Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming

The University of Hong Kong (HKU)

Status and phase: Enrolling; Phase 4

Conditions: Delivery Problem

Treatments: Combination Product: Cook double-balloon catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT06438081

UW 24-172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

Cook double-balloon catheter

Active Comparator group

Description:

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.

Treatment:

Combination Product: Cook double-balloon catheter

Propess

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: Cook double-balloon catheter