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Is it cost effective to start early oral maternal feeding after cesarean section under regional anesthesia - A cross sectional study trial in Pakistan
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注册号：

Registration number：

 ChiCTR-IOR-17012898 

最近更新日期：

Date of Last Refreshed on：

 2017-10-08 12:01:29 

注册时间：

Date of Registration：

 2017-10-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Is it cost effective to start early oral maternal feeding after cesarean section under regional anesthesia - A cross sectional study trial in Pakistan

Public title：

Is it cost effective to start early oral maternal feeding after cesarean section under regional anesthesia - A cross sectional study trial in Pakistan

注册题目简写：

English Acronym：

EF vs DF

研究课题的正式科学名称：

Is it cost effective to start early oral maternal feeding after cesarean section under regional anesthesia - A cross sectional study trial in Pakistan

Scientific title：

Is it cost effective to start early oral maternal feeding after cesarean section under regional anesthesia - A cross sectional study trial in Pakistan

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：

ProF. Dr Shabeen Naz Masood 

研究负责人：

ProF. Dr Shabeen Naz Masood 

Applicant：

Prof. Dr Shabeen Naz Masood 

Study leader：

Prof. Dr Shabeen Naz Masood 

申请注册联系人电话：

Applicant telephone：

 +92 333 32233414

研究负责人电话：

Study leader's
telephone：

+92 333 2233414

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：

 sh_naz@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 sh_naz@yahoo.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：

U-19, Hasan Apartment Extension, Hasan Square, Gulshan-e-Iqbal, Block-13D, Karachi, PAKISTAN.

研究负责人通讯地址：

U-19, Hasan Apartment Extension, Hasan Square, Gulshan-e-Iqbal, Block-13D, Karachi, PAKISTAN.

Applicant address：

U-19, Hasan Apartment Extension, Hasan Square, Gulshan-e-Iqbal, Block-13D, Karachi, PAKISTAN.

Study leader's address：

U-19, Hasan Apartment Extension, Hasan Square, Gulshan-e-Iqbal, Block-13D, Karachi, PAKISTAN.

申请注册联系人邮政编码：

Applicant postcode：

 75300

研究负责人邮政编码：

Study leader's postcode：

 75300

申请人所在单位：

Room 18, 4th Floor, International center for Clinical Research Pakistan, Fatima Bai Hospital, Business Recorder Road, Garden East, Karachi, PAKISTAN.

Applicant's institution：

Room 18, 4th Floor, International center for Clinical Research Pakistan, Fatima Bai Hospital, Business Recorder Road, Garden East, Karachi, PAKISTAN.

研究负责人所在单位：

Room 18, 4th Floor, International center for Clinical Research Pakistan, Fatima Bai Hospital, Business Recorder Road, Garden East, Karachi, PAKISTAN

Affiliation of the Leader：

Room 18, 4th Floor, International center for Clinical Research Pakistan, Fatima Bai Hospital, Business Recorder Road, Garden East, Karachi, PAKISTAN.

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：

 ERB/FBH-17-0020

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：

Ethical Review Board Fatima Bai Hospital

Name of the ethic committee：

Ethical Review Board Fatima Bai Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-06-05 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

Fatima Bai Hospital

Primary sponsor：

Fatima Bai Hospital

研究实施负责（组长）单位地址：

Plot no 511-24, Fatima Bai Hospital, Business Recorder Road, Garden East, Karachi, PAKISTAN.

Primary sponsor's address：

Plot no 511-24, Fatima Bai Hospital, Business Recorder Road, Garden East, Karachi, PAKISTAN.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Haji Yaqoob Wali Mohammad Ghandi Foundation

Source(s) of funding：

Haji Yaqoob Wali Mohammad Ghandi Foundation

研究疾病：

Cesarean Section  

Target disease：

Cesarean Section

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To assess if early oral maternal feeding in uncomplicated C-Sec is cost effective and can be made a 5 daycare procedure. Primary Objective: To estimate the post-operative cost difference in out of pocket expenditures between early oral maternal feeding and conventional maternal feeding in uncomplicated Caesarean births under regional anesthesia (RA) from the provider (hospital) and user (patient) perspective. Secondary Objective: To estimate the readmission rate of mother and neonate as a result of early discharge from hospital.  

Objectives of Study：

To assess if early oral maternal feeding in uncomplicated C-Sec is cost effective and can be made a 5 daycare procedure. Primary Objective: To estimate the post-operative cost difference in out of pocket expenditures between early oral maternal feeding and conventional maternal feeding in uncomplicated Caesarean births under regional anesthesia (RA) from the provider (hospital) and user (patient) perspective. Secondary Objective: To estimate the readmission rate of mother and neonate as a result of early discharge from hospital.

药物成份或治疗方案详述：

As per surgeon practices, women in the early feeding group will be given 250cc of liquid (water, tea, coffee, tetra pack milk, canned juice) 2 hour after the surgery. Solid diet will be allowed after one hour of the liquid diet. Out of bed mobility will be encouraged within 7 – 8 hours post C-Section and intravenous fluids will be stopped after 12 hours of surgery. The women will be discharged within 30-36 hours after surgery. The post-operative expenses, the drug and supplies will be calculated including room, bed occupancy charges, nursing, and housekeeping. The women undergoing C-sec for surgeons practicing delayed feeding will follow the conventional method of feeding as observed earlier by research team and confirm by interviewing the doctors and nursing staff before making this proposal. As per prevalent conventional practice of doctors, they will be given a liquid diet after more than 6 – 12 hours of the surgery and solid diet after 12 – 18 hrs. The patient will be on I/V fluids for about 18 hours and usually are not encouraged to move out of bed before 18 -24 hours after C-Section. Post-operative expenditures between both the groups will be calculated. Prolonged stay due to delayed introduction of food and readmission rate of women and neonate as a result of early discharge will also be analyzed.  

Description for medicine or protocol of treatment in detail：

As per surgeon practices, women in the early feeding group will be given 250cc of liquid (water, tea, coffee, tetra pack milk, canned juice) 2 hour after the surgery. Solid diet will be allowed after one hour of the liquid diet. Out of bed mobility will be encouraged within 7 – 8 hours post C-Section and intravenous fluids will be stopped after 12 hours of surgery. The women will be discharged within 30-36 hours after surgery. The post-operative expenses, the drug and supplies will be calculated including room, bed occupancy charges, nursing, and housekeeping. The women undergoing C-sec for surgeons practicing delayed feeding will follow the conventional method of feeding as observed earlier by research team and confirm by interviewing the doctors and nursing staff before making this proposal. As per prevalent conventional practice of doctors, they will be given a liquid diet after more than 6 – 12 hours of the surgery and solid diet after 12 – 18 hrs. The patient will be on I/V fluids for about 18 hours and usually are not encouraged to move out of bed before 18 -24 hours after C-Section. Post-operative expenditures between both the groups will be calculated. Prolonged stay due to delayed introduction of food and readmission rate of women and neonate as a result of early discharge will also be analyzed.  

纳入标准：

Inclusion criteria

排除标准：

1. Vaginal births;
2. Women who are insured or paid by third party.

Exclusion criteria：

1. Vaginal births;
2. Women who are insured or paid by third party.

研究实施时间：

Study execute time：

从 From 2017-09-25 00:00:00至 To 2018-09-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-10-09 00:00:00 至 To 2018-07-31 00:00:00

干预措施：

Interventions：

组别：

Early Feeding

样本量：

 199

Group：

Early Feeding

Sample size：

干预措施：

Liquid 250cc (water, tea, coffee, tetra pack milk, canned juice) 2 hours after the surgery. Solid diet will be allowed after one hour of the liquid diet.

干预措施代码：

Intervention：

Liquid 250cc (water, tea, coffee, tetra pack milk, canned juice) 2 hours after the surgery. Solid diet will be allowed after one hour of the liquid diet.

Intervention code：

组别：

Delayed Feeding

样本量：

 199

Group：

Delayed Feeding

Sample size：

干预措施：

Liquid diet will be allowed after 6 – 12 hours of the surgery and solid diet will be started after 12 – 18 hours of surgery.

干预措施代码：

Intervention：

Liquid diet will be allowed after 6 – 12 hours of the surgery and solid diet will be started after 12 – 18 hours of surgery.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Pakistan

省(直辖市)：

 Sindh 

市(区县)：

 Karachi 

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

 Fatima Bai Hospital 

单位级别：

 Trust-based 

Institution
hospital：

Fatima Bai Hospital

Level of the institution：

Trust-based

国家：

 Pakistan

省(直辖市)：

 Sindh 

市(区县)：

 Hyderabad 

Country：

Pakistan

Province：

Sindh

City：

Hyderabad

单位(医院)：

 Countess of Dufferin 

单位级别：

 Government-based 

Institution
hospital：

Countess of Dufferin

Level of the institution：

Government-based

测量指标：

Outcomes：

指标中文名：

Cost effectiveness

指标类型：

主要指标

Outcome：

Cost effectiveness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Readmission rate

指标类型：

次要指标

Outcome：

Readmission rate

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：

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 岁 years
最大 Max age 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）：

A computer generated random number sequence will be followed for randomization.

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

A computer generated random number sequence will be followed for randomization.

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：

Blinding：

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

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）：

Not applicable

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

Not applicable

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：

Not applicable

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

Not applicable

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2017-10-08 12:01:29
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