复发性流产患者婚姻质量与生育压力的相关性研究

注册号:

Registration number:

ChiCTR2600118777 

最近更新日期:

Date of Last Refreshed on:

2026-02-10 17:51:24 

注册时间:

Date of Registration:

2026-02-10 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

复发性流产患者婚姻质量与生育压力的相关性研究

Public title:

A Study on the Correlation between Marital Quality and Fertility Pressure in Patients with Recurrent Miscarriage

注册题目简写:

English Acronym:

研究课题的正式科学名称:

复发性流产患者婚姻质量与生育压力的相关性研究

Scientific title:

A Study on the Correlation between Marital Quality and Fertility Pressure in Patients with Recurrent Miscarriage

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:

刘玉琳 

研究负责人:

覃晓玲 

Applicant:

Yulin Liu 

Study leader:

xiaoling qin 

申请注册联系人电话:

Applicant telephone:

+86 188 2778 9049

研究负责人电话:

Study leader's
telephone:

+86 188 2778 9049

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:

3465262600@qq.com

研究负责人电子邮件:

Study leader's E-mail:

3465262600@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:

广东省深圳市福田区福保街道号3012号

研究负责人通讯地址:

广东省深圳市福田区福保街道号3012号

Applicant address:

No. 3012, Fubao Street, Futian District, Shenzhen, Guangdong, China

Study leader's address:

No. 3012, Fubao Street, Futian District, Shenzhen, Guangdong, 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:

深圳市妇幼保健院

Applicant's institution:

Shenzhen Maternity and Child Healthcare Hospital

研究负责人所在单位:

深圳市妇幼保健院

Affiliation of the Leader:

Shenzhen Maternity and Child Healthcare Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

SFYLS[2026]008

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:

深圳市妇幼保健院科研伦理委员会

Name of the ethic committee:

Ethics Committee of the Shenzhen Maternity and Child Healthcare Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-27 00:00:00

伦理委员会联系人:

戴宇婷

Contact Name of the ethic committee:

Yuting Dai

伦理委员会联系地址:

广东省深圳市福田区福保街道号3012号

Contact Address of the ethic committee:

No. 3012, Fubao Street, Futian District, Shenzhen, Guangdong, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 82869849

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:

深圳市妇幼保健院

Primary sponsor:

Shenzhen Maternity and Child Healthcare Hospital

研究实施负责(组长)单位地址:

广东省深圳市福田区福保街道号3012号

Primary sponsor's address:

No. 3012, Fubao Street, Futian District, Shenzhen, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

深圳市妇幼保健院

具体地址:

广东省深圳市福田区福保街道号3012号

Institution
hospital:

Shenzhen Maternity and Child Healthcare Hospital

Address:

No. 3012, Fubao Street, Futian District, Shenzhen, Guangdong, China

经费或物资来源:

Source(s) of funding:

None

研究疾病:

复发性流产  

Target disease:

Recurrent abortion

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

本研究调查复发性流产患者婚姻质量现状并分析其与生育压力的相关性,旨在为后续降低复发性流产患者生育压力、提高婚姻幸福感的干预策略提供参考。  

Objectives of Study:

This study investigates the current marital quality of patients with recurrent miscarriage and analyzes its correlation with fertility pressure, aiming to provide references for subsequent intervention strategies to reduce fertility pressure and enhance marital happiness for these patients.

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

排除标准:

(1)合并躯体疾病(如恶性肿瘤等)和(或)严重精神疾病。 (2)合并严重视力、听力障碍。 (3)处于其他疾病急性期,或合并严重肝肾功能、心肺功能损害。

Exclusion criteria:

(1) Comorbid with physical diseases (such as malignant tumors, etc.) and/or severe mental disorders. (2) Comorbid with severe visual or hearing impairments. (3) In the acute stage of other diseases,or comorbid with severe liver and kidney function, or cardiac and pulmonary function impairments.

研究实施时间:

Study execute time:

From 2026-02-17 00:00:00 To 2027-01-27 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-02-17 00:00:00 To 2027-01-27 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

253

Group:

Observation group

Sample size:

干预措施:

本研究采用问卷调查,无干预措施

干预措施代码:

Intervention:

This study used a questionnaire survey, no intervention measures.

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):

深圳市妇幼保健院 

单位级别:

三甲 

Institution
hospital:

Shenzhen Maternity and Child Healthcare Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

生育压力量表得分

指标类型:

主要指标

Outcome:

Fertility stress scale score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一般资料

指标类型:

次要指标

Outcome:

General Information

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:

组织:

Sample Name:

no

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 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):

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

None

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:

Blinding:

None

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):

邮箱索取

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

3465262600@qq.com

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:

数据采集使用纸质病例记录表,数据管理采用excel

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

Paper version of case record form will be used for data collection.excel will be uesd for data management

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:

 2026-02-10 17:51:16