ChiCTR2500108087 版本V1.0 版本创建时间2025/08/25 10:37:03 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：

 ChiCTR2500108087 

最近更新日期：

Date of Last Refreshed on：

 2025-08-25 10:36:57 

注册时间：

Date of Registration：

 2025-08-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

产时会阴热敷按摩对降低产妇会阴损伤及改善分娩结局的效果研究

Public title：

A study on the effect of perineal hot compress and massage during labor on reducing perineal injury and in parturients and improving delivery outcomes

注册题目简写：

English Acronym：

研究课题的正式科学名称：

产时会阴热敷按摩对降低产妇会阴损伤及改善分娩结局的效果研究

Scientific title：

A study on the effect of perineal hot compress and massage during labor on reducing perineal injury and in parturients and improving delivery 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：

殷一腾 

研究负责人：

殷一腾 

Applicant：

YiTeng Yin 

Study leader：

YiTeng Yin 

申请注册联系人电话：

Applicant telephone：

 +86 134 6678 4540

研究负责人电话：

Study leader's
telephone：

+86 134 6678 4540

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：

 as19880801@126.com

研究负责人电子邮件：

Study leader's E-mail：

 as19880801@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：

北京市顺义区顺康路1号

研究负责人通讯地址：

北京市顺义区顺康路1号

Applicant address：

No.1 Shunkang Road, Shunyi District, Beijing

Study leader's address：

No.1 Shunkang Road, Shunyi District, Beijing

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：

顺义妇幼保健医院

Applicant's institution：

Shunyi Maternal and Child Health Hospital

研究负责人所在单位：

顺义妇幼保健医院

Affiliation of the Leader：

Shunyi Maternal and Child Health 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：

 2025-024-1

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：

北京市顺义区妇幼保健院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shunyi District Maternal and Child Health Hospital, Beijing

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-12 00:00:00

伦理委员会联系人：

张毅

Contact Name of the ethic committee：

Yi Zhang

伦理委员会联系地址：

北京市顺义区顺康路1号

Contact Address of the ethic committee：

No.1 Shunkang Road, Shunyi District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 134 6678 4540

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：

顺义妇幼保健医院

Primary sponsor：

Shunyi Maternal and Child Health Hospital

研究实施负责（组长）单位地址：

北京市顺义区顺康路1号

Primary sponsor's address：

No.1 Shunkang Road, Shunyi District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

顺义妇幼保健医院

具体地址：

北京市顺义区顺康路1号

Institution
hospital：

Shunyi Maternal and Child Health Hospital

Address：

No.1 Shunkang Road, Shunyi District, Beijing

经费或物资来源：

院内科研基金

Source(s) of funding：

Internal Medicine Research Fund

研究疾病：

产科疾病  

Target disease：

Obstetric diseases

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在探讨产时会阴热敷按摩技术对降低初产妇会阴损伤及改善分娩结局的临床效果。通过随机对照试验，明确三项核心目标：（1）评估该技术对会阴完整率的提升效果及严重裂伤（Ⅲ-Ⅳ度）发生率的降低作用；（2）分析其对第二产程时长、会阴切开率及产妇疼痛程度的影响；（3）建立标准化操作流程（SOP），包括最佳温度（40-45℃）、按摩手法（U型定向施压）、应用时机（第二产程启动后）及操作参数（20-30秒/次，2-3次/宫缩）。研究结果将为临床提供循证依据，推动非药物性会阴保护措施的规范化应用，最终实现降低分娩创伤、优化产时护理质量的目标，响应WHO促进母婴健康的战略需求。  

