ChiCTR2200065552 版本V1.1 版本创建时间2023/05/05 22:57:27 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：

 ChiCTR2200065552 

最近更新日期：

Date of Last Refreshed on：

 2022-11-08 17:24:57 

注册时间：

Date of Registration：

 2022-11-08 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于连续性伙伴关系的分娩计划书对分娩结局的影响

Public title：

The effects of birth plan based on continuous partnership on delivery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于连续性伙伴关系的分娩计划书对分娩结局的影响

Scientific title：

The effects of birth plan based on continuous partnership on delivery

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：

李彤 

研究负责人：

李彤 

Applicant：

Tong Li 

Study leader：

Tong Li 

申请注册联系人电话：

Applicant telephone：

 18289741101

研究负责人电话：

Study leader's
telephone：

18289741101

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：

 870060798@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 870060798@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www.hainmc.edu.cn/

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：

海南省海口市龙华区城西学院路三号

研究负责人通讯地址：

海南省海口市龙华区城西学院路三号

Applicant address：

No.3, Chengxi college Road, Longhua District, Haikou City, Hainan Province

Study leader's address：

No.3, Chengxi Xueyuan Road, Longhua District, Haikou City, Hainan Province

申请注册联系人邮政编码：

Applicant postcode：

 570100

研究负责人邮政编码：

Study leader's postcode：

 570100

申请人所在单位：

海南医学院

Applicant's institution：

Hai Nan Medical University

研究负责人所在单位：

海南医学院第二附属医院/ 海南医学院

Affiliation of the Leader：

The Second Affiliated Hospital of Hainan Medical University/Hai Nan Medical University

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：

 LW2022023

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：

海南医学院第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Hainan Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-12-23 00:00:00

伦理委员会联系人：

文泉

Contact Name of the ethic committee：

Quan Wen

伦理委员会联系地址：

海南省海口市龙华区椰海大道168号

Contact Address of the ethic committee：

168 Ye Hai road, Longhua District, Haikou City, Hainan Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 18808960646

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：

海南医学院第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Hainan Medical University

研究实施负责（组长）单位地址：

海南省海口市龙华区椰海大道168号

Primary sponsor's address：

168 Ye Hai road, Longhua District, Haikou City, Hainan Province, 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)：

海南

市(区县)：

海口

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

海南医学院

具体地址：

海南省海口市龙华区城西学院路三号

Institution
hospital：

Hainan Medical University

Address：

No.3, Chengxi Xueyuan Road, Longhua District, Haikou City, Hainan Province

经费或物资来源：

海南省科学基金青年项目

Source(s) of funding：

Youth Project of Hainan Provincial Science Foundation

研究疾病：

孕产期保健  

Target disease：

maternal health care

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：

制定较为严谨、科学的分娩计划书内容模板；以分娩计划书内容模板为基础、以冰山理论为指导深入剖析与挖掘孕妇需求，与孕妇建立伙伴关系制定并实施符合孕妇个人需求的分娩计划书；探讨基于伙伴关系的分娩计划书对分娩结局、产妇焦虑及分娩服务满意度的影响。  

Objectives of Study：

To develop a more rigorous and scientific content template for birthplan; Based on the content template of the birth plan and guided by the iceberg theory, in-depth analysis and exploration of the needs of pregnant women, andestablish partnership with pregnant women to develop and implement the birth plan; To explore the impact of plan based on continuous partnership outcome, maternal anxiety and birth service satisfaction.

药物成份或治疗方案详述：

在基于两轮专家咨询制定了较为严谨、科学的分娩计划书的基础上，选取 2020年6月至 2020年12月于海南省某综合性三甲医院产科进行建档并规律产检的健康初产妇 90 名为研究对象。采用随机数字表法将纳入研究对象随机分为干预组与对照组各 45 例。对照组进行常规产检及产房分娩等产科护理服务，干预组孕妇于孕 28 周（±3 天）至分娩结束通过面对面交流、陪伴产检、微信交流、电话沟通等方式与研究者建立连续性伙伴关系，结合冰山理论内涵制定分娩计划书并实施。比较两组产妇产程时间及产后2小时出血量、会阴侧切率、催产素使用率、总剖宫产率及非医学指征性剖宫产率、新生儿阿氏评分、产妇焦虑程度及分娩服务满意度等。具体干预组及对照组的方案如下： 对照组:孕妇及配偶在孕28周后的产检过程中，助产士以《孕前与孕期保健指南》（2018）为指导提供对照组孕妇及其配偶常规孕期护理服务及健康宣教，包括（1）在产科门诊定期行血压、体重、宫高腹围、胎心监护和B超等产前检查，向孕妇及配偶详细介绍各项指标意义；（2）宣传孕产期健康教育如孕期个人卫生管理、自数胎动等；（3）指导孕妇及其配偶参与线上、线下孕妇学校学习；（4）告知产程发动时征兆及表现，提供助产分娩及围产期护理等产科护理服务。对照组配偶陪伴产妇妻子产程发动时在产房外或病房内等待直至分娩结束。 干预组：干预组妇女及配偶在对照组护理基础上，助产士尝试将连续性伙伴关系为基础的分娩计划书应用于助产照护服务。具体实施如下： （1）建立伙伴关系，动态制定与修订分娩计划书 助产士与妇女在孕28周开始，通过当面交流、自我介绍、互添微信、电话建立初步联系并预约下次产检时间；孕30周至31周陪伴产检1次，耐心讲解本次产检项目、检查结果及意义，了解其孕期信息并介绍分娩计划书；孕32周至33周陪伴产检1次，掌握孕妇及胎儿健康情况及产检存在问题，以冰山理论为指导，了解孕妇显性需求并剖析其行为、神情、言语深意以深入挖掘潜在需求，与孕妇初步制定分娩计划书；孕34周至35周陪伴产检1次，与孕妇深入讨论其对分娩的需求及期望，结合产检现存问题，以倾听者角度了解孕妇希望解决现存问题的方法与喜好，并将具体方法记录于分娩计划书中；孕36周后每周陪伴产检，鼓励孕妇主动表达孕期生理变化所引发心理感受及需求，通过孕妇语言、动作、行为、微表情及家庭社会支持情况深入剖析其孕娩需求并及时修改分娩计划书，解答妇女孕期疑惑并不断完善分娩计划书。 （2）实施分娩预演 本研究将“分娩预演”纳入分娩计划书，所有实验组妇女均有实施分娩预演需求。分娩预演即对分娩流程、步骤、场景的提前模拟演练，孕37周时由助产士带着妇女及家属进入产科病房，一起预演分娩过程如下：①产前入院：指导孕妇提前备好“分娩包”，告知其产程发动前兆，向孕妇及家属演示入院流程，带领其熟悉门诊、急诊与产房位置，为入院节省时间；②产时分娩：带领孕妇参观产房环境、讲解产房设施与用途、指导孕妇上产床熟悉分娩体位，教会其呼吸与用力技巧；③产后康复与出院：带领孕妇参观产科病房，教会其母乳喂养、环保婴儿方法，指导其进行乳房按摩与凯格尔运动、讲解新生儿出生证明及出院办理注意事项。 （3）应用分娩计划书 孕妇在出现临产征兆时及时与自己的助产士电话或微信联系，助产士根据孕妇生理指征指导孕妇居家待产或陪伴其入院、帮助办理手续并完善专科检查。产时分娩时，由该助产士“一对一”陪伴并按照产妇分娩计划书中的个人意愿及需求提供产时助产照护。 

Description for medicine or protocol of treatment in detail：

From June 2020 to December 2020, a total of 90 healthy primary uniparas were selected for the study. The included subjects were randomly divided into the intervention group and the observation group by the random number table and envelope method, each group includes 45 cases. The control group was provided with routine prenatal examination and obstetric nursing services such as obstetric examination and delivery; the intervention group was provided with continuous partnership service from 28 weeks of pregnancy (±3days) to the end of delivery through face-to-face communication, accompanying prenatal examination, WeChat communication, telephone communication, etc. The birth plan was formulated based on the connotation of iceberg theory and implemented in the delivery room. The objective physiological indexes include labor time and postpartum 2h postpartum bleeding, perineal lateral incision rate, oxytocin utilization rate, total cesarean section rate and non-medically indicated cesarean section rate. The objective physiological indicators of neonatal delivery outcome include neonatal albino score, transfer rate. The subjective psychological index includes maternal and spouses anxiety level and childbirth satisfaction. In the control group, pregnant women and their spouse received routine pregnancy care and health education during pregnancy check-ups (gestational week 28 and thereafter) from midwives based on Pre-pregnancy and Pregnancy Care (2018), including (1) regular pregnancy check-ups at the obstetrics clinic (blood pressure, weight, uterine height, abdominal circumference, fetal heart rate monitoring, and?B-mode ultrasound, with a detailed explanation of each item; (2) health education about pregnancy and childbirth (e.g., personal hygiene and self-monitoring of fetal movements); (3) counseling for pregnant women and spouses in online and offline maternity school; and (4) health education for pregnant women and spouses regarding the signs and symptoms of the onset of labor and providing obstetric care and midwifery care during the birth. The spouses accompanied their wives and waited outside the delivery room or in the ward after the onset of labor until delivery. In addition to routine care, pregnant women and spouses in the experimental group received midwifery care with a continuous partnership-based birth plan that included the following. (1) Building a partnership and dynamic monitoring and revision of the birth planMidwives established the initial connection and made the next appointment for pregnancy check-ups with pregnant women at gestation week 28 through in-person communication, self-introduction, WeChat, and/or phone calls. After that, midwives accompanied pregnant women to the check-up scheduled for gestational week 30-31; patiently explained the items, results, and meaning of the check-up; learned about each womans pregnancy; and introduced the birth plan. The second time for midwives to accompany pregnant women to the check-up scheduled for gestational week 32-33, they gathered information about the health of the mother and fetus and any issues identified during the check-up; assessed the explicit needs and analyzed the behavior, facial expressions, and body language of pregnant women based on the iceberg theory to understand any hidden needs; and developed a preliminary birth plan with pregnant women. Next time scheduled for gestational week 34-35, the midwife had discussions with the pregnant women about their needs and expectations about childbirth; listened to and gained an understanding of the women methods and preferences for solving issues identified during the check-up; and recorded information in the birth plan. After week 36, the Midwife accompanied pregnant women to the check-up scheduled for every week; encouraged pregnant women to express their emotional feelings and needs caused by physical changes during pregnancy; analyzed the womens needs based on their language, actions, behaviors, micro-expressions, and family and social support; addressed any concerns about pregnancy; and continuously revised the birth plan as needed. (2) Childbirth rehearsal In this study, we included "childbirth rehearsal" in the birth plan to address a common need of the experimental group.?During childbirth rehearsal, pregnant women rehearsed the process, procedures, and setting of childbirth. At?gestational week 37, midwives took pregnant women and their family to the obstetric ward for rehearsal as follows: ① prenatal admission: instructed pregnant women to prepare a "childbirth kit" in advance, informed pregnant women and their family about the signs of the onset of labor; demonstrated the admission process to pregnant women and their family, showing the location of the clinic, emergency room, and delivery room (to save time during admission); ② childbirth: showed pregnant women the delivery room, explained to the women the delivery room facilities and uses, directed pregnant women to get onto the delivery table and become familiar with the childbirth position, and taught pregnant women about breathing and labor techniques; and ③ postpartum recovery and discharge: showed pregnant women the maternity ward, taught them about breastfeeding and environmentally friendly nursing methods, taught pregnant women about breast massage and Kegel exercises, and explained the procedures for applying for a birth certificate for the newborn and the procedures for discharge. (3) Implementation of the birth plan Pregnant women were instructed to promptly contact their midwife via phone or WeChat once they experienced signs of the onset of labor. The midwife informed the pregnant woman to stay at home or go to the hospital (accompanied by the midwife) based on physical indications and assisted in registration and special exams. During childbirth, the midwife stayed with the pregnant woman (one-on-one) and provided midwifery care based on the pregnant womans wishes and needs as recorded in the birth plan.  

纳入标准：

本研究的目标人群是孕28±3周、有意向或计划经阴道分娩的健康初产妇。
被纳入本研究的妇女符合以下标准：(1)18-35周岁；(2)孕28±3周单胎初产妇，头位;(3)胎动、胎心正常，B超证实胎儿体重、大小与孕周符合;(4)坐骨结节间径大于9cm、有阴道分娩意愿。

Inclusion criteria

The target population of this study was healthy primiparous women at gestational week 28 ± 3 who intended or planned to undergo vaginal delivery. The inclusion criteria were as follows: (1) age 18-35 years; (2) primiparous women with a single pregnancy (head down) at gestational week 28 ± 3; (3) normal fetal movement and fetal heart rate and gestational age-appropriate fetal weight and size based on B-mode ultrasound; (4) distance between the ischial tuberosities greater than 9cm; and (5) a desire for vaginal delivery.

排除标准：

排除标准：(1)存在妊娠合并症或并发症;(2)存在精神疾病或表达障碍。

Exclusion criteria：

The exclusion criteria were as follows: (1) pregnancy comorbidities or complications; or (2) mental illness or inability to express oneself.

研究实施时间：

Study execute time：

从 From 2020-01-01 00:00:00至 To 2021-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-03-01 00:00:00 至 To 2022-09-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 45

Group：

control group

Sample size：

干预措施：

基于《孕前与孕期保健指南》（2018）为指导提供对照组孕妇及其配偶常规孕期护理服务及健康宣教

干预措施代码：

Intervention：

pregnant women and their spouse received routine pregnancy care and health education during pregnancy check-ups (gestational week 28 and thereafter) from midwives based on Pre-pregnancy and Pregnancy Care

Intervention code：

组别：

干预组

样本量：

 45

Group：

Intervention group

Sample size：

干预措施：

制定并实施基于伙伴关系的分娩计划书

干预措施代码：

Intervention：

Develop and implement a birth plan based on the partnership between mothers and midwifery

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南 

市(区县)：

 海口 

Country：

China

Province：

Hainan

City：

Haikou

单位(医院)：

 海南医学院第二附属医院 

单位级别：

 公立三级甲等医院 

Institution
hospital：

The Second Affiliated Hospital of Hainan Medical University

Level of the institution：

A public tertiary hospital

测量指标：

Outcomes：

指标中文名：

分娩方式（剖宫产或阴道分娩）

指标类型：

主要指标

Outcome：

Mode of delivery (cesarean section or vaginal delivery)

Type：

Primary indicator

测量时间点：

研究对象分娩时

测量方法：

现场记录/病例档案记录

Measure time point of outcome：

During delivery period

Measure method：

指标中文名：

会阴侧切率

指标类型：

次要指标

Outcome：

Lateral perineal incision rate

Type：

Secondary indicator

测量时间点：

研究对象分娩时

测量方法：

现场记录/病例档案记录

Measure time point of outcome：

During delivery period

Measure method：

指标中文名：

新生儿阿氏评分

指标类型：

次要指标

Outcome：

Apgar score of infant

Type：

Secondary indicator

测量时间点：

第二产程后

测量方法：

现场记录/病例档案记录

Measure time point of outcome：

After the second stage of labor

Measure method：

指标中文名：

NICU转入率

指标类型：

附加指标

Outcome：

hospitalization rate of NICU

Type：

Additional indicator

测量时间点：

第二产程后

测量方法：

现场记录/病例档案记录

Measure time point of outcome：

After the second stage of labor

Measure method：

指标中文名：

产妇焦虑程度

指标类型：

次要指标

Outcome：

Maternal anxiety level

Type：

Secondary indicator

测量时间点：

入院待产时与分娩时

测量方法：

应用量表进行现场评价

Measure time point of outcome：

Admission to the hospital for labor and delivery

Measure method：

指标中文名：

产妇分娩满意度

指标类型：

附加指标

Outcome：

Maternal satisfaction with childbirth

Type：

Additional indicator

测量时间点：

产后3天内

测量方法：

现场直接问询

Measure time point of outcome：

Within 3 days after delivery

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

no

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 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）：

随机数字表法，应用计算机软件生成一组随机数字

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

We use the random number table method, the application of computer software to generate a group of random numbers

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：

考虑本研究的特殊性，体现为孕产期一种全新关系与服务工具的应用，研究对象具有一定的知情权，干预组与对照组的措施干预更直接体现在日常孕产期保健服务中，因此无法设置盲法

Blinding：

Considering the particularity of this study, it is reflected in the application of a brand new relationship and service tool during pregnancy and perinatal period. The subjects of this study have a certain right to know, and the intervention measures of the intervention group and the control group are more directly reflected in the daily pregnancy and perinatal care services, so the blind method cannot be set up

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

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）：

http://www.medresman.org.cn/pub/cn/proj/search.aspx

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

http://www.medresman.org.cn/pub/cn/proj/search.aspx

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：

本研究主要通过现场纸质版问卷填写方法来进行数据收集。纳入本研究的实验组和对照组分别独立进行填写，两组研究对象被分为实验组和对照组的比率均等(1:1)。当已知晓本研究目的、方法的潜在参与者表现出对本研究兴趣时，由研究者发放个人信息表组织参与者现场填写并回收；在两组产妇产程发动入产房待产10min内，由责任助产士以口头对话方式询问研究对象的焦虑程度并帮助其填写焦虑自评量表，第二产程初期再次以同样方式再次填写该产妇的焦虑自评量表；两组产妇分娩时由实施分娩计划书的助产士记录其分娩相关信息，包括分娩方式（剖宫产、催产素应用、会阴侧切）、新生儿Apgar评分、分娩焦虑程度及分娩满意度；产后3天内由责任助产士发放分娩满意度调查表，由产妇填写后并回收。每位研究对象的数据收集时间控制在10-15min内

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

In this study, data were primarily collected with onsite questionnaires. The experimental group and the control group (1:1) completed the questionnaires independently. When potential participants informed about the purpose and methods of this study were interested in participating, the investigators provided them with a personal information sheet and asked them to complete it on site. Once labor had started and the pregnant woman was in the delivery room, the responsible midwife asked the pregnant woman about her level of anxiety within 10 min and helped her to complete the SAS. The SAS was completed again at the start of the second stage of labor. The midwives responsible for implementing the birth plan recorded information about childbirth, including delivery method (cesarean section, use of oxytocin, and episiotomy), neonatal Apgar scores, the level of anxiety during childbirth, and satisfaction regarding childbirth. The responsible midwife distributed the questionnaire for satisfaction regarding childbirth again within 3 days of delivery to be completed by the subject. Data collection was completed in 10-15?min for each timepoint.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-11-08 17:23:49