Caesarean Section; InfectionNCT04342741
Inpatient and Outpatient Balloon Catheter Cervical Ripening
A study testing Foley catheter cervical ripening in people with Caesarean Section; Infection, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section; Infection
- What is being tested?
- Foley catheter cervical ripening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2017to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- intrauterine death
- intrauterine fetal growth restriction
- estimated fetal weight more than 4000gram
- fetal anomalies
- abnormal pre-induction cardiotocograph
- non-vertex presentation
Show all 15Show fewer
- unstable lie
- sepsis
- hypertension
- allergy to latex
- previous uterine scar
- history of antepartum haemorrhage
- parity of 6 and more
- placenta praevia
- suspected cephalopelvic disproportion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial
A randomised controlled trial comparing cervical ripening using foley catheter as in- or outpatient setting.
Read the 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.
- Conditions
- Caesarean Section; Infection
- Being tested
- Foley catheter cervical ripening
- Keywords
- cervical ripening, Foley catheter, Patient satisfaction
- Medical subject headings
- Infections, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheter cervical ripeningDevice
Participants were assessed when labour was established or the following morning.
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter inpatient | Active comparator | Participants had intracervical ripening with foley catheter after admission into the ward. Receives: Device: Foley catheter cervical ripening |
| Foley catheter outpatient | Active comparator | Participants had intracervical ripening with foley catheter and allowed home. Receives: Device: Foley catheter cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section rate
Percentage of Caesarean section
Measured: From the time of recruitment until delivery
Neonatal sepsis
Percentage of neonates with sepsis
Measured: From birth up to 30 days
Secondary outcomes (33)
Maternal age
Mean maternal age in years
Measured: At the time of recruitment
Ethnicity
Percentage of each races
Measured: At the time of recruitment
Education level
Percentage of participants with secondary or higher education level
Measured: At the time of recruitment
Occupation
Percentage of participants who were professional or non professional or housewives
Measured: At the time of recruitment
Pre-pregnancy maternal body mass index
Mean pre-pregnancy body mass index in kg/m2
Measured: At the time of recruitment
Parity
Percentage of participants who are nulliparous or multiparous
Measured: At the time of recruitment
Gestation at recruitment
Percentage of participants who were recruited at 40 or 40 weeks and 10 days
Measured: At the time of recruitment
Indication
Percentage of participants who were induced based on indication
Measured: 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.
Measured: 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.
Measured: 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
Measured: At time of recruitment until delivery
Duration from induction until favourable Bishop score
Mean duration taken from induction until favourable Bishop score in hours
Measured: At time of recruitment until delivery
Augmentation with oxytocin
Percentage of participants who required oxytocin augmentation
Measured: At time of recruitment until delivery
Duration of oxytocin use
Mean duration of oxytocin use in minutes
Measured: At time of recruitment until delivery
Duration from amniotomy until delivery
Mean duration from amniotomy until delivery in hours
Measured: At time of recruitment until delivery
Duration from induction until delivery
Mean duration from induction until delivery in hours
Measured: At time of recruitment until delivery
Delivery within 24 hours
Percentage of participants who delivered within 24 hours from induction
Measured: At time of recruitment until delivery
Duration of inpatient stay
Mean duration of inpatient stay in hours
Measured: At time of recruitment until delivery
Total blood loss
Median blood loss in millilitres
Measured: At the time of delivery
Intrapartum pyrexia
Percentage of participants with intrapartum pyrexia
Measured: At the time of delivery
Primary postpartum haemorrhage
Percentage of participants with primary postpartum haemorrhage
Measured: Immediately at delivery up to 42 days
Birth weight
Mean birth weight in grams
Measured: At the time of delivery
Arterial cord blood acidity or alkalinity
Mean arterial cord blood acidity or alkalinity
Measured: At the time of delivery
Neonatal white cell count
Mean neonatal white cell count in liter
Measured: At the time of delivery
Neonatal C-reactive protein
Median neonatal C-reactive protein in milligram per liter
Measured: At the time of delivery
Discomfort with foley catheter
Percentage of participants experienced discomfort with foley catheter
Measured: At the time of recruitment until active phase of labour
Ability to cope with discomfort
Percentage of participants able to cope with discomfort
Measured: 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
Measured: Through study completion until delivery
Feeling alone during induction
Percentage of participants who felt lonely during induction
Measured: At the time of recruitment until delivery
Duration of sleep
Duration of sleep during induction in hours
Measured: At the time of recruitment until delivery
Able to rest and relax
Percentage of participants who are able to rest and relax
Measured: At the time of recruitment until delivery
Feeling of unsafe during cervical ripening
Percentage of participants who felt unsafe during cervical ripening
Measured: At the time of recruitment until active phase of labour
Embarrassed by the method
Percentage of participants who felt embarrassed by the method
Measured: At the time of recruitment until active phase of labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Aug 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Section; InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342741
- Sponsor's protocol ID
- FF-2017-358
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Inpatient and Outpatient Balloon Catheter Cervical Ripening: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04342741
- Acronym / sponsor ID
- FF-2017-358
- Conditions
- Caesarean Section; Infection
- Keywords
- cervical ripening, Foley catheter, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients were randomised to cervical ripening with foley catheter as inpatient or outpatient setting.
| Arm | Type | Receives |
|---|---|---|
| Foley catheter inpatient | Active comparator | Device: Foley catheter cervical ripeningParticipants had intracervical ripening with foley catheter after admission into the ward. |
| Foley catheter outpatient | Active comparator | Device: Foley catheter cervical ripeningParticipants had intracervical ripening with foley catheter and allowed home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- singleton
- gestational age beyond 37 weeks
- cephalic presentation
- intact membranes
- Bishop score less than 6
Key exclusion criteria (15 listed)
- intrauterine death
- intrauterine fetal growth restriction
- estimated fetal weight more than 4000gram
- fetal anomalies
- abnormal pre-induction cardiotocograph
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheter cervical ripeningParticipants were assessed when labour was established or the following morning. | Device | Foley catheter inpatient, Foley catheter outpatient |
Primary outcome
Caesarean section rate
Time frame: From the time of recruitment until delivery
Percentage of Caesarean section
Neonatal sepsis
Time frame: From birth up to 30 days
Percentage of neonates with sepsis
33 secondary outcomes
Maternal age
Time frame: At the time of recruitment
Ethnicity
Time frame: At the time of recruitment
Education level
Time frame: At the time of recruitment
Occupation
Time frame: At the time of recruitment
Pre-pregnancy maternal body mass index
Time frame: At the time of recruitment
Parity
Time frame: At the time of recruitment
Gestation at recruitment
Time frame: At the time of recruitment
Indication
Time frame: At the time of recruitment
Bishop score pre-induction
Time frame: Pre-intervention
Bishop score at second assessment
Time frame: From insertion of Foley catheter until labour established or the following morning
Management at second assessment
Time frame: At time of recruitment until delivery
Duration from induction until favourable Bishop score
Time frame: At time of recruitment until delivery
Augmentation with oxytocin
Time frame: At time of recruitment until delivery
Duration of oxytocin use
Time frame: At time of recruitment until delivery
Duration from amniotomy until delivery
Time frame: At time of recruitment until delivery
Duration from induction until delivery
Time frame: At time of recruitment until delivery
Delivery within 24 hours
Time frame: At time of recruitment until delivery
Duration of inpatient stay
Time frame: At time of recruitment until delivery
Total blood loss
Time frame: At the time of delivery
Intrapartum pyrexia
Time frame: At the time of delivery
Primary postpartum haemorrhage
Time frame: Immediately at delivery up to 42 days
Birth weight
Time frame: At the time of delivery
Arterial cord blood acidity or alkalinity
Time frame: At the time of delivery
Neonatal white cell count
Time frame: At the time of delivery
Neonatal C-reactive protein
Time frame: At the time of delivery
Discomfort with foley catheter
Time frame: At the time of recruitment until active phase of labour
Ability to cope with discomfort
Time frame: At the time of recruitment until active phase of labour
Intention to use the method again
Time frame: Through study completion until delivery
Feeling alone during induction
Time frame: At the time of recruitment until delivery
Duration of sleep
Time frame: At the time of recruitment until delivery
Able to rest and relax
Time frame: At the time of recruitment until delivery
Feeling of unsafe during cervical ripening
Time frame: At the time of recruitment until active phase of labour
Embarrassed by the method
Time frame: At the time of recruitment until active phase of labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Individual participant dataSharing planned: No
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Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley catheter cervical ripening in people with Caesarean Section; Infection, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section rate (time frame: From the time of recruitment until delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.