Objectives of Study：

This study aims to explore the clinical effect of perineal hot compress and massage technique during labor on reducing perineal injury and improving delivery outcomes in primiparas. Through a randomized controlled trial, three core objectives are clearly defined: (1) to evaluate the effect of this technique on increasing the rate of intact perineum and reducing the incidence of severe lacerations (grade III-IV); (2) to analyze its impact on the duration of the second stage of labor, the rate of episiotomy, and the degree of pain experienced by the parturient; (3) to establish a standardized operation procedure (SOP), including the optimal temperature (40-45℃), massage technique (U-shaped directional pressure), application timing (after the start of the second stage of labor), and operation parameters (20-30 seconds per time, 2-3 times per contraction). The research results will provide evidence-based support for clinical practice, promote the standardized application of non-pharmacological perineal protection measures, and ultimately achieve the goal of reducing delivery trauma and optimizing the quality of intrapartum care, in response to the strategic needs of the WHO to promote maternal and infant health.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.均为单胎足月妊娠; 2.孕妇年龄：>=20年龄＜35岁; 3.胎儿预估体重：>=2.5kg儿预估体重<=4.0kg； 4.拟自然分娩、头位、无阴道分娩禁忌证; 5.会阴发育良好，无瘢痕; 6.产妇及家属均签署同意书。

Inclusion criteria

1. All were singleton full-term pregnancies. 2. The age of the pregnant women: >= 20 years old and < 35 years old. 3. Estimated fetal weight: >= 2.5 kg and <= 4.0 kg. 4. Planned natural delivery, cephalic presentation, and no contraindications to vaginal delivery. 5. Good perineal development without scars. 6. Both the parturient and her family members signed the consent form.

排除标准：

1.手术助产、中转剖宫产 2.胎位不正、头盆不称等; 3.产程快未应用热敷按摩； 4.孕晚期有阴道感染史及炎症； 5.伴随严重产科合并症（重度子痫前期、高度近视等）; 6.精神异常; 7.存在语言交流障碍； 8.自愿退出研究者；

Exclusion criteria：

1. Operative delivery, emergency cesarean section 2. Malpresentation, cephalopelvic disproportion, etc. 3. Rapid labor without application of hot compress and massage 4. History of vaginal infection and inflammation in the third trimester 5. Accompanied by severe obstetric complications (severe preeclampsia, high myopia, etc.) 6. Mental disorders 7. Presence of language communication barriers 8. Those who voluntarily withdrew from the study

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2027-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-01 00:00:00 至 To 2026-09-01 00:00:00

干预措施：

Interventions：

组别：

A组为对照组实施常规助产技术

样本量：

 80

Group：

Group A was the control group that received conventional midwifery techniques.

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

B组为单纯按摩组：进入第二产程，宫口开全胎先露S+2及以下至胎头拨露2cm

样本量：

 80

Group：

Group B was the simple massage group: entering the second stage of labor, the cervix was dilated and the whole fetus was exposed for S+2 or less until the fetal head was exposed for 2cm.

Sample size：

干预措施：

按摩技术：会阴冲洗消毒后，医务人员手卫生，戴无菌手套，食指与中指涂抹润滑剂（无菌石蜡油、其他无菌植物油等），在会阴后联合3点至9点区域反复涂抹润滑剂20-30秒，宫缩时再次取润滑剂，手指深入阴道2-2.5cm，从会阴3点至9点方向，以U型手法沿阴道后壁向坐骨结节方向施压，持续时间为20-30秒/次，频率为2-3次/宫缩。

干预措施代码：

Intervention：

Massage techniques After the perineum is rinsed and disinfected, medical staff should maintain hand hygiene, wear sterile gloves, and apply lubricant (sterile paraffin oil, other sterile vegetable oil, etc.) to the index and middle fingers. The lubricant should be repeatedly applied to the area from 3 to 9 on the back of the perineum for 20 to 30 seconds. When contractions occur, the lubricant should be removed again. The fingers should be inserted into the vagina for 2 to 2.5cm, starting from 3 to 9 on the perineum. Apply pressure along the posterior vaginal wall towards the ischial tubercle in a U-shaped manner for 20 to 30 seconds each time, with a frequency of 2 to 3 contractions per uterine contraction.

Intervention code：

组别：

C组为热敷+按摩组：进入第二产程，宫口开全胎先露S+2及以下至胎头拨露2cm。

样本量：

 80

Group：

Group C was the hot compress + massage group: entering the second stage of labor, the cervix was dilated and the whole fetus was exposed for S+2 or less until the fetal head was exposed for 2cm.

Sample size：

干预措施：

热敷参数：采用40-45℃无菌盐水纱布包，每宫缩间歇期覆盖会阴部，持续20-30秒。按摩技术：会阴冲洗消毒后，医务人员手卫生，戴无菌手套，食指与中指涂抹润滑剂（无菌石蜡油、其他无菌植物油等），在会阴后联合3点至9点区域反复涂抹润滑剂20-30秒，宫缩时再次取润滑剂，手指深入阴道2-2.5cm，从会阴3点至9点方向，以U型手法沿阴道后壁向坐骨结节方向施压，持续时间为20-30秒/次，频率为2-3次/宫缩。

干预措施代码：

Intervention：

Hot compress parameters: Use e bag at 40-45℃ to cover the perineum during the intervals between uterine contractions for 20-30 seconds. Massage techniques After the perineum is rinsed and disinfected, medical staff should maintain hand hygiene, wear sterile gloves, and apply lubricant (sterile paraffin oil, other sterile vegetable oil, etc.) to the index and middle fingers. The lubricant should be repeatedly applied to the area from 3 to 9 on the back of the perineum for 20 to 30 seconds. When contractions occur, the lubricant should be removed again. The fingers should be inserted into the vagina for 2 to 2.5cm, starting from 3 to 9 on the perineum. Apply pressure along the posterior vaginal wall towards the ischial tubercle in a U-shaped manner for 20 to 30 seconds each time, with a frequency of 2 to 3 contractions per uterine contraction.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 北京 

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

 顺义妇幼保健医院 

单位级别：

 三甲 

Institution
hospital：

Shunyi Maternal and Child Health Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

会阴裂伤程度

指标类型：

主要指标

Outcome：

The degree of perineal laceration

Type：

Primary 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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 20 岁 years
最大 Max age 35 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）：

采用简单随机分组方式，应用随机数字表法随机分组。获取随机数字表；编号：将所有研究对象进行统一编号，按照就诊顺序，编号01到240（预留安全边际情况下）；选择起点：在随机数字表上随机选择一个起点；录取号码：从选定的起点开始，按照自左向右的顺序方向依次录取号码，遇到大于总体的号码或重复的号码应舍去不要，直至录取到所需的样本数240；分组：随机数除以组数（本例中为3）求余数，余数1、2、3分别代表进入试验组、对照1组和对照2组。调整：如果分组不均等，继续从随机数字表中获取更多的随机数，并根据这些数字将参与者分配到人数较少的组中，直到各组数目相等。确认分组：确保每组的人数相等，并确认每个研究对象都被正确地分配到了相应的组别。

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

A simple random grouping method was adopted, and random grouping was carried out using the random number table method. Obtain the random number table; Numbering: All research subjects should be uniformly numbered in the order of their visits, from 01 to 240 (provided a margin of safety is reserved). Select the starting point: Randomly choose a starting point from the random number table; Admission numbers: Starting from the selected starting point, admit numbers in sequence from left to right. If there are numbers larger than the total or duplicate numbers, they should be discarded until the required sample size of 240 is admitted. Grouping: Divide the random number by the number of groups (in this case, it is 3) to find the remainder. The remainder 1, 2, and 3 represent the entry into the experimental group, control group 1, and control group 2, respectively. Adjustment: If the groups are not evenly divided, continue to obtain more random numbers from the random number table and assign participants to smaller groups based on these numbers until the number of participants in each group is equal. Confirm grouping: Ensure that the number of people in each group is equal and confirm that each research subject has been correctly assigned to the corresponding 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：

开放标签

Blinding：

Open label

是否共享原始数据：

IPD sharing

否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）：

2028年1月后，as19880801@126.com

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

Via email (as19880801@126.com) after January 2028

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：

CRF

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

CRF

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：

  2025-08-25 10:36:57