A Phase 4 interventional study of Cook double-balloon catheter in Delivery Problem, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by The University of Hong Kong · Phase 4, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 28 is below the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Combination Product: Cook double-balloon catheter
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.
Combination Product: Cook double-balloon catheter
To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval
Priming to delivery interval
Time for priming (device placement) to delivery interval
Time frame: 1 year
Vaginal delivery within 24 hours after priming
delivery within 24 hours
Time frame: 1 year
Caesarean section rate
need of resort to Caesarean section and the corresponding indication
Time frame: 1 year
Vaginal delivery rate
included instrumental delivery, e.g. vacuum extraction, forcep delivery
Time frame: 1 year
Priming to induction interval
Time from priming to induction
Time frame: 1 year
Need of induction with oxytocin
Chance of going into spontaneous labor after priming
Time frame: 1 year
Amount of oxytocin use
calculate the amount of oxytocin use
Time frame: 1 year
Malpresentation after priming
to confirm if cephalic presentation before start of induction
Time frame: 1 year
Failed induction rate
defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin
Time frame: 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
Time frame: 1 year
Suspected intrauterine infection rate
infection rate that require antibiotics treatment
Time frame: 1 year
Primary postpartum haemorrhage
Blood loss \>500ml within 24 hours of delivery
Time frame: 1 year
Length of hospital stay
calculate length of hospital stay after delivery
Time frame: 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
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2025, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.