Caesarean Section; Infection
Conditions
Keywords
cervical ripening, Foley catheter, Patient satisfaction
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.
Interventions
DEVICEFoley catheter cervical ripening
Participants were assessed when labour was established or the following morning.
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caesarean section rate | From the time of recruitment until delivery | Percentage of Caesarean section |
| Neonatal sepsis | From birth up to 30 days | Percentage of neonates with sepsis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal age | At the time of recruitment | Mean maternal age in years |
| Ethnicity | At the time of recruitment | Percentage of each races |
| Education level | At the time of recruitment | Percentage of participants with secondary or higher education level |
| Occupation | At the time of recruitment | Percentage of participants who were professional or non professional or housewives |
| Pre-pregnancy maternal body mass index | At the time of recruitment | Mean pre-pregnancy body mass index in kg/m2 |
| Parity | At the time of recruitment | Percentage of participants who are nulliparous or multiparous |
| Gestation at recruitment | At the time of recruitment | Percentage of participants who were recruited at 40 or 40 weeks and 10 days |
| Indication | At the time of recruitment | Percentage of participants who were induced based on indication |
| Bishop score pre-induction | Pre-intervention | Mean Bishop score prior to induction. Unfavourable score has minimum score of 0 and maximum score of 5. |
| Bishop score at second assessment | From insertion of Foley catheter until labour established or the following morning | Mean Bishop score at second assessment. Unfavourable score has minimum score of 0 and maximum score of 5. |
| Management at second assessment | At time of recruitment until delivery | Percentage of participants who had dinoprostone insertion or artificial rupture of membranes |
| Duration from induction until favourable Bishop score | At time of recruitment until delivery | Mean duration taken from induction until favourable Bishop score in hours |
| Augmentation with oxytocin | At time of recruitment until delivery | Percentage of participants who required oxytocin augmentation |
| Duration of oxytocin use | At time of recruitment until delivery | Mean duration of oxytocin use in minutes |
| Duration from amniotomy until delivery | At time of recruitment until delivery | Mean duration from amniotomy until delivery in hours |
| Birth weight | At the time of delivery | Mean birth weight in grams |
| Delivery within 24 hours | At time of recruitment until delivery | Percentage of participants who delivered within 24 hours from induction |
| Duration of inpatient stay | At time of recruitment until delivery | Mean duration of inpatient stay in hours |
| Total blood loss | At the time of delivery | Median blood loss in millilitres |
| Intrapartum pyrexia | At the time of delivery | Percentage of participants with intrapartum pyrexia |
| Arterial cord blood acidity or alkalinity | At the time of delivery | Mean arterial cord blood acidity or alkalinity |
| Neonatal white cell count | At the time of delivery | Mean neonatal white cell count in liter |
| Neonatal C-reactive protein | At the time of delivery | Median neonatal C-reactive protein in milligram per liter |
| Discomfort with foley catheter | At the time of recruitment until active phase of labour | Percentage of participants experienced discomfort with foley catheter |
| Ability to cope with discomfort | At the time of recruitment until active phase of labour | Percentage of participants able to cope with discomfort |
| Intention to use the method again | Through study completion until delivery | Percentage of participants who intend to use similar method in future |
| Feeling alone during induction | At the time of recruitment until delivery | Percentage of participants who felt lonely during induction |
| Duration of sleep | At the time of recruitment until delivery | Duration of sleep during induction in hours |
| Able to rest and relax | At the time of recruitment until delivery | Percentage of participants who are able to rest and relax |
| Feeling of unsafe during cervical ripening | At the time of recruitment until active phase of labour | Percentage of participants who felt unsafe during cervical ripening |
| Embarrassed by the method | At the time of recruitment until active phase of labour | Percentage of participants who felt embarrassed by the method |
| Duration from induction until delivery | At time of recruitment until delivery | Mean duration from induction until delivery in hours |
| Primary postpartum haemorrhage | Immediately at delivery up to 42 days | Percentage of participants with primary postpartum haemorrhage |
Countries
Malaysia
Outcome results
None listed