Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foley catheter inpatient | Active Comparator | Participants had intracervical ripening with foley catheter after admission into the ward. |
|
| Foley catheter outpatient | Active Comparator | Participants had intracervical ripening with foley catheter and allowed home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley catheter cervical ripening | Device | Participants were assessed when labour was established or the following morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caesarean section rate | Percentage of Caesarean section | From the time of recruitment until delivery |
| Neonatal sepsis | Percentage of neonates with sepsis | From birth up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal age | Mean maternal age in years | At the time of recruitment |
| Ethnicity | Percentage of each races | At the time of recruitment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKM Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
Not provided
Not provided
Not provided
Not provided
| Education level | Percentage of participants with secondary or higher education level | At the time of recruitment |
| Occupation | Percentage of participants who were professional or non professional or housewives | At the time of recruitment |
| Pre-pregnancy maternal body mass index | Mean pre-pregnancy body mass index in kg/m2 | At the time of recruitment |
| Parity | Percentage of participants who are nulliparous or multiparous | At the time of recruitment |
| Gestation at recruitment | Percentage of participants who were recruited at 40 or 40 weeks and 10 days | At the time of recruitment |
| Indication | Percentage of participants who were induced based on indication | 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. | 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. | 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 | At time of recruitment until delivery |
| Duration from induction until favourable Bishop score | Mean duration taken from induction until favourable Bishop score in hours | At time of recruitment until delivery |
| Augmentation with oxytocin | Percentage of participants who required oxytocin augmentation | At time of recruitment until delivery |
| Duration of oxytocin use | Mean duration of oxytocin use in minutes | At time of recruitment until delivery |
| Duration from amniotomy until delivery | Mean duration from amniotomy until delivery in hours | At time of recruitment until delivery |
| Duration from induction until delivery | Mean duration from induction until delivery in hours | At time of recruitment until delivery |
| Delivery within 24 hours | Percentage of participants who delivered within 24 hours from induction | At time of recruitment until delivery |
| Duration of inpatient stay | Mean duration of inpatient stay in hours | At time of recruitment until delivery |
| Total blood loss | Median blood loss in millilitres | At the time of delivery |
| Intrapartum pyrexia | Percentage of participants with intrapartum pyrexia | At the time of delivery |
| Primary postpartum haemorrhage | Percentage of participants with primary postpartum haemorrhage | Immediately at delivery up to 42 days |
| Birth weight | Mean birth weight in grams | At the time of delivery |
| Arterial cord blood acidity or alkalinity | Mean arterial cord blood acidity or alkalinity | At the time of delivery |
| Neonatal white cell count | Mean neonatal white cell count in liter | At the time of delivery |
| Neonatal C-reactive protein | Median neonatal C-reactive protein in milligram per liter | At the time of delivery |
| Discomfort with foley catheter | Percentage of participants experienced discomfort with foley catheter | At the time of recruitment until active phase of labour |
| Ability to cope with discomfort | Percentage of participants able to cope with discomfort | 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 | Through study completion until delivery |
| Feeling alone during induction | Percentage of participants who felt lonely during induction | At the time of recruitment until delivery |
| Duration of sleep | Duration of sleep during induction in hours | At the time of recruitment until delivery |
| Able to rest and relax | Percentage of participants who are able to rest and relax | At the time of recruitment until delivery |
| Feeling of unsafe during cervical ripening | Percentage of participants who felt unsafe during cervical ripening | At the time of recruitment until active phase of labour |
| Embarrassed by the method | Percentage of participants who felt embarrassed by the method | At the time of recruitment until active phase of labour |