Status:

COMPLETED

Inpatient and Outpatient Balloon Catheter Cervical Ripening

Lead Sponsor:

National University of Malaysia

Conditions:

Caesarean Section; Infection

Eligibility:

FEMALE

18+ years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2018

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04342741

Start Date

August 1 2017

End Date

May 31 2018

Last Update

April 13 2020

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

UKM Medical Centre

Cheras, Kuala Lumpur, Malaysia, 56000