Failed Induction of LaborNCT01317706
Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment
A study testing Assessment of cervical status in people with Failed Induction of Labor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Failed Induction of Labor
- What is being tested?
- Assessment of cervical status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Aug 2010
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- nulliparous patients
- singleton pregnancy
- live fetus with vertex presentation
- intact amniotic membranes
- > 37 weeks gestation
- absence of labor
- no previous uterine surgical procedures
Who cannot join
- major congenital anomaly
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term.
- Conditions
- Failed Induction of Labor
- Being tested
- Assessment of cervical status
- Keywords
- Bishop score, Cervical length, Cervical ripening, Labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of cervical statusOther
Assessment of cervical status based on Bishop score versus sonographically measured cervical length
| Study group | Role | What they receive |
|---|---|---|
| Bishop score | Active comparator | Not described Receives: Other: Assessment of cervical status |
| transvaginal ultrasound | Active comparator | Not described Receives: Other: Assessment of cervical status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful labor induction
Induction success was defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥ 4 cm within 11 hours of initiating oxytocin (i.e., within 22 hours of the administration of a dinoprostone vaginal insert) on the first day of induction.
Measured: Eleven hours of initiating oxytocin on the fist day of induction
Secondary outcomes (1)
the need for oxytocin induction
- the interval from start of oxytocin to the active phase of labor
- the interval from start of oxytocin to delivery
- vaginal delivery within 24 hours of starting induction
- the incidence of cesarean delivery
Measured: After removing prostaglandin, the following day when an intravenous oxytocin infusion was started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startNov 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Induction of LaborStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyo Hoon Park, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317706
- Sponsor's protocol ID
- BS_CL_01
- Status last verified
- Mar 2011
- First submitted
- 16 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment
- ClinicalTrials.gov ID
- NCT01317706
- Acronym / sponsor ID
- BS_CL_01
- Conditions
- Failed Induction of Labor
- Keywords
- Bishop score, Cervical length, Cervical ripening, Labor induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Mar 2011 (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.
To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bishop score | Active comparator | Other: Assessment of cervical status |
| transvaginal ultrasound | Active comparator | Other: Assessment of cervical status |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- nulliparous patients
- singleton pregnancy
- live fetus with vertex presentation
- intact amniotic membranes
- > 37 weeks gestation
Key exclusion criteria (1 listed)
- major congenital anomaly
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 |
|---|---|---|
| Assessment of cervical statusAssessment of cervical status based on Bishop score versus sonographically measured cervical length | Other | Bishop score, transvaginal ultrasound |
Primary outcome
Successful labor induction
Time frame: Eleven hours of initiating oxytocin on the fist day of induction
Induction success was defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥ 4 cm within 11 hours of initiating oxytocin (i.e., within 22 hours of the administration of a dinoprostone vaginal insert) on the first day of induction.
1 secondary outcome
the need for oxytocin induction
Time frame: After removing prostaglandin, the following day when an intravenous oxytocin infusion was started
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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.
Kyo Hoon Park, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of cervical status in people with Failed Induction of Labor, run by Seoul National University Hospital at 1 site in South Korea.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2011. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful labor induction (time frame: Eleven hours of initiating oxytocin on the fist day of induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2011.