The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor

Labor; Forced or Induced, Affecting Fetus or Newborn Clinical Trial

Official title:

The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02202083
• Other study ID #: WCSH2014
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2014
• Last updated: June 4, 2015
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: West China Second University Hospital
• Contact: li zhang, Dr
• Phone: +8613882198624
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Gestation age =37week

• Single fetus

• No serious complications

Exclusion Criteria:

• Gestation age <37week

• Multiple fetus

• With serious complications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

• Labor; Forced or Induced, Affecting Fetus or Newborn

Intervention

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.

Locations

Country	Name	City	State
China	West China Second Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of induced labor		one year	Yes

External Links

•   this link is the official website of our hospital.