Clinical trial NCT04342741: Inpatient and Outpatient Balloon Catheter Cervical Ripening
Official title: A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section; Infection
Keywords: cervical ripening
Foley catheter
Patient satisfaction
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caesarean section rate
timeFrame: From the time of recruitment until delivery
measure: Neonatal sepsis
timeFrame: From birth up to 30 days
Secondary outcomes:
measure: Maternal age
timeFrame: At the time of recruitment
measure: Ethnicity
timeFrame: At the time of recruitment
measure: Education level
timeFrame: At the time of recruitment
measure: Occupation
timeFrame: At the time of recruitment
measure: Pre-pregnancy maternal body mass index
timeFrame: At the time of recruitment
measure: Parity
timeFrame: At the time of recruitment
measure: Gestation at recruitment
timeFrame: At the time of recruitment
measure: Indication
timeFrame: At the time of recruitment
measure: Bishop score pre-induction
timeFrame: Pre-intervention
measure: Bishop score at second assessment
timeFrame: From insertion of Foley catheter until labour established or the following morning
measure: Management at second assessment
timeFrame: At time of recruitment until delivery
measure: Duration from induction until favourable Bishop score
timeFrame: At time of recruitment until delivery
measure: Augmentation with oxytocin
timeFrame: At time of recruitment until delivery
measure: Duration of oxytocin use
timeFrame: At time of recruitment until delivery
measure: Duration from amniotomy until delivery
timeFrame: At time of recruitment until delivery
measure: Duration from induction until delivery
timeFrame: At time of recruitment until delivery
measure: Delivery within 24 hours
timeFrame: At time of recruitment until delivery
measure: Duration of inpatient stay
timeFrame: At time of recruitment until delivery
measure: Total blood loss
timeFrame: At the time of delivery
measure: Intrapartum pyrexia
timeFrame: At the time of delivery
measure: Primary postpartum haemorrhage
timeFrame: Immediately at delivery up to 42 days
measure: Birth weight
timeFrame: At the time of delivery
measure: Arterial cord blood acidity or alkalinity
timeFrame: At the time of delivery
measure: Neonatal white cell count
timeFrame: At the time of delivery
measure: Neonatal C-reactive protein
timeFrame: At the time of delivery
measure: Discomfort with foley catheter
timeFrame: At the time of recruitment until active phase of labour
measure: Ability to cope with discomfort
timeFrame: At the time of recruitment until active phase of labour
measure: Intention to use the method again
timeFrame: Through study completion until delivery
measure: Feeling alone during induction
timeFrame: At the time of recruitment until delivery
measure: Duration of sleep
timeFrame: At the time of recruitment until delivery
measure: Able to rest and relax
timeFrame: At the time of recruitment until delivery
measure: Feeling of unsafe during cervical ripening
timeFrame: At the time of recruitment until active phase of labour
measure: Embarrassed by the method
timeFrame: At the time of recruitment until active phase of labour
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: UKM Medical Centre
state: Kuala Lumpur
Study officials:
References: