A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
Participants were assessed when labour was established or the following morning.
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
Caesarean section rate
Percentage of Caesarean section
Time frame: From the time of recruitment until delivery
Neonatal sepsis
Percentage of neonates with sepsis
Time frame: From birth up to 30 days
Maternal age
Mean maternal age in years
Time frame: At the time of recruitment
Ethnicity
Percentage of each races
Time frame: At the time of recruitment
Education level
Percentage of participants with secondary or higher education level
Time frame: At the time of recruitment
Occupation
Percentage of participants who were professional or non professional or housewives
Time frame: At the time of recruitment
Pre-pregnancy maternal body mass index
Mean pre-pregnancy body mass index in kg/m2
Time frame: At the time of recruitment
Parity
Percentage of participants who are nulliparous or multiparous
Time frame: At the time of recruitment
Gestation at recruitment
Percentage of participants who were recruited at 40 or 40 weeks and 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At the time of recruitment
Indication
Percentage of participants who were induced based on indication
Time frame: At the time of recruitment
Bishop score pre-induction
Mean Bishop score prior to induction. Unfavourable score has minimum score of 0 and maximum score of 5.
Time frame: Pre-intervention
Bishop score at second assessment
Mean Bishop score at second assessment. Unfavourable score has minimum score of 0 and maximum score of 5.
Time frame: From insertion of Foley catheter until labour established or the following morning
Management at second assessment
Percentage of participants who had dinoprostone insertion or artificial rupture of membranes
Time frame: At time of recruitment until delivery
Duration from induction until favourable Bishop score
Mean duration taken from induction until favourable Bishop score in hours
Time frame: At time of recruitment until delivery
Augmentation with oxytocin
Percentage of participants who required oxytocin augmentation
Time frame: At time of recruitment until delivery
Duration of oxytocin use
Mean duration of oxytocin use in minutes
Time frame: At time of recruitment until delivery
Duration from amniotomy until delivery
Mean duration from amniotomy until delivery in hours
Time frame: At time of recruitment until delivery
Duration from induction until delivery
Mean duration from induction until delivery in hours
Time frame: At time of recruitment until delivery
Delivery within 24 hours
Percentage of participants who delivered within 24 hours from induction
Time frame: At time of recruitment until delivery
Duration of inpatient stay
Mean duration of inpatient stay in hours
Time frame: At time of recruitment until delivery
Total blood loss
Median blood loss in millilitres
Time frame: At the time of delivery
Intrapartum pyrexia
Percentage of participants with intrapartum pyrexia
Time frame: At the time of delivery
Primary postpartum haemorrhage
Percentage of participants with primary postpartum haemorrhage
Time frame: Immediately at delivery up to 42 days
Birth weight
Mean birth weight in grams
Time frame: At the time of delivery
Arterial cord blood acidity or alkalinity
Mean arterial cord blood acidity or alkalinity
Time frame: At the time of delivery
Neonatal white cell count
Mean neonatal white cell count in liter
Time frame: At the time of delivery
Neonatal C-reactive protein
Median neonatal C-reactive protein in milligram per liter
Time frame: At the time of delivery
Discomfort with foley catheter
Percentage of participants experienced discomfort with foley catheter
Time frame: At the time of recruitment until active phase of labour
Ability to cope with discomfort
Percentage of participants able to cope with discomfort
Time frame: At the time of recruitment until active phase of labour
Intention to use the method again
Percentage of participants who intend to use similar method in future
Time frame: Through study completion until delivery
Feeling alone during induction
Percentage of participants who felt lonely during induction
Time frame: At the time of recruitment until delivery
Duration of sleep
Duration of sleep during induction in hours
Time frame: At the time of recruitment until delivery
Able to rest and relax
Percentage of participants who are able to rest and relax
Time frame: At the time of recruitment until delivery
Feeling of unsafe during cervical ripening
Percentage of participants who felt unsafe during cervical ripening
Time frame: At the time of recruitment until active phase of labour
Embarrassed by the method
Percentage of participants who felt embarrassed by the method
Time frame: At the time of recruitment until active phase of labour