Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming
- Conditions
- Delivery Problem
- Interventions
- Combination Product: Cook double-balloon catheter
- Registration Number
- NCT06438081
- Lead Sponsor
- The University of Hong Kong
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 28
- Viable singleton pregnancy
- Cephalic presentation
- Bishop score <7
- At term (>=37+0 weeks of gestation)
- Nulliparous women
- Gestation <37weeks
- Multiple pregnancy
- Bishop score <7
- Malpresentation
- Contraindication to vaginal delivery
- Previous Caesarean section
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cook double-balloon catheter Cook double-balloon catheter 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. Propess 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.
- Primary Outcome Measures
Name Time Method Priming to delivery interval 1 year Time for priming (device placement) to delivery interval
- Secondary Outcome Measures
Name Time Method Uterine hyperstimulation 1 year defined by a single contraction lasting for more than 2 minutes or more than 5 contractions in 10 minutes for 30 minutes
Suspected intrauterine infection rate 1 year infection rate that require antibiotics treatment
Caesarean section rate 1 year need of resort to Caesarean section and the corresponding indication
Need of induction with oxytocin 1 year Chance of going into spontaneous labor after priming
Vaginal delivery within 24 hours after priming 1 year delivery within 24 hours
Priming to induction interval 1 year Time from priming to induction
Failed induction rate 1 year defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin
Length of hospital stay 1 year calculate length of hospital stay after delivery
Vaginal delivery rate 1 year included instrumental delivery, e.g. vacuum extraction, forcep delivery
Amount of oxytocin use 1 year calculate the amount of oxytocin use
Malpresentation after priming 1 year to confirm if cephalic presentation before start of induction
Primary postpartum haemorrhage 1 year Blood loss \>500ml within 24 hours of delivery
Maternal satisfaction with the procedure 1 year on a visual analogue scale to rate maternal satisfaction of from 1 to 5, 5 is better, 1 is worse
Trial Locations
- Locations (1)
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong