中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400091332
最近更新日期： Date of Last Refreshed on：	2024-10-25 17:29:00
注册时间： Date of Registration：	2024-10-25 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	提高妊娠期高血压疾病患者运动康复参与度的护理干预方案的构建和应用研究
Public title：	Effectiveness of a theory-based exercise intervention in pregnant women with hypertensive disorders of pregnancy: a randomized controlled trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	提高妊娠期高血压疾病患者运动康复参与度的护理干预方案的构建和应用研究
Scientific title：	The Construction and Application Research of the Nursing Intervention Program for Improving the Participation Degree of Exercise Rehabilitation of Patients with Hypertensive Disorders in Pregnancy
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：	徐文	研究负责人：	徐文
Applicant：	Wen Xu	Study leader：	Wen Xu
申请注册联系人电话： Applicant telephone：	+86 135 2872 6183	研究负责人电话： Study leader's telephone：	+86 135 2872 6183
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：	754908650@qq.com	研究负责人电子邮件： Study leader's E-mail：	754908650@qq.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：	广东省深圳市光明区马田街道松白路4253号和4221号	研究负责人通讯地址：	广东省深圳市光明区马田街道松白路4253号和4221号
Applicant address：	4253 and 4221 Songbai Road, Matan Street, Guangming District, Shenzhen City, Guangdong Province	Study leader's address：	4253 and 4221 Songbai Road, Matan Street, Guangming District, Shenzhen City, Guangdong Province
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：	深圳市光明区人民医院
Applicant's institution：	Shenzhen Guangming District People's Hospital
研究负责人所在单位：	深圳市光明区人民医院
Affiliation of the Leader：	Shenzhen Guangming District People's Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	LL-KT-2024064	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：	深圳市光明区人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of Shenzhen Guangming District People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-06-05 00:00:00
伦理委员会联系人：	邹琛
Contact Name of the ethic committee：	Chen Zou
伦理委员会联系地址：	广东省深圳市光明区马田街道松白路4253号和4221号
Contact Address of the ethic committee：	4253 and 4221 Songbai Road, Matan Street, Guangming District, Shenzhen City, Guangdong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 135 2848 7990	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：

深圳市光明区人民医院

Primary sponsor：

Shenzhen Guangming District People's Hospital

研究实施负责（组长）单位地址：

广东省深圳市光明区马田街道松白路4253号和4221号

Primary sponsor's address：

4253 and 4221 Songbai Road, Matan Street, Guangming District, Shenzhen City, Guangdong Province

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	市(区县)：	深圳
Country：	China	Province：	Guangdong	City：	Shenzhen
单位(医院)：	深圳市光明区人民医院	具体地址：	广东省深圳市光明区马田街道松白路4253号和4221号
Institution hospital：	Shenzhen Guangming District People's Hospital	Address：	4253 and 4221 Songbai Road, Matan Street, Guangming District, Shenzhen City, Guangdong Province

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

妊娠期高血压疾病

Target disease：

Hypertensive disorders of pregnancy

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

在健康信念理论模型（HBM）指导下，研制提高妊娠期高血压疾病患者运动康复参与率的干预方案。让医护团队在临床实践中，实施基于理论的干预措施，提高妊娠期高血压患者运动康复参与率，改善母婴结局。

Objectives of Study：

To develop an intervention program to improve the exercise participation rate of patients with hypertensive disorders complicating pregnancy under the guidance of the health belief model. Let the medical team implement theory-based interventions in clinical practice to improve the participation rate of exercise rehabilitation in patients with gestational hypertension.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Gestational hypertension, preeclampsia, pregnancy with chronic hypertension, chronic hypertension with preeclampsia. The specific criteria are as follows:
(1) Hypertension during pregnancy: hypertension appears for the first time after 20 weeks of pregnancy, systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg; Urine protein test is negative.
(2) Preeclampsia: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of pregnancy, accompanied by any of the following: urine protein quantification ≥0.3g/24 h, or urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+); No proteinuria but with involvement of any one of the following organs or systems: heart, lungs, liver, kidneys and other important organs, or abnormal changes in the blood, digestive and nervous systems, placenta-fetal involvement, etc.
(3) Pregnancy complicated with chronic hypertension: pregnant women have secondary or primary hypertension of various reasons.
(4) Chronic hypertension with preeclampsia: pregnant women with chronic hypertension have no proteinuria before 20 weeks of pregnancy, and have urine protein quantification ≥0.3 g/24 h or random urine protein ≥ (+) after 20 weeks of pregnancy, clean midstream urine and exclude confusion when urine is less and urine specific gravity is increased; or proteinuria before 20 weeks of gestation, and the amount of protein in the urine increases significantly after 20 weeks of gestation; or any of the above manifestations of severe preeclampsia, such as a further increase in blood pressure.
2. All of them are singleton pregnancies with normal fetal development;
3. Under the age of 45;
4. Voluntarily participate in this study, and give informed consent to the content of the study, and sign the informed consent form.

