Induction of Labor Affected Fetus / NewbornNCT03944187
Sonographic Assessment for Prediction of Labor Induction Success
An observational study of Induction of Labor Affected Fetus / Newborn, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle. 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?
- Transvaginal sonography
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2019to 1 Apr 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 with singleton pregnancy over 37 weeks' gestation
Who may be able to join
- Singleton pregnancy.
- Term pregnancy.
Who cannot join
- Multiple gestation.
- Fetal anomalies and malformations.
- Preterm pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Assessment of Fetal Head Circumference, Cervical Length and Fetal Head to Cervix Angle for Prediction of Labor Induction Success
The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.
Read the detailed description
Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent.
After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured.
Relevant demographic and obstetric information will be collected from a computerized database.
- Being tested
- Transvaginal sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal sonographyDiagnostic test
Transvaginal sonography for measurement of cervical length, fetal head circumference and fetal head to cervix angle .
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in induction of labor
Vaginal delivery rate after labor induction
Measured: From admission to the obstetric emergency room up to 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2021
- Study completion1 Apr 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT03944187
- Sponsor's protocol ID
- 0529-18-RMB
- Status last verified
- Apr 2022
- First submitted
- 8 May 2019
- Last updated
- 20 Apr 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment of Fetal Head Circumference, Cervical Length and Fetal Head to Cervix Angle for Prediction of Labor Induction Success
- ClinicalTrials.gov ID
- NCT03944187
- Acronym / sponsor ID
- 0529-18-RMB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 9 May 2019 (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.
The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.
Detailed description
Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent.
After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured.
Relevant demographic and obstetric information will be collected from a computerized database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women with singleton pregnancy over 37 weeks' gestation
Key inclusion criteria (2 listed)
- Singleton pregnancy.
- Term pregnancy.
Key exclusion criteria (3 listed)
- Multiple gestation.
- Fetal anomalies and malformations.
- Preterm pregnancy.
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 |
|---|---|---|
| Transvaginal sonographyTransvaginal sonography for measurement of cervical length, fetal head circumference and fetal head to cervix angle . | Diagnostic test | – |
Primary outcome
Success in induction of labor
Time frame: From admission to the obstetric emergency room up to 24 hours postpartum
Vaginal delivery rate after labor induction
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 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
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 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: finished, as of the sponsor's last update on 20 Apr 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?
Success in induction of labor (time frame: From admission to the obstetric emergency room up to 24 hours postpartum). 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 20 Apr 2022.