Delivery ProblemPhase 4NCT06438081
Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming
A Phase 4 study testing Cook double-balloon catheter in people with Delivery Problem, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Delivery Problem
- What is being tested?
- Cook double-balloon catheter
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2024to 1 Dec 2025
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Viable singleton pregnancy
- Cephalic presentation
- Bishop score <7
- At term (>=37+0 weeks of gestation)
- Nulliparous women
Who cannot join
- Gestation <37weeks
- Multiple pregnancy
- Bishop score <7
- Malpresentation
- Contraindication to vaginal delivery
- Previous Caesarean section
Show all 14Show fewer
- History of myomectomy
- Maternal fever
- Suspected infection
- Abnormal fetal heart-rate patterns
- Rupture of membranes
- Intrauterine growth restriction
- Not fit for giving consent
- Allergic to Propess or PGE2
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Yin Fong Leung, MBBS, (852)-2255-4517, yin_fong18@yahoo.com.hk
About this study
Official title: Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial
The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.
Read the detailed description
Previous studies focused on use of PGE2 instead of Propess, which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. Compared with PGE2, Propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking. The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.
- Conditions
- Delivery Problem
- Being tested
- Cook double-balloon catheter
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook double-balloon catheterCombination product
To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval
| Study group | Role | What they receive |
|---|---|---|
| Cook double-balloon catheter | Active comparator | Participant is placed in lithotomy position, then to clean vulval and vaginal area, followed by inserting vaginal speculum. Cook double-balloon catheter will be inserted under standard technique. Doctor or midwife guide the cervical ripening balloon with stylet to pass through the cervix. Uterine balloon should be place above level of internal os, then to remove the stylet before further advancing the catheter. Cook double-balloon catheter is further advancing through the cervix until both balloons entered cervical canal. Uterine and vaginal balloons are both inflated with up to 80ml normal saline according to manufacturer recommendation. Maximal duration of balloon placement will be 12 hours. If cervix remains unfavorable after Cook double-catheter balloons, she will be given another Cook double-catheter balloons priming the next day. If cervix remains unfavourable after two balloon priming, elective Caesarean section will be advised. Receives: Combination Product: Cook double-balloon catheter |
| Propess | Placebo comparator | Participant will be firstly confirmed reactive tracing and without regular contraction by non-stress test for 20mins. Propess will be checked its integrity and applied with lubricating jelly before insertion. Propess is inserted to the posterior vaginal fornix. Woman should inform medical staff if they have leaking sensation. After insertion, woman will be advised to lie down and perform non-stress test for 2 hours. Propess will be removed after 24 hours post insertion. Cervical assessment is performed the next day after removal of Propess. Patient with favourable cervix, i.e. Bishop score >= 7, will start artificial rupture of membrane and syntocinon infusion. Patient with unfavorable cervix, i.e. Bishop score <7 is arranged another day of priming by PGE2. If the cervix remains unfavorable after 2 days of pharmacological priming, women will be given a rest day or continued priming by Cook double-balloon catheter. Receives: Combination Product: Cook double-balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Priming to delivery interval
Time for priming (device placement) to delivery interval
Measured: 1 year
Secondary outcomes (13)
Vaginal delivery within 24 hours after priming
delivery within 24 hours
Measured: 1 year
Caesarean section rate
need of resort to Caesarean section and the corresponding indication
Measured: 1 year
Vaginal delivery rate
included instrumental delivery, e.g. vacuum extraction, forcep delivery
Measured: 1 year
Priming to induction interval
Time from priming to induction
Measured: 1 year
Need of induction with oxytocin
Chance of going into spontaneous labor after priming
Measured: 1 year
Amount of oxytocin use
calculate the amount of oxytocin use
Measured: 1 year
Malpresentation after priming
to confirm if cephalic presentation before start of induction
Measured: 1 year
Failed induction rate
defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin
Measured: 1 year
Uterine hyperstimulation
defined by a single contraction lasting for more than 2 minutes or more than 5 contractions in 10 minutes for 30 minutes
Measured: 1 year
Suspected intrauterine infection rate
infection rate that require antibiotics treatment
Measured: 1 year
Primary postpartum haemorrhage
Blood loss >500ml within 24 hours of delivery
Measured: 1 year
Length of hospital stay
calculate length of hospital stay after delivery
Measured: 1 year
Maternal satisfaction with the procedure
on a visual analogue scale to rate maternal satisfaction of from 1 to 5, 5 is better, 1 is worse
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ProblemStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Model description
- The investigators did a pilot study to compare 5 patients using Cook double-catheter balloon priming and 5 patients using Propess. The investigators found the mean priming to delivery interval was 1971.6 minutes in Propess group and 1212.0 minutes in Cook double-catheter balloon group. The investigators assumed ratio of sample size in Propess and Cook double-catheter balloon was 1:1. In order to achieve 35% reduction of priming to delivery interval, a sample size of 28 is required for Type I error of 0.05, and Type II error of 0.2.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin Fong Leung, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438081
- Sponsor's protocol ID
- UW 24-172
- Status last verified
- May 2024
- First submitted
- 26 May 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06438081
- Acronym / sponsor ID
- UW 24-172
- Conditions
- Delivery Problem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 May 2024 (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.
