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Induction of labor by oral misoprostol solution
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注册号：

Registration number：

 ChiCTR2100047385 

最近更新日期：

Date of Last Refreshed on：

 2021-06-13 07:52:37 

注册时间：

Date of Registration：

 2021-06-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Induction of labor by oral misoprostol solution

Public title：

Induction of labor by oral misoprostol solution

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Randomized control study of titrated and static oral misoprostol solution for induction of labor at term

Scientific title：

A Randomized control study of titrated and static oral misoprostol solution for induction of labor at term

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：

Dr Barbie Sharma 

研究负责人：

Dr Barbie Sharma 

Applicant：

Dr Barbie Sharma 

Study leader：

Dr Barbie Sharma 

申请注册联系人电话：

Applicant telephone：

 +91 88 00328108

研究负责人电话：

Study leader's
telephone：

+91 88 00328108

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：

 barbiesharma.9@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 barbiesharma.9@gmail.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：

Department of Obstetrics and Gynecology, Christian Medical College and Hospital, Ludhiana, Punjab, India

研究负责人通讯地址：

Department of Obstetrics and Gynecology, Christian Medical College and Hospital, Ludhiana, Punjab, India

Applicant address：

Department of Obstetrics and Gynecology, Christian Medical College and Hospital, Ludhiana, Punjab, India

Study leader's address：

Department of Obstetrics and Gynecology, Christian Medical College and Hospital, Ludhiana, Punjab, India

申请注册联系人邮政编码：

Applicant postcode：

 141008

研究负责人邮政编码：

Study leader's postcode：

 141008

申请人所在单位：

印度旁遮普邦卢迪亚纳基督教医学院及医院

Applicant's institution：

Christian Medical College and Hospital, Ludhiana, Punjab

研究负责人所在单位：

印度旁遮普邦卢迪亚纳基督教医学院及医院

Affiliation of the Leader：

Christian Medical College and Hospital, Ludhiana, Punjab

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：

 201801-018-IEC/CMCL-APPRVL-PG.THESIS/OB & GYN

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：

Institutional research and ethics committee

Name of the ethic committee：

Institutional research and ethics committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-01-18 00:00:00

伦理委员会联系人：

Institutional research and ethics committee

Contact Name of the ethic committee：

Institutional research and ethics committee

伦理委员会联系地址：

印度旁遮普邦卢迪亚纳基督教医学院及医院

Contact Address of the ethic committee：

Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab, India,141008

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +91 0161-210856

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ethicscmcl@gmail.com

研究实施负责（组长）单位：

Dr Barbie Sharma

Primary sponsor：

Dr Barbie Sharma

研究实施负责（组长）单位地址：

印度旁遮普邦卢迪亚纳基督教医学院及医院

Primary sponsor's address：

Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab, India,141008

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Dr Barbie Sharma

Source(s) of funding：

Dr Barbie Sharma

研究疾病：

Induction of labor  

Target disease：

Induction of labor

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：

Our objective in this study was to evaluate effectiveness and safety of titrated oral misoprostol solution in comparison with static-dose oral misoprostol solution for induction of labor at term.  

Objectives of Study：

Our objective in this study was to evaluate effectiveness and safety of titrated oral misoprostol solution in comparison with static-dose oral misoprostol solution for induction of labor at term.

药物成份或治疗方案详述：

Method Of Preparation Of Oral Misoprostol Solution: Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours. Method of administration: A) TITRATED OMS GROUP: All the women enrolled into the group A were given oral misoprostol solution according to the regimen described by Wang X et al, 2016. B) STATIC OMS GROUP: In group B, the recommended FIGO regimen was used. Oral misoprostol solution 25 mcg (25 ml) was administered every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity. 

Description for medicine or protocol of treatment in detail：

Method Of Preparation Of Oral Misoprostol Solution: Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours. Method of administration: A) TITRATED OMS GROUP: All the women enrolled into the group A were given oral misoprostol solution according to the regimen described by Wang X et al, 2016. B) STATIC OMS GROUP: In group B, the recommended FIGO regimen was used. Oral misoprostol solution 25 mcg (25 ml) was administered every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity. 

纳入标准：

Inclusion criteria

排除标准：

1) Hypersensitivity to misoprostol;
2) Uterine scar due to previous cesarean section or other uterine surgery;
3) Grand multipara;
4) Multiple gestations;
5) High risk pregnancies preeclampsia with severe features significant maternal cardiac, renal, liver disease;
6) Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage;
7) Intrauterine fetal demise.

Exclusion criteria：

1) Hypersensitivity to misoprostol;
2) Uterine scar due to previous cesarean section or other uterine surgery;
3) Grand multipara;
4) Multiple gestations;
5) High risk pregnancies preeclampsia with severe features significant maternal cardiac, renal, liver disease;
6) Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage;
7) Intrauterine fetal demise.

研究实施时间：

Study execute time：

从 From 2017-11-01 00:00:00至 To 2019-12-24 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-12-01 00:00:00 至 To 2018-11-30 00:00:00

干预措施：

Interventions：

组别：

titrated oral misoprostol solution versus static-dose oral misoprostol solution

样本量：

 264

Group：

titrated oral misoprostol solution versus static-dose oral misoprostol solution

Sample size：

干预措施：

titrated oral misoprostol solution versus static-dose oral misoprostol solution

干预措施代码：

Intervention：

titrated oral misoprostol solution versus static-dose oral misoprostol solution

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度

省(直辖市)：

 旁遮普 

市(区县)：

 卢迪亚纳 

Country：

India

Province：

Punjab

City：

Ludhiana

单位(医院)：

 基督教医学院及医院 

单位级别：

  

Institution
hospital：

Christian Medical College and Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Induction to delivery time

指标类型：

主要指标

Outcome：

Induction to delivery time

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：

no

组织：

Sample Name：

N/A

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 40 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）：

Women were randomized (1:1) into the treatment groups A) Titrated-dose OMS group B) Static dose OMS group; using computer generated number sequence.

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

Women were randomized (1:1) into the treatment groups A) Titrated-dose OMS group B) Static dose OMS group; using computer generated number sequence.

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：

Study investigators and attending care teams were aware of the allocated arm, patients were kept blinded to the allocation. Study investigators and outcome assessors could not be blinded as the data collection and analysis included outcome measures timing of oral misoprostol solution doses.

Blinding：

Study investigators and attending care teams were aware of the allocated arm, patients were kept blinded to the allocation. Study investigators and outcome assessors could not be blinded as the data collection and analysis included outcome measures timing of oral misoprostol solution doses.

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）：

https://figshare.com/s/7d016cc29a1be1419f63

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

https://figshare.com/s/7d016cc29a1be1419f63

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：

https://figshare.com/s/3571b3e03e08843dccd3

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

https://figshare.com/s/3571b3e03e08843dccd3

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-06-13 07:52:37
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