Labor; Forced or Induced, Affecting Fetus or NewbornPhase 4NCT02202083
The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor
A Phase 4 study testing Cook Balloon in people with Labor; Forced or Induced, Affecting Fetus or Newborn, run by West China Second University Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor; Forced or Induced, Affecting Fetus or Newborn
- What is being tested?
- Cook Balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gestation age ≥37week
- Single fetus
- No serious complications
Who cannot join
- Gestation age <37week
- Multiple fetus
- With serious complications
Trial locations and contacts
1 site in 1 country.
li zhang, Dr contact
China1 site, 1 recruiting
- Recruiting
West China Second Hospital
Chengdu, Sichuan, 610041
qiang wei, Dr, +8613980729930, wei.qiang.99@163.com
qiang wei, Dr
About this study
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.
Read the 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.
- Being tested
- Cook Balloon
- Keywords
- Oxytocin, Cook Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook BalloonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | 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. Receives: Other: Cook Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of induced labor
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor; Forced or Induced, Affecting Fetus or NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, qiang wei, West China Second University Hospital
- Investigators
- li zhang, Dr, Study director, West China second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202083
- Sponsor's protocol ID
- WCSH2014
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor
- ClinicalTrials.gov ID
- NCT02202083
- Acronym / sponsor ID
- WCSH2014
- Keywords
- Oxytocin, Cook Balloon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Other: Cook BalloonThere 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestation age ≥37week
- Single fetus
- No serious complications
Key exclusion criteria (3 listed)
- Gestation age <37week
- Multiple fetus
- With serious complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook BalloonThere 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 | oxytocin |
Primary outcome
The success rate of induced labor
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- this link is the official website of our hospital.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
li zhang, Dr contact
li zhang, Dr study director
West China second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cook Balloon in people with Labor; Forced or Induced, Affecting Fetus or Newborn, run by West China Second University Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact li zhang, Dr (+8613882198624), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of induced labor (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.