The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.
Detailed description
Previous studies focused on use of PGE2 instead of Propess, which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. Compared with PGE2, Propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking. The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators did a pilot study to compare 5 patients using Cook double-catheter balloon priming and 5 patients using Propess. The investigators found the mean priming to delivery interval was 1971.6 minutes in Propess group and 1212.0 minutes in Cook double-catheter balloon group. The investigators assumed ratio of sample size in Propess and Cook double-catheter balloon was 1:1. In order to achieve 35% reduction of priming to delivery interval, a sample size of 28 is required for Type I error of 0.05, and Type II error of 0.2.
| Arm | Type | Receives |
|---|---|---|
| Cook double-balloon catheter | Active comparator | Combination Product: Cook double-balloon catheterParticipant is placed in lithotomy position, then to clean vulval and vaginal area, followed by inserting vaginal speculum. Cook double-balloon catheter will be inserted under standard technique. Doctor or midwife guide the cervical ripening balloon with stylet to pass through the cervix. Uterine balloon should be place above level of internal os, then to remove the stylet before further advancing the catheter. Cook double-balloon catheter is further advancing through the cervix until both balloons entered cervical canal. Uterine and vaginal balloons are both inflated with up to 80ml normal saline according to manufacturer recommendation. Maximal duration of balloon placement will be 12 hours. If cervix remains unfavorable after Cook double-catheter balloons, she will be given another Cook double-catheter balloons priming the next day. If cervix remains unfavourable after two balloon priming, elective Caesarean section will be advised. |
| Propess | Placebo comparator | Combination Product: Cook double-balloon catheterParticipant will be firstly confirmed reactive tracing and without regular contraction by non-stress test for 20mins. Propess will be checked its integrity and applied with lubricating jelly before insertion. Propess is inserted to the posterior vaginal fornix. Woman should inform medical staff if they have leaking sensation. After insertion, woman will be advised to lie down and perform non-stress test for 2 hours. Propess will be removed after 24 hours post insertion. Cervical assessment is performed the next day after removal of Propess. Patient with favourable cervix, i.e. Bishop score >= 7, will start artificial rupture of membrane and syntocinon infusion. Patient with unfavorable cervix, i.e. Bishop score <7 is arranged another day of priming by PGE2. If the cervix remains unfavorable after 2 days of pharmacological priming, women will be given a rest day or continued priming by Cook double-balloon catheter. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Viable singleton pregnancy
- Cephalic presentation
- Bishop score <7
- At term (>=37+0 weeks of gestation)
- Nulliparous women
Key exclusion criteria (14 listed)
- Gestation <37weeks
- Multiple pregnancy
- Bishop score <7
- Malpresentation
- Contraindication to vaginal delivery
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 |
|---|---|---|
| Cook double-balloon catheterTo compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval | Combination product | Cook double-balloon catheter, Propess |
Primary outcome
Priming to delivery interval
Time frame: 1 year
Time for priming (device placement) to delivery interval
13 secondary outcomes
Vaginal delivery within 24 hours after priming
Time frame: 1 year
Caesarean section rate
Time frame: 1 year
Vaginal delivery rate
Time frame: 1 year
Priming to induction interval
Time frame: 1 year
Need of induction with oxytocin
Time frame: 1 year
Amount of oxytocin use
Time frame: 1 year
Malpresentation after priming
Time frame: 1 year
Failed induction rate
Time frame: 1 year
Uterine hyperstimulation
Time frame: 1 year
Suspected intrauterine infection rate
Time frame: 1 year
Primary postpartum haemorrhage
Time frame: 1 year
Length of hospital stay
Time frame: 1 year
Maternal satisfaction with the procedure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Yin Fong Leung, MBBS principal investigator
The University of Hong Kong
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 Cook double-balloon catheter in people with Delivery Problem, run by The University of Hong Kong at 1 site in Hong Kong.
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 14 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: status not confirmed, as of the sponsor's last update on 24 Jul 2024. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin Fong Leung, MBBS (852 22554517, lyf971@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Priming to delivery interval (time frame: 1 year). 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 24 Jul 2024.