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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Ripening

Intervention / Treatment
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* Procedure: balloon catheter insertion approach for labor induction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singelton parous women Term pregnancy Vertex position - Exclusion Criteria: Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: speculum guided<br>view-guided approach using a speculum | Procedure: balloon catheter insertion approach for labor induction<br>* 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<br>|
| Experimental: manual guided<br>manual guided approach at cervical examination | Procedure: balloon catheter insertion approach for labor induction<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor induction, balloon catheter, cervical ripenning, speculum