Induction of Labor Affected Fetus / NewbornNCT03948932
Cervix Uteri "Resistance" Measurements
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, after 37 weeks' gestation will undergo cervical ripening for labor induction via cervical ripening balloon. Transvaginal sonography will be performed before balloon insertion. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Transvaginal sonography and Pressure watch
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2019to 1 Apr 2024
- 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 44 years
- Women only
- Adult
Study population: Pregnant women between 24-42 weeks gestation that are candidates for labor induction with a cervical ripening balloon.
Who may be able to join
- Obstetrical or medical indication for induction of labor
- Unfavorable cervix
- Gestational age between 24 - 42 weeks
- Singleton pregnancy
Who cannot join
- Any contraindication for vaginal delivery
- Rupture of membranes
- Fetal malformations incompatible with life
- Amnionitis
- Genital viral infection (HIV, HCV, HBV)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam health care campus
Haifa
Roy Lauterbach, MD, 0529432416, r_lauterbach@rambam.health.gov.il
Roy Lauterbach, MD
About this study
Official title: Cervical "Resistance" Measurements - a Novel Method for Evaluation of Cervical "Ripeness" Prior to Labor Induction
Pregnant women at term, after 37 weeks' gestation will undergo cervical ripening for labor induction via cervical ripening balloon. Transvaginal sonography will be performed before balloon insertion. During balloon insertion and after uterine balloon inflation a pressure watch will be attached to the balloon and inflation pressures of the vaginal balloon will be measured and documented.
Read the detailed description
The investigators routinely use the Cook balloon catheter 13 for mechanical induction of labor 10-11 - this is a medical grade, double balloon catheter, comprised of a slender, flexible tube open at one end and closed at the opposite end; an inflatable distal balloon fixed to the tube at its closed end and designed to be inflated in the uterus; an inflatable proximal balloon located slightly below the uterine balloon (labeled as the cervical balloon).
The catheter will be inserted according to the manufacturer's instructions with the patient in a lithotomy position under visualization of the cervix. When both balloons are inserted, the uterine balloon will be inflated through valve V1; using 40 ml of sterile saline solution. With a slight downward pull on the catheter, the cervical balloon will be located inside the cervix. In order to measure the cervical resistance, the investigators will connect a sensitive, passive pressure gauge to the cervical inflated balloon with the use of a by a bi-directional valve. At this point the investigators will gradually inflate the cervical balloon via valve V2 with 80 ml of sterile saline solution. The cervical resistance will be measured and documented every 10 ml. Finally, the uterine balloon will be further inflated with additional saline to a volume of 40 ml. (as per our standard mechanical induction protocol). The investigators believe that this system provides an objective and quantifiable evaluation of the pressure exerted on the cervical balloon as it is gradually inflated. As the cervical stiffness ("resistance") increases the pressure within the cervical balloon will be higher with a given volume of fluid within it. Therefore, the investigators define cervical resistance as the pressure vs. volume curve within the cervical balloon.
A group of 100 patients, (50 multiparas \& 50 nulliparas) with an obstetrical or medical indication for induction of labor will be recruited and consented for participation in this study. A transvaginal ultrasound will be performed prior to the initiation of the procedure to exclude placenta previa and to confirm a vertex presentation. Cervical length and angle will be recorded. All women will undergo a pelvic examination in order to obtain an initial Bishop Score.
- Being tested
- Transvaginal sonography, Pressure watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal sonographyDevice
Measurement of cervical length via transvaginal sonography prior to labor induction.
Pressure watchDevice
Measurement of inflation pressure in a cervical ripening balloon is PSI units.
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume versus pressure
To define pressure versus volume characteristics of the expanding uterine cervical balloon.
Measured: From patient admission 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 posted14 May 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
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
- 100 participants (estimated)
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
- NCT03948932
- Sponsor's protocol ID
- 0246-16-RMB
- Status last verified
- Feb 2022
- First submitted
- 8 May 2019
- Last updated
- 7 Feb 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical "Resistance" Measurements - a Novel Method for Evaluation of Cervical "Ripeness" Prior to Labor Induction
- ClinicalTrials.gov ID
- NCT03948932
- Acronym / sponsor ID
- 0246-16-RMB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 14 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.
Pregnant women at term, after 37 weeks' gestation will undergo cervical ripening for labor induction via cervical ripening balloon. Transvaginal sonography will be performed before balloon insertion. During balloon insertion and after uterine balloon inflation a pressure watch will be attached to the balloon and inflation pressures of the vaginal balloon will be measured and documented.
Detailed description
The investigators routinely use the Cook balloon catheter 13 for mechanical induction of labor 10-11 - this is a medical grade, double balloon catheter, comprised of a slender, flexible tube open at one end and closed at the opposite end; an inflatable distal balloon fixed to the tube at its closed end and designed to be inflated in the uterus; an inflatable proximal balloon located slightly below the uterine balloon (labeled as the cervical balloon).
The catheter will be inserted according to the manufacturer's instructions with the patient in a lithotomy position under visualization of the cervix. When both balloons are inserted, the uterine balloon will be inflated through valve V1; using 40 ml of sterile saline solution. With a slight downward pull on the catheter, the cervical balloon will be located inside the cervix. In order to measure the cervical resistance, the investigators will connect a sensitive, passive pressure gauge to the cervical inflated balloon with the use of a by a bi-directional valve. At this point the investigators will gradually inflate the cervical balloon via valve V2 with 80 ml of sterile saline solution. The cervical resistance will be measured and documented every 10 ml. Finally, the uterine balloon will be further inflated with additional saline to a volume of 40 ml. (as per our standard mechanical induction protocol). The investigators believe that this system provides an objective and quantifiable evaluation of the pressure exerted on the cervical balloon as it is gradually inflated. As the cervical stiffness ("resistance") increases the pressure within the cervical balloon will be higher with a given volume of fluid within it. Therefore, the investigators define cervical resistance as the pressure vs. volume curve within the cervical balloon.
A group of 100 patients, (50 multiparas \& 50 nulliparas) with an obstetrical or medical indication for induction of labor will be recruited and consented for participation in this study. A transvaginal ultrasound will be performed prior to the initiation of the procedure to exclude placenta previa and to confirm a vertex presentation. Cervical length and angle will be recorded. All women will undergo a pelvic examination in order to obtain an initial Bishop Score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women between 24-42 weeks gestation that are candidates for labor induction with a cervical ripening balloon.
Key inclusion criteria (4 listed)
- Obstetrical or medical indication for induction of labor
- Unfavorable cervix
- Gestational age between 24 - 42 weeks
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Any contraindication for vaginal delivery
- Rupture of membranes
- Fetal malformations incompatible with life
- Amnionitis
- Genital viral infection (HIV, HCV, HBV)
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 sonographyMeasurement of cervical length via transvaginal sonography prior to labor induction. | Device | – |
| Pressure watchMeasurement of inflation pressure in a cervical ripening balloon is PSI units. | Device | – |
Primary outcome
Volume versus pressure
Time frame: From patient admission up to 24 hours postpartum.
To define pressure versus volume characteristics of the expanding uterine cervical balloon.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 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 4 inclusion and 5 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 7 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy Lauterbach, MD (0529432416, r_lauterbach@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume versus pressure (time frame: From patient admission 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 7 Feb 2022.