Induction of Labor Affected Fetus / NewbornNCT04220320
The Success of Labor Induction Based on a Modified BISHOP Score.
An observational study of Induction of Labor Affected Fetus / Newborn, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Pregnant women at term will be divided randomly into 3 groups: 1. Gynecological evaluation based on classic BISHOP score. 2. Gynecological evaluation based on a modified BISHOP score. 3. Gynecological evaluation based on cervical length as measured by transvaginal sonography. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Vaginal examination. and Transvaginal sonography.
- How many people
- 758 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 1 Oct 2022
- 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 18 to 45 years
- Women only
- Adult
Study population: Pregnant women over 37 weeks' gestation that are candidates for induction of labor for obstetric/other medical indications.
Who may be able to join
- Singleton pregnancies.
- Candidates for vaginal delivery.
Who cannot join
- Multiple pregnancies.
- Candidates for cesarean section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Success of Labor Induction Based on a Modified BISHOP Score Compared to Classic BISHOP Score and Cervical Length in Transvaginal Sonography.
Pregnant women at term will be divided randomly into 3 groups:
- Gynecological evaluation based on classic BISHOP score.
- Gynecological evaluation based on a modified BISHOP score.
- Gynecological evaluation based on cervical length as measured by transvaginal sonography.
After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.
Read the detailed description
Women presenting to the obstetric emergency room for follow-up for various obstetric/other medical conditions over 37 weeks' gestation that are candidates for labor induction will receive an explanation regarding the study and sign informed consent.
The women will be divided randomly into 3 groups:
- Gynecological evaluation based on classic BISHOP score.
- Gynecological evaluation based on a modified BISHOP score.
- Gynecological evaluation based on cervical length as measured by transvaginal sonography.
After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.
- Being tested
- Vaginal examination., Transvaginal sonography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal examination.Diagnostic test
Cervical properties as evaluated by a vaginal examination.
Transvaginal sonography.Diagnostic test
Cervical length as evaluated by a transvaginal sonography.
| Study group | Role | What they receive |
|---|---|---|
| Classic BISHOP score | Gynecological evaluation based on vaginal examination including cervical dilatation, effacement, texture, station and position. Receives: Diagnostic Test: Vaginal examination. | |
| Modified BISHOP score | Gynecological evaluation based on vaginal examination including cervical dilatation and effacement alone. Receives: Diagnostic Test: Vaginal examination. | |
| Cervical Length | Gynecological evaluation based on cervical length measured by transvaginal sonography. Receives: Diagnostic Test: Transvaginal sonography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to delivery
The time from induction commencement to delivery of the newborn.
Measured: Up to 72 hours.
Secondary outcomes (1)
BISHOP score after primary induction.
BISHOP score after primary induction. BISHOP is not an abbreviation and is just the name of the score. The minimum score is 0 and the maximum score is 13. The higher the score, the more favorable the cervix is considered before induction of labor.
Measured: Up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Mar 2020
- Primary completion30 Apr 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 758 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220320
- Sponsor's protocol ID
- 0622-19-RMB
- Status last verified
- Oct 2022
- First submitted
- 5 Jan 2020
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success of Labor Induction Based on a Modified BISHOP Score Compared to Classic BISHOP Score and Cervical Length in Transvaginal Sonography.
- ClinicalTrials.gov ID
- NCT04220320
- Acronym / sponsor ID
- 0622-19-RMB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 758 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- 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.
Pregnant women at term will be divided randomly into 3 groups:
- Gynecological evaluation based on classic BISHOP score.
- Gynecological evaluation based on a modified BISHOP score.
- Gynecological evaluation based on cervical length as measured by transvaginal sonography.
After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.
Detailed description
Women presenting to the obstetric emergency room for follow-up for various obstetric/other medical conditions over 37 weeks' gestation that are candidates for labor induction will receive an explanation regarding the study and sign informed consent.
The women will be divided randomly into 3 groups:
- Gynecological evaluation based on classic BISHOP score.
- Gynecological evaluation based on a modified BISHOP score.
- Gynecological evaluation based on cervical length as measured by transvaginal sonography.
After gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classic BISHOP score | – | Diagnostic Test: Vaginal examination.Gynecological evaluation based on vaginal examination including cervical dilatation, effacement, texture, station and position. |
| Modified BISHOP score | – | Diagnostic Test: Vaginal examination.Gynecological evaluation based on vaginal examination including cervical dilatation and effacement alone. |
| Cervical Length | – | Diagnostic Test: Transvaginal sonography.Gynecological evaluation based on cervical length measured by transvaginal sonography. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women over 37 weeks' gestation that are candidates for induction of labor for obstetric/other medical indications.
Key inclusion criteria (2 listed)
- Singleton pregnancies.
- Candidates for vaginal delivery.
Key exclusion criteria (2 listed)
- Multiple pregnancies.
- Candidates for cesarean section.
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 |
|---|---|---|
| Vaginal examination.Cervical properties as evaluated by a vaginal examination. | Diagnostic test | Classic BISHOP score, Modified BISHOP score |
| Transvaginal sonography.Cervical length as evaluated by a transvaginal sonography. | Diagnostic test | Cervical Length |
Primary outcome
Time to delivery
Time frame: Up to 72 hours.
The time from induction commencement to delivery of the newborn.
1 secondary outcome
BISHOP score after primary induction.
Time frame: Up to 24 hours.
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 26 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Induction of Labor Affected Fetus / Newborn
Active, not recruitingPhase 4
The Stimulation To Induce Mothers Study
Oxytocin, Labor Pain
Recruiting
Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
Induction of Labor Affected Fetus / Newborn
Recruiting
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Induction of Labor Affected Fetus / Newborn
Active, not recruiting
Induction ATAD Catheter and Lower Segment Thickness
Induction of Labor Affected Fetus / Newborn
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.
Roy Lauterbach, MD principal investigator
Rambam Healthcare Campus
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 Induction of Labor Affected Fetus / Newborn, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 2 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 26 Oct 2022. 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 Israel. 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?
Time to delivery (time frame: Up to 72 hours.). 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 26 Oct 2022.