Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-08-01
2024-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Transvaginal sonography
Measurement of cervical length via transvaginal sonography prior to labor induction.
Pressure watch
Measurement of inflation pressure in a cervical ripening balloon is PSI units.
Eligibility Criteria
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Inclusion Criteria
* Unfavorable cervix
* Gestational age between 24 - 42 weeks
* Singleton pregnancy
Exclusion Criteria
* Rupture of membranes
* Fetal malformations incompatible with life
* Amnionitis
* Genital viral infection (HIV, HCV, HBV)
18 Years
44 Years
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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ROY LAUTERBACH MD
Principal Investigator
Principal Investigators
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Roy Lauterbach, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam healthcare campus
Locations
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Rambam health care campus
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0246-16-RMB
Identifier Type: -
Identifier Source: org_study_id
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