Clinical trial NCT06438081: Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming
Official title: Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Delivery Problem
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Priming to delivery interval
timeFrame: 1 year
Secondary outcomes:
measure: Vaginal delivery within 24 hours after priming
timeFrame: 1 year
measure: Caesarean section rate
timeFrame: 1 year
measure: Vaginal delivery rate
timeFrame: 1 year
measure: Priming to induction interval
timeFrame: 1 year
measure: Need of induction with oxytocin
timeFrame: 1 year
measure: Amount of oxytocin use
timeFrame: 1 year
measure: Malpresentation after priming
timeFrame: 1 year
measure: Failed induction rate
timeFrame: 1 year
measure: Uterine hyperstimulation
timeFrame: 1 year
measure: Suspected intrauterine infection rate
timeFrame: 1 year
measure: Primary postpartum haemorrhage
timeFrame: 1 year
measure: Length of hospital stay
timeFrame: 1 year
measure: Maternal satisfaction with the procedure
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Yin Fong Leung, MBBS
role: PRINCIPAL_INVESTIGATOR
References: