Inpatient and Outpatient Balloon Catheter Cervical Ripening

National University of Malaysia

Status: Completed

Conditions: Caesarean Section; Infection

Treatments: Device: Foley catheter cervical ripening

Study type: Interventional

Funder types: Other

Identifiers

NCT04342741

FF-2017-358

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Foley catheter inpatient

Active Comparator group

Description:

Participants had intracervical ripening with foley catheter after admission into the ward.

Treatment:

Device: Foley catheter cervical ripening

Foley catheter outpatient

Active Comparator group

Description:

Participants had intracervical ripening with foley catheter and allowed home.

Treatment:

Device: Foley catheter cervical ripening