Inpatient and Outpatient Balloon Catheter Cervical Ripening

Not Applicable

Completed

• Conditions: Caesarean Section; Infection
• Interventions: Device: Foley catheter cervical ripening

• Registration Number: NCT04342741
• Lead Sponsor: National University of Malaysia

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-09
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley catheter inpatient	Foley catheter cervical ripening	Participants had intracervical ripening with foley catheter after admission into the ward.
Foley catheter outpatient	Foley catheter cervical ripening	Participants had intracervical ripening with foley catheter and allowed home.

Primary Outcome Measures

Name	Time	Method
Caesarean section rate	From the time of recruitment until delivery	Percentage of Caesarean section
Neonatal sepsis	From birth up to 30 days	Percentage of neonates with sepsis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UKM Medical Centre; 🇲🇾 Cheras, Kuala Lumpur, Malaysia