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)
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1
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000