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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook double-balloon catheter | Combination Product | To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval |
| Measure | Description | Time Frame |
|---|---|---|
| Priming to delivery interval | Time for priming (device placement) to delivery interval | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal delivery within 24 hours after priming | delivery within 24 hours | 1 year |
| Caesarean section rate | need of resort to Caesarean section and the corresponding indication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Fong Leung, MBBS | Contact | 852 22554517 | lyf971@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Yin Fong Leung, MBBS | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| 1 year |
| Vaginal delivery rate | included instrumental delivery, e.g. vacuum extraction, forcep delivery | 1 year |
| Priming to induction interval | Time from priming to induction | 1 year |
| Need of induction with oxytocin | Chance of going into spontaneous labor after priming | 1 year |
| Amount of oxytocin use | calculate the amount of oxytocin use | 1 year |
| Malpresentation after priming | to confirm if cephalic presentation before start of induction | 1 year |
| Failed induction rate | defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin | 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 | 1 year |
| Suspected intrauterine infection rate | infection rate that require antibiotics treatment | 1 year |
| Primary postpartum haemorrhage | Blood loss >500ml within 24 hours of delivery | 1 year |
| Length of hospital stay | calculate length of hospital stay after delivery | 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 | 1 year |