ChiCTR2400081994 版本V1.0 版本创建时间2024/03/18 15:20:36 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：

ChiCTR2400081994 

最近更新日期：

Date of Last Refreshed on：

2024-03-18 15:20:30 

注册时间：

Date of Registration：

2024-03-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

硬膜外分娩镇痛输液方案对产妇及新生儿结局的影响

Public title：

Effect of epidural labour analgesia infusion regimen on maternal and neonatal outcomes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

硬膜外分娩镇痛输液方案对产妇及新生儿结局的影响

Scientific title：

Effect of epidural labour analgesia infusion regimen on maternal and neonatal outcomes

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：

胡冰 

研究负责人：

胡冰 

Applicant：

Bing Hu 

Study leader：

Bing Hu 

申请注册联系人电话：

Applicant telephone：

+86 135 8768 5029

研究负责人电话：

Study leader's telephone：

+86 135 8768 5029

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：

hubing0206105@126.com

研究负责人电子邮件：

Study leader's E-mail：

hubing0206105@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：

杭州市上城区鲲鹏路369号

研究负责人通讯地址：

杭州市上城区鲲鹏路369号

Applicant address：

369 kunpeng road, shangcheng district, hangzhou, China

Study leader's address：

369 kunpeng road, shangcheng district, hangzhou, China

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：

杭州市妇产科医院

Applicant's institution：

Hangzhou maternity hospital

研究负责人所在单位：

杭州市妇产科医院

Affiliation of the Leader：

Hangzhou maternity 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：

(2024)医伦审A第(007)号

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：

杭州市妇产科医院（杭州市妇幼保健院）伦理委员会

Name of the ethic committee：

Ethics committee of hangzhou maternity hospital (hangzhou maternal and child health hospital)

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-07 00:00:00

伦理委员会联系人：

何茶英

Contact Name of the ethic committee：

Chaying He

伦理委员会联系地址：

杭州市上城区鲲鹏路369号

Contact Address of the ethic committee：

369 kunpeng road, shangcheng district, hangzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571 5600 5077

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：

杭州市妇产科医院

Primary sponsor：

Hangzhou maternity hospital

研究实施负责（组长）单位地址：

杭州市上城区鲲鹏路369号

Primary sponsor's address：

369 kunpeng road, shangcheng district, hangzhou, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

杭州市妇产科医院

具体地址：

杭州市上城区鲲鹏路369号

Institution
hospital：

Hangzhou maternity hospital

Address：

369 kunpeng road, shangcheng district, hangzhou, China

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Epidural labour analgesia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

对低血容量产妇实施硬膜外分娩镇痛时，采用不同输液方案对产妇及新生儿结局的影响  

Objectives of Study：

The effect of different infusion regimens on maternal and neonatal outcomes when administering epidural labour analgesia to hypovolemic women

药物成份或治疗方案详述：

硬膜外组分娩镇痛方法：分娩镇痛操作均由麻醉科主治以上医师操作。硬膜外穿刺针常规于 L2～L3行硬膜外穿刺，采取硬膜外腔负压试验确认穿刺针到达硬膜外腔，向头侧置管3-5cm，回抽无回血及脑脊液后，妥善固定导管后，经硬膜外腔给予实验剂量 0.1%罗哌卡因5ml，观察5min无脊麻和局麻药中毒现象后再向硬膜外缓慢注入负荷剂量0.1%罗哌卡因15ml(>30 s)，观察 5 min 无麻醉异常后接PCA泵于硬膜外导管，持续监测血压及胎心监护30min，PCA泵中配成0.1％罗哌卡因加芬太尼 (2ug／mL)镇痛液，背景剂量2ml／h，脉冲剂量8ml／h，自控追加剂量8mL，锁定时间为20min。 随机分组、双盲法及药物配制：开始分娩时静脉输液前，对可能符合条件的妇女进行血压评估，以确定脉压。所有研究患者均采用多功能监护仪测量血压，患者处于平卧位，测量是在两次宫缩之间，宫缩结束后至少1分钟内进行。试验入组要求两次连续测量的脉压值均低于45 mmHg。采用随机数字表法将产妇分为对照组(S组)、少输液组(L组)和多输液组(H组)，每组70例。S组仅开放静脉，不予输液；L组和H组在硬膜外穿刺开始时输注复方氯化钠注射液，L组输液量为10mL/kg/h，H组输液量为20ml/kg/h。在硬膜外穿刺开始时进行补液，持续时间为30分钟。 第一位麻醉医生只参与随机分组和硬膜外分娩镇痛，另一位麻醉医生只参与数据收集和数据统计分析，一位助产士负责胎心监护。除随机分组的第一位麻醉医师外，其余医务人员以及受试者均对实验分组不知情。 

