Cervix Uteri "Resistance" Measurements

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

Cervical "Resistance" Measurements - a Novel Method for Evaluation of Cervical "Ripeness" Prior to Labor Induction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948932
• Other study ID #: 0246-16-RMB
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2022
• Source: Rambam Health Care Campus
• Contact: Roy Lauterbach, MD
• Phone: 0529432416
• Email: r_lauterbach[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Obstetrical or medical indication for induction of labor

• Unfavorable cervix

• Gestational age between 24 - 42 weeks

• Singleton pregnancy

Exclusion Criteria:

• Any contraindication for vaginal delivery

• Rupture of membranes

• Fetal malformations incompatible with life

• Amnionitis

• Genital viral infection (HIV, HCV, HBV)

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume versus pressure	To define pressure versus volume characteristics of the expanding uterine cervical balloon.	From patient admission up to 24 hours postpartum.