PregnancyPhase 4CRBIINCT02620215
Cervical Ripening Balloon in Induction of Labour at Term
A Phase 4 study testing Cervical Ripening Balloon and Prostin in people with Pregnancy, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Cervical Ripening Balloon and Prostin
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2015to 7 Dec 2017
- Phase
- Phase 4
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 21 - 40 years old
- Singleton pregnancy with no major fetal anomaly
- Planned induction of labour at 37+0 weeks to 41+6 weeks gestation
- Vaginal delivery is appropriate
- Patient able to give informed consent to participate in the trial
Who cannot join
- Spontaneous labour at start of planned induction
- Bishop score <6 and cervical dilatation >=3 cm at start of induction
- Confirmed rupture of membrane
- Abnormal CTG at start of induction
- Caesarean section delivery is indicated
- Scarred uterus such as previous caesarean section
Show all 9Show fewer
- Malpresentation in labour
- Latex allergy, severe asthma and glaucoma
- Patient withdraw consent to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Ripening Balloon in Induction of Labour at Term (CRBII) - A Prospective Randomized Controlled Trial
About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic reviews comparing mechanical method against pharmacological and surgical IOL showed that mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled trial concluded that both cervical ripening balloon and prostaglandin are effective and complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined the effects of pain.
The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test the acceptability of women in Singapore in using the CRB as an alternative method of induction of labour while using a non-incremental balloon filling regime. Currently, there is no efficient method of induction that can be used safely in an outpatient setting. Through this study, the investigators hope to show that there are no major adverse events in the 12h after patients are induced with CRB, this potentially supports outpatient IOL with CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will decrease time delays and may increase patient satisfaction during its use in induction of labour.
Read the detailed description
This is a prospective cohort randomised controlled trial conducted at the KK Women's and Children's Hospital (KKH) and University Malaya Medical Centre (UMMC).
NICE guidelines on induction of labour defined uterine hyperstimulation as contractions more than 5 in 10 mins for more then 20 mins or contractions lasting more than 2 mins in duration. A retrospective study involving prostaglandin induction of labour showed that hyperstimulation occurred in 5.8% of cases. The sample size is calculated based on a 4.8% reduction in hyperstimulation in all induction of labour by CRB. At a level of significance of 5%, 80% power, 200 patients in each arm is required. Preliminary study by Tan TL et al had a dropout rate of 4.6%. Hence the proposed sample size is 420.
The investigators plan to collaborate on a multi-centre trial with the University Malaya Medical Centre. In which, each centre will recruit 210 patients for the study.
Randomization of the participants is achieved with third party sealed envelope allocation. 210 envelopes containing CRB allocation and another 210 identical envelopes containing prostin allocation will be prepared by a third party. The 420 envelops will be shuffled according to a computer randomisation code after sealing and labelled with a randomization allocation number from 1 to 420. The 210 envelops will then be handed to the each centre's PI, and will be kept in the clinical store on labour ward together with the stock of CRB and prostin.
Unfortunately, it is not possible to blind the allocation to the investigator or the patient. The investigator however has no part in observing any adverse events, the CTGs should be interpreted by the attending clinician and vet by team to avoid missing abnormal CTG. The patient herself will have to report contractions and pain scores and satisfaction scores with validated standard pain and satisfaction assessment tools to minimise the potential bias. The allocation will also be omitted from the database so as to blind the analyst in order to prevent manipulation.
There will be no additional clinic visit or labour ward admission required by the study. The potential patient receiving subsidized obstetric care who require elective IOL at term will be will be identified by doctors and clinical research coordinator in the subsidized clinic or labour ward or obstetric subsidized wards, and screened accordingly with inclusion criteria and exclusion criteria.
Inclusion criteria: Pregnant women aged 21 - 40 years old, singleton pregnancy, no major fetal anomaly, planned induction of labour at 37+0 weeks to 41+6 weeks gestation, vaginal delivery is appropriate, patient able to give informed consent to participate in the trial
Exclusion criteria: Spontaneous labour at start of planned induction, Bishop score <6 and cervical dilatation >=3 cm at start of induction, confirmed rupture of membrane, abnormal CTG at start of induction, caesarean section delivery is indicated, scarred uterus such as previous caesarean section, malpresentation in labour, patient withdraw consent to participate in the trial. Latex allergy, severe asthma and glaucoma.