Description for medicine or protocol of treatment in detail：

Methods of labour analgesia in epidural group: Labour analgesia operations were performed by anaesthesiologists above the level of attending physician. The epidural puncture needle was routinely used for epidural puncture at L2~L3, and the negative pressure test was taken to confirm that the puncture needle had reached the epidural cavity, and the tube was placed 3-5cm to the cephalic side, and the catheter was fixed appropriately after pumping back without returning blood and cerebrospinal fluid, and an experimental dose of 0.1% ropivacaine was given in 5ml through the epidural cavity, and the loaded dose of 0.1% ropivacaine 15ml (>30 s) was then injected slowly into the epidural cavity under 5 minutes of observation without any anesthetic anomalies or poisoning of local anesthetics. 0.1% ropivacaine 15 ml (>30 s), after 5 min of observation without anaesthesia abnormality, the PCA pump was connected to the epidural catheter, and the blood pressure and foetal heart rate monitoring were continuously monitored for 30 min, and the PCA pump was formulated with 0.1% ropivacaine plus fentanyl (2ug/mL) analgesic solution, with the background dose of 2 ml/h, the impulse dose of 8 ml/h, and the self-control additional dose of 8 ml, and the locking time was 20 min. The lock-in time was 20 min. Randomisation, double-blind method and drug preparation: blood pressure was assessed to determine pulse pressure in potentially eligible women before starting intravenous infusion during labour. Blood pressure was measured in all study patients using a multifunctional monitor, with the patient in the prone position, and measurements were taken between contractions and at least 1 min after the end of the contraction. Two consecutive measurements of pulse pressure were required to be less than 45 mmHg for trial entry.The mothers were divided into a control group (group S), a less-infusion group (group L), and a more-infusion group (group H), with 70 cases in each group using the random number table method.In group S, only the vein was opened, and no infusion was given.Groups L and H were infused with a compounded sodium chloride injection at the beginning of the epidural puncture, with an infusion rate of 10mL/kg/h in group L, and 20 ml/kg/h in group H. In group S, only the vein was open, and no infusion was given; group L and H were infused with a complex sodium chloride injection at the beginning of the epidural puncture, with an infusion rate of 10mL/kg/h in group L and Rehydration was performed at the beginning of the epidural puncture and lasted for 30 minutes. The first anaesthetist was involved only in the randomisation group and epidural labour analgesia, another anaesthetist was involved only in data collection and statistical analysis of the data, and a midwife was responsible for fetal heart rate monitoring. Except for the first anaesthetist who was randomly grouped, the rest of the medical staff as well as the subjects were unaware of the experimental grouping. 

纳入标准：

1. 单胎妊娠初产妇。 2. 孕37~41周。 3. PP值<45 mm Hg。 4. ASA II级。

Inclusion criteria

1. Single pregnancy primigravida. 2. 37-41 weeks of gestation. 3. PP <45 mm Hg. 4. ASA class II.

排除标准：

1. 年龄＜18岁。 2. BMI＞30kg/㎡。 3. 身高＜150cm。 4. 椎管内麻醉禁忌症。 5. 收缩压低于90 mmHg。 6. 胎儿宫内生长受限或染色体异常、第2类或第3类FHR。

Exclusion criteria：

1. Age <18 years. 2. BMI >30kg/m2. 3. Height <150cm. 4. Contraindication to intralesional anaesthesia. 5. Systolic blood pressure less than 90 mmHg. 6. Fetal intrauterine growth restriction or chromosomal abnormalities, category 2 or 3 FHR.

研究实施时间：

Study execute time：

从 From 2024-03-25 00:00:00至 To 2024-07-25 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-03-25 00:00:00 至 To 2024-07-25 00:00:00  

干预措施：

Interventions：

组别：

实验组S

样本量：

70

Group：

The experimental group S

Sample size：

干预措施：

开放静脉，不予输液

干预措施代码：

Intervention：

Open vein, no fluids

Intervention code：

组别：

实验组L

样本量：

70

Group：

The experimental group L

Sample size：

干预措施：

L组输液量为10mL/kg/h

干预措施代码：

Intervention：

Infusion rate of 10mL/kg/h

Intervention code：

组别：

实验组H

样本量：

70

Group：

The experimental group H

Sample size：

干预措施：

H组输液量为20ml/kg/h

干预措施代码：

Intervention：

Infusion rate of 20mL/kg/h

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 杭州 

Country：

China 

Province：

Zhejaing 

City：

Hangzhou 

单位(医院)：

杭州市妇产科医院 

单位级别：

三甲 

Institution
hospital：

Hangzhou maternity 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：

分娩镇痛开始后5min/次，持续测量半小时

测量方法：

无创血压监测

Measure time point of outcome：

Measurements were taken 5 min/times for half an hour after the onset of labour analgesia.

Measure method：

Non-invasive blood pressure monitoring

指标中文名：

胎心变异

指标类型：

主要指标

Outcome：

variation in fetal heart rate

Type：

Primary indicator

测量时间点：

分娩镇痛开始半小时内，持续监测

测量方法：

胎心监护仪

Measure time point of outcome：

Continuous monitoring within half an hour of the start of labour analgesia

Measure method：

fetal heart monitor

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

no

Tissue：

no

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

no

征募研究对象情况：

Recruiting status：

尚未开始

Not yet 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）：

操作者试验开始前从纸箱中抽取分组序号

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

The operator extracts the grouping number from the carton before starting the test

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：

第一位麻醉医生只参与随机分组和硬膜外分娩镇痛，另一位麻醉医生只参与数据收集和数据统计分析，一位助产士负责胎心监护。除随机分组的第一位麻醉医师外，对其他医务人员以及受试者施盲。

Blinding：

The first anaesthetist was involved only in the randomisation group and epidural labour analgesia, another anaesthetist was involved only in data collection and statistical analysis of the data, and a midwife was responsible for fetal heart rate monitoring. Except for the first anaesthetist who was randomly grouped, the rest of the medical staff as well as the subjects were unaware of the experimental grouping.

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

No

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）：

no

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

no

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：

no

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

no

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-03-18 15:20:30