remote fetal monitoring for monitoring preeclampsia patients during pregnancy, and determine whether this technology can replace and outperform the traditional management method of outpatient monitoring for preeclampsia patients. 2. Research and develop corresponding regulatory standards to improve pregnancy outcomes while minimizing hospital admissions, saving time and costs, and providing patient convenience, in order to ensure the safety of mother and fetus for preeclampsia patients. 1. Adult pregnant and postpartum women (≥ 18 years old); If the gestational age is ≥ 30 weeks and ≤ 36 weeks, the informed consent form of the patient shall be signed. 2. Diagnostic criteria: After 20 weeks of pregnancy, blood pressure increases, systolic blood pressure is greater than or equal to 140mm Hg, and/or diastolic blood pressure is greater than or equal to 90mm Hg, accompanied by 24-hour urine protein quantification greater than 0.3g or random urine protein (+) or combined with thrombocytopenia, liver function damage, renal function damage, pulmonary edema, newly occurring central nervous system abnormalities or visual impairment. 3. Single or twin pregnancy.

排除标准：

1) 重度子痫前期 2) 妊娠前诊断有心脑血管疾病 3) 精神疾病者 4) 存在沟通障碍者 5) 合并严重代谢类疾病者 6) 合并免疫类疾病者 7) 合并凝血功能障碍者 8) 临床资料不完整者 9) 依从性较差者

Exclusion criteria：

1) Severe preeclampsia 2) Diagnosed with cardiovascular and cerebrovascular diseases before pregnancy 3) Individuals with mental illness 4) have communication barriers 5) Patients with severe metabolic diseases 6) Patients with immune diseases 7) Patients with concomitant coagulation dysfunction 8) Patients with incomplete clinical data 9) Those with poor compliance

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2026-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-15 00:00:00 至 To 2026-02-28 00:00:00  

干预措施：

Interventions：

组别：

远程监护组

样本量：

109

Group：

Remote monitoring group

Sample size：

干预措施：

⑴远程血压监护：患者经门诊护士宣教后，每日晨起及睡前利用自动血压仪各进行血压测量 1 次，头痛、胸闷等不适时随时测量血压，所测量得的血压数值上传至上传至远程胎监 app；⑵远程胎心监护：① 由专人指导孕妇及家属使用远程胎心监护仪。②确保孕妇除了常规的产前检查外（常规产检 30 周至 36 周每 2 周产检 1 次，36 至 37 周产检 1 次，共进行 5 次产检，据病情酌情增加产检次数，满 37 周建议入院分娩），隔日在固定时间进行胎心监测并上传至远程胎监 app，如果出现胎动异常，可随时上传胎心监测情况。

干预措施代码：

Intervention：

Remote monitoring group (1) Remote blood pressure monitoring: After being taught by outpatient nurses, patients can use their own blood pressure monitoring system every morning and before going to bed Blood pressure is measured once with a blood pressure monitor, and when there is discomfort such as headaches or chest tightness, blood pressure is measured at any time. The measured blood pressure upload the values to the remote tire monitoring app; ⑵ Remote fetal heart rate monitoring:① A dedicated person will guide pregnant women and their families to use a remote fetal heart rate monitor Ensure that pregnant women not only undergo routine prenatal examinations, but also (Routine prenatal examination is conducted once every 2 weeks from 30 to 36 weeks, and once every 36 to 37 weeks. A total of 5 prenatal examinations are conducted.),Increase the number of prenatal examinations according to the condition, and it is recommended to be admitted for delivery after 37 weeks. Fetal heart rate monitoring should be conducted at a fixed time the next day.And upload it to the remote fetal monitoring app. If there is abnormal fetal movement, the fetal heart rate monitoring status can be uploaded at any time.

Intervention code：

组别：

对照组

样本量：

109

Group：

control group

Sample size：

干预措施：

⑴门诊观察患者于产检固定时间（常规产检 30 周至 36 周每 2 周产检 1次，36 至 37 周产检 1 次，共进行 5 次产检，据病情酌情增加产检次数，满 37 周建议入院分娩）前往医疗机构进行一次血压测量，测量数值记录于妇幼产检系统，住院患者每日晨起及睡前由护士进行血压测量 1 次，测量数值记录于我院电子病历系统护理记录单；⑵门诊观察患者于产检固定时间前往医疗机构进行一次胎心监测，住院患者隔日固定时间进行一次胎心监测，如果住院期出现胎动异常，可随时行胎心监测。

干预措施代码：

Intervention：

(1) Outpatient observation: Patients are required to undergo a blood pressure measurement at a fixed time during the prenatal examination (routine prenatal examination once every 2 weeks from 30 to 36 weeks, and once every 36 to 37 weeks, with a total of 5 prenatal examinations. Depending on the condition, the number of prenatal examinations may be increased, and it is recommended to be admitted for delivery after 37 weeks). The measured values are recorded in the maternal and child prenatal examination system. Inpatient blood pressure measurements are taken by nurses every morning and before bedtime, Record the measurement values on the nursing record sheet of our hospital's electronic medical record system; ⑵ Outpatient observation patients go to a medical institution for fetal heart rate monitoring at a fixed time during prenatal examination, and hospitalized patients undergo fetal heart rate monitoring at a fixed time every other day. If abnormal fetal movements occur during hospitalization, fetal heart rate monitoring can be performed at any time.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

深圳市第二人民医院 

单位级别：

三甲 

Institution
hospital：

Shenzhen Second People's Hospital

Level of the institution：

Class A tertiary hospital

测量指标：

Outcomes：

指标中文名：

新生儿不良结局发生率

指标类型：

主要指标

Outcome：

Incidence of adverse outcomes in newborns

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

母体并发症

指标类型：

次要指标

Outcome：

Maternal complications

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 55 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

研究者采用随机数法分组

Randomization Procedure (please state who generates the random number sequence and by what method)：

Researchers grouped using random number method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

使用临床试验公共管理平台http://www.medresman.org.cn/login.aspx，在试验结束6个月内上传试验数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Use the clinical trial public management platform http://www.medresman.org.cn/login.aspx to upload the trial data within 6 months of the end of the trial.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

使用病例记录表和电子采集系统（医院电子病历系统）

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Using case record forms and electronic collection systems (hospital electronic medical record systems)

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-08-29 14:18:30