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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval
Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGPriming 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
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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