Inpatient and Outpatient Balloon Catheter Cervical Ripening

Study Overview
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Brief Summary
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A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.

Detailed Description
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The study evaluated the efficacy and safety of outpatient versus inpatient Foley catheter cervical ripening and patients' satisfaction. Sixty low-risk women were randomized to outpatient and inpatient management of intracervical Foley catheter digital insertion. The outpatient group was provided with verbal and written 24-hours contact information and instructions. Both groups were reassessed the next morning unless labor had begun or the catheter had dropped off.

Official Title
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A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial

Conditions
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Caesarean Section; Infection

Intervention / Treatment
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* Device: Foley catheter cervical ripening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton gestational age beyond 37 weeks cephalic presentation intact membranes Bishop score less than 6 lives within 10km from National University Malaysia Medical Centre or able to reach within 30 minutes readily available transport Exclusion Criteria: intrauterine death intrauterine fetal growth restriction estimated fetal weight more than 4000gram fetal anomalies abnormal pre-induction cardiotocograph non-vertex presentation unstable lie sepsis hypertension allergy to latex previous uterine scar history of antepartum haemorrhage parity of 6 and more placenta praevia suspected cephalopelvic disproportion

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Foley catheter inpatient<br>Participants had intracervical ripening with foley catheter after admission into the ward. | Device: Foley catheter cervical ripening<br>* Participants were assessed when labour was established or the following morning.<br>|
| Active Comparator: Foley catheter outpatient<br>Participants had intracervical ripening with foley catheter and allowed home. | Device: Foley catheter cervical ripening<br>* Participants were assessed when labour was established or the following morning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean section rate | Percentage of Caesarean section | From the time of recruitment until delivery | 
| Neonatal sepsis | Percentage of neonates with sepsis | From birth up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal age | Mean maternal age in years | At the time of recruitment | 
| Ethnicity | Percentage of each races | At the time of recruitment | 
| Education level | Percentage of participants with secondary or higher education level | At the time of recruitment | 
| Occupation | Percentage of participants who were professional or non professional or housewives | At the time of recruitment | 
| Pre-pregnancy maternal body mass index | Mean pre-pregnancy body mass index in kg/m2 | At the time of recruitment | 
| Parity | Percentage of participants who are nulliparous or multiparous | At the time of recruitment | 
| Gestation at recruitment | Percentage of participants who were recruited at 40 or 40 weeks and 10 days | At the time of recruitment | 
| Indication | Percentage of participants who were induced based on indication | At the time of recruitment | 
| Bishop score pre-induction | Mean Bishop score prior to induction. Unfavourable score has minimum score of 0 and maximum score of 5. | Pre-intervention | 
| Bishop score at second assessment | Mean Bishop score at second assessment. Unfavourable score has minimum score of 0 and maximum score of 5. | From insertion of Foley catheter until labour established or the following morning | 
| Management at second assessment | Percentage of participants who had dinoprostone insertion or artificial rupture of membranes | At time of recruitment until delivery | 
| Duration from induction until favourable Bishop score | Mean duration taken from induction until favourable Bishop score in hours | At time of recruitment until delivery | 
| Augmentation with oxytocin | Percentage of participants who required oxytocin augmentation | At time of recruitment until delivery | 
| Duration of oxytocin use | Mean duration of oxytocin use in minutes | At time of recruitment until delivery | 
| Duration from amniotomy until delivery | Mean duration from amniotomy until delivery in hours | At time of recruitment until delivery | 
| Duration from induction until delivery | Mean duration from induction until delivery in hours | At time of recruitment until delivery | 
| Delivery within 24 hours | Percentage of participants who delivered within 24 hours from induction | At time of recruitment until delivery | 
| Duration of inpatient stay | Mean duration of inpatient stay in hours | At time of recruitment until delivery | 
| Total blood loss | Median blood loss in millilitres | At the time of delivery | 
| Intrapartum pyrexia | Percentage of participants with intrapartum pyrexia | At the time of delivery | 
| Primary postpartum haemorrhage | Percentage of participants with primary postpartum haemorrhage | Immediately at delivery up to 42 days | 
| Birth weight | Mean birth weight in grams | At the time of delivery | 
| Arterial cord blood acidity or alkalinity | Mean arterial cord blood acidity or alkalinity | At the time of delivery | 
| Neonatal white cell count | Mean neonatal white cell count in liter | At the time of delivery | 
| Neonatal C-reactive protein | Median neonatal C-reactive protein in milligram per liter | At the time of delivery | 
| Discomfort with foley catheter | Percentage of participants experienced discomfort with foley catheter | At the time of recruitment until active phase of labour | 
| Ability to cope with discomfort | Percentage of participants able to cope with discomfort | At the time of recruitment until active phase of labour | 
| Intention to use the method again | Percentage of participants who intend to use similar method in future | Through study completion until delivery | 
| Feeling alone during induction | Percentage of participants who felt lonely during induction | At the time of recruitment until delivery | 
| Duration of sleep | Duration of sleep during induction in hours | At the time of recruitment until delivery | 
| Able to rest and relax | Percentage of participants who are able to rest and relax | At the time of recruitment until delivery | 
| Feeling of unsafe during cervical ripening | Percentage of participants who felt unsafe during cervical ripening | At the time of recruitment until active phase of labour | 
| Embarrassed by the method | Percentage of participants who felt embarrassed by the method | At the time of recruitment until active phase of labour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical ripening, Foley catheter, Patient satisfaction