Prolonged LaborNCT01402310
Bishop Score, Cervical Length and Multiple Proteins in Cervicovaginal Fluid at 40 Weeks to Predict Onset of Labor
An observational study of Prolonged Labor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare Bishop score, sonographic cervical length and multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to spontaneous labor and mode of delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prolonged Labor
- What is being tested?
- Ultrasound and digital cervical examination
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Sep 2012
- Phase
- Observational
- 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
Study population: Single tertiary hospital
Who may be able to join
- Women between 39+6 and 40+1 weeks of gestation
- singleton pregnancy
- viable fetus with vertex presentation
- intact amniotic membranes
- no pregnancy complications
- absence of labor
- no history of previous uterine surgery
- planned vaginal delivery
Who cannot join
None listed.
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
The purpose of this study is to compare Bishop score, sonographic cervical length and multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to spontaneous labor and mode of delivery.
- Conditions
- Prolonged Labor
- Being tested
- Ultrasound and digital cervical examination
- Keywords
- Onset of labor, Bishop score, Cervical length, Multiple proteins, Cervicovaginal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and digital cervical examinationOther
Cervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples
| Study group | Role | What they receive |
|---|---|---|
| Women attending antenatal clinic | Women attending antenatal clinic were consecutively enrolled at between 39+6 and 40+1 weeks of gestation. Receives: Other: Ultrasound and digital cervical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of labor/delivery ≤10days
Measured: Baseline
Secondary outcomes (1)
Cesarean delivery in labor
- Time to onset of spontaneous labor
- Postterm delivery (≥40 + 11 weeks of pregnancy)
- The rate of cesarean delivery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startNov 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyo Hoon Park, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402310
- Sponsor's protocol ID
- BS_CL_40wk
- Status last verified
- Dec 2013
- First submitted
- 17 Mar 2011
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bishop Score, Cervical Length and Multiple Proteins in Cervicovaginal Fluid at 40 Weeks to Predict Onset of Labor
- ClinicalTrials.gov ID
- NCT01402310
- Acronym / sponsor ID
- BS_CL_40wk
- Conditions
- Prolonged Labor
- Keywords
- Onset of labor, Bishop score, Cervical length, Multiple proteins, Cervicovaginal fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jul 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.
The purpose of this study is to compare Bishop score, sonographic cervical length and multiple proteins in cervicovaginal fluid at 40 weeks gestation to predict time to spontaneous labor and mode of delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women attending antenatal clinic | – | Other: Ultrasound and digital cervical examinationWomen attending antenatal clinic were consecutively enrolled at between 39+6 and 40+1 weeks of gestation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Single tertiary hospital
Key inclusion criteria (8 listed)
- Women between 39+6 and 40+1 weeks of gestation
- singleton pregnancy
- viable fetus with vertex presentation
- intact amniotic membranes
- no pregnancy complications
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound and digital cervical examinationCervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples | Other | Women attending antenatal clinic |
Primary outcome
Onset of labor/delivery ≤10days
Time frame: Baseline
1 secondary outcome
Cesarean delivery in labor
Time frame: Baseline
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 10 Dec 2013.
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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?
An observational study of Prolonged 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 8 inclusion and 0 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 10 Dec 2013. 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?
Onset of labor/delivery ≤10days (time frame: Baseline). 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 10 Dec 2013.