Caesarean Section; Infection Clinical Trial
Official title:
A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial
| NCT number | NCT04342741 |
| Other study ID # | FF-2017-358 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 1, 2017 |
| Est. completion date | May 31, 2018 |
| Verified date | April 2020 |
| Source | National University of Malaysia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | May 31, 2018 |
| Est. primary completion date | May 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | UKM Medical Centre | Cheras | Kuala Lumpur |
| Lead Sponsor | Collaborator |
|---|---|
| National University of Malaysia |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Caesarean section rate | Percentage of Caesarean section | From the time of recruitment until delivery | |
| Primary | Neonatal sepsis | Percentage of neonates with sepsis | From birth up to 30 days | |
| Secondary | Maternal age | Mean maternal age in years | At the time of recruitment | |
| Secondary | Ethnicity | Percentage of each races | At the time of recruitment | |
| Secondary | Education level | Percentage of participants with secondary or higher education level | At the time of recruitment | |
| Secondary | Occupation | Percentage of participants who were professional or non professional or housewives | At the time of recruitment | |
| Secondary | Pre-pregnancy maternal body mass index | Mean pre-pregnancy body mass index in kg/m2 | At the time of recruitment | |
| Secondary | Parity | Percentage of participants who are nulliparous or multiparous | At the time of recruitment | |
| Secondary | Gestation at recruitment | Percentage of participants who were recruited at 40 or 40 weeks and 10 days | At the time of recruitment | |
| Secondary | Indication | Percentage of participants who were induced based on indication | At the time of recruitment | |
| Secondary | Bishop score pre-induction | Mean Bishop score prior to induction. Unfavourable score has minimum score of 0 and maximum score of 5. | Pre-intervention | |
| Secondary | 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 | |
| Secondary | Management at second assessment | Percentage of participants who had dinoprostone insertion or artificial rupture of membranes | At time of recruitment until delivery | |
| Secondary | Duration from induction until favourable Bishop score | Mean duration taken from induction until favourable Bishop score in hours | At time of recruitment until delivery | |
| Secondary | Augmentation with oxytocin | Percentage of participants who required oxytocin augmentation | At time of recruitment until delivery | |
| Secondary | Duration of oxytocin use | Mean duration of oxytocin use in minutes | At time of recruitment until delivery | |
| Secondary | Duration from amniotomy until delivery | Mean duration from amniotomy until delivery in hours | At time of recruitment until delivery | |
| Secondary | Duration from induction until delivery | Mean duration from induction until delivery in hours | At time of recruitment until delivery | |
| Secondary | Delivery within 24 hours | Percentage of participants who delivered within 24 hours from induction | At time of recruitment until delivery | |
| Secondary | Duration of inpatient stay | Mean duration of inpatient stay in hours | At time of recruitment until delivery | |
| Secondary | Total blood loss | Median blood loss in millilitres | At the time of delivery | |
| Secondary | Intrapartum pyrexia | Percentage of participants with intrapartum pyrexia | At the time of delivery | |
| Secondary | Primary postpartum haemorrhage | Percentage of participants with primary postpartum haemorrhage | Immediately at delivery up to 42 days | |
| Secondary | Birth weight | Mean birth weight in grams | At the time of delivery | |
| Secondary | Arterial cord blood acidity or alkalinity | Mean arterial cord blood acidity or alkalinity | At the time of delivery | |
| Secondary | Neonatal white cell count | Mean neonatal white cell count in liter | At the time of delivery | |
| Secondary | Neonatal C-reactive protein | Median neonatal C-reactive protein in milligram per liter | At the time of delivery | |
| Secondary | Discomfort with foley catheter | Percentage of participants experienced discomfort with foley catheter | At the time of recruitment until active phase of labour | |
| Secondary | Ability to cope with discomfort | Percentage of participants able to cope with discomfort | At the time of recruitment until active phase of labour | |
| Secondary | Intention to use the method again | Percentage of participants who intend to use similar method in future | Through study completion until delivery | |
| Secondary | Feeling alone during induction | Percentage of participants who felt lonely during induction | At the time of recruitment until delivery | |
| Secondary | Duration of sleep | Duration of sleep during induction in hours | At the time of recruitment until delivery | |
| Secondary | Able to rest and relax | Percentage of participants who are able to rest and relax | At the time of recruitment until delivery | |
| Secondary | 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 | |
| Secondary | Embarrassed by the method | Percentage of participants who felt embarrassed by the method | At the time of recruitment until active phase of labour |