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

Not Applicable

Recruiting

• Conditions: Cervical Ripening
• Interventions: Procedure: balloon catheter insertion approach for labor induction

• Registration Number: NCT05253690
• Lead Sponsor: Western Galilee Hospital-Nahariya

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.

Study Timeline

• Study Start: 2022-01-10
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-13
• Study First Posted: 2022-02-24
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-19
• Last Update Posted: 2022-04-01
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Singelton parous women Term pregnancy Vertex position

Exclusion Criteria

Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual guided	balloon catheter insertion approach for labor induction	manual guided approach at cervical examination
speculum guided	balloon catheter insertion approach for labor induction	view-guided approach using a speculum

Primary Outcome Measures

Name	Time	Method
induction to delivery duration	through study completion, an average of 1 year	hours
Maternal pain sensation during the procedure	during the procedure	VAS (visual analog scale) SCORE scale 0-10 0-better outcome 10-worse outcome

Secondary Outcome Measures

Name	Time	Method
chorioamnionitis- fever during labor	during labor up to 48 hours	clinical diagnosis
maternal satisfaction- questionnaire	during one hour after the procedure	questionnaire including 5 questions about maternal preference for catheter insertion methods
catheter insertion duration	during the procedure	minutes

Trial Locations

Locations (1)

Galil Medical Center; 🇮🇱 Nahariya, Israel