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The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202083
Recruitment Status : Unknown
Verified June 2015 by qiang wei, West China Second University Hospital.
Recruitment status was:  Recruiting
First Posted : July 28, 2014
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
qiang wei, West China Second University Hospital

Study Description
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Brief Summary:
Currently, the study about intervention on the induced abortion at trimester is so little. So, the investigators want to compare the safety and effectiveness of different induced labor.

Condition or disease Intervention/treatment Phase
Labor; Forced or Induced, Affecting Fetus or Newborn Other: Cook Balloon Phase 4

Detailed Description:
In this study , the investigators want to compare the safety and effectiveness of different induced labor. The safety and effectiveness such as the success rate of induced labor and the gestation outcome,etc.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Official Title: The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor
Study Start Date : June 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: oxytocin

There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.

This group is term gestaion,with bishop score less than 6.

 Other: Cook Balloon

There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.

This group is term gestaion,with bishop score less than 6.


Outcome Measures
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Primary Outcome Measures :
  1. The success rate of induced labor [ Time Frame: one year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestation age ≥37week
  • Single fetus
  • No serious complications

Exclusion Criteria:

  • Gestation age <37week
  • Multiple fetus
  • With serious complications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202083


Contacts
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Contact: li zhang, Dr +8613882198624

Locations
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China, Sichuan
West China Second Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: qiang wei, Dr    +8613980729930    wei.qiang.99@163.com   
Principal Investigator: qiang wei, Dr         
Sponsors and Collaborators
West China Second University Hospital
Investigators
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Study Director: li zhang, Dr West China second Hospital
More Information
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Additional Information:

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Responsible Party: qiang wei, Dr, West China Second University Hospital
ClinicalTrials.gov Identifier: NCT02202083    
Other Study ID Numbers: WCSH2014
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by qiang wei, West China Second University Hospital:
Oxytocin
Cook Balloon