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

Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Delivery Problem
• Intervention / Treatment: Combination product: Cook double-balloon catheter

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yin Fong Leung, MBBS; Phone Number: 852 22554517; Email: lyf971@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Yin Fong Leung, MBBS; Phone Number: (852)-2255-4517; Email: yin_fong18@yahoo.com.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cook double-balloon catheter; 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.	Combination product: Cook double-balloon catheter; To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval
Placebo Comparator: Propess; 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.	Combination product: Cook double-balloon catheter; To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Priming to delivery interval	Time for priming (device placement) to delivery interval	1 year

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Yin Fong Leung, MBBS, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: May 26, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dystocia
• Other Study ID Numbers: UW 24-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes