Delivery Problem
Conditions
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.
Interventions
COMBINATION_PRODUCTCook double-balloon catheter
To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Viable singleton pregnancy * Cephalic presentation * Bishop score \<7 * At term (\>=37+0 weeks of gestation) * Nulliparous women
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Priming to delivery interval | 1 year | Time for priming (device placement) to delivery interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 1 year | calculate length of hospital stay after delivery |
| Vaginal delivery within 24 hours after priming | 1 year | delivery within 24 hours |
| Caesarean section rate | 1 year | need of resort to Caesarean section and the corresponding indication |
| Vaginal delivery rate | 1 year | included instrumental delivery, e.g. vacuum extraction, forcep delivery |
| Priming to induction interval | 1 year | Time from priming to induction |
| Need of induction with oxytocin | 1 year | Chance of going into spontaneous labor after priming |
| Primary postpartum haemorrhage | 1 year | Blood loss \>500ml within 24 hours of delivery |
| Malpresentation after priming | 1 year | to confirm if cephalic presentation before start of induction |
| Failed induction rate | 1 year | defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin |
| 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 |
| 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 |
| Amount of oxytocin use | 1 year | calculate the amount of oxytocin use |
Countries
Hong Kong
Contacts
Primary ContactYin Fong Leung, MBBS
Outcome results
None listed