Inpatient and Outpatient Balloon Catheter Cervical Ripening

NCT04342741 | Completed

• 1 other identifier: FF-2017-358
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caesarean Section; Infection

Keywords

cervical ripening; Foley catheter; Patient satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (33)

• Maternal age

  At the time of recruitment

• Ethnicity

  At the time of recruitment

• Education level

  At the time of recruitment

• Occupation

  At the time of recruitment

• Pre-pregnancy maternal body mass index

  At the time of recruitment

Study Arms (2)

Foley catheter inpatient

ACTIVE COMPARATOR

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

Device: Foley catheter cervical ripening

Foley catheter outpatient

ACTIVE COMPARATOR

Participants had intracervical ripening with foley catheter and allowed home.

Device: Foley catheter cervical ripening

Interventions

Foley catheter cervical ripening DEVICE

Participants were assessed when labour was established or the following morning.

Foley catheter inpatient; Foley catheter outpatient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

UKM Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Infections; Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-primary investigator

Model Details: The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: August 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)