排除标准：

1.重度子痫前期、子痫、慢性高血压并发重度子痫。具体标准如下： ①重度子痫前期（severe pre-eclampsia）：子痫前期孕妇出现下述任一表现：（1）血压持续升高不可控制：收缩压≥160 mmHg 和（或）舒张压≥110 mmHg；（2）持续性头痛、视觉障碍或其他中枢神经系统异常表现；（3）持续性上腹部疼痛及肝包膜下血肿或肝破裂表现；（4）转氨酶水平异常：血丙氨酸转氨酶（ALT）或天冬氨酸转氨酶（AST）水平升高；（5）肾功能受损：尿蛋白定量>2.0g/24 h；少尿（24h尿量<400 ml，或每小时尿量<17 ml），或血肌酐水平>106μmol/L；（6）低蛋白血症伴腹水、胸水或心包积液；（7）血液系统异常：血小板计数呈持续性下降并低于100×109/L；微血管内溶血，表现有贫血、血乳酸脱氢酶（LDH）水平升高或黄疸；（8）心功能衰竭；（9）肺水肿；（10）胎儿生长受限或羊水过少、胎死宫内、胎盘早剥等。 ②子痫：子痫前期基础上发生不能用其他原因解释的强直性抽搐，可以发生在产前、产时或产后，也可以发生在无临床子痫前期表现时。 ③慢性高血压并发重度子痫： 2.有早产史、前置胎盘、先兆早产等高危妊娠的孕妇，因过度运动可能诱发宫缩，增加早产风险。 3.严重心理和认知障碍，智力障碍、语言沟通障碍，无法完成本研究的患者； 4.患有精神神经障碍患者； 5.糖尿病合并妊娠； 6.甲状腺功能亢进或心脏、血管、肺部疾病的孕妇，因过度运动可能加重原有疾病负担。 7.孕晚期30周后的孕妇，因妊娠晚期过度运动可能增加胎膜早破的风险，这会对母婴健康构成威胁。

Exclusion criteria：

1. Severe preeclampsia, eclampsia, chronic hypertension complicated by severe eclampsia. The specific criteria are as follows: 1)Severe pre-eclampsia: pregnant women with preeclampsia have any of the following manifestations: (1) Uncontrollable continuous increase in blood pressure: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 110 mmHg; (2) persistent headache, visual disturbances or other central nervous system abnormalities; (3) persistent epigastric pain and hepatic subcapsular hematoma or liver rupture; (4) Abnormal aminotransferase level: blood alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level is elevated; (5) Impaired renal function: urine protein quantification >2.0g/24 h; oliguria (24-hour urine output < 400 mL, or urine output <17 mL per hour), or serum creatinine level > 106 micromol/L; (6) Hypoproteinemia with ascites, pleural effusion or pericardial effusion; (7) Hematologic abnormalities: platelet count is continuously declining and lower than 100×109/L; microvascular hemolysis with anemia, elevated serum lactate dehydrogenase (LDH) levels, or jaundice; (8) heart failure; (9) pulmonary edema; (10) Fetal growth restriction or oligohydramnios, fetal death in utero, placental abruption, etc. 2).Eclampsia: tonic tics that cannot be explained by other causes occur on the basis of preeclampsia, which can occur prenatal, intrapartum or postpartum, or when there are no clinical manifestations of preeclampsia. 3) Chronic hypertension complicated by severe eclampsia: 2. Pregnant women with a history of preterm birth, placenta previa, threatened preterm birth and other high-risk pregnancies may induce uterine contractions and increase the risk of preterm birth due to excessive exercise. 3. Patients with severe psychological and cognitive impairment, intellectual disability, language communication disorder, unable to complete this study; 4. Patients with psychiatric and neurological disorders; 5. Diabetes mellitus complicated with pregnancy; 6. Pregnant women with hyperthyroidism or heart, blood vessel and lung diseases may increase the burden of pre-existing diseases due to excessive exercise. 7. Pregnant women after 30 weeks in the third trimester of pregnancy, excessive exercise in the third trimester may increase the risk of premature rupture of membranes, which will pose a threat to the health of the mother and baby.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-06-06 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	60
Group：	Intervention group	Sample size：	60
干预措施：	参与者接受基于健康信念理论的运动干预方案	干预措施代码：	1
Intervention：	Participants received an exercise intervention based on the Health Belief Model.	Intervention code：	1

组别：	对照组	样本量：	60
Group：	Control group	Sample size：	60
干预措施：	参与者接受由护士应用产前手册中的信息进行的简单的活动指导	干预措施代码：	2
Intervention：	Participants receive simple activity guidance from nurses using information from the prenatal manual.	Intervention code：	2

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：	深圳
Country：	China	Province：	Guangdong	City：	Shenzhen
单位(医院)：	深圳市光明区人民医院	单位级别：	三甲
Institution hospital：	Shenzhen Guangming District People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	血压	指标类型：	主要指标
Outcome：	Blood pressure	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	运动参与度	指标类型：	次要指标
Outcome：	Adherence to exercise	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	六分钟步行试验	指标类型：	次要指标
Outcome：	Six-minute walk test	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病知识认知与运动自我效能得分	指标类型：	次要指标
Outcome：	Disease knowledge and motor self-efficacy scores	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	母婴结局	指标类型：	主要指标
Outcome：	Maternal and infant outcomes	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者满意度	指标类型：	次要指标
Outcome：	Patient satisfaction	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	45	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）：

由统计专家利用SAS软件产生随机分配表，将满足入排标准的受试者从1到N编号，从随机数字表中任意一个数开始，沿同一方向顺序依次获取每一个受试者的一个随机数字，将获取的随机数除以组数2，求余数,若整除则余数为2。余数为1的受试者为1组，余数为2的受试者为另一组。

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

A randomization table is generated by statistical experts using SAS software, where eligible subjects are numbered from 1 to N. Starting from a random number from a random number table, numbers are sequentially obtained in the same direction for each subject. The obtained random numbers are divided by the group number 2, and the remainder is calculated. If the number is divisible by 2, the remainder is 2. Subjects with a remainder of 1 are assigned to Group 1, and those with a remainder of 2 are assigned to the other group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	是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）：	实验完成后6个月公开在百度云网盘http://pan.baidu.com/share/manage
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	6 months after the completion of the experiment, it will be publicly available in Baidu cloud network disk
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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-10-25 17:27:15