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Comparing Methods for Balloon Catheter Inserting: View Guided (Speculum) Versus Manual Guided at Cervical Examination

Comparing Two Methods for Inserting a Balloon Catheter : View-guided Approach Using a Speculum Versus Manual Guided Approach at Cervical Examination - a Prospective Randomized Trail

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05253690
Enrollment
100
Registered
2022-02-24
Start date
2022-01-10
Completion date
2025-01-10
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening

Keywords

labor induction, balloon catheter, cervical ripenning, speculum

Brief summary

Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluated the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score\<6.

Detailed description

Globally, there has been an increase in birth-induced labor from 9.5% to 29% in the last 3 decades. Circumstances requiring induction include gestational age of 41 weeks or more, hypertension, fetal growth disorder, gestational diabetes and others. There are different methods of induction, the choice of the best method depends on the bishop score, an estimate based on cervical related data like opening (cm), deletion (%) and other parameters, also the choice of induction method depends on the obstetric history of the mother. Bishop score less than 6, indicates an immature cervix, and therefore increases the chance of induction failure. The mechanism by which the catheter works includes a mechanical effect that causes the cervix to dilate, but in addition the direct stress on the inner surface of the cervix tissue and lower segment of the uterus indirectly causes local secretion of prostoglandins which help softening the cervix and may induce contractions. Inserting a single or double balloon catheter, is traditionally performed in a lithotomy position, and after inserting a speculum, disinfecting with polydine, identifying the external os of the cervix and then inserting the catheter, inflating the balloon with saline up to 30-80 ml while looking at the position of the balloon. Insertion of the catheter is typically speculum guided, but digital insertion has been reported to be faster, better tolerated and with similar insertion success and infections rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluate the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score\<6. Methods: A randomized trial. Participants are parous at term with unripe cervixes (Bishop Score ≤ 6) admitted for induction of labor. They will be randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position (1:1, 50 in each group). Primary outcomes are pain score \[VAS\] and time to birth. Secondary outcomes are procedure duration, maternal satisfaction, success and bishop score change.

Interventions

PROCEDUREballoon catheter insertion approach for labor induction

Parous women will be randomized to labor induction by view-guided approach using a speculum for catheter insersion versus manual guided catheter balloon insersion at cervical examination

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The obstetrician evaluating labor progress is blinded for type of intervention

Intervention model description

Randomized control trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Singelton parous women Term pregnancy Vertex position \-

Exclusion criteria

Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly

Design outcomes

Primary

MeasureTime frameDescription
Maternal pain sensation during the procedureduring the procedureVAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome
induction to delivery durationthrough study completion, an average of 1 yearhours

Secondary

MeasureTime frameDescription
catheter insertion durationduring the procedureminutes
maternal satisfaction- questionnaireduring one hour after the procedurequestionnaire including 5 questions about maternal preference for catheter insertion methods
chorioamnionitis- fever during laborduring labor up to 48 hoursclinical diagnosis

Countries

Israel

Contacts

Primary ContactMaya Wolf, MD
mayaw@gmc.gov.il972-50-7887800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026