- Conditions
- Pregnancy
- Being tested
- Cervical Ripening Balloon, Prostin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Ripening BalloonDevice
Cook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80
ProstinDrug
Also called Prostin E2 vaginal tablets
Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Ripening Balloon | Experimental | Cook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80 Receives: Device: Cervical Ripening Balloon |
| Prostin | Active comparator | Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally. Receives: Drug: Prostin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events in the first 12 hours after Cook's Cervical Ripening Balloon insertion for induction of labour, in comparison to 1st prostin insertion
Measured: Up to 24 hours after induction of labour
Secondary outcomes (3)
Efficacy of Cook's Cervical Ripening Balloonas a devide for induction of labour, in comparison to prostin, in achieving vaginal deliveries
Measured: Up to 96 hours after delivery
Patient satisfaction of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point scale
Score 1 for poor and score 10 for excellent
Measured: From induction of labour to up to 4 days after delivery
Patients' experience of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point pain assessment scale
Score 1 for no pain, score 3 for pain similar insertion of IV access line, and score 8 for labour pain at time of request for epidural or labour if no epidural is used
Measured: From induction of labour to up to 4 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Responsible party
- Principal investigator, Tagore Shephali, KK Women's and Children's Hospital
- Investigators
- Shephali Tagore, MRCOG, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620215
- Sponsor's protocol ID
- 2015/2730
- Acronym
- CRBII
- Status last verified
- Aug 2018
- First submitted
- 9 Nov 2015
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264Grace Ng YH, Aminuddin AA, Tan TL, Kuppusamy R, Tagore S, Yeo GSH. Multicentre randomised controlled trial comparing the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter and prostaglandin pessary for induction of labour. Arch Gynecol Obstet. 2022 Jan;305(1):11-18. doi: 10.1007/s00404-021-06090-y. Epub 2021 May 11.
PubMed 33973051
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening Balloon in Induction of Labour at Term (CRBII) - A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02620215
- Acronym / sponsor ID
- CRBII / 2015/2730
- Conditions
- Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- University of Malaya
- Study start
- Nov 2015
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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.
About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic reviews comparing mechanical method against pharmacological and surgical IOL showed that mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled trial concluded that both cervical ripening balloon and prostaglandin are effective and complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined the effects of pain.
The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test the acceptability of women in Singapore in using the CRB as an alternative method of induction of labour while using a non-incremental balloon filling regime. Currently, there is no efficient method of induction that can be used safely in an outpatient setting. Through this study, the investigators hope to show that there are no major adverse events in the 12h after patients are induced with CRB, this potentially supports outpatient IOL with CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will decrease time delays and may increase patient satisfaction during its use in induction of labour.
Detailed description
This is a prospective cohort randomised controlled trial conducted at the KK Women's and Children's Hospital (KKH) and University Malaya Medical Centre (UMMC).
NICE guidelines on induction of labour defined uterine hyperstimulation as contractions more than 5 in 10 mins for more then 20 mins or contractions lasting more than 2 mins in duration. A retrospective study involving prostaglandin induction of labour showed that hyperstimulation occurred in 5.8% of cases. The sample size is calculated based on a 4.8% reduction in hyperstimulation in all induction of labour by CRB. At a level of significance of 5%, 80% power, 200 patients in each arm is required. Preliminary study by Tan TL et al had a dropout rate of 4.6%. Hence the proposed sample size is 420.
The investigators plan to collaborate on a multi-centre trial with the University Malaya Medical Centre. In which, each centre will recruit 210 patients for the study.
Randomization of the participants is achieved with third party sealed envelope allocation. 210 envelopes containing CRB allocation and another 210 identical envelopes containing prostin allocation will be prepared by a third party. The 420 envelops will be shuffled according to a computer randomisation code after sealing and labelled with a randomization allocation number from 1 to 420. The 210 envelops will then be handed to the each centre's PI, and will be kept in the clinical store on labour ward together with the stock of CRB and prostin.
Unfortunately, it is not possible to blind the allocation to the investigator or the patient. The investigator however has no part in observing any adverse events, the CTGs should be interpreted by the attending clinician and vet by team to avoid missing abnormal CTG. The patient herself will have to report contractions and pain scores and satisfaction scores with validated standard pain and satisfaction assessment tools to minimise the potential bias. The allocation will also be omitted from the database so as to blind the analyst in order to prevent manipulation.
There will be no additional clinic visit or labour ward admission required by the study. The potential patient receiving subsidized obstetric care who require elective IOL at term will be will be identified by doctors and clinical research coordinator in the subsidized clinic or labour ward or obstetric subsidized wards, and screened accordingly with inclusion criteria and exclusion criteria.
Inclusion criteria: Pregnant women aged 21 - 40 years old, singleton pregnancy, no major fetal anomaly, planned induction of labour at 37+0 weeks to 41+6 weeks gestation, vaginal delivery is appropriate, patient able to give informed consent to participate in the trial
Exclusion criteria: Spontaneous labour at start of planned induction, Bishop score <6 and cervical dilatation >=3 cm at start of induction, confirmed rupture of membrane, abnormal CTG at start of induction, caesarean section delivery is indicated, scarred uterus such as previous caesarean section, malpresentation in labour, patient withdraw consent to participate in the trial. Latex allergy, severe asthma and glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Ripening Balloon | Experimental | Device: Cervical Ripening BalloonCook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80 |
| Prostin | Active comparator | Drug: ProstinProstin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women aged 21 - 40 years old
- Singleton pregnancy with no major fetal anomaly
- Planned induction of labour at 37+0 weeks to 41+6 weeks gestation
- Vaginal delivery is appropriate
- Patient able to give informed consent to participate in the trial
Key exclusion criteria (9 listed)
- Spontaneous labour at start of planned induction
- Bishop score <6 and cervical dilatation >=3 cm at start of induction
- Confirmed rupture of membrane
- Abnormal CTG at start of induction
- Caesarean section delivery is indicated
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 |
|---|---|---|
| Cervical Ripening BalloonCook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80 | Device | Cervical Ripening Balloon |
| ProstinAlso: Prostin E2 vaginal tabletsProstin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally. | Drug | Prostin |
Primary outcome
Adverse events in the first 12 hours after Cook's Cervical Ripening Balloon insertion for induction of labour, in comparison to 1st prostin insertion
Time frame: Up to 24 hours after induction of labour
3 secondary outcomes
Efficacy of Cook's Cervical Ripening Balloonas a devide for induction of labour, in comparison to prostin, in achieving vaginal deliveries
Time frame: Up to 96 hours after delivery
Patient satisfaction of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point scale
Time frame: From induction of labour to up to 4 days after delivery
Patients' experience of the Cook's Cervical Ripening Balloon as a devide for induction of labour, in comparison to prostin, by using a 10-point pain assessment scale
Time frame: From induction of labour to up to 4 days after delivery
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 16 Aug 2018.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Derived from this study: PubMed 33973051Grace Ng YH, Aminuddin AA, Tan TL, Kuppusamy R, Tagore S, Yeo GSH. Multicentre randomised controlled trial comparing the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter and prostaglandin pessary for induction of labour. Arch Gynecol Obstet. 2022 Jan;305(1):11-18. doi: 10.1007/s00404-021-06090-y. Epub 2021 May 11.
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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.
Shephali Tagore, MRCOG principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cervical Ripening Balloon and Prostin in people with Pregnancy, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 5 inclusion and 9 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 16 Aug 2018. 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 Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse events in the first 12 hours after Cook's Cervical Ripening Balloon insertion for induction of labour, in comparison to 1st prostin insertion (time frame: Up to 24 hours after induction of labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02620215, which also lists 2 linked publications.
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 16 Aug